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It's Catalyst vs. the feds as tiny drugmaker sues FDA over 'capricious' approval for rivalFor a relatively unknown drugmaker, Catalyst Pharmaceuticals has made plenty of headlines since it won approval for its rare disease drug Firdapse. And isn’t shying away from more controversy.2019/6/11
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Accidental court filing reveals Novartis' kickback settlement talks: reportAfter six years of legal wrangling and unflattering headlines, Novartis appears close to putting a doctor kickback lawsuit behind it—and the revelation came from a court filing that was supposed to b2019/6/11
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Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complicationOne brand-new FDA approval and one trial win for its blood cancer drug Gazyva added up to a double dose of good news for Roche Monday. The Swiss drugmaker snapped up a comboapproval for lympho2019/6/10
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Merck's Keytruda, passing Opdivo, bags double head and neck cancer OKTuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients. Regulatorsgreen-lightedthe immuno-oncolog2019/6/10
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J&J's struggling Invokana slashes heart, kidney risks in latest trial winSAN FRANCISCO—Johnson & Johnson and its fellow SGLT2 drug makers are all working to show benefits for patients with kidney disease. But in that group, J&J can tout data its rivals don’t have.2019/6/6
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Eli Lilly's Taltz touts long-term clear skin data after unimpressive first-quarter salesAfter undershooting analyst sales forecasts in the first quarter, Eli Lilly’s psoriasis drug Taltz is on the hot seat in an immunology market packed with blockbusters. Lilly is hoping some new data on2019/6/6
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Lilly, Boehringer's DPP-4 drug Tradjenta ties generic rival in heart safety studySAN FRANCISCO—Boehringer Ingelheim and Eli Lilly have already shown that Tradjenta doesn’t hurt patients’ hearts. But the pair is back with even more supporting evidence that they hopewill bolster th2019/6/5
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How to correct opioid misinformation? Spend $285M on countermarketing, expert says in J&J trialCountless lawsuits have sought to estimate thecosts of fixing the U.S. opioid and addiction epidemic. Now, thanks to an expert in Oklahoma's ongoing trial against Johnson & Johnson, we have one d2019/6/5
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Roche snags first-in-class FDA nod for lymphoma drug PolivyRoche has a trio of lucrative cancer blockbusters coming under a growing biosimilar attack, but now the company has scored an FDA nod for its latest cancer launch—and it's a first-in-class drug for2019/6/4
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PTC scores new Emflaza approval in DMD patients 2 and olderDuchenne muscular dystrophy (DMD) drug Emflaza had a controversial past under its previous owner, butits current captain, PTC Therapeutics, is forging ahead—and a new FDA approval could help. T2019/6/4