Pfizer Inc. may have a blockbuster on its hands with the U.S. FDA’s approval of Velsipity (etrasimod), a selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). Read More

Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down. Read More

Precision cancer biotech Abion Inc. announced a positive interim phase II readout for ABN-401, its novel c-mesenchymal-epithelial transition (c-MET)-targeting tyrosine kinase inhibitor (TKI) for advanced non-small-cell lung cancer (NSCLC), lighting a runway to its next trial as a combination regimen. Read More

Through Q3 2023 biopharma values are down 4.5% year over year, with 1,007 deals valued at $130.58 billion this year, compared to 1,179 deals worth $136.73 billion in the same time period in 2022. Biopharma deals have averaged $14.51 billion per month this year, a decrease from 2022’s average of $17.18 billion per month. September deals outpaced the average of both years, reaching $18.46 billion. Read More

Drug discovery in Japan has been steadily declining, and it has reached a crisis point where swift action is needed or pharma companies will leave Japan or stop listing products here, said speakers at the BioJapan 2023 meeting held Oct. 10 to 13 in Yokohama, Japan. Read More

With shares dropping again, this time more than 15% on Oct. 13, Cassava Sciences Inc. has found itself entangled in a mess involving short-sellers, data that were allegedly mishandled involving its oral Alzheimer’s disease (AD) candidate simufilam, and a leaked investigation report from the City University of New York (CUNY). Read More

Biopharmas raising money in public or private financings, including: Edesa, Innocan. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Akeso, Allorion, Alzecure, Annovis, Asieris, Aviceda, BMS, Carsgen, Clearb, Cyrano, Cyteir, Dermavant, Eli Lilly, Escient, Ferring, Genentech, Hanall, Hansa, In8bio, Sun, Systimmune, Theratechnologies, Ultimovacs. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canariabio, Rational Vaccines, Specialised Therapeutics Asia, Theratechnologies. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Mimivax, Pepgen, Pfizer, South Rampart. Read More

Total raised in public, private and other financings of biopharma companies, comparing 2023 vs. 2022 vs. 2021 vs. 2020 vs. 2019. Read More

Year-to-date money raised in public, private and other financings of biopharma companies. Read More