Pharmacyte Biotech Inc. has raised $90 million to move its live cell encapsulation technology for cancer and diabetes further into the clinic. CEO Kenneth Waggoner told BioWorld that the first task is to work through studies and gather other information required by the FDA to get a clinical hold, imposed last November, lifted on trials in pancreatic cancer.
A potential new treatment for the rare condition Wilson disease moved a step closer to reality after Alexion Pharmaceuticals Inc., now part of Astrazeneca plc, announced positive top-line results from a phase III trial of ALXN-1840 (tiomolibdate choline). Astrazeneca’s shares (NASDAQ:AZN) ticked up following the announcement, closing Aug. 26 at $58.76, up 18 cents. From the point of view of the big U.K. pharma, it’s a good piece of news as it hopes to build a rare disease franchise from its $39 billion acquisition of Alexion, which was completed last month.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
Atavistik Bio Inc. has raised $60 million in a series A financing round to advance its preclinical molecules targeting genetically validated targets in metabolic diseases and cancer.
The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company.
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.
A month after Astrazeneca plc’s $39 billion takeover of Alexion Pharmaceuticals Inc. was finalized, the merged company has hit its first speed bump after the new unit discontinued a phase III rare disease trial. Alexion, of Boston, said it axed the 382-patient CHAMPION-ALS trial of its long-acting C5 complement inhibitor Ultomiris (ravulizumab) in amyotrophic lateral sclerosis (ALS).
Visus Therapeutics Inc. has expanded its ophthalmic drug portfolio, in-licensing investigational therapies for glaucoma and age-related macular degeneration from Cella Therapeutics LLC, which will be developed by Finland’s Delsitech Ltd. using its extended-release depot technology.
Exevir Bio NV is honing its attack on the crowded market for COVID-19 antibodies, beginning clinical development of a potential subcutaneously administered drug targeting outpatients with early symptoms who are at risk of further progression.
Aurinia Pharmaceuticals Inc. has added two potential drugs to its pipeline targeting autoimmune and kidney-related diseases through an acquisition and a licensing deal. Victoria, British Columbia-based Aurinia is building on its first ever FDA approval at the beginning of the year, for Lupkynis (voclosporin) for treating active lupus nephritis in adults.
