Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems. Read More
After a disappointment with the same product in another indication about two years ago, Sensorion SA met the primary endpoint in its proof-of-concept phase IIa trial with SENS-401 for residual hearing preservation after cochlear implant. Read More
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time. Read More
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria. Read More
The third day of the AD/PD 2024 conference in Lisbon started with a plenary lecture given by Professor Howard Fillit entitled, “Translating the biology of aging into new therapeutics for Alzheimer’s disease.” Fillit, a recognized neuroscientist and geriatrician, and co-founder of the Alzheimer’s Drug Discovery Foundation (ADDF), pointed to the geroscience hypothesis which postulates that targeting aging processes may result in preventive and therapeutic options for diseases of old age, including Alzheimer’s disease (AD). Read More
Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s. Read More
Several presentations at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) held in Denver from March 3 to 6, 2024, focused on childhood HIV and highlighted the lack of pediatric data. The epicenter of this pandemic in the youngest is in the southern region of the African continent. However, there are few studies for children with HIV, mostly for the northern hemisphere. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acumen, Akero, Amylyx, Arrowhead, Athira, Curasen, Inventiva, Kiora, Promontory, Regeneron, Spisparc, Vaxxinity. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Basilea, Biora, Bosplice, Calidi, Cymabay, Enumera, Gilead, Merck & Co., Nanna, Newcourt, Oncozenge, Pfizer, Psyence, Qu, Ubiquigent. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bristol Myes Squibb, Eli Lilly, Transthera, Visen. Read More
