Adam Lenkowsky, chief commercial officer for Bristol Myers Squibb Co. (BMS), said his firm plans to launch Karxt (xanomeline-trospium) in the U.S. as soon as it’s approved by the U.S. FDA, and “expect[s] to accumulate sales in early 2025.” BMS tied a bow on the year by disclosing its plan to pay $330 per share to take over Karuna Therapeutics Inc. in a deal valued at $14 billion to bring aboard Karxt, which acts as a dual M1/M4 muscarinic acetylcholine receptor agonist. The FDA has assigned Sept. 26, 2024, as the PDUFA date for Karxt as a new treatment for schizophrenia in adults. Read More
A new self-injectable therapy for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) will be available in January 2024 now that the U.S. FDA has approved Ionis Pharmaceuticals Inc.’s Wainua (eplontersen), a ligand-conjugated antisense oligonucleotide. Read More
What Piper Sandler analyst Christopher Raymond called the “shocking” decision by Allovir Inc. to scrap development of posoleucel – which had advanced to three phase III trials – for all indications sent shares of the firm (NASDAQ:ALVR) in a tailspin, closing Dec. 22 at 76 cents, down $1.56, or 67%. Read More
As its pharma peers continue to place big bets on antibody-drug conjugates (ADCs), Sanofi SA is ditching the only advertised ADC program in its pipeline, after it failed an independent interim analysis. Read More
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July. Read More
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma. Read More
The biopharma industry is still adjusting from the heady days of the COVID-19 pandemic, and nowhere is this so apparent as in financings. The value of financings has returned to what could be called a new normal, down from the surge of capital seen in 2020-2021. However, there are signs that the trend is heading back upward at a steady pace. Read More
In November, investigators at the Chinese Academy of Sciences reported generating a chimeric monkey by injecting an embryonic stem cell into the morula, which is an extremely early embryo consisting of 16 to 32 cells. Read More
If two recent reports about the NIH’s oversight of its grant programs were grades, the U.S. agency would have received failing marks – again. Read More
In November, the U.S. FDA approved a total of 12 drugs, a decrease from 27 the previous month that marked the highest number of approvals since June 2020, as reported by BioWorld. From January to November, FDA approvals reached 167, an increase of 21.9% from 137 drugs approved during the same time period the previous year. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adimab, AFT, Alpine Immune, Astellas, Genovior, Hyloris, Immunoscape, Juniper, Linkedup, Mithra, Polaris, Propella, Rafa, Shionogi, Tianti. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Arch, Arrowhead, Biontech, Calliditas, Clene, Gracell, Immutep, Johnson & Johnson, Matinas, Merck, Northwest, Ocugen, Ocumension, Rennexion, Sellas, Serum Institute of India, University of Oxford. Read More
