The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
BioSpace sits down with four NextGen companies that are thriving despite a multi-year down period. You will hear about ways they are defying the odds to churn out clinical data that may finally provide the industry with a ladder out. Watch now.
FEATURED STORIES
As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise.
Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future.
The vaginal microbiome plays a critical role in women’s health, from infection resistance to fertility, yet it continues to remain underexplored. With DNA Genotek™’s OMNIgene™•VAGINAL collection kit, researchers and innovators are empowered to collect stablized samples with precision to support women’s healthcare research and development of healthcare for women.
Contingent value rights are rising in a down market, helping to close the gap between buyer and seller expectations in biotech transactions.
Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
LATEST PODCASTS
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Job Trends
In the biopharma industry, engineers are pivotal drivers of innovation, helping to shape the landscape of healthcare discoveries.
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SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
DEALS
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Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday. This leaves Amgen and Sanofi at the bidding table. -
FUJIFILM Diosynth Biotechnologies is offering unique opportunities to join one of the top global CDMOs focused on solving some of the most complex healthcare challenges. -
Shares of Horizon Therapeutics are soaring in premarket trading Wednesday after the rare disease company confirmed it is being courted for a potential acquisition by three pharma giants.
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AstraZeneca and Neogene have entered into a definitive acquisition agreement in which AstraZeneca will buy all outstanding equity in the smaller company. -
Many biopharma companies raised funds in 2022, but not enough to reach their next milestone. Investors have been constricting investments, so companies needing additional funding require a larger toolbox.
WEIGHT LOSS
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This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona. -
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets. -
The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries. -
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
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Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race.
POLICY
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Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients. -
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings. -
Experts say approval of Lykos Therapeutics’ MDMA capsules for post-traumatic stress disorder would open the door to further research into psychedelic-assisted therapies. -
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. -
Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.
Results from a recent BioSpace Community Survey indicated that 67% of life science respondents are likely to look for a job in the next 12 months. With an influx of talent in the market, how can life science professionals set themselves apart to make a positive impression and land the job?
Figuring out how to become a more qualified, competitive job candidate can seem overwhelming. But here we have mentioned some career strategies to clear your confusion.
BioSpace spoke with Dr. Samuel Dyer, CEO of The MSL Society, to find out everything you need to know to become a medical science liaison.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Which channel is better when applying for jobs?
Asking great questions to your interviewer is one of the most important parts of the job interview process. Here are some top interview questions you can learn to ask.
Enhance your skills using this soft skills list to get hired. Evaluating job candidates for their soft skills rather than their technical know-how has become a top priority of employers.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma. -
The settlement agreement between the companies follows three patent-infringement lawsuits filed by Bristol-Myers Squibb over the blockbuster cancer immunotherapies. -
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer. -
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity. -
AstraZeneca has been struggling to find an effective use for its anti-CTLA-4 antibody tremelimumab. It may have finally found it.
NEUROSCIENCE
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While Biogen and Eisai’s recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer’s disease. -
Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease. -
This week, researchers published results from studies on treatments in lung disease, Alzheimer’s and various cancers. Here’s a look at that and more. -
Eisai and Biogen announced positive data from a Phase III trial in Alzheimer’s of its drug lecanemab. Still, questions remain about the drug’s implications for the future of Alzheimer’s treatment. -
The anti-amyloid approach to treating Alzheimer’s disease is seeing new life after Eisai and Biogen announced that lecanemab slowed progression of disease in a Phase III study.
CELL AND GENE THERAPY
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Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy. -
It can cure deadly diseases, save long-term healthcare costs and transform lives. But the U.S. insurance system still isn’t ready to pay for it. -
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy. -
Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month.
