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Newest Imbruvica 'breakthrough' tag gives J&J, AbbVie hope for expansion outside blood cancersJohnson & Johnson and AbbVie have been charging hard to rack up additional indications for star med Imbruvica in hematologic cancers. But with the med’s latest breakthrough designation, there’s ho2016/7/14
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Pfizer's bococizumab may hit the PCSK9 market just in timPfizer tallied a couple more wins in its lineup of late-stage PCSK9 trials: Bococizumab, a would-be competitor to similar meds from Amgen, Sanofi and Regeneron, beat placebo at pulling down cholestero2016/7/13
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With no time to waste, AstraZeneca sues FDA to block Crestor copycatsAstraZeneca isn’t waiting for the FDA to answer its citizen petition to block Crestor generics. With time short before the arrival of a slew of cheap rivals to its big-selling statin, the company has2016/7/13
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NICE releases ACD to not recommend AstraZeneca’s Tagrisso for NSCLC treatmentUK's National Institute for Health and Care Excellence (NICE) has published an Appraisal Consultation Document (ACD) for British pharmaceutical company AstraZeneca's Tagrisso (osimertinib). Tagrisso2016/7/12
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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