Shares of TG Therapeutics Inc. (NASDAQ:TGTX) were trading midday at $9.31, up 88 cents, or 10.4% as Wall Street heard of preparations for the would-be launch of ublituximab for relapsing multiple sclerosis (MS). A glycoengineered anti-CD20 monoclonal antibody, ublituximab bears a Dec. 28 PDUFA date. Late-cycle review talks are done and initial labeling talks are underway with the U.S. FDA, TG said.

SITC 2022: Business is shaky, but science is groundbreaking for engineered T-cell study

In August, Pact Pharma Inc. suspended its phase I trial after 16 patients had been treated with its autologous CRISPR-edited T cells “for business reasons,” the company announced at the time. Scientifically, though, the trial broke enough new ground to be concurrently presented in a late-breaking oral session at the 2022 annual meeting of the Society for the Immunotherapy of Cancer (SITC) and published as an accelerated article preview in Nature on Nov. 10, 2022.

GSK to limit Zejula in second-line maintenance treatment

GSK plc said it will restrict the second-line maintenance indication for its PARP inhibitor, Zejula (niraparib), to only patients with deleterious or suspected germline BRCA mutations, at the request of the U.S. FDA. The move follows a regulatory review of final overall survival analysis of the phase III ENGOT-OV16-NOVA trial. Shares of GSK (NYSE:GSK) were down more than 5% in early afternoon trading.

Immutep’s LAG-3 efti meets primary endpoint in first-line NSCLC in combination with pembrolizumab

Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%.

Newco news: Atriva taking host-targeted antiviral approach into basket study

Atriva Therapeutics GmbH, a small firm founded in 2015 to develop a host-targeted antiviral approach for treating respiratory viral infections, seems to have found itself in thick of it. As the U.S. CDC and other health agencies warn of an uptick in respiratory viral infections – the so-called “tripledemic” of influenza, respiratory syncytial virus and COVID-19 – the German company is gearing up to launch a basket trial testing lead candidate zapnometinib in all three indications.

FTC promises to get tough on anticompetitive tactics

Acting on its new promise to restore “rigorous enforcement” of the U.S. ban on unfair methods of competition, the FTC filed an amicus brief Nov. 10 supporting Avadel CNS Pharmaceuticals LLC’s motion to delist a Jazz Pharmaceuticals Inc. patent from the FDA’s Orange Book.

SEC targets two men for insider trading

Viatris Inc.’s chief information officer, Ramkumar Rayapureddy, is facing an SEC insider trading complaint, along with criminal charges brought by the fraud division of the U.S. Department of Justice. Another man, Brian Wong, was charged with illegal trading ahead of Merck & Co. Inc.’s acquisition of Pandion Therapeutics Inc.

Hong Kong is a fertile ground for health care robotics

Easy access to financing, talent, and connection to big potential markets are Hong Kong’s advantages to develop the health care robotics industry, according to speakers at the Asia Summit on Global Health. “The appetite for risk in funding, especially venture capital, is very low in the majority of Europe. Asia is proving to be an excellent market to try to pitch some of the technologies that are maturing quickly,” said Ferdinando Rodriguez y Baena, professor of medical robotics in the department of mechanical engineering at Imperial College London. “I had the opportunity to see mainland China, Hong Kong and Taiwan. I have to say it is the most fertile ground for this sort of high-tech commercialization that I have seen.”

Also in the news

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