Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for another possible AD therapy, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling submission, in pursuit of an accelerated approval, was primarily based on data from a phase IIb trial in people with early AD and confirmed amyloid pathology. Read More
Denmark’s Union Therapeutics A/S has begun a strategic collaboration with Innovent Biologics Inc. over orismilast, a next-generation oral PDE4 inhibitor for inflammatory dermatology conditions that could compete directly with Amgen Inc.’s psoriasis blockbuster, Otezla (apremilast). At the same time, the company is looking for partners in the medium term to develop the drug in the rest of the world as it bids to take on Amgen and other dermatology players such as Bristol-Myers Squibb Co. Read More
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind. Read More
LONDON – A large-scale analysis of U.S. data shows that 57% of patients with a recorded diagnosis of COVID-19 subsequently presented to their physicians with symptom(s) of long COVID. Read More
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan. Read More
Horseshoe or Rhinopolus bats in Laos carry coronavirus species with a near-identical receptor binding domain to SARS-CoV-2, according to a paper posted on the preprint server Research Square by investigators from the Pasteur Institutes of Paris and Laos. Read More
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception. Read More
New hires and promotions in the biopharma industry, including: Aarvik, Adaptive Phage, ASC, Brii, Cartesian, Enara, Esker, Genprex, Jupiter, Maia, Nanocan, Ono, SAB, Verge. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acasti, Acurx, ADC, Anheart, Aslan, Astrazeneca, Biohaven, Blue Lake, Cyanvac, Evelo, Harbour, Hua, Innovent, Intra-Cellular, Janssen, JW, Merck, Nrx, Pfizer, Phathom, Pulmotect, RDIF, Senhwa, Tyme. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astellas, Atara, BMS, Eisai, Genetx, Immunoforge, JW, Kintor, Lipidor, Moderna, Opko, Takeda, Transcenta, Ultragenyx, Vifor. Read More
