The Search is Over: Struggling Teva Finally Gets a New CEO
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-teva-kare-schultz.jpg" NAME"The Search is Over: Struggling Teva Finally Gets a New CEO" ALT"The Search is Over: Struggling Teva Finally Gets a New CEO"September 11, 2017By Alex Keown, BioSpace.com Breaking…
Why This Bay Area Biotech Could be a Cash Cow for Investors
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks.jpg" NAME"Why This Bay Area Biotech Could be a Cash Cow for Investors" ALT"Why This Bay Area Biotech Could be a Cash Cow for Investors"September 11, 2017By Mark Terry,…
Otsuka Loses Again in Challenge to FDA Green Light for Competing Drug
A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug.…
FDA Researchers Seek Ways to Avoid Shelf-Life Chemical Reactions in Complex Proteins
FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Source: Drug Industry Daily
ICH Finalizes Q&A Doc on Justifying Drug Starting Materials
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Source: Drug Industry Daily
FDA Advisory Committee Recommends Warning for Gadolinium MRI Agents
An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Source:…
FDA Berates Pfizer Unit for EpiPen Misfires During 'Life-Threatening Emergencies'
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-fda.jpg" NAME"FDA Berates Pfizer Unit for EpiPen Misfires During 'Life-Threatening Emergencies'" ALT"FDA Berates Pfizer Unit for EpiPen Misfires During 'Life-Threatening Emergencies'"September 8, 2017By Alex Keown, BioSpace... Source: BioSpace
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