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  • Medicine

    Addressing Unmet Needs with LP-284 for Relapsed/Refractory Lymphomas and Solid Tumors

    May 12, 2024 - By admin

    In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, discusses how LP-284 uniquely addresses unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors.

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  • Medicine

    Biotech’s Road to Recovery Takes a Wobbly Turn

    May 11, 2024 - By admin

    Now-unclear timing on rate cuts puts onus back on fundamentals.

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  • Medicine

    Avoiding the Digital Age is Hurting Research Efforts

    May 11, 2024 - By admin

    A greater shift from paper records and physical assets is achievable.

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  • Medicine

    Yvonne Greenstreet: Answering the Call

    May 10, 2024 - By admin

    From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients.

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  • Medicine

    Flagship Pioneering, Metaphore Biotechnologies Strike Deal with Novo Nordisk to Develop High-End Obesity Treatments

    May 10, 2024 - By admin

    The collaboration is a part of a broader strategy to combat cardiometabolic and rare diseases.

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  • Medicine

    Verona Pharma Receives $650M Investment from Oaktree Capital Management and OMERS Life Sciences

    May 9, 2024 - By admin

    Strategic financing from Oaktree Capital Management and OMERS Life Sciences is expected to support the US launch of ensifentrine, Verona’s promising chronic obstructive pulmonary disease treatment.

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  • Medicine

    Assessing LP-284 with RADR for NHL and Other Targeted Cancers

    May 9, 2024 - By admin

    In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, explains which specific endpoints they’ll be looking at in the Phase I trial to assess LP-284’s potential efficacy and how the insights gained will be fed back into RADR®

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  • Medicine

    Planning for Unique Challenges Faced by Cell & Gene Therapy Developers

    May 8, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi,

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  • Medicine

    AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis

    May 8, 2024 - By admin

    Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs.

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  • Medicine

    Pharma Pulse 5/7/24: Challenges With Feasibility Studies, AI Has ‘Enormous Potential for Harm’ & more

    May 7, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

    May 7, 2024 - By admin

    Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

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  • Medicine

    NJ Doctor Becomes First In State to Use PathKeeper Surgical Navigation System on Patient

    May 6, 2024 - By admin

    Dr. Lewis used the AI-powered device on a patient with severe lumbar stenosis.

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  • Medicine

    Poseida Therapeutics Enters into Partnership with Astellas Subsidiary Xyphos

    May 6, 2024 - By admin

    The two companies will work together to develop gene therapies in oncology.

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  • Medicine

    FDA Grants Fast Track Designation to Amolyt Pharma’s Eneboparatide to Treat Hypoparathyroidism

    May 5, 2024 - By admin

    Currently in Phase III of clinical trials, eneboparatide has shown promise in normalizing key calcium levels and improving bone health in patients with hypoparathyroidism.

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  • Medicine

    Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

    May 5, 2024 - By admin

    Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers.

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  • Medicine

    Pricing Climate Impacting Commercial Considerations

    May 4, 2024 - By admin

    In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, talks about the influence of Medicare Part D drug price negotiations on manufacturer go-to-market strategies and decision-making, and the industry’s response to the wider dialogue on pricing transparency.

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  • Medicine

    Cencora VP of Emerging Therapies Discusses Cell & Gene Therapy Distribution Strategies

    May 4, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, offers a synopsis on what questions cell and gene therapy developers need to answer to inform their distribution strategy.

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  • Medicine

    Pharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more

    May 3, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity

    May 3, 2024 - By admin

    Partnership expected to utilize Walgreens’ pharmacies as recruitment and trial sites for a clinical study regarding obesity, weight issues, and type 2 diabetes, mainly in historically underrepresented groups.

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  • Medicine

    How Diverse Skills Can Drive Success in Biotech

    May 2, 2024 - By admin

    In this Pharmaceutical Executive video interview, Chris Martin, Chief Commercial Officer, Verona Pharma, discusses which skills or experiences he thinks are most valuable for team members tasked with launching a novel treatment in a competitive market.

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  • Medicine

    FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases

    May 2, 2024 - By admin

    New formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.

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  • Medicine

    Why Early Communication is Crucial for a Successful Drug Launch

    May 1, 2024 - By admin

    In this Pharmaceutical Executive video interview, Chris Martin, Chief Commercial Officer, Verona Pharma, discusses specific advantages for a small biotech company in crafting a unique commercialization strategy and the importance of starting early and getting aligned.

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  • Medicine

    FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee

    May 1, 2024 - By admin

    Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

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  • Medicine

    A Decade in the Anti-Obesity Arena

    April 30, 2024 - By admin

    Currax Pharmaceuticals CEO, George Hampton discusses what patient success has looked like for their oral anti-obesity medication, how expanded access can help with the world’s obesity epidemic, when prices should come down, and much more.

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  • Medicine

    FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years

    April 30, 2024 - By admin

    Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.

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  • Medicine

    Exploring Luma & Luma Lab Connect

    April 29, 2024 - By admin

    In this Pharmaceutical Executive video interview, Kalim Saliba, Chief Product Officer, Dotmatics discusses their Luma platform, Luma Lab Connect, and what this technology could mean for industry.

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  • Medicine

    Solving the First Mile Problem: Q&A with Mark Melton

    April 29, 2024 - By admin

    Melton, customer advocacy executive at Magnolia, discusses how new technologies can be used to ensure data is accurate.

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  • Medicine

    Going Beyond Visuals to Connect with Diverse Audiences

    April 28, 2024 - By admin

    In this Pharmaceutical Executive video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One, discusses what other tactics healthcare marketers can utilize to connect with diverse audiences on a deeper level

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  • Medicine

    FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B

    April 28, 2024 - By admin

    Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.

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  • Medicine

    FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV

    April 27, 2024 - By admin

    Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

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  • Medicine

    Coya Therapeutics CEO Discusses Company's Treatment Pipeline

    April 27, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization’s pipeline.

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  • Medicine

    CVS Health Announces New Work Force Development and Community Center in Louisiana

    April 26, 2024 - By admin

    The center will offer local residents with opportunities and training to enter the pharmacy work force.

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  • Medicine

    Novartis, Medicines for Malaria Venture Release Positive Results from Phase II/III Trial of Coartem for Infants with Malaria

    April 26, 2024 - By admin

    Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

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  • Medicine

    Howard Berman Discusses Potential Indications for Coya 302

    April 25, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics, provides a look into the potential of further indications for Coya 302 amid promising ALS study.

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  • Medicine

    Coya Therapeutics CEO Discusses Next Steps Amid Positive Results from Coya 302 Trial for ALS Treatment

    April 25, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a preview on what the nexts steps are after presenting positive data on Coya 302 for the treatment of ALS.

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  • Medicine

    Pharma Pulse 4/24/24: 5 Things You Should Know About Women's Health, Microsoft Makes Push Into Smaller AI Systems & more

    April 24, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves Novartis' Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors

    April 24, 2024 - By admin

    Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

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  • Medicine

    Upcoming US Pharma and Biotech Summit Spotlights Innovation, Challenges in Healthcare

    April 23, 2024 - By admin

    Leaders in areas such as drug discovery, clinical development and market access will meet to discuss AI, failing life expectancy, and a new generation of talent.

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  • Medicine

    Current State of the Pharma Sales and Marketing Sales Force

    April 23, 2024 - By admin

    Industry executives dive into trends like utilizing AI and influencers for content creation, personalizing messages to the patient, combatting the spread of misinformation and much more in the video version of our executive roundtable discussion

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  • Medicine

    Using AI to Create New Parkinson’s Treatments: Q&A with Mattias Alder

    April 22, 2024 - By admin

    Alder, CEO of Gain Therapeutics, discusses how the Magellan platform was used in the creation of GT-02287.

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  • Medicine

    Lene Oddershede Discusses Upcoming Projects from the Novo Nordisk Foundation

    April 22, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Lene Oddershede, SVP, Natural & Technical Sciences, Novo Nordisk Foundation offers a synopsis of upcoming projects from the Novo Nordisk Foundation.

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  • Medicine

    FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC

    April 21, 2024 - By admin

    Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.

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  • Medicine

    FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease

    April 21, 2024 - By admin

    Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

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  • Medicine

    Essential Pharma Acquires Reminyl, a Cholinesterase Inhibitor to Treat Mild to Moderately Severe Dementia from Janssen Pharmaceutica NV

    April 20, 2024 - By admin

    Acquisition includes rights to marketing in the European Economic Area, Thailand, South Korea, and other regions for oral treatment of mild to moderately severe dementia associated with Alzheimer disease.

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  • Medicine

    Texas Biomed Developing Potential Bird Flu Vaccine

    April 20, 2024 - By admin

    While human infections of the virus are rare, a strain recently appeared in dairy cows before infecting a human in Texas.

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  • Medicine

    Will Synthetic, AI-Based Digital Humans Change Pharma and Life Sciences? Q&A with Abid Rahman, SVP Innovation, EVERSANA

    April 19, 2024 - By admin

    Rahman discusses the new opportunities that digital twins present to researchers.

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  • Medicine

    Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis

    April 19, 2024 - By admin

    According to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks 12 to 52.

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  • Medicine

    Pharma Pulse 4/18/24: Is it Fair Certain Biotech Investors Get an Early Look? The Health and Healthcare of Millennials & more

    April 18, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Pharmaceutical Executive: April 2024 Issue (PDF)

    April 18, 2024 - By admin

    Click the title above for a link to open the Pharmaceutical Executive April 2024 issue in an interactive PDF format.

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  • Medicine

    Pharma Pulse 4/17/24: AI has a Measurement Problem, How Advancements in Technology Are Transforming the Field & more

    April 17, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    The IRA Impact: Navigating Its Evolving Complexities

    April 17, 2024 - By admin

    Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their strategic planning process—and do it now.

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  • Medicine

    Pharma Pulse 4/16/24: Mitigating Drug Shortages, PBM Legislation in Washington & more

    April 16, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Fighting for Innovation

    April 16, 2024 - By admin

    Damien Bailly, president of established markets at Astellas, discusses why partnerships and collaborations are a critical organizational—and wider ecosystem—imperative in ensuring that patients have access to the medicines they need.

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  • Medicine

    Rare Disease Summit Recap

    April 15, 2024 - By admin

    Greater Than One’s Chief Strategy Officer, Andrew Bast, shares his takeaways from 2024 Rare Disease Summit in Philadelphia, PA.

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  • Medicine

    Supply Shortages in Weight Loss Drugs

    April 15, 2024 - By admin

    In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses factors that are contributing to ongoing supply issues and if prices for these therapies are coming down anytime soon.

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  • Medicine

    Trends in Continuing Medical Education

    April 14, 2024 - By admin

    Elliott Yoo, Senior Media Strategist at epocrates, takes a closer look at the trends in CME consumption and what the future of medical education will be – from the priorities for physicians as they juggle learning with patient care, to what type of activities resonate most with prescribers.

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  • Medicine

    The Rapid Growth of Remote Patient Monitoring Solutions Can Accelerate Decentralized Clinical Trials

    April 14, 2024 - By admin

    Pharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.

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  • Medicine

    Aspiring for the C-Suite? Consider Being a Chief of Staff

    April 13, 2024 - By admin

    Why this role provides a critical ‘boot camp’ for future pharma leaders.

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  • Medicine

    Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer

    April 13, 2024 - By admin

    Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.

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  • Medicine

    Vera Whole Health Announces Launch of Value-Based Primary Care Center in Atlanta

    April 12, 2024 - By admin

    This facility is the first of four facilities to be built in the area.

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  • Medicine

    FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures

    April 12, 2024 - By admin

    New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube.

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  • Medicine

    Embedded and agile–The next phase of the DCT evolution

    April 11, 2024 - By admin

    Ellenor discusses key points from the recent SCOPE presentation.

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  • Medicine

    Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

    April 11, 2024 - By admin

    Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts.

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  • Medicine

    Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

    April 10, 2024 - By admin

    The vaccine is already approved for older adults.

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  • Medicine

    Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

    April 10, 2024 - By admin

    Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.

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  • Medicine

    Labcorp Announces Expansions to Oncology Portfolio

    April 9, 2024 - By admin

    These expansions include a new product, along with improvements to existing products.

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  • Medicine

    FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV

    April 9, 2024 - By admin

    Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.

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  • Medicine

    Pharma Pulse 4/8/24: Rite Aid Announces Availability of Opill, List Prices for Pharmaceuticals in the US Compared to Other Countries & more

    April 8, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Pharma Pulse 4/5/24: Patient with Pig Kidney Goes Home, Combining AI and Market Access & more

    April 8, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

    April 7, 2024 - By admin

    Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy.

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  • Medicine

    A Decade of Data Under the Belt

    April 7, 2024 - By admin

    In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space.

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  • Medicine

    Amylyx Begins Process of Discontinuing Relyvrio/Albrioza for Treatment of ALS

    April 6, 2024 - By admin

    Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

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  • Medicine

    Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division

    April 6, 2024 - By admin

    The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets.

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  • Medicine

    QuantalX Joins FDA’s Total Life Cycle Advisory Program

    April 5, 2024 - By admin

    FDA’s program will provide guidance to the development of the company’s Delphi-MD technology.

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  • Medicine

    Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia

    April 5, 2024 - By admin

    Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.

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  • Medicine

    CVS Health Announces New Offerings for Pharmacy Students

    April 4, 2024 - By admin

    The two programs will be offered to students and CVS interns.

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  • Medicine

    FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder

    April 4, 2024 - By admin

    Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

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  • Medicine

    Non-Gene Edited Therapeutics: Q&A with Jeffrey Erickson, Vice President of Business Development at Triumvira

    April 3, 2024 - By admin

    Erickson discusses his work developing unique, targeted autologous and allogeneic T cell therapeutics.

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  • Medicine

    FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside

    April 3, 2024 - By admin

    The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

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  • Medicine

    Pharma Pulse 4/2/24: Bird Flu in Texas, Anxiety/Depression Treatment Linked with Heart Disease Outcomes & more

    April 2, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Mishe Announces Omnichannel Pharmacy Network

    April 2, 2024 - By admin

    The network will work with DiRx and MakoRX.

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  • Medicine

    Bristol Myers Squibb’s Phase III Clinical Trial for Zeposia Fails to Meet Primary Endpoint of Clinical Remission in Crohn Disease

    April 1, 2024 - By admin

    Company says it remains committed to advancing research for immune-mediated diseases and intends to share trial data at a later date.

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  • Medicine

    Fierce Females in the Life Science Space

    April 1, 2024 - By admin

    In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with female KOLs that she’s been fortunate enough to speak with over this past month for content across a few of our brands.

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  • Medicine

    Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

    March 31, 2024 - By admin

    Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.

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  • Medicine

    FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

    March 31, 2024 - By admin

    Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.

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  • Medicine

    Researchers Present First Study Using Biomimetic AI Digital Twins

    March 30, 2024 - By admin

    The study used technology developed by a variety of companies, including RYLTI.

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  • Medicine

    Pfizer Makes Publicis New Global Creative Duties Partner

    March 30, 2024 - By admin

    The news comes less than a year after Pfizer announced that IPG would handle this role.

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  • Medicine

    Pharma Pulse 3/29/24: Super Micro’s AI Boom Carries a Big Price Tag, Leveraging Digital Tools to Optimize Manufacturing & more

    March 29, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Grants 501(k) to Two Avicenna.AI Products

    March 29, 2024 - By admin

    Both products are designed to help radiologists.

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  • Medicine

    Pharma Pulse 3/28/24: The Fight for AI Talent, Atopic Dermatitis and Mental Health & more

    March 28, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors

    March 28, 2024 - By admin

    Action marks the first FDA-approved blood screening test for malaria.

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  • Medicine

    Pharma Pulse 3/27/24: Patients Hate ‘Forever’ Drugs—Is Wegovy Different? Low Melatonin Can Increase Risk of Neurological Disorders & more

    March 27, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    Viking Therapeutics Reveals Positive Results from Oral Obesity Drug

    March 27, 2024 - By admin

    Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.

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  • Medicine

    UCB's Women of Childbearing Age Program

    March 26, 2024 - By admin

    In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the program’s creation and their most successful strategies for encouraging the inclusion of women of childbearing age in clinical trials.

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  • Medicine

    FDA Approves AstraZeneca’s Ultomiris for Neuromyelitis Optica Spectrum Disorder

    March 26, 2024 - By admin

    Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

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  • Medicine

    CDC Releases Health Alert and Pushes for Increase in Measles Vaccinations

    March 25, 2024 - By admin

    The agency released guidelines for vaccinations guidelines for children as young as 6 months old.

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  • Medicine

    Pharma Pulse 3/22/24: Surgeons Transplant Pig Kidney into a Patient, Effective Ways to Engage Patients, Caregivers, and Advocacy Groups & more

    March 25, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy

    March 24, 2024 - By admin

    Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

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  • Medicine

    Addressing Unmet Needs in Schizophrenia, Pulmonary Arterial Hypertension & NASH

    March 24, 2024 - By admin

    In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug Pipeline Insights Report for 2024 and which unmet needs they address.

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  • Medicine

    Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

    March 23, 2024 - By admin

    Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.

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  • Medicine

    Medicare to Cover Wegovy for Certain Indications

    March 23, 2024 - By admin

    The drug was recently cleared to treat cardiovascular risks, making it eligible for Medicare Part D.

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  • Medicine

    Emerging Trends at the Intersection of AI & Marketing

    March 22, 2024 - By admin

    In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, talks about what’s coming marketing with the use of AI.

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  • Medicine

    Research Lab Unveils Tool to Improve Clinical Trial Participation

    March 22, 2024 - By admin

    Cold Spring Harbor Laboratory details how the new tool will help reduce common barriers to trial participation.

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  • Medicine

    FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension

    March 21, 2024 - By admin

    Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

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  • Medicine

    Pharmatizing AI

    March 21, 2024 - By admin

    Using the 3 Rs to guide AI transformation in Pharma.

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  • Medicine

    AstraZeneca Announces Plans to Acquire Fusion

    March 20, 2024 - By admin

    The acquisition will bolster AstraZeneca’s ability to develop radioconjugates for cancer treatments.

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  • Medicine

    FDA Grants Accelerated Approval to Takeda's Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

    March 20, 2024 - By admin

    Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

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  • Medicine

    AI’s Impact on CEO/Founder Sustainability

    March 19, 2024 - By admin

    In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs.

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  • Medicine

    FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

    March 19, 2024 - By admin

    In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

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  • Medicine

    BeiGene and Leukemia & Lymphoma Society Sign Three Year Agreement

    March 18, 2024 - By admin

    As part of the partnership, BeiGene will serve as a sponsor at LLS events.

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  • Medicine

    Pharma Pulse 3/15/24:Pharma Dealt Loss Over Discount Program, Adopting New Manufacturing Technologies & more

    March 18, 2024 - By admin

    The latest news for pharma industry insiders.

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  • Medicine

    FDA Approves First Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

    March 17, 2024 - By admin

    Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).

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  • Medicine

    FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL

    March 17, 2024 - By admin

    CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

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  • Medicine

    FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

    March 16, 2024 - By admin

    Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

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  • Medicine

    Hurdles Hindering the Translation of AI-Powered Research into Tangible Clinical Benefits

    March 16, 2024 - By admin

    In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses why no novel active substances have yet been brought to market through AI technology despite increasing investments in the space for drug discovery as shown in IQVIA’s Global Trends in R&D…

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  • Medicine

    How AI Could Have Helped Past Challenges

    March 15, 2024 - By admin

    In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses how AI could have helped address past challenges.

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  • Medicine

    AstraZeneca Acquires Amolyt Pharma with the Aim of Developing Rare Endocrine Disease Treatments

    March 15, 2024 - By admin

    Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.

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  • Medicine

    How’s Business?

    March 14, 2024 - By admin

    The new season could bring with it more possibilities for renewal in the biotech sector, as our coverage this month highlights.

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  • Medicine

    Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

    March 14, 2024 - By admin

    The voluntary recall was ordered due to potential silicon particulate exposure.

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  • Medicine

    Putting Menopause Medication on the Main Stage

    March 13, 2024 - By admin

    In this Pharmaceutical Executive interview, Jill Jaroch, Senior Director, Women’s Health & Urology Marketing at Astellas, discusses the decision to continue VEOZAH’s presence during the big game, the inspiration and message behind the commercial, and if Taylor Swift played a factor in their decision making

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  • Medicine

    Positioning Medical Information as a Trust Driver for Your Brand

    March 13, 2024 - By admin

    Four steps to maximize the impact of medical information services as an engagement gateway.

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  • Medicine

    Contributing Factors to the Growing Gap in Access Between the US and Europe

    March 12, 2024 - By admin

    In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings from IQVIA’s Global Trends in R&D 2024 report that shows why the US continued to lead in new drug launches in 2023.

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  • Medicine

    FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

    March 12, 2024 - By admin

    Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.

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  • Medicine

    Boehringer Ingelheim Unveils New Out-of-Pocket Cap Initiative for its Inhaler Product Portfolio

    March 11, 2024 - By admin

    Starting June 1, Boehringer Ingelheim plans to cap inhaler products for respiratory diseases at $35 per month for eligible patients.

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  • Medicine

    FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

    March 11, 2024 - By admin

    BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

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  • Medicine

    Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information

    March 10, 2024 - By admin

    Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

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  • Medicine

    How Data Integrity Landscape Will Evolve Over the Five Years

    March 10, 2024 - By admin

    In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.

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  • Medicine

    FDA Approves Expanded Indication for Wegovy to Lower Cardiovascular Risk in Adults with Heart Disease, Obesity

    March 9, 2024 - By admin

    FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.

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  • Medicine

    Relyvrio Falls Short of Primary Endpoint in Phase III PHOENIX Trial in Patients with ALS

    March 9, 2024 - By admin

    Relyvrio did not significantly alter amyotrophic lateral sclerosis disease progression as measured by the ALSFRS-R total score at Week 48 compared to placebo.

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  • Medicine

    FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

    March 8, 2024 - By admin

    Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

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  • Medicine

    Lilly Updates Open Letter Regarding the Use of Tirzepatide for Cosmetic Weight Loss

    March 8, 2024 - By admin

    Eli Lilly continues to emphasize the potential harm that could come with using GLP-1 receptor agonists for off-label purposes.

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  • Medicine

    Gilead, Merus Strike Deal to Develop Novel Trispecific T-Cell Antibodies for Cancer Treatment

    March 7, 2024 - By admin

    Agreement to focus on research, option, and licensing for discovery of dual tumor-associated antigen-targeting antibodies.

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  • Medicine

    Bayer Won’t Be Splitting Up

    March 7, 2024 - By admin

    The company plans to spend the coming years strengthening its market position and pipeline while also clearing its issues with litigation and debt.

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  • Medicine

    FDA Approves Pair of Interchangeable Denosumab Biosimilars

    March 6, 2024 - By admin

    The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.

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  • Medicine

    FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

    March 6, 2024 - By admin

    This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing.

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  • Medicine

    How the Pandemic Changed the Way Pharma Looks at Data Integrity in 2024

    March 5, 2024 - By admin

    In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, discusses data security threats from human error to AI tech and how COVID-19 impacted data integrity.

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  • Medicine

    Amring Changes Name to Nordic Pharma, Inc. Amid Ownership Change

    March 5, 2024 - By admin

    Rebranding aims to align company with its parent company and other subsidiaries.

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  • Medicine

    FDA and Workflow Services Detail First 100 Days of Data Collection Partnership

    March 4, 2024 - By admin

    The agency teamed up with the software company to develop platforms and networks to collect de-identified data.

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  • Medicine

    CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors

    March 4, 2024 - By admin

    The agency updated its recommendations after a vote by the ACIP advisory committee.

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  • Medicine

    The State of Obesity-Related Clinical Research: Q&A with Simon Bruce, Vice President, Internal Medicine, Drug Development Solutions, ICON

    March 3, 2024 - By admin

    Simon discusses a recent survey ICON conducted with professionals in obesity-related clinical research.

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  • Medicine

    Bristol Myers Squibb Reveals Promising Results from Trial of Zeposia for Multiple Sclerosis

    March 3, 2024 - By admin

    Phase III DAYBREAK study found consistent safety with Zeposia in patients with relapsing forms of multiple sclerosis.

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  • Medicine

    CMS Signals Looming Sunshine Act Audits: How to Prepare

    March 2, 2024 - By admin

    New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.

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  • Medicine

    With the Rise of GLP-1 Agonists for Treating Obesity, Will Access Challenges Prevent Progress?

    March 2, 2024 - By admin

    JAMA commentary suggests that issues such as high costs, access, and equity will stop patients from obtaining GLP-1 agonists to treat obesity.

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  • Medicine

    Biosimilars Report Shows Challenges, Opportunities Across Disease States

    March 1, 2024 - By admin

    Cardinal Health report highlights new biosimilar treatments, legislative developments, and multiple industry perspectives.

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  • Medicine

    Indapta Therapeutics Granted FDA Fast Track Designation for Natural Killer Cell Therapy for Hematologic Malignancies

    March 1, 2024 - By admin

    IDP-023 is a highly potent natural killer cell platform under evaluation for patients with multiple myeloma and non-Hodgkin lymphoma.

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  • Medicine

    AbbVie, OSE Immunotherapeutics Strike Deal to Develop Monoclonal Antibody for Chronic Inflammation

    February 29, 2024 - By admin

    OSE-230 was developed to activate a unique mechanism for resolving chronic inflammation, focusing on modulation of macrophages and neutrophils.

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  • Medicine

    Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

    February 29, 2024 - By admin

    NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer.

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  • Medicine

    Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections

    February 28, 2024 - By admin

    The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.

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  • Medicine

    IQVIA Study Highlights the Importance of Adult Vaccination in the US

    February 28, 2024 - By admin

    Results of the study determined that adult flu vaccination rates among Medicaid populations were significantly low, highlighting other health inequities.

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  • Medicine

    Asthma Medication Xolair May Reduce Peanut Allergies, New Study Finds

    February 27, 2024 - By admin

    FDA has approved the medication in adults and children with allergies.

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  • Medicine

    Bayer Granted FDA Breakthrough Therapy Designation for Non-Small Cell Lung Cancer Drug

    February 27, 2024 - By admin

    BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non-small cell lung cancer with tumors that have activating HER2 mutations.

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  • Medicine

    IQVIA Executive Director Discusses Global Use of Medicines 2024 Report – Part 1

    February 26, 2024 - By admin

    Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending and growth in diabetes and global obesity

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  • Medicine

    HLTH Inc. and GE Healthcare Reveal Healthcare-Themed Art Gallery

    February 25, 2024 - By admin

    The gallery will be a part of the HLTH Europe event and will be open to all attendees.

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  • Medicine

    FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease

    February 25, 2024 - By admin

    The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.

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  • Medicine

    FDA Warns Against Using Smartwatches or Smart Rings to Measure Blood Glucose Levels

    February 24, 2024 - By admin

    The agency issued a statement reminding the public that it has not approved any such devices for this use.

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  • Medicine

    NIH Study Estimates Pfizer’s Paxlovid Could Reduce COVID-19 Hospitalizations, Saving Billions in Healthcare Costs

    February 24, 2024 - By admin

    Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of hospitalizations associated with COVID-19.

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  • Medicine

    Frontier Medicines Announces Series C Funding to Advance Development of Next Generation KRAS Blocker

    February 23, 2024 - By admin

    Funds expected to advance multiple programs into clinical studies, including FMC-376, which targets KRASG12C cancers.

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  • Medicine

    Study Finds Parkinson Disease Drug Nearly Matches Wegovy in Weight Loss Effects

    February 23, 2024 - By admin

    Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease.

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  • Medicine

    Senators Pen Letter to FDA Urging Stronger Enforcement on Deceptive Direct-to-Consumer Social Media Ads Promoting Prescription Drugs

    February 22, 2024 - By admin

    Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.

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  • Medicine

    Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

    February 22, 2024 - By admin

    The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

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  • Medicine

    Teva Reports Positive Data from Anti-TL1A Antibody for Inflammatory Bowel Diseases

    February 21, 2024 - By admin

    TEV-’574 has shown potential as a treatment for inflammatory bowel diseases such as ulcerative colitis and Crohn disease.

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  • Medicine

    WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy

    February 21, 2024 - By admin

    Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.

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  • Medicine

    Servier’s Potential First-in-Class Targeted Therapy for IDH-Mutant Gliomas Granted FDA Priority Review

    February 20, 2024 - By admin

    The FDA has assigned a Prescription Drug User Fee Act action date of August 20, 2024, for Servier’s New Drug Application for vorasidenib.

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  • Medicine

    AstraZeneca’s Tagrisso With Chemotherapy Gets FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer

    February 20, 2024 - By admin

    The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.

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  • Medicine

    Copay Adjustment Programs: What’s Next for Manufacturers?

    February 19, 2024 - By admin

    Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.

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  • Medicine

    Study Shows Potential of Artificial Intelligence in Predicting Responses to Treatment for Major Depressive Disorder

    February 19, 2024 - By admin

    Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.

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  • Medicine

    Cultivating a Bespoke Recruitment Strategy for Your FSP Partnership

    February 18, 2024 - By admin

    How a multipronged approach to staff recruitment can accelerate trial success.

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  • Medicine

    Cancer & Work: Acting Together: An Interview With Raj Verma, Chief Diversity, Culture, and Experience Officer at Sanofi

    February 18, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses features of the company’s support program for patients diagnosed with cancer and other critical illnesses.

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  • Medicine

    Digging Deeper Into Bayer’s ASCO GU Presentation

    February 17, 2024 - By admin

    Iris Kuss, head of clinical development, and Jorge Ortiz, head of medical affairs, discuss the company’s recent presentation at ASCO GU.

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  • Medicine

    Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

    February 17, 2024 - By admin

    Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

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  • Medicine

    FDA Grants Traditional Approval to Tepmetko for Metastatic Non–Small Cell Lung Cancer

    February 16, 2024 - By admin

    The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

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  • Medicine

    GSK Completes Acquisition of Aiolos Bio

    February 16, 2024 - By admin

    This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.

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  • Medicine

    Citius Pharmaceuticals Resubmits BLA for Lymphir to Address FDA Complete Response Letter

    February 15, 2024 - By admin

    Lymphir is an immunotherapy under evaluation for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma following at least one previous line of systemic therapy.

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  • Medicine

    Aurlumyn Becomes First Severe Frostbite Medication to Receive FDA Approval

    February 15, 2024 - By admin

    Treatment aims to reduce the risk of finger or toe amputation due to frostbite.

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  • Medicine

    FDA Approves Ipsen’s Onivyde Combination for Metastatic Pancreatic Adenocarcinoma

    February 14, 2024 - By admin

    Pancreatic adenocarcinoma is the most common form of pancreatic cancer, with more than 60,000 diagnoses per year in the United States.

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  • Medicine

    Roche Ends Agreement With Repare Therapeutics to Develop ATR Inhibitor Camonsertib

    February 14, 2024 - By admin

    Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.

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  • Medicine

    Building Resiliency: Essential Leadership Principles for 2024

    February 13, 2024 - By admin

    Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a stable foundation amid lingering uncertainty.

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  • Medicine

    FDA Fast Tracks GSK's Bepirovirsen for Chronic Hepatitis B Virus

    February 13, 2024 - By admin

    In clinical trials, bepirovirsen showed the potential to address a significant unmet medical need for patients with chronic hepatitis B by reducing hepatitis B surface antigen levels and HBV DNA.

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  • Medicine

    Using AI to Solve Drug Shortage Issues

    February 12, 2024 - By admin

    In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.

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  • Medicine

    Takeda's TAK-861 Shows Promising Results in Phase IIb Trial for Narcolepsy Type 1

    February 12, 2024 - By admin

    Novel oral orexin receptor 2 agonist produced statistically significant and clinically meaningful improvements in wakefulness compared with placebo in patients with narcolepsy type 1.

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  • Medicine

    Samgsung Biologics, LegoChem Biosciences Partner on Development of Antibody-Drug Conjugate

    February 11, 2024 - By admin

    Joint venture aims to submit an Investigational New Drug application to the FDA by early next year for treatment that targets solid tumors.

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  • Medicine

    The Promise and Peril of AI in the Physical World

    February 10, 2024 - By admin

    The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.

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  • Medicine

    New Report Says Generic Drug Market Is Set to Grow Over $175 Billion by 2027

    February 10, 2024 - By admin

    According to the study conducted by Technavio, North America will contribute to 37% of the expected growth.

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  • Medicine

    BioNTech and Autolus Announce Strategic Alliance to Bolster CAR-T Cell Pipeline

    February 9, 2024 - By admin

    BioNTech will invest $200 million and get access to Autolus’ manufacturing sites.

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  • Medicine

    2024 Life Sciences Accounting & Reporting Congress

    February 9, 2024 - By admin

    2024 Life Sciences Accounting & Reporting Congress

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  • Medicine

    Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

    February 8, 2024 - By admin

    The three-year initiative comes with $15 million in funding.

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  • Medicine

    Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death

    February 8, 2024 - By admin

    Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.

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  • Medicine

    Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

    February 7, 2024 - By admin

    Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.

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  • Medicine

    Amgen's Novel Weight Loss Drug Shows Potential for Longer Lasting Effect With Less Frequent Dosing Than Wegovy, Zepbound

    February 7, 2024 - By admin

    In a Phase I trial, data suggest that Amgen’s maridebart cafraglutide (MariTide) may allow patients to take lower and less frequent doses over time while still maintaining significant weight loss.

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  • Medicine

    FDA Grants Priority Review to Expand Indication of GSK's Arexvy for RSV Protection in Adults Aged 50-59 Years

    February 6, 2024 - By admin

    The FDA assigned a Prescription Drug User Fee Act action date of June 7, 2024, to an application that would expand the indication of Arexvy to include adults 50-59 years with an increased risk of respiratory syncytial virus-related lower respiratory tract disease.

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  • Medicine

    Synchron, Potential Competitor to Elon Musk’s Neuralink, Obtains Equity Interest in Acquandas to Accelerate Development of Brain-Computer Interface

    February 6, 2024 - By admin

    Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.

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  • Medicine

    Report: Insulin Prices in US Substantially Higher than Other Countries

    February 5, 2024 - By admin

    Higher prices of insulin attributed to significant annual increases, outpacing general inflation.

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  • Medicine

    Novartis Terminates Licensing Rights With Allarity for Cancer Drug Due to Missed Payments

    February 5, 2024 - By admin

    Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.

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  • Medicine

    Novo Nordisk Increases Supply of Lower-Dose Wegovy to Meet Continued Demand

    February 4, 2024 - By admin

    The company has struggled to supply the drug to patients due to overwhelming popularity.

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  • Medicine

    FDA Issues Warning of Contaminated Copycat Eyedrops

    February 4, 2024 - By admin

    The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.

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  • Medicine

    Sanofi Announces New Reservation Program to Mitigate Shortages of RSV Vaccine for Next Season

    February 3, 2024 - By admin

    Beyfortus (nirsevimab-alip), a monoclonal antibody that protects against respiratory syncytial virus-associated lower respiratory tract disease, experienced higher than anticipated demand that led to shortages during the 2023-2024 season.

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  • Medicine

    Shubh Goel, VP, Head of Immuno-Oncology and Gastrointestinal Tumors Franchise, US Oncology Business Unit, AstraZeneca, Discusses Positive Results From Phase III Trial In Patients With HCC

    February 3, 2024 - By admin

    In an interview with Pharm Exec Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.

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  • Medicine

    CDC STI Surveillance Report Finds Over 2.5 Million Cases of Sexually Transmitted Infections, Skyrocketing Rates of Syphilis

    February 2, 2024 - By admin

    The US Department of Health and Human Services has initiated a comprehensive strategy to address the escalating syphilis rates, as a result.

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  • Medicine

    DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response

    February 2, 2024 - By admin

    DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.

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  • Medicine

    Veracity Benefits, Levrx Technology Reveal New Digital Health Tech App

    February 1, 2024 - By admin

    App aims to leverage digital technology to significantly reduce pharmacy costs.

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