http://www.mmm-online.com/regulatory/topic/203/ Articles tagged with Regulatory from Medical Marketing and Media MMM mmmsubs@haymarketmedia.com no Pfizer seeks full Zoetis split, Novartis gets another NICE Lucentis indication, BI tussles with the FDA and Elsevier names a Cleveland Clinic doc EIC http://www.mmm-online.com/business-briefs-pfizer-novartis-boehringer-ingelheim-elsevier/article/294393/ Wed, 22 May 2013 15:46:35 GMT Pfizer seeks full Zoetis split, Novartis gets another NICE Lucentis indication, BI tussles with the FDA and Elsevier names a Cleveland Clinic doc EIC MMM The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer. http://www.mmm-online.com/fda-gut-checks-dtc-clarity/article/293327/ Tue, 14 May 2013 17:50:23 GMT The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer. MMM Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status. http://www.mmm-online.com/fda-move-gives-purdue-edge-in-painkiller-market/article/293166/ Mon, 13 May 2013 17:25:56 GMT Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status. MMM The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US. http://www.mmm-online.com/gsk-adds-competitor-to-copd-market/article/292934/ Fri, 10 May 2013 20:43:31 GMT The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US. MMM Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status. http://www.mmm-online.com/business-briefs-arena-takeda-teva-cubist/article/292521/ Wed, 08 May 2013 17:05:17 GMT Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status. MMM A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options. http://www.mmm-online.com/fda-streamlines-patient-access-information/article/292080/ Mon, 06 May 2013 15:58:20 GMT A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options. MMM Health-seeking consumers continue social-media push; Scioderm scores FDA's "Breakthrough" designation for bullosa agent; and GSK files NDA for airway treatment. http://www.mmm-online.com/business-briefs-manhattan-research-kpmg-scioderm-and-gsk/article/291222/ Tue, 30 Apr 2013 16:48:24 GMT Health-seeking consumers continue social-media push; Scioderm scores FDA's "Breakthrough" designation for bullosa agent; and GSK files NDA for airway treatment. MMM Sales slipped 9% during the quarter, compared to the same period last year, but analysts zeroed in on if and when the company will split and how arthritis pill Xeljanz will tackle Europe. http://www.mmm-online.com/breakup-xeljanz-plans-dominate-pfizer-earnings-call/article/291220/ Tue, 30 Apr 2013 16:32:13 GMT Sales slipped 9% during the quarter, compared to the same period last year, but analysts zeroed in on if and when the company will split and how arthritis pill Xeljanz will tackle Europe. MMM It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year. http://www.mmm-online.com/novartis-lawsuits-layoffs-and-by-the-way-earnings/article/290399/ Wed, 24 Apr 2013 19:38:13 GMT It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year. MMM Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars. http://www.mmm-online.com/amgen-sales-up-for-the-quarter-but-biosimilars-grab-buzz/article/290372/ Wed, 24 Apr 2013 16:56:02 GMT Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars. MMM