FDA Rejects Regeneron’s Eylea HD Citing Manufacturing Deficiencies.
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 Faces Operational Strain Amid Government Shutdown, Causing Delays for Biopharma Companies
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 Small and Mid-Cap Pharma Companies Ripe for M&A Deals
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…
A Disrupted Flu Season Tests Biopharma’s Resilience and Redefines Vaccine Strategy
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…
Pharma Companies Hope FDA PreCheck Program Will Reduce Facility-Related Drug Rejections
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…
Roche Announces Positive Phase III Results for Gazyva in Idiopathic Nephrotic Syndrome
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 and Empirico Partner on First-in-Class Oligonucleotide for Respiratory Diseases
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 Approves LEQEMBI® (lecanemab) for the Treatment of Early-Stage Alzheimer’s Disease.
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…
Four Huntington’s Disease Therapies Racing to Catch Up with UniQure
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 Offers New Hope for Patients, Though Experts Advise Caution
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 Drops 2seventy’s CAR T Cell Therapy for Lymphoma in Strategic Shift
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 Strengthens Gene Therapy Pipeline With Up to $262 Million Adverum Acquisition
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…