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AstraZeneca beats back investor lawsuit over COVID-19 vaccine testing woesAstraZenecastumbled several timesduring the testing and rollout process for its COVID-19 vaccine and never securedan authorization in the U.S. Upset overinvesting losses, some AZ shareholders opted t2022/9/15
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Novartis touts Cosentyx win in debilitating skin condition. Can it challenge AbbVie's Humira?Among its dozen FDA approvals for a variety of autoimmune disorders, AbbVie’s Humira has plenty of competition in most of its indications. In the debilitating skin condition hidradenitis suppurativa2022/9/15
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Novartis dodges Gilenya kickback claims—again—after whistleblower lawsuit dismissedFor the second time in as many years, Novartis has dodged claims it paid doctors kickbacks at “sham” speaker programs to boost prescriptions of its multiple sclerosis blockbuster Gilenya.2022/9/13
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OTC birth control could be on the way from Perrigo, as FDA gathers expert panelAmericans might soon get their hands on a birth control pill, no prescription needed. A joint FDA advisory committee meeting isscheduledfor November 18 to review Perrigo’s application for2022/9/13
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FDA rejects Alvotech's Humira copycat on manufacturing issuesThe FDArejectedAlvotech’s application to approve its biosimilar copycat drug of AbbVie’s blockbuster immunology asset Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing pla2022/9/9
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Orca Bio, hunting cell therapy's production white whale, tees up new commercial plantWith manufacturing a major hang-up for cell therapies, late-stage player Orca Bio is also looking beyond the clinic. Orca, focused on development of precision cell therapies for cancer, g2022/9/9
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Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospectAmneal Pharmaceuticals hasfiledfor FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. With Amneal hitting its third-quar2022/9/6
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Fierce Pharma Asia—Biocon's biosimilar production faults; Fosun unit's PD-1 plan; Takeda-Finch IBD severanceBiocon'sbiosimilar manufacturing sites were hitwith several FDA Forms 483. Fosun Pharma's Shanghai Henlius Biotech is looking for a U.S. partner for its PD-1 inhibitor as the company shifts focus fro2022/9/6
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AstraZeneca scores injunction to temporarily halt former exec's start at crosstown rival GSKAstraZeneca has logged a last-minute victory—for now—in its executive tug of war with GSK. Just hours before outgoing AZ exec Chris Sheldon was set to take up his post at crosstown rival2022/9/1
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Bayer’s BlueRock inks cardiovascular cell therapy delivery dealBayer’s BlueRock Therapeutics haspartneredwith BioCardia on the delivery of cell therapies, paying a “sizable” upfront fee to access minimally invasive technology that could get its heart failure can2022/9/1