The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year. Read More
In the company’s largest acquisition and potentially the fifth biggest biotech M&A ever, Gilead Sciences Inc. will acquire Immunomedics Inc. for $21 billion in a move that substantially transforms Gilead’s oncology portfolio. Read More
Though falling short of the outright takeover that some may have hoped for, Merck & Co. Inc.’s dual tie-ups with Seattle Genetics Inc. (Seagen) put the latter in solid position to shop for acquisitions of its own. Read More
LONDON – Neogene Therapeutics BV has raised $110 million in a series A round to advance development of a novel T-cell immunotherapy for treating solid tumors. Read More
A new analysis of biomarkers, superseding confusing results released in May, appears to have re-ignited enthusiasm for the experimental Alzheimer’s disease (AD) candidate, sumifilam, the lead development candidate at Texas-based Cassava Sciences Inc. Read More
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug. Read More
The BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 37% year-to-date. Read More
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001. Read More
PERTH, Australia – With the launch of its lead product, Scenesse (afamelanotide), in the U.S. and Europe, Melbourne-based Clinuvel Pharmaceuticals Ltd. is expanding its global footprint and widening its pipeline as it opens a new R&D center in Singapore and builds up its franchise in photo medicine. Read More
Ignoring industry’s threat of a lawsuit, U.S. President Donald Trump is moving forward with his plan for “most-favored nation” pricing of certain prescription drugs. The president, on Sept. 13, signed the executive order he threatened in July if industry didn’t come up with a better offer by Aug. 24. Industry did make a counter offer last month, but apparently it wasn’t enough. Read More
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection). Read More
HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments. Read More
Biopharmas raising money in public or private financings, including: Athira, Attralus, Atyr, Compass, Escape, Escient, Painreform, Resolution, Syncona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm. Read More
