The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Alphamab, CSPC, Nrx, Oncolyze, Oncotelic, Oncternal, Samsung, Simcere.
Be careful who you’re doing business with. That’s the warning the U.S. Court of Appeals for the District of Columbia Circuit sent this week to multinational drug and device companies doing business in terrorist hot spots around the world. Reversing a lower court, the D.C. Circuit cleared the way Jan. 4 for 21 drug and device companies to potentially be held accountable for doing business with Jaysh al-Mahdi terrorists, operating through the Iraqi Ministry of Health, who injured or killed hundreds of U.S. troops and civilians in Iraq.
Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.
A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.
After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.
Pfizer Inc.'s oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Great Britain after the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorization for the medicine, called Paxlovid (PF-07321332, ritonavir).
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lexicon, Mesoblast, Xeris.
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