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Pfizer marks first 'mass air shipment' of COVID-19 shot amid cold-chain scrutinyPfizer, alone among its peers, has faced fever-pitchscrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the d2020/11/26
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Novavax, swamped with FDA's manufacturing 'questions,' hopes for US coronavirus shot trial within the yearWith two players in the race for a COVID-19 vaccine nearing the finish line on world-first regulatory approvals, Maryland biotech Novavax continues to lag behind in getting its candidate into a late-2020/11/26
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Fierce Pharma Politics—Canada restricts U.S. drug exports after Trump executive orderWelcome to theFiercePharmapolitical roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewherethat could affect drug pricing and howdrugmakersoperate. After President2020/11/25
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Rhythm Pharmaceuticals scores first FDA approval for obesity med targeting genetic defectsObesity is a major problem worldwide, but, for a fraction of patients, genetic mutations rather than habits are driving the disease. With its new FDA approval for Imcivree, Rhythm Pharmaceuticals is2020/11/24
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Feds on COVID-19 mRNA vaccine distribution: Pfizer's dry runs predict a 'very doable process'What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December? Alex Azar, secretary of health and human se2020/11/24
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Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defenseGilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas aboutthe drug’s worth.2020/11/23
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Fresenius Kabi recalls hospital sedative on accidental mix with lidocaine—againIn hospital settings, powerful anesthetics are often reserved for the most critical procedures, and it's important that they work exactly as intended. But Fresenius Kabi slipped on a major banana pee2020/11/20
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Newly passed House bill could close orphan drug loophole that evergreens exclusivityThe Orphan Drug Act of 1983 was intended to reward biopharma companies for developing drugs for rare diseases. But over the years, criticism has increased over unexpected misuse of the law. Now, a2020/11/20
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Samsung Biologics, AstraZeneca to dissolve biosimilar JV, scrap Rituxan copy program: reportBack in 2014, Samsung Biologics and AstraZeneca set up a joint venture to develop a biosimilar to Roche’s blockbuster cancer drug Rituxan. Fast-forward to 2020, and the pair has admitted defeat. Arch2020/11/19
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Pfizer aims to ship COVID-19 vaccine doses 'within hours' of regulatory nods, CEO says. Will a 'race to regulate' ensue?After Pfizer’s leading COVID-19 vaccine turned in strong data in a late-stage trial, the company planned to submit its program to U.S. authorities for an emergency use authorization “within days.”2020/11/19