Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
The German conglomerate announced a licensing agreement with Puhe BioPharma for a PRMT5 inhibitor used in a variety of cancers. Financial details of the deal were not disclosed.
WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II FORWARD-53 trial. Wave plans to file for accelerated approval of the candidate in 2026.
Donald Trump’s proposed tariffs on the EU would increase manufacturing costs for pharma companies and would stall medical innovation, according to the results of a recent survey by the Biotechnology Innovation Organization.
Eisai’s new fiscal 2027 forecast for Leqembi is roughly 50% lower than its projections a year ago.
Blujepa, which treats UTIs in female patients aged 12 and up with common and uncomplicated infections, will hit the market in the second half of this year.
Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency.
President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
With crucial lessons learned from the manufacturing shortages of injectable GLP-1s, experts say securing adequate supply of the upcoming oral options will be the sector’s next great challenge.
AbbVie’s Humira was the top-selling drug in the world for many years. Now, its sales are eroding as doctors switch to biosimilars and new options enter the market.
After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s.
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products
— Veteran Physician-Scientist Brings Over 25 Years of Pulmonary and Cardiopulmonary Clinical Development Leadership Spanning Pfizer, Gilead, and Aerovate Therapeutics —