FDA Formally Rejects Regeneron’s Eylea HD Over Manufacturing Issues. Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital…
FDA Struggles to Keep Lights On Amid Shutdown as Biopharmas Begin To See Delays While the FDA continues to put out guidance documents and approve drugs, some companies are already…
5 SMID-Cap Pharmas Poised for M&A Action Mergers and acquisitions are not just for Big Pharma. A new report from Leerink Partners takes a stab at identifying the small- to…
Opinion: An Unpredictable Flu Season Brings Both Challenges and Opportunities for Biopharm vaccine The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, prevention and…
Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste…
Study shows Roche Gazyva/Gazyvaro significantly improves outcomes in pediatric and young adult patients with idiopathic nephrotic syndrome. Roche Announces Positive Phase III Results for Gazyva in Idiopathic Nephrotic Syndromeannounced today…
Gsk Partnership to advance first-in-class siRNA therapy for COPD and other respiratory diseases. GSK plc and Empirico Inc. (Empirico), a clinical-stage biotechnology company with leading capabilities in human genetics-driven target…
Health Canada Grants Authorization for LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease In Canada, lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of…
4 Huntington’s Therapies Chasing UniQure Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for…
UniQure’s Huntington’s Breakthrough Brings Hope to Patients but Experts Urge Caution Pivotal results from uniQure’s gene therapy for Huntington’s disease have brought new light to patients who have known only…
Regeneron Cans 2seventy-Acquired CAR T Candidate for Lymphoma in ‘Strategic’ Move The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets…
Lilly Dives Deeper Into Gene Therapy With up to $262M Adverum Buy The cornerstone of the deal is Ixo-vec, an intravitreal gene therapy currently in Phase III development for wet…