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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
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When will COVID-19 vaccines be widely available? Feds lay out an ambitious timelineWith Moderna and Pfizer both reporting sky-high response rates to their COVID-19 vaccines, the pressure is on federal health officials to ensure a rapid—but smooth—rollout. Wednesday, they unveiled a2020/11/18
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Alnylam scores European approval for rare disease med Oxlumo, plans 'sustainable' access dealsAfter years of research into RNAi medicine lumasiran, rare disease drugmaker Alnylam has scored its regulatory nod for the drug, to be marketed as Oxlumo, in the ultra-orphan rare disease primary hyp2020/11/18
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CDMO August Bioservices, riding the 'onshore' movement, plots sterile injectable facility in TennesseeWith tensions running high amid COVID-19 and a trade war with China, the "onshoring" movement for drug production has escalated in recent months and seen some pretty sizable investments. Now, a Tenne2020/11/18
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Viatris' growth story hinges on M&A as China, Japan hang in the balance: analystAfter months of delay thanks to a U.S. antitrust roadblock, Pfizer and Mylan finallywrapped uptheir generics merger on Monday.Enter Viatris, which hopes the additional geographic reach offered by Pfi2020/11/17
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Celltrion plots $453M South Korean expansion to aid ambitious biosimilar pipeline push: reportSouth Korea's Celltrion has made its name recently with biosimilar copies of big-name blockbusters, and it has plans to add even more in the coming years. To get there, Celltrion is betting big on an2020/11/17