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The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either...Moderna...said it was recalling one Spikevax lot in Europe...The batch contains 764,900 doses made by CDMO Rovi that were deployed across Norway, Poland, Portugal, Spain and Sweden between Jan. 13 and Jan. 14. Moderna yanked the shots because of a “foreign body” found in one vial of the batch made at Rovi’s site in Spain...READ MORE

As Nevada’s COVID-19 case rates plummet to their lowest levels since last summer, state health officials are turning more attention to therapeutic treatments for those who can’t get vaccinated or are most at risk of severe illness or death...It’s the latest step in the evolution of a nearly two-year effort to combat the virus after the omicron variant pushed caseloads to new highs in January, said Julia Peek, deputy administrator for Nevada’s Division of Public and Behavioral Health. It comes as governments across the country lift restrictions and move away from emergency measures...READ MORE

Pfizer projects it will generate record-high revenue in 2022, saying...it expects to sell $32 billion of its Covid-19 shots and $22 billion of its antiviral coronavirus treatment pill Paxlovid this year...Pfizer CEO Albert Bourla said sales of Paxlovid could be higher than the company’s guidance, but the expectations are based on deals signed or close to being signed...However, Pfizer’s fourth-quarter revenue more than doubled overall to $23.84 billion year-over-year, driven by $12.5 billion in sales of its Covid vaccine. The company’s antiviral pill that fights Covid, Paxlovid, contributed $76 million in U.S. sales during the fourth quarter...READ MORE

Nearly 4,000 people may have received a slightly less than recommended dose of the Pfizer COVID-19 vaccine at a Kaiser Permanente location in California last year. The health system is offering repeat vaccinations to anyone affected...The vaccinations were given at the Kaiser Permanente Walnut Creek Medical Center...Individuals may have received between 0.01 and 0.04 milliliters less than the correct 0.3-ml dose. The health system reportedly said the incident was a misunderstanding among staff, which it has retrained, and is contacting patients about the error...READ MORE

Thirty five generic drugmakers around the world will make cheap versions of Pfizer Inc's highly effective COVID-19 oral antiviral Paxlovid to supply the treatment in 95 poorer countries, the U.N.-backed Medicines Patent Pool said...Pfizer struck a deal...with the group to allow generic drugmakers to make the pills for 95 low- and middle-income countries...Paxlovid is expected to be an important tool in the fight against COVID-19 after it reduced hospitalizations in high-risk patients...Merck, on its own and through the MPP license, has deals with dozens of drugmakers to make its pill...available in some countries...Read More

Those working in the healthcare sector saw smaller average wage increases during the first 15 months of the pandemic compared to workers across other industries, according to a recent analysis of U.S. Bureau of Labor Statistics data...Average wages in healthcare rose 5% from 2019 to 2020 while all industries’ average wages rose 6.7% during the same time...The difference was broader when looking at the first six months of 2021, when healthcare and all industries’ average wage increases were 1.5% and 6.9%, respectively...READ MORE

Doctors and hospital leaders are pushing back against a package of Republican bills that seek to bar health care providers from withholding unproven treatments for COVID-19...The three bills released this week would prevent health systems and medical credentialing boards from disciplining doctors for ordering or advocating for therapies or medicine for patients that go against medical opinions held by their employers or regulators...
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Less than three weeks after two companies sued Moderna, claiming the vaccine maker infringed on their patents in developing its COVID-19 shot, Alnylam has done the same, suing Moderna and Pfizer in separate lawsuits...In...federal court, Alnylam filed claims against the two COVID-19 vaccine producers alleging that more than a decade ago it invented the delivery technology employed by both shots...Alnylam says its Patent No. 11,246,933 covers “a breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles that carry and safely deliver” mRNA-based vaccines...Alnylam is not attempting to halt production of the vaccines, it is seeking damages for the “defendants’ wrongful acts in an amount to be determined at trial” and royalties...READ MORE

Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the messenger RNA vaccine giant for infringement, but when. Now...Arbutus and Roivant’s Genevant Sciences on Monday filed a lawsuit against Moderna in the U.S. District Court for the District of Delaware. In their suit, the companies seek damages for infringement on six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine...The patents relate to nucleic acid-lipid particles and lipid vesicles, plus compositions and methods for their use...READ MORE

Florida has been forced to shut down sites administering monoclonal antibodies, which have been widely used as supplemental treatment for Covid-19, after the FDA revoked authorization for distribution...“This evening, without any advanced notice, the U.S. Food and Drug Administration revised the Emergency Use Authorization for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States,” a press release from the Florida Department of Health read...“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” it continued...READ MORE