Astrazeneca plc’s Alexion rare diseases unit has taken an option to buy all remaining equity in Caelum Biosciences Inc., adding a rare disease drug to its pipeline in a deal worth $500 million. At the center of the deal is CAEL-101, a potentially first-in-class monoclonal antibody designed to tackle the toxic amyloid deposits that build up in organs of people with the rare disease light chain amyloidosis.
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.
Astrazeneca plc and Merck & Co. Inc. have data for a new indication for their blockbuster PARP inhibitor class drug Lynparza (olaparib) in advanced prostate cancer in combination with standard abiraterone therapy. The companies said the Propel phase III study testing Lynparza in combination with abiraterone showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival in first-line metastatic castration-resistant prostate cancer vs. standard abiraterone care.
A second activist investor has questioned the leadership of Glaxosmithkline plc’s CEO Emma Walmsley, after Bluebell Capital Partners Ltd. took a reported £10 million (US$13.7 million) stake in the embattled U.K. pharma.
Bluebird Bio Inc. has completed a rolling BLA filing of beta-thalassemia gene therapy beti-cel in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
Pfizer Inc. and Biontech SE have announced new data that could pave the way for childhood COVID-19 vaccine programs, with findings of a trial showing their shot is safe and effective in children of 5 to 12 years of age.
European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
Chicago-based Vanqua Bio Inc. has raised $85 million in series B financing to accelerate development of its therapies tackling Parkinson’s and other neurodegenerative diseases. Founded in 2019, Vanqua’s technology is focused on developing small-molecule activators of glucocerebrosidase, an enzyme that regulates levels of lipids in cells.