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Benefits of FDA Third-Party Review ProgrammesIt is indisputable that third-party review can speed the time to market for a 510(k) and prevent RTA. On the other hand, does the money need to be spent? Does the time to market matter? Are you sure2016/7/12
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Roche's MS med ocrelizumab hits FDA fast track, eyeing earlier-than-expected launchWatch out, multiple sclerosis drugs. The competition from Roche could arrive sooner than expected. Roche’s Ocrevus (ocrelizumab) won FDA priority review, the Swiss drugmaker said Tuesday, meaning it2016/7/11
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Free the FDA from overweening HHS bureaucracy, ex-agency chiefs sayThe U.S. Food and Drug Administration needs more power. Or it needs more autonomy. Either way, the FDA needs to come out from under the Department of Health and Human Services. That’s according to 62016/7/11
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British watchdogs suspend Astellas UK after investigations, audits, and a crackdown from Japanese HQAstellas is in bigtrouble with British pharma cops. The Japanese drugmaker’s U.K. unit has been suspended from the Association of the British Pharmaceutical Industry after sending doctors on a junket2016/7/8
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FDA panel to debate lucrative label change for Lilly's JardianceWhen Eli Lilly and Boehringer Ingelheim announced last year that their SGLT2 med, Jardiance, had become the first in that class of diabetes meds to show it could lower the risk of major cardiovascular2016/7/8
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Brexit means EMA must find a new home, and so much moreThe European Medicines Agency, the drug regulator for Europe, is headquartered in London. The problem is that the U.K. voted Thursday to leave the European Union, meaning the EMA will now have to leav2016/7/7
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Merck's Keytruda tops chemo in first-line lung cancer trialMerck & Co. just scored a point in its immuno-oncology rivalry against Bristol-Myers Squibb. The PD-1 checkpoint inhibitor Keytruda hit its goals in a new trial in previously untreated non-small c2016/7/7
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Latest Sunshine Act fact? Drug and device makers shelled out $6.5B to docs, hospitals last yearDrug and device makers handed over almost $6.5 billion to doctors and medical institutions in 2015, according to the latest release from the U.S. government’s Open Payments database. Add in various ow2016/7/6
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Spain's Almirall eyes embattled Valeant's dermatology assetsTroubled Valeant may have a buyer to help it pull off some of the asset sales it’s been touting as it looks to cut down its debt pile. Spain’s Almirall, for one, is eyeing some of the company’s meds,2016/7/6
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Jury smacks J&J with $70M in damages in latest Risperdal breast caseJohnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and the company has landed on the wrong side of a jury verd2016/7/5