Sen. Cassidy: Time for US FDA to reclaim its Orange Book duties
Oct 2, 2024 · It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner …
By the numbers: US leads charge of cell and gene therapies
Oct 22, 2024 · By the numbers: US leads charge of cell and gene therapies. Oct. 22, 2024. By Marian (YoonJee) Chu. U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and ...
Kent Imaging looking to raise $25M for wound care devices
Oct 1, 2024 · Kent Imaging Inc. is looking to raise $25 million in a series B financing round to expand the use of its imaging device for measuring wound and tissue oxygenation, and to support the launch of a new product, Pierre Lemire, CEO, told BioWorld. Nearly $3.8 billion was earned by Novo Nordisk A/S and Eli Lilly and Co. in the third quarter for their ...
Apimeds prices $11.5M IPO for bee venom-based therapy
Sep 30, 2024 · Apimeds prices $11.5M IPO for bee venom-based therapy. Sep. 30, 2024. By Marian (YoonJee) Chu. Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
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Regulatory front. Nearly $3.8 billion was earned by Novo Nordisk A/S and Eli Lilly and Co. in the third quarter for their glucagon-like peptide-1 (GLP-1) drugs to treat obesity.... BioWorld. Today's news. Analysis and data insight. Clinical. Data Snapshots. Deals and M&A.
Complete Genomics seeks way out of Biosecure Act | BioWorld
Oct 9, 2024 · With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove ...
Chemistry Nobel awarded for 3D protein design, prediction work
Oct 9, 2024 · David Baker, Demis Hassabis and John Jumper share the 2024 Nobel Prize in Chemistry for their contributions to the science of protein structure. David Baker was awarded half the prize “for computational protein design,” according to the Royal Swedish Academy of Sciences. Hassabis and Jumper shared the other half “for protein structure prediction.”
Biopharma financings surge to $86.2B in 2024, with $8.7B in …
Oct 4, 2024 · Biopharma financings continued to outperform over the first nine months of 2024, hitting $86.2 billion, a 75% increase from the $49.35 billion raised during the same period in 2023. September alone saw a significant boost from the prior month, with financings more than doubling to $8.7 billion from $3.5 billion in August.
Astrazeneca’s AZD-6234 prompts body weight loss due to …
Sep 18, 2024 · Astrazeneca’s AZD-6234 prompts body weight loss due to reduced food intake. Sep. 18, 2024. Amylin is a hormone co-secreted with insulin in the pancreas that has anorexigenic effects, since it promotes satiety and reduces food intake. Amylin analogs and dual agonists of the amylin and calcitonin receptors have been developed for treating obesity.
US FDA clears Cobenfy, first new schizophrenia drug in decades
Sep 27, 2024 · The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies.