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Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.
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A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
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Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA, announced the U.S. Department of Agriculture approval of NOBIVAC® NXT Canine Flu H3N2, a next-level solution to help safeguard dogs against the ongoing threat of canine influenza.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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BioSpace’s Q3 2025 U.S. Life Sciences Job Market Report reveals a turbulent quarter for biopharma hiring, with record declines in job postings, rising layoffs, and cautious employer sentiment shaping the industry’s employment landscape.
Due largely to CSL, Merck and Novo Nordisk’s reorganizations that could total about 19,350 people, Q3 cuts rose significantly year over year and quarter over quarter, based on BioSpace tallies.
Novo Nordisk strikes another deal, this time with Omeros, amid a broader pipeline restructuring that recently claimed its cell therapy work.
After beating Novo Nordisk’s semaglutide last month, Lilly’s much anticipated oral candidate orforglipron has taken down AstraZeneca’s Farxiga in a head-to-head trial.
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
The company is pursuing a Phase III trial for its topical stem cell-rejuvenating molecule that aims to reactivate hair growth.
2025 has been a busy year for Boehringer Ingelheim, which has so far inked at least five hefty partnerships—including its latest one with South Korea’s AimedBio for an antibody-drug conjugate therapy for cancer.
Bristol Myers Squibb and insitro first partnered in 2020 to develop induced pluripotent stem cell models of amyotrophic lateral sclerosis and frontotemporal dementia. Last December, BMS exercised its option for an ALS target.
The acquisition will give BioCryst an investigational injectable drug for hereditary angioedema, potentially complementing its FDA-approved oral drug Orladeyo.
After the FDA revoked Sarepta Therapeutics’ platform designation in July, Krystal Biotech is “poised to be the first major beneficiary” of this program, according to analysts at William Blair.