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With omicron on the prowl, FDA extends inspection pause into FebruaryThe pandemic continues to drag on the FDA’s inspection plans. Now, the regulator is prolonging an intermission that kicked off just before the new year and was pegged to conclude last week.2022/1/25
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Biogen CEO Vounatsos summons support to fight Aduhelm's paralyzing coverage decisionBiogen's take on the Centers for Medicare & Medicaid Services' (CMS') stifling coverage proposal for Alzheimer's disease drug Aduhelm? "Strong disagreement," CEO Michel Vounatsos said at the top2022/1/18
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US faces 'critical moment' in pricing reform that 'won't come again,' nonprofit founder says after tallying 554 new hikesWith 2021 over, the pharmaceutical industry kicked off the New Year with one of its favorite pastimes: raising the prices on hundreds of branded meds. Public and political scrutiny didn’t stop many o2022/1/18
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JPM 2022: Bluebird bio hopes for clear skies ahead as it gears up for trio of gene therapy launchesAfter a false start in Europe, bluebird bio is determined to give its trio of gene therapies a better shot in the U.S. Bluebird is readying the commercial nest ahead of a May decision on2022/1/14
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JPM 2022: J&J, Legend hope to avoid supply challenges that have ailed Bristol Myers' Abecma as cilta-cel nears FDA nodLegend Biotech is prepping its Johnson & Johnson-partnered, “paradigm shifting” CAR-T multiple myeloma treatment cilta-cel for launch with a global manufacturing operation, which CEO Ying Huang,2022/1/14
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JPM 2022: How Novavax plans to be a COVID-19 vaccine force in 2022Could 2022 be the year of the Novavax vaccine? Since the COVID-19 pandemic’s early days, the Gaithersburg, Maryland-based biotech has been plugging away on its shot, turning out impressive data but s2022/1/12
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JPM 2022: Bluebird CEO sees 'unfinished business' with Zynteglo in Europe, but scale-up needed firstAndrew Obenshain officially took over as bluebird bio’s CEO when the company split into two back in November. But there’s one item from his prior desk that's still on his mind: the removal of Zyntegl2022/1/12
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COVID-19 tracker: GSK, Vir to supply more antibody doses to US; BioNTech, InstaDeep develop variant early-warning systemWith the omicron variant surging, the U.S. has agreed to purchase additional doses of GlaxoSmithKline and Vir’s antibody treatment, which has been shown to retain its effectiveness against the new2022/1/10
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JPM 2022: Pfizer CEO eyes 50% boost to Paxlovid production—and capacity expansions, tooDeveloping a COVID-19 vaccine at breakneck speed was a monumental achievement for Pfizer and BioNTech. The accompanying manufacturing effort is just as onerous. Similarly, as rapidly as2022/1/10
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Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the USWith two COVID-fighting antiviral pills now on tap, the U.S. government is calling for a second helping of Pfizer’s treatment. The U.S. has doubled its order for Pfizer’s COVID-19 antivir2022/1/6