Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
Alexion Pharmaceuticals Inc. has demonstrated the commercial potential for rare disease drugs with its complement inhibitor Soliris (eculizumab) and long-lasting follow-up Ultomiris (ravulizumab) driving blockbuster sales. A host of other companies are hoping to compete with Ultomiris, which is U.S. FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Satellite Biosciences Inc. has become the latest biotech to emerge from stealth, backed with more than $110 million in VC financing to develop bioengineered tissues that fix damaged tissues or organs. With former Novartis executive Dave Lennon leading as CEO, the Cambridge, Mass.-based company is hoping to find therapies for hard-to-treat diseases.
Satellite Biosciences Inc. has become the latest biotech to emerge from stealth, backed with more than $110 million in VC financing to develop bioengineered tissues that fix damaged tissues or organs. With former Novartis executive Dave Lennon leading as CEO, the Cambridge, Mass.-based company is hoping to find therapies for hard-to-treat diseases.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
Oncology specialist Affimed NV is pushing forward with clinical development of technology that encourages natural killer cells to attack solid tumors. The move, supported by data the company presented at the annual meeting of the American Association for Cancer Research (AACR), is backing its creation of “innate cell engager” molecules.
After a difficult start, there’s been more progress in PIK3 drug class, with FDA approval of Novartis AG’s Vijoice (alpelisib) for the rare condition PIK3CA-related overgrowth spectrum (PROS).
Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant.
Astrazeneca plc and Ionis Pharmaceuticals Inc. have unveiled some eye-catching figures from their cholesterol drug, AZD-8233, in a phase IIb trial, taking aim at the PCSK9 inhibitor market where Novartis AG, Sanofi SA/Regeneron Inc. and Amgen Inc. are vying for supremacy.
