Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee.

Eli Lilly advertisement emphasizes that advancements in in medicine can lead to improved population health.

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to be evaluated in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor.

Portals are finally a viable channel as life sciences companies shift to modular to build their digital ecosystems, create and approve content, and deliver omnichannel experiences.

The agency recognized the medication as a significant advancement for the treatment of IPF.

A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.

Report comes after the FDA seized thousands of counterfeit Ozempic units.

Substance use disorder is a complex condition that demands innovative solutions, one of which that has shown promise is the use of long-acting injectables.

In an interview with PharmExec Associate Editor Don Tracy, Jingsong Wang discusses Nona Biosciences’ recent exclusive license agreement with Pfizer Inc. for the development and commercialization of HBM9033.

Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to develop more severe forms of liver disease, including cirrhosis and liver cancer.

Atypical antidepressant linked to severe adverse effects and death as a result of misuse.

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.

The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.

New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.

Embracing new digital-based tools is critical throughout the healthcare landscape to prepare for the rise of telemedicine as a permanent way of life.

NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.

The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.

Pharma marketing strategies that are both socially and ethically responsible can build long term success for the life sciences industry.

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

Will the FDA ultimately step in and mandate a credible effort to eradicate the mindset that long-term adherence is not achievable?

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the changing role of PBMs and recent price structure overhauls.

Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.

Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.

According to the university, new nanotech scaffolding can be used to support tissue growth.

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

Webinar Date/Time: Thu, Feb 15, 2024 11:00 AM EST

Sun Pharmaceutical Industries will purchase Taro’s outstanding shares for $43 each, which will total $348 million.

Researchers believe low numbers in the use of direct-to-consumer healthcare services could rapidly trend up.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.

Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.

The device can produce AI-assisted readings.

The BioThrax vaccine is indicated for active immunization to prevent anthrax disease caused by Bacillus anthracis in individuals aged 18 through 65 years.

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

The survey is part of the brand’s new marketing campaign.

RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.

The company also announced that it has submitted its new glucose monitoring system to the FDA for approval.

If the FDA approves the abbreviated new drug application for Lutetium Lu 177 Dotatate, the drug will be eligible for 180 days of generic marketing exclusivity in the United States for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors.

While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies.

Both companies are now under the Norstella umbrella. Evaluate announced the acquisition of J+D Forecasting, a provider of forecasting solutions focused on the pharmaceutical and life sciences industry. The move will bring J+D under the Norstella umbrella, the parent company of Evaluate. The parent company also includes Citeline, MMIT, Panalgo,…

SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription…

Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies. Both Merck and Johnson & Johnson have announced separate acquisitions of biopharmaceutical companies in moves that strengthen their respective oncology…

Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising. Following a review spanning November and December 2023, on December 29, 2023, the US District Court for the Southern District of New York granted the Federal Trade Commission’s (FTC) request for a preliminary block to prevent IQVIA from…

Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions. Telix Pharmaceuticals has filed a biologics license application (BLA) to the FDA for the novel positron emission tomography (PET) imaging agent 89Zr-DFO-girentuximab (TLX250-CDx; Zircaix) for clear cell renal cell carcinoma (ccRCC).1 The…

Tina Fresta, BA, MPH is the Strategic Solutions Senior Manager at epocrates, keeps a close eye on the pharmaceutical and bio science industry shifts, leveraging those insights to inform both our partners and our company of the most strategic approach to reach business goals. Specialty-based drugs are dominating today’s pharmaceutical…

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment…

For companies in the life science industry, managing their processes in house on their own platforms proved beneficial. For many growing biotechs, it can be difficult to choose a safety or pharmacovigilance (PV) operating model that works for their organization’s size, budget, and case volume. Some biotechs see owning their…

VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults…

JAMA study evaluates the ability of artificial intelligence to transform electronic health. In modern times, dependence on the internet when it comes to nutritional information has grown significantly. Despite this, close to half of online nutrition-related content (approximately 49%) has been found to be inaccurate or of low quality. Although…

Practical recommendations for a path forward for both biopharma C-Suites and their employees. Kerry McKittrick is a co-director of the Harvard Project on Workforce, an interdisciplinary applied research project between the Harvard Kennedy School’s Malcolm Wiener Center for Social Policy, the Harvard Business School’s Managing the Future of Work Project,…

Artificial intelligence (AI) has enormous potential in healthcare, but all too often, it gets misunderstood. Especially with the proliferation of AI in other industries and chatGPT. And yet, AI offers more promise than that. With the right supporting infrastructure and context, intelligent tools stand to not only pump out data…

CDC data show hospitalizations among all age groups spiked by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus over the past four weeks, emphasizing the need for improved outreach efforts among at-risk populations. The CDC has issued a health alert regarding an urgent need to boost…

Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly…

The importance of enabling customer intelligence at scale. Most healthcare professionals (91%) place a high value on scientific exchange1 with medical science liaisons (MSLs) and say that biopharma is underutilizing its MSL workforce. In addition, Veeva Pulse data shows that field medical growth has remained flat over the past 12…

Erasca will initiate the pivotal SEACRAFT-2 trial in the first half of 2024 to evaluate naporafenib in combination with trametinib in adults with unresectable or metastatic melanoma with an NRAS mutation. Erasca’s naporafenib (ERAS-254) has been granted FDA Fast Track Designation for the treatment of adults with unresectable or metastatic…

Zoryve (roflumilast) topical foam, 0.3% is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades. The FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve (roflumilast) topical foam, 0.3% to treat seborrheic dermatitis in patients aged 9 years and older. The once-daily, steroid-free…

Pharm Exec spent the year speaking with some of the most interesting professionals from the life sciences industry.

Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or…

As companies continued to expand their DE&I efforts, Pharm Exec was there to cover it in 2023. Equity for Women in Healthcare: 131 Years is Too Long to Wait Closing the gender gap in pharma—and how we get there together. Q&A with Amy West, Head of US Digital Health &…

Pharma marketing teams had to deal with big changes in 2023. Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval The UCB executive speaks on recent FDA approval of Bimzelx. Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing Experts from Hootsuite noted that the primary social media…

Published on: December 27, 2023 Our top five episodes of the year. The Explosive Arrival of Chat GPT and Generative AIFran Pollaro talks with Faruk Capan is the CEO, EVERSANA INTOUCH & Chief Innovation Officer, EVERSANA about the arrival of Chat GPT and generative AI in the public consciousness. This is…

As this exciting technology exploded in 2023, Pharm Exec was there to cover it all. The Promise and Challenges of Generative AI in Healthcare Pharma industry stakeholders must develop actionable roadmaps to prioritize the areas in which the use of generative artificial intelligence can create the greatest benefits. Embracing AI:…

Five trends in pharmaceutical marketing from the past year. Doctors as influencers A recent Hootsuite social trends presentation focused on healthcare revealed that a significant majority of Gen Z use social media platforms like TikTok and LinkedIn to look up health-related information. Using a mix of medical, personal, and trendy…

Pivotal trial findings show favorable clinical safety and efficacy data for mRNA-1345 in lowering the incidence of respiratory syncytial virus-associated lower respiratory tract disease. The results of a pivotal Phase III trial show favorable clinical safety and efficacy data for Moderna’s investigational respiratory syncytial virus (RSV) vaccine mRNA-1345. In findings…

Enabling Authenticity Natalie Bickford, chief people officer at Sanofi, reveals how she approaches the employee experience, which ultimately influences employee retention, and discusses the importance of a corporate DE&I strategy in those efforts. Built for the Moment Starting out with limited pharma business knowledge, how the lessons learned and realizations…

Indication of Adbry (tralokinumab-ldrm) expanded to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. The FDA has approved an expanded indication for LEO Pharma’s Adbry (tralokinumab-ldrm) for patients 12…

Filsuvez (birch triterpenes) is indicated to treat partial thickness wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. The FDA has approved Chiesi Global Rare Diseases’ topical gel Filsuvez (birch triterpenes) to treat partial thickness wounds associated with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). The regulatory…

Garadacimab is a novel, first-in-class, recombinant monoclonal antibody for hereditary angioedema that targets activated Factor XII. The FDA has accepted a Biologics License Application (BLA) for CSL Behring’s garadacimab (CSL312), a once-monthly prophylactic therapy for hereditary angioedema (HAE). A Marketing Authorization Application (MAA) filed by CSL Behring was also accepted…

Published on: December 21, 2023 Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert who discusses maximizing returns on investment, upholding data integrity while managing cost containment, and adopting digital best practices. This podcast addresses critical topics such as…

In a recent article published by Oxford Academic, authors discussed a number of ways that artificial intelligence (AI) and machine learning (ML) could transform biomedical research and healthcare. This includes enhancing operational efficiency, reducing costs, improving diagnostics, identifying therapeutic targets, and enabling personalized treatment. Despite these opportunities, challenges, such as…

Published on: December 21, 2023 Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert who discusses maximizing returns on investment, upholding data integrity while managing cost containment, and adopting digital best practices. This podcast addresses critical topics such as…

American Heart Association survey suggests holiday stress has a major impact on health habits. A recent survey released by the American Heart Association revealed that 79% of respondents tend to neglect their health needs during the holidays, focusing instead on creating special moments for others. Additionally, 51% of Americans state…

Data will continue to grow in importance in 2024. Many of the biggest stories in 2023 were related to technological advancements in the life sciences industry. These advancements have increased the importance of having high-quality data. Christoph Bug, vice president of global medical at Veeva, spoke with Pharmaceutical Executive about…

If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such…

Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a…

JAMA study aims to discover whether ignoring medical advice relates to financial status among patients with heart failure. Recently published research points to a need for greater outreach efforts to improve medication uptake among underserved patient populations. In a JAMA Network study published last week, the authors set out to…

Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty? How much is a prescription medicine really worth? For patients suffering from cancer or other severe illnesses where the right drug is a matter of life or death, no price…

In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital. The breakneck pace of digital transformation spurred by COVID-19 continued to reshape the life sciences landscape in 2023. Rather than a single watershed moment,…

In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for…