Biotech veterans weigh in on getting drugs through Gottlieb’s FDA
September 28, 2017
By Neozene

What are the comparative advantages of “breakthrough,” “fast track” and other FDA designations? Is the agency becoming more amenable to approving drugs based on small phase 2 studies? And how will these and other FDA policies change under new commissioner Scott Gottlieb? Those were some of the questions addressed by three biotech veterans who spoke at the second annual FierceBiotech Drug Development Forum in Boston this week. All brought different perspectives to the issue of how companies can chart the clearest path to drug approval, but they all agreed on

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Pfizer leads Big Pharma’s emerging markets growth as GlaxoSmithKline, Eli Lilly lag
September 26, 2017
By Neozene

Big Pharma’s businesses in emerging markets grew 6.1% sequentially in the second quarter, the fastest in more than two years, according to a recent tally by Bernstein analysts, but some grew much faster than others. AstraZeneca, GlaxoSmithKline, Eli Lilly, Merck & Co., Novartis, Pfizer, Roche and Sanofi together turned in that growth, and it’s a strong trend when compared with the 0.1% in sales growth these drugmakers managed to cultivate from the U.S. and the rest of the world. Pfizer enjoyed the fastest emerging markets growth, at 7%, driven primarily

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FDA slaps enrollment hold on 2 Tecentriq studies after Keytruda myeloma trial deaths
September 19, 2017
By Neozene

Keytruda’s stumble in multiple myeloma has hit another of its peers. Roche said Friday that, because of deaths in Keytruda’s combo trials with Celgene medications, the FDA put a partial hold on certain Tecentriq studies so it can assess the situation. Roche is studying Tecentriq in multiple cancers, but it’s phase 1b and phase 1/2b studies in relapsed or treatment-resistant multiple myeloma and follicular lymphoma that are now on a partial hold as the FDA checks for a potential classwide safety concern—or an issue only with certain drug combos. Back

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