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 of time to a transformative program that will eliminate inspection-related…
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 statistically significant and clinically meaningful results from the phase III…
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 discovery and siRNA medicines, today announced that they have entered…
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 mild cognitive impairment or mild dementia due to Alzheimer’s disease…
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 FDA approval, BioSpace looks at four more candidates on the near horizon.…
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 disappointment in recent years—but one expert worries that communication of…
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 for $5 million upfront in January 2024.”Regeneron is pulling the…
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 age-related macular degeneration. Eli Lilly made another foray into genetic…
Biogen Grows Immunology Pipeline With Vanqua’s Anti-Inflammatory Molecule Biogen has licensed Vanqua Bio’s preclinical oral C5aR1 antagonist in a bid to pump up its immunology pipeline.Under the terms of the deal, Vanqua will receive a $70 million upfront payment, with…
CHINA NMPA ACCEPTS NEW DRUG APPLICATION FOR HS-10365 CAPSULES FOR THE TREATMENT OF RET FUSION-POSITIVE NSCLC Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announces that the New Drug Application(NDA) of the Group’s innovative drug “HS-10365 capsules”, a potent…
Arcturus Plunges on ‘Mixed’ Cystic Fibrosis Data for Inhaled mRNA Drug Arcturus Therapeutics’ inhaled mRNA therapy ARCT-032 failed to show meaningful improvements in lung function in a Phase II trial for cystic fibrosis, sending the company’s shares tumbling by nearly…
MERS-CoV virus isolate added to the WHO BioHub System, enabling further research and pandemic preparedness Through the BioHub, countries can voluntarily share and request biological materials with epidemic or pandemic potential. This initiative, set up by the Director-General of WHO…