Analysts at Leerink Partners said in a Monday note that DESTINY-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.
Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson.
California-based Tempest Therapeutics is laying off 21 of its 26 full-time employees. The cuts come while the biotech is exploring strategic alternatives, including a merger or acquisition, as it tries to move its investigational PPARα antagonist into late-stage development.
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.
In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that autism could potentially be driven by certain environmental factors.
FEATURED STORIES
Long considered resistant to economic downturns, the pharmaceutical industry may face a greater challenge this time around as GLP-1s dominate and the population grows older.
Researchers in pharma and beyond have historically glommed onto a limited number of disease targets, limiting innovation. AI could change that.
Akero Therapeutics, 89bio, Boston Pharmaceuticals and more are working to bring novel treatment options for metabolic dysfunction-associated steatohepatitis to a market that could reach $16 billion by 2033.
FROM BIOSPACE INSIGHTS
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.
LATEST PODCASTS
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis talks to Tom Whitehead, co-founder of the Emily Whitehead Foundation, about how standard care, cell and gene therapies and their impact on patients.
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval.
Job Trends
As it shifts focus to a death receptor 3 (DR3) antagonist antibody, Shattuck Labs is cutting a significant number of employees before the end of the year.
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
DEALS
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While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation. -
J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry. -
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday. -
The multi-billion deal, in which Eli Lilly will acquire Scorpion Therapeutics’ STX-478 program, is a shot in the arm for PI3K treatments, which have had a mixed history over the past few years. -
On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.
WEIGHT LOSS
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Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers. -
Obesity drug developers Aardvark, Helicore and Metsera have all netted raises in the past two weeks. -
The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders. -
From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals. -
Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
FDA
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Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces. -
While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too. -
Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals. -
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings. -
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
By building and nurturing a strong personal brand, you can benefit in multiple ways, including enhancing your credibility, attracting opportunities and inspiring investor confidence.
To avoid being laid off, a third of biopharma professionals would take a pay cut and nearly a quarter would take a demotion, according to BioSpace LinkedIn polls. We spoke to several professionals about their layoff experiences and what they would—and wouldn’t—have done to keep their jobs.
Plus, learn how to handle vacation time in a new job and navigate the stress of a recent promotion to leadership.
A BioSpace LinkedIn poll showed that just 19% of respondents believe biopharma professionals need Ph.D.s for scientist roles.
Employers have adjusted to higher salaries. That also means they’ve become adamant they get specific skill sets, according to Greg Clouse, BioSpace recruitment manager.
Looking for a job in Texas? Check out these nine companies hiring life sciences professionals like you.
HOTBEDS
REPORTS
In the final instalment of our Diversity in Life Sciences series, BioSpace provides life sciences organizations with practical solutions and benchmarking data to strengthen their DEI initiatives.
BioSpace surveyed industry employers and professionals to understand what to expect from the recruitment market in 2022. What do professionals want? How difficult will it be to recruit new talent?
Get up to speed with BioSpace’s data with up-to-date info about retention, layoffs, “quiet quitting” and projections for 2023.
CANCER
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At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma. -
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures. -
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors. -
The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies. -
The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.
NEUROSCIENCE
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Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy. -
The approval comes days after Germany’s Merck KGaA confirmed it was in advanced talks to acquire SpringWorks. -
Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
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Bristol Myers Squibb clocked $10 million in sales for new schizophrenia drug Cobenfy in the fourth quarter of 2024, with the launch proceeding ahead of expectations. -
Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.
CELL AND GENE THERAPY
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Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta. -
Vertex expects to make the newly approved non-opioid pain medicine Journavx available by the end of February. -
Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
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Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies. -
Several companies—including JCR Pharmaceuticals, Denali Therapeutics and Regenxbio—have products in the pipeline that could improve treatment options for this rare disease.
