Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lexicon, MBX, Novartis, Soligenix, Veru.
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
The U.S. FDA’s guidance for unique device identifiers (UDIs) is heavily adjusted to account for a device’s inherent risk class, and many class I devices are now going to enjoy another reprieve from UDI requirements per an updated FDA guidance.
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
It’s not a done deal yet, but Teva Pharmaceutical Industries Ltd. has agreed in principle to pay up to $4.25 billion, plus about $100 million to Native American tribes, to end most of the lawsuits it’s facing across the U.S. over its opioid sales. The figure includes settlements the company already has made with some state and local governments, as well as the supply of up to $1.2 billion worth of Teva’s generic naloxone nasal spray.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus, Ambu, Biotronik, Rapid Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biogen, Cidara, Editas, ERC, Genuine, GBT, GSK, Inflarx, Ionis, LFB, Novavax, Sirnaomics.
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir.
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
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