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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Biotech’s Road to Recovery Takes a Wobbly Turn
Now-unclear timing on rate cuts puts onus back on fundamentals.
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Avoiding the Digital Age is Hurting Research Efforts
A greater shift from paper records and physical assets is achievable.
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Yvonne Greenstreet: Answering the Call
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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Flagship Pioneering, Metaphore Biotechnologies Strike Deal with Novo Nordisk to Develop High-End Obesity Treatments
The collaboration is a part of a broader strategy to combat cardiometabolic and rare diseases.
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Verona Pharma Receives $650M Investment from Oaktree Capital Management and OMERS Life Sciences
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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Assessing LP-284 with RADR for NHL and Other Targeted Cancers
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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Planning for Unique Challenges Faced by Cell & Gene Therapy Developers
In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi,
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AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis
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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Pharma Pulse 5/7/24: Challenges With Feasibility Studies, AI Has ‘Enormous Potential for Harm’ & more
The latest news for pharma industry insiders.
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FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients
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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NJ Doctor Becomes First In State to Use PathKeeper Surgical Navigation System on Patient
Dr. Lewis used the AI-powered device on a patient with severe lumbar stenosis.
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Poseida Therapeutics Enters into Partnership with Astellas Subsidiary Xyphos
The two companies will work together to develop gene therapies in oncology.
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FDA Grants Fast Track Designation to Amolyt Pharma’s Eneboparatide to Treat Hypoparathyroidism
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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Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline
Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers.
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Pricing Climate Impacting Commercial Considerations
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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Cencora VP of Emerging Therapies Discusses Cell & Gene Therapy Distribution Strategies
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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Pharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more
The latest news for pharma industry insiders.
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Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity
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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How Diverse Skills Can Drive Success in Biotech
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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FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases
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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Why Early Communication is Crucial for a Successful Drug Launch
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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FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
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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A Decade in the Anti-Obesity Arena
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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FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years
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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Exploring Luma & Luma Lab Connect
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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Solving the First Mile Problem: Q&A with Mark Melton
Melton, customer advocacy executive at Magnolia, discusses how new technologies can be used to ensure data is accurate.
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Going Beyond Visuals to Connect with Diverse Audiences
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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FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B
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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FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV
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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Coya Therapeutics CEO Discusses Company's Treatment Pipeline
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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CVS Health Announces New Work Force Development and Community Center in Louisiana
The center will offer local residents with opportunities and training to enter the pharmacy work force.
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Novartis, Medicines for Malaria Venture Release Positive Results from Phase II/III Trial of Coartem for Infants with Malaria
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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Howard Berman Discusses Potential Indications for Coya 302
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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Coya Therapeutics CEO Discusses Next Steps Amid Positive Results from Coya 302 Trial for ALS Treatment
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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Pharma Pulse 4/24/24: 5 Things You Should Know About Women's Health, Microsoft Makes Push Into Smaller AI Systems & more
The latest news for pharma industry insiders.
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FDA Approves Novartis' Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors
Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
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Upcoming US Pharma and Biotech Summit Spotlights Innovation, Challenges in Healthcare
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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Current State of the Pharma Sales and Marketing Sales Force
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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Using AI to Create New Parkinson’s Treatments: Q&A with Mattias Alder
Alder, CEO of Gain Therapeutics, discusses how the Magellan platform was used in the creation of GT-02287.
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Lene Oddershede Discusses Upcoming Projects from the Novo Nordisk Foundation
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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FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC
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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FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease
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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Essential Pharma Acquires Reminyl, a Cholinesterase Inhibitor to Treat Mild to Moderately Severe Dementia from Janssen Pharmaceutica NV
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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Texas Biomed Developing Potential Bird Flu Vaccine
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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Will Synthetic, AI-Based Digital Humans Change Pharma and Life Sciences? Q&A with Abid Rahman, SVP Innovation, EVERSANA
Rahman discusses the new opportunities that digital twins present to researchers.
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Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis
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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Pharma Pulse 4/18/24: Is it Fair Certain Biotech Investors Get an Early Look? The Health and Healthcare of Millennials & more
The latest news for pharma industry insiders.
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Pharmaceutical Executive: April 2024 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive April 2024 issue in an interactive PDF format.
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Pharma Pulse 4/17/24: AI has a Measurement Problem, How Advancements in Technology Are Transforming the Field & more
The latest news for pharma industry insiders.
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The IRA Impact: Navigating Its Evolving Complexities
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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Pharma Pulse 4/16/24: Mitigating Drug Shortages, PBM Legislation in Washington & more
The latest news for pharma industry insiders.
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Fighting for Innovation
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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Rare Disease Summit Recap
Greater Than One’s Chief Strategy Officer, Andrew Bast, shares his takeaways from 2024 Rare Disease Summit in Philadelphia, PA.
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Supply Shortages in Weight Loss Drugs
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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Trends in Continuing Medical Education
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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The Rapid Growth of Remote Patient Monitoring Solutions Can Accelerate Decentralized Clinical Trials
Pharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.
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Aspiring for the C-Suite? Consider Being a Chief of Staff
Why this role provides a critical ‘boot camp’ for future pharma leaders.
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Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer
Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.
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Vera Whole Health Announces Launch of Value-Based Primary Care Center in Atlanta
This facility is the first of four facilities to be built in the area.
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FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures
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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Embedded and agile–The next phase of the DCT evolution
Ellenor discusses key points from the recent SCOPE presentation.
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Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies
Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts.
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Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old
The vaccine is already approved for older adults.
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Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases
Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.
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Labcorp Announces Expansions to Oncology Portfolio
These expansions include a new product, along with improvements to existing products.
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FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV
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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Pharma Pulse 4/8/24: Rite Aid Announces Availability of Opill, List Prices for Pharmaceuticals in the US Compared to Other Countries & more
The latest news for pharma industry insiders.
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Pharma Pulse 4/5/24: Patient with Pig Kidney Goes Home, Combining AI and Market Access & more
The latest news for pharma industry insiders.
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FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy
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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A Decade of Data Under the Belt
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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Amylyx Begins Process of Discontinuing Relyvrio/Albrioza for Treatment of ALS
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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Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division
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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QuantalX Joins FDA’s Total Life Cycle Advisory Program
FDA’s program will provide guidance to the development of the company’s Delphi-MD technology.
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Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia
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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CVS Health Announces New Offerings for Pharmacy Students
The two programs will be offered to students and CVS interns.
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FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder
Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.
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Non-Gene Edited Therapeutics: Q&A with Jeffrey Erickson, Vice President of Business Development at Triumvira
Erickson discusses his work developing unique, targeted autologous and allogeneic T cell therapeutics.
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FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside
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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Pharma Pulse 4/2/24: Bird Flu in Texas, Anxiety/Depression Treatment Linked with Heart Disease Outcomes & more
The latest news for pharma industry insiders.
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Mishe Announces Omnichannel Pharmacy Network
The network will work with DiRx and MakoRX.
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Bristol Myers Squibb’s Phase III Clinical Trial for Zeposia Fails to Meet Primary Endpoint of Clinical Remission in Crohn Disease
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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Fierce Females in the Life Science Space
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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Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12
Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.
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FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients
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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Researchers Present First Study Using Biomimetic AI Digital Twins
The study used technology developed by a variety of companies, including RYLTI.
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Pfizer Makes Publicis New Global Creative Duties Partner
The news comes less than a year after Pfizer announced that IPG would handle this role.
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Pharma Pulse 3/29/24: Super Micro’s AI Boom Carries a Big Price Tag, Leveraging Digital Tools to Optimize Manufacturing & more
The latest news for pharma industry insiders.
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FDA Grants 501(k) to Two Avicenna.AI Products
Both products are designed to help radiologists.
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Pharma Pulse 3/28/24: The Fight for AI Talent, Atopic Dermatitis and Mental Health & more
The latest news for pharma industry insiders.
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FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors
Action marks the first FDA-approved blood screening test for malaria.
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Pharma Pulse 3/27/24: Patients Hate ‘Forever’ Drugs—Is Wegovy Different? Low Melatonin Can Increase Risk of Neurological Disorders & more
The latest news for pharma industry insiders.
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Viking Therapeutics Reveals Positive Results from Oral Obesity Drug
Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.
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UCB's Women of Childbearing Age Program
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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FDA Approves AstraZeneca’s Ultomiris for Neuromyelitis Optica Spectrum Disorder
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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CDC Releases Health Alert and Pushes for Increase in Measles Vaccinations
The agency released guidelines for vaccinations guidelines for children as young as 6 months old.
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Pharma Pulse 3/22/24: Surgeons Transplant Pig Kidney into a Patient, Effective Ways to Engage Patients, Caregivers, and Advocacy Groups & more
The latest news for pharma industry insiders.
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FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy
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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Addressing Unmet Needs in Schizophrenia, Pulmonary Arterial Hypertension & NASH
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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Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer
Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.
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Medicare to Cover Wegovy for Certain Indications
The drug was recently cleared to treat cardiovascular risks, making it eligible for Medicare Part D.
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Emerging Trends at the Intersection of AI & Marketing
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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Research Lab Unveils Tool to Improve Clinical Trial Participation
Cold Spring Harbor Laboratory details how the new tool will help reduce common barriers to trial participation.
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FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension
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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Pharmatizing AI
Using the 3 Rs to guide AI transformation in Pharma.
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AstraZeneca Announces Plans to Acquire Fusion
The acquisition will bolster AstraZeneca’s ability to develop radioconjugates for cancer treatments.
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FDA Grants Accelerated Approval to Takeda's Iclusig for Ph-Positive Acute Lymphoblastic Leukemia
Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.
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AI’s Impact on CEO/Founder Sustainability
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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FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma
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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BeiGene and Leukemia & Lymphoma Society Sign Three Year Agreement
As part of the partnership, BeiGene will serve as a sponsor at LLS events.
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Pharma Pulse 3/15/24:Pharma Dealt Loss Over Discount Program, Adopting New Manufacturing Technologies & more
The latest news for pharma industry insiders.
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FDA Approves First Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).
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FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL
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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FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma
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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Hurdles Hindering the Translation of AI-Powered Research into Tangible Clinical Benefits
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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How AI Could Have Helped Past Challenges
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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AstraZeneca Acquires Amolyt Pharma with the Aim of Developing Rare Endocrine Disease Treatments
Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.
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How’s Business?
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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Par Pharmaceutical Issues Recall of Single Lot of Treprostinil
The voluntary recall was ordered due to potential silicon particulate exposure.
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Putting Menopause Medication on the Main Stage
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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Positioning Medical Information as a Trust Driver for Your Brand
Four steps to maximize the impact of medical information services as an engagement gateway.
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Contributing Factors to the Growing Gap in Access Between the US and Europe
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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FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH
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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Boehringer Ingelheim Unveils New Out-of-Pocket Cap Initiative for its Inhaler Product Portfolio
Starting June 1, Boehringer Ingelheim plans to cap inhaler products for respiratory diseases at $35 per month for eligible patients.
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FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma
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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Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information
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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How Data Integrity Landscape Will Evolve Over the Five Years
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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FDA Approves Expanded Indication for Wegovy to Lower Cardiovascular Risk in Adults with Heart Disease, Obesity
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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Relyvrio Falls Short of Primary Endpoint in Phase III PHOENIX Trial in Patients with ALS
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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FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma
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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Lilly Updates Open Letter Regarding the Use of Tirzepatide for Cosmetic Weight Loss
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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Gilead, Merus Strike Deal to Develop Novel Trispecific T-Cell Antibodies for Cancer Treatment
Agreement to focus on research, option, and licensing for discovery of dual tumor-associated antigen-targeting antibodies.
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Bayer Won’t Be Splitting Up
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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FDA Approves Pair of Interchangeable Denosumab Biosimilars
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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FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing
This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing.
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How the Pandemic Changed the Way Pharma Looks at Data Integrity in 2024
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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Amring Changes Name to Nordic Pharma, Inc. Amid Ownership Change
Rebranding aims to align company with its parent company and other subsidiaries.
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FDA and Workflow Services Detail First 100 Days of Data Collection Partnership
The agency teamed up with the software company to develop platforms and networks to collect de-identified data.
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CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors
The agency updated its recommendations after a vote by the ACIP advisory committee.
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The State of Obesity-Related Clinical Research: Q&A with Simon Bruce, Vice President, Internal Medicine, Drug Development Solutions, ICON
Simon discusses a recent survey ICON conducted with professionals in obesity-related clinical research.
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Bristol Myers Squibb Reveals Promising Results from Trial of Zeposia for Multiple Sclerosis
Phase III DAYBREAK study found consistent safety with Zeposia in patients with relapsing forms of multiple sclerosis.
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CMS Signals Looming Sunshine Act Audits: How to Prepare
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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With the Rise of GLP-1 Agonists for Treating Obesity, Will Access Challenges Prevent Progress?
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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Biosimilars Report Shows Challenges, Opportunities Across Disease States
Cardinal Health report highlights new biosimilar treatments, legislative developments, and multiple industry perspectives.
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Indapta Therapeutics Granted FDA Fast Track Designation for Natural Killer Cell Therapy for Hematologic Malignancies
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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AbbVie, OSE Immunotherapeutics Strike Deal to Develop Monoclonal Antibody for Chronic Inflammation
OSE-230 was developed to activate a unique mechanism for resolving chronic inflammation, focusing on modulation of macrophages and neutrophils.
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Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug
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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Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections
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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IQVIA Study Highlights the Importance of Adult Vaccination in the US
Results of the study determined that adult flu vaccination rates among Medicaid populations were significantly low, highlighting other health inequities.
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Asthma Medication Xolair May Reduce Peanut Allergies, New Study Finds
FDA has approved the medication in adults and children with allergies.
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Bayer Granted FDA Breakthrough Therapy Designation for Non-Small Cell Lung Cancer Drug
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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IQVIA Executive Director Discusses Global Use of Medicines 2024 Report – Part 1
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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HLTH Inc. and GE Healthcare Reveal Healthcare-Themed Art Gallery
The gallery will be a part of the HLTH Europe event and will be open to all attendees.
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FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease
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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FDA Warns Against Using Smartwatches or Smart Rings to Measure Blood Glucose Levels
The agency issued a statement reminding the public that it has not approved any such devices for this use.
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NIH Study Estimates Pfizer’s Paxlovid Could Reduce COVID-19 Hospitalizations, Saving Billions in Healthcare Costs
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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Frontier Medicines Announces Series C Funding to Advance Development of Next Generation KRAS Blocker
Funds expected to advance multiple programs into clinical studies, including FMC-376, which targets KRASG12C cancers.
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Study Finds Parkinson Disease Drug Nearly Matches Wegovy in Weight Loss Effects
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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Senators Pen Letter to FDA Urging Stronger Enforcement on Deceptive Direct-to-Consumer Social Media Ads Promoting Prescription Drugs
Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.
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Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma
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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Teva Reports Positive Data from Anti-TL1A Antibody for Inflammatory Bowel Diseases
TEV-’574 has shown potential as a treatment for inflammatory bowel diseases such as ulcerative colitis and Crohn disease.
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WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy
Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.
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Servier’s Potential First-in-Class Targeted Therapy for IDH-Mutant Gliomas Granted FDA Priority Review
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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AstraZeneca’s Tagrisso With Chemotherapy Gets FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer
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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Copay Adjustment Programs: What’s Next for Manufacturers?
Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.
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Study Shows Potential of Artificial Intelligence in Predicting Responses to Treatment for Major Depressive Disorder
Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.
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Cultivating a Bespoke Recruitment Strategy for Your FSP Partnership
How a multipronged approach to staff recruitment can accelerate trial success.
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Cancer & Work: Acting Together: An Interview With Raj Verma, Chief Diversity, Culture, and Experience Officer at Sanofi
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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Digging Deeper Into Bayer’s ASCO GU Presentation
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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Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients
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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FDA Grants Traditional Approval to Tepmetko for Metastatic Non–Small Cell Lung Cancer
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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GSK Completes Acquisition of Aiolos Bio
This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.
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Citius Pharmaceuticals Resubmits BLA for Lymphir to Address FDA Complete Response Letter
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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Aurlumyn Becomes First Severe Frostbite Medication to Receive FDA Approval
Treatment aims to reduce the risk of finger or toe amputation due to frostbite.
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FDA Approves Ipsen’s Onivyde Combination for Metastatic Pancreatic Adenocarcinoma
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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Roche Ends Agreement With Repare Therapeutics to Develop ATR Inhibitor Camonsertib
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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Building Resiliency: Essential Leadership Principles for 2024
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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FDA Fast Tracks GSK's Bepirovirsen for Chronic Hepatitis B Virus
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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Using AI to Solve Drug Shortage Issues
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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Takeda's TAK-861 Shows Promising Results in Phase IIb Trial for Narcolepsy Type 1
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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Samgsung Biologics, LegoChem Biosciences Partner on Development of Antibody-Drug Conjugate
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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The Promise and Peril of AI in the Physical World
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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New Report Says Generic Drug Market Is Set to Grow Over $175 Billion by 2027
According to the study conducted by Technavio, North America will contribute to 37% of the expected growth.
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BioNTech and Autolus Announce Strategic Alliance to Bolster CAR-T Cell Pipeline
BioNTech will invest $200 million and get access to Autolus’ manufacturing sites.
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2024 Life Sciences Accounting & Reporting Congress
2024 Life Sciences Accounting & Reporting Congress
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Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities
The three-year initiative comes with $15 million in funding.
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Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death
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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Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
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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Amgen's Novel Weight Loss Drug Shows Potential for Longer Lasting Effect With Less Frequent Dosing Than Wegovy, Zepbound
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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FDA Grants Priority Review to Expand Indication of GSK's Arexvy for RSV Protection in Adults Aged 50-59 Years
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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Synchron, Potential Competitor to Elon Musk’s Neuralink, Obtains Equity Interest in Acquandas to Accelerate Development of Brain-Computer Interface
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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Report: Insulin Prices in US Substantially Higher than Other Countries
Higher prices of insulin attributed to significant annual increases, outpacing general inflation.
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Novartis Terminates Licensing Rights With Allarity for Cancer Drug Due to Missed Payments
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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Novo Nordisk Increases Supply of Lower-Dose Wegovy to Meet Continued Demand
The company has struggled to supply the drug to patients due to overwhelming popularity.
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FDA Issues Warning of Contaminated Copycat Eyedrops
The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.
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Sanofi Announces New Reservation Program to Mitigate Shortages of RSV Vaccine for Next Season
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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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
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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CDC STI Surveillance Report Finds Over 2.5 Million Cases of Sexually Transmitted Infections, Skyrocketing Rates of Syphilis
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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DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response
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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Veracity Benefits, Levrx Technology Reveal New Digital Health Tech App
App aims to leverage digital technology to significantly reduce pharmacy costs.