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Flu shot makers delivered a record 194 million doses to the U.S. last season as public health experts warned against the dreaded overlap between the two pathogens. Flu vaccine demand skyrocketed. ... This season, flu shot makers are again gearing up for another record year, with deliveries set to match the historic figures reported in 2020. Despite the widely deployed COVID-19 vaccines from Pfizer, Moderna and Johnson & Johnson, this flu season could prove just as precarious as society tries to roar back to pre-pandemic life, vaccine execs contend. (Higgins-Dunn, 8/25)

Sesen Bio, a small biotech firm whose investigational cancer treatment once seemed poised for approval, said Wednesday that it had withdrawn its application to market the drug in Europe. The news follows the Food and Drug Administration’s decision to reject Sesen’s drug, called Vicineum, on Aug. 13. (Garde, 8/25)

This could have been Elizabeth Holmes’ moment. When the then-19-year-old founded Theranos in 2003, she promised to put patients in control of their own health. Her Edison machine would allow anyone to go to the pharmacy, order a cheap diagnostic test, and walk out knowing answers were on the way — no doctor’s note required. That future is now. During the pandemic, millions of people ordered up their own Covid-19 tests. As testing appointments became scarce, they swabbed their own noses at home and shipped their samples to labs. And with the Delta variant surging, 15-minute, over-the-counter antigen tests are flying off pharmacy shelves. (Palmer, 8/26)

KHN: Apple, Bose And Others Pump Up The Volume On Hearing Aid Options, Filling Void Left By FDA

Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017 to allow over-the-counter sales, with hopes it would boost competition and lower prices. Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief. In August 2017, President Donald Trump signed the legislation that called for the Food and Drug Administration to issue regulations by 2020 for hearing aids that could be sold in stores without a prescription or a visit to an audiologist or other hearing specialist. That hasn’t happened yet, and President Joe Biden last month ordered the FDA to produce those rules for over-the-counter (OTC) purchases by mid-November. That means it will likely take at least until next summer for consumers to feel the direct effects of the law. (Galewitz, 8/26)