Now that the U.S. Department of Health and Human Services (HHS) has declared monkeypox a public health emergency, nearly two weeks after a similar declaration from the World Health Organization, the way is cleared for a coordinated response and emergency use authorizations to address supply challenges that could limit the availability of currently approved vaccines. It also has several companies ready to leap into the fray if their preclinical studies show a path to approval. HHS said it just shipped more than 602,000 doses of the Jynneos vaccine to states and jurisdictions, an increase of 266,000 in the past week. Read More
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief. Read More
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.” Read More
While biopharma M&As fail to keep up with prior years, the dealmaking environment remains strong, as deal values continue to grow. Through early August of this year, biopharma companies have completed 955 deals, including licensings, joint ventures and collaborations, valued at $114.5 billion, which is 7% more than last year ($107 billion) and 2% more than 2020 ($112.2 billion). Read More
The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House. Read More
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Astria, Biogen, Noema, Novavax, PDS, Pfizer, Rain, Scynexis, Union, Xortx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzex, Entrada, Incyte, Invox, F-star, Moberg, Nanoviricides, Trinity, Voyager. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Biocryst, Immunabs, Janssen, Jubilant, Panbela, Syros, Vaxcyte, Xortx. Read More
