Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents. Read More
Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell 66.3% to $4.02 on Nov. 17 following news that its autologous cell therapy candidate, Nurown, missed the primary efficacy endpoint of a phase III amyotrophic lateral sclerosis (ALS) study. Read More
LONDON – Results from the phase I/II trial of Coronavac, a COVID-19 vaccine based on a traditional inactivated whole SARS-CoV-2 virus that circulated in China in the early days of the pandemic, show it is safe and induces an antibody response in healthy volunteers ages 18 to 59. Read More
HONG KONG – Peptidream Inc. has partnered with four other Japanese companies to research and develop peptide therapeutics capable of neutralizing the SARS-CoV-2 virus as well as potential future coronavirus outbreaks. Peptiaid Inc., the joint venture established with Fujitsu Ltd., Mizuho Financial Group Inc. subsidiary Mizuho Capital Co. Ltd., Takenaka Corp. and Kishida Chemical Co. Ltd., will have capital totaling ¥599 million (US$5.73 million) by Dec. 31. Read More
Researchers at the University of California at San Francisco have developed a method to diagnose any known pathogen from any body fluid within a day – or, depending on the sequencing method, within a few hours. For an unknown pathogen, the method spits out its nearest known relative. Read More
The latest global regulatory news, changes and updates affecting biopharma, including CDER, CBER promise EUA transparency; FDA plasma guidance updated, again; WHO targets cervical cancer; Draft guidance to help FDA respond to 2012 citizen petition; More time to comment on instituting PTAB trials. Read More
New hires and promotions in the biopharma industry, including: Assembly, Avvinity, Bexion, Cellectis, Enlivex, Imara, Immunic, Neubase, Scancell, Sophia, Syneos. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy Ophthalmology 2020 Annual Meeting Nov. 13-15, including: Clearside, Eyepoint, Innovant, Janssen, Lineage, Meiragtx. Read More
Biopharmas raising money in public or private financings, including: D3, Histogen, Hutchison, Inmed, Kodiak, Lixte, Promis, Sapience, Ysopia. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Almac, Antibe, Biomarin, Bridgebio, Bristol, Concert, Curevac, Deep Genomics, Evotec, Evox, Foresee, Genscience, Insilico, Lilly, Medison, Merck, Moderna, Myokardia, Novartis, Ocuphire, OS Therapies, Pear, Reveragen, Samsung, Storm, Treefrog, Tris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Apellis, Azurrx, BMS, CNS, Cytodyn, Inovio, Istari, Kiniksa, Moderna, Plx, Praxis, Redhill, UCB, Verrica, Viiv. Read More
