In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan. Read More
An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2. Read More
Evotec AG and Sernova Corp. are joining forces in a bid to develop a functional cure for type 1 diabetes. The companies plan to file an IND early in 2024 for a combined cell therapy and medical device product comprising Evotec’s human beta cells, derived from the company’s induced pluripotent stem cell platform, and Sernova’s Cell Pouch delivery system, which provides transplanted cells with a vascularized, physiologically appropriate environment that enables them to secrete insulin and other hormones involved in regulating blood glucose levels. Read More
Antifungals specialist F2G Ltd. has signed an agreement with Japanese pharma Shionogi & Co. Ltd. for development and commercialization of its treatment for invasive aspergillosis in both Asia and Europe. Under the terms of the deal, F2G is getting $100 million up front and regulatory and commercialization milestones of up to $380 million. The two partners will share clinical development costs. Read More
It was a patient-reported outcome, one that could actually be seen in the mirror, that alerted researchers they might be on track in their phase I/II study of cystinosis. The patient noticed that for the first time in his life his hair had become darker, like his brother’s. It was all because the rare disease inhibiting the pigment in his body was being impacted by the treatment. “It’s a secondary issue, but I find it fascinating,” Avrobio Inc.’s CEO, Geoff MacKay, told BioWorld. “When you run trials like this, you stumble upon some fascinating results.” Read More
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier. Read More
Off-the-shelf cancer vaccine specialist Nouscom AG has taken the wraps off a multiproject agreement with Janssen Research and Development LLC, after the lead candidate received FDA approval to enter clinical trials. Read More
While biopharma mergers and acquisitions are at an all-time low, a company that stood in the front battle lines fighting the COVID-19 pandemic not only completed the top M&A so far in 2022, but it also announced plans for another mega-merger shortly thereafter. Read More
Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.” Read More
New hires and promotions in the biopharma industry, including: AC Immune, Arcellx, Aum, Beyond Cancer, Civetta, Crispr, Endevica, Exo, Inversago, Mediwound, Mereo, Mirati, Nkarta, Oak Hill, Talaris, Thabor, Visiox, Xilio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atamyo, Eli Lilly, Faron, Galera, Gedeon, Inmagene, Junshi, Mitsubishi, Point, Scpharmaceuticals, Sifi, Travere, Valneva, Zenas. Read More
