Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna.
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
Moderna Inc.’s and Pfizer Inc.-Biontech SE’s COVID-19 bivalent boosters could be coming to the U.S. in the first week or so of September – even though the U.S. FDA just received the completed emergency use authorization (EUA) requests for the vaccines this week. The CDC is already taking pre-orders from providers, states and other jurisdictions for the yet-to-be authorized booster doses as part of its fall-winter booster campaign strategy. It also scheduled a Sept. 1-2 meeting of its Advisory Committee for Immunization Practices, signaling that it expects the FDA to grant the EUAs by the end of August.
While other COVID-19 vaccine makers are developing bivalent boosters comprising the original SARS-CoV-2 strain and an omicron variant, Russia’s Gamaleya National Research Center of Epidemiology and Microbiology is trekking a different course. Leaving behind the ancestral strain, Gamaleya’s next generation of the Sputnik V vaccine has been specifically adapted against delta and omicron variants of the coronavirus.
It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
Pfizer Inc. plans to pay about $5.8 billion – total equity value – for Global Blood Therapeutics Inc. (GBT) and its oral sickle cell disease (SCD) treatment Oxbryta (voxelotor). The company reported the enterprise value as $5.4 billion, which includes debt and net cash. If completed, the GBT buy would be the second largest M&A in 2022 after Pfizer’s $6.7 billion buyout of Arena Pharmaceuticals Inc. Oxbryta, which netted about $195 million in sales in 2021, gained U.S. FDA approval in November 2019 for the treatment of SCD in adults and pediatric patients ages 12 and up. The FDA later expanded Oxbryta’s approved uses to SCD patients 4 years of age and older in December 2021.
