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With Bayer's new launches in infancy, Eylea and Xarelto still rule its pharma business—but for how long?Bayer is gradually shifting its pharma focus to a group of new blockbuster candidates and novel platforms. But before those drugs realize their potential, eye med Eylea and blood thinner Xarelto rema2022/3/2
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Gilead's HIV prospect lenacapavir hits FDA approval snag amid vial compatibility concernsAfter a quality glitchscuppered multiple trials of an investigational HIV drug late last year, Gilead Sciences vowed to sort out the problem swiftly. Now, the drug also faces a hurdle on its path to2022/2/28
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FibroGen’s roxadustat safety mess draws SEC scrutiny as AstraZeneca-partnered anemia drug remains in limboFibroGen and partner AstraZeneca have yet to figure out an FDA path for their once-rejected anemia drug roxadustat. And now, another regulator is piling into the mess. FibroGen received a subpo2022/2/28
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Johnson & Johnson, Moderna set to face shareholder votes on vaccine pricing strategy, manufacturing tech sharingThroughout the global push to produce COVID-19 vaccines, pharma companies have frequently come under fire for unequal access to their shots. Oxfam, in a bid to force better access, has scored a pair2022/2/24
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AbbVie advances major depressive disorder ambitions for Vraylar with hopes for $4B-plus in salesAbbVie’s Allergan-acquired antipsychotic medicine Vraylar is alreadygoing gangbusters in its twoapproved indications. An expansion into tough-to-treat depression, meanwhile, would only build on the m2022/2/24
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Moderna taps Thermo Fisher for 15-year mRNA production pact for COVID vaccines and moreIn the third year of the pandemic, mRNA specialist Moderna is marshaling one of its tried-and-true manufacturing partners to lock up production of its COVID shot for years to come. Modern2022/2/22
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Biohaven lines up rhinosinusitis patients for trial of its migraine med Nurtec ODTEven in a crowded field full of formidable competitors, Biohaven has set itself apart with migraine medication Nurtec ODT just two years after it was approved. Now the company has another2022/2/22
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ASCO GU: J&J plays up precision therapy approach for Zejula's prostate cancer bid after mixed resultsIn 2017 and 2020, Zejula snagged broad FDA labels for ovarian cancer patients who responded well to a chemotherapy. But in prostate cancer, the PARP inhibitor appears to work only for a niche populat2022/2/16
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ASCO GU: AstraZeneca, Merck’s Lynparza one-ups J&J’s Zejula with prostate cancer win regardless of gene mutationsAstraZeneca and Merck & Co.’s Lynparza may have a narrower label than GlaxoSmithKline’s rival drug Zejula in ovarian cancer, but in prostate cancer, the situation could flip. Adding L2022/2/16
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After Califf survives narrow Senate vote, FDA nominee looks set to be confirmed this weekStanding alongside a poster of a young constituent, former West Virginia University cheerleader Lauren Cole, who died of an opiate overdose, West Virginia Senator Joe Manchinexplainedwhy he opposed t2022/2/14