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Ex-FDA chief Gottlieb pushes for antibody manufacturing scale up as 2021 pandemic 'insurance policy'Even as COVID-19 vaccines start to creep across the regulatory finish line, supplies willbe limited for months at least. Meanwhile, antibody drugs, hailed as a crucial stopgap treatment since the pan2020/12/16
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Lilly eyes up to $2B in COVID-19 sales by year-end—plus revenue boosts in cancer, diabetes and moreEli Lilly has the rare distinction of scoring not just one, but two, FDA emergency use authorizations for COVID-19 therapeutics—and now we know what that distinction will deliver to its top and botto2020/12/15
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Pfizer/BioNTech weren't alone: Moderna COVID-19 vaccine data targeted in EMA cyberattackLooks like Pfizer and BioNTech’s COVID-19 vaccine was not the sole target of a recent cyberattack at the European Medicines Agency. ModernasaidMonday that documents from itspre-submission discussions2020/12/14
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Does AstraZeneca get enough out of its $39B deal for Alexion—and vice versa?Industry watchers have been searching their crystal balls, trying to read Alexion's future. Theyfloated several potential buyers—including Pfizer, Sanofi, Biogen and Amgen—but not AstraZeneca. So whe2020/12/14
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Pick the Commish: Hamburg, Gottlieb, Glimcher and Abernethy make the final fourThe FiercePharma voter search for FDA commissioner is now down to four—with women as three of the remaining candidates. Former FDA commissioner Peggy Hamburg, current deputy commissioner Amy Aberneth2020/12/11
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As Pfizer's first COVID-19 vaccine doses roll across the U.S., analysts size up the hurdles aheadAftera“historically eventful”fewdays for COVID-19 vaccines—featuring key meetings at the FDA and CDC, plusan emergency authorization—a massive immunization programkickedoff Monday morning. Vaccinatio2020/12/10
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Fierce Pharma Politics—Amid Pfizer, U.S. coronavirus vaccine talks, Azar suggests using Defense Production Act to snare dosesWelcome to theFiercePharmapolitical roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewherethat could affect drug pricing and howdrugmakersoperate. As Pfizer ships2020/12/10
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With Pfizer shot spoken for, U.S. snaps up 100M more Moderna COVID-19 vaccine dosesWith oneCOVID-19 vaccine authorized in the U.S. and another candidate speeding toward an OK this week, Operation Warp Speed is hustling to lock down hundreds of millions ofshots for a massive U.S.imm2020/12/8
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AvKARE bottles mix Viagra generics with antidepressant, triggering recallA generic drugmaker with a Rolodex full of federal clients is pulling an antidepressant and an erectile dysfunction med after the two were packaged together in the same bottles. Pulaski, Tennessee-ba2020/12/8
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JSR's CDMO arm plans $150M biologics facility in Research Triangle alongside unnamed pharma partnerBiologics production has mushroomed in recent years with massive investments from big biopharma and contract manufacturing alike. Just over a month after its parent company pledged to expand clinical2020/12/4