| This week's sponsor is Pfizer CentreOne. | | | Pfizer CentreOne™ is a global contract manufacturer that focuses on API synthesis, sterile injectables fill-finish and highly potent solids. Learn more. |
| Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications. | |
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Featured Story | | | Tuesday, June 13, 2017 The streak of positive Keytruda updates had to end somewhere. After an onslaught of upbeat trial results and regulatory news, drug maker Merck Monday night announced that it was pausing enrollment on a pair of phase 3 multiple myeloma studies to investigate patient deaths. |
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Top Stories Of The Week Monday, June 12, 2017 Coherus' copycat version of Amgen’s blockbuster drug Neulasta (pegfilgrastim) has been rejected by the FDA. Monday, June 12, 2017 Biosimilar makers scored a big win Monday as the Supreme Court ruled with Sandoz in a much-watched legal dispute with Amgen. The landmark decision, set to define competition in the budding field, allows biosim makers to give marketing notice before FDA approval, meaning their products can launch faster. Friday, June 9, 2017 Mathai Mammen, M.D., Ph.D., is leaving Merck after a little more than one year at the company to take up a position at Johnson & Johnson. The Theravance Biopharma co-founder is set to take over from William Hait, M.D., Ph.D., as global head of R&D, freeing Hait to start a new role overseeing J&J’s prolific partnering operation. Monday, June 12, 2017 Massachusetts General Hospital scientist Denise Faustman has been on a quest since the late 1990s to transform an old tuberculosis vaccine into an entirely new way to treat Type 1 diabetes. On Saturday, Faustman presented the latest milestone in that effort—strong evidence that the vaccine increases the activity of beneficial genes that prevent the immune system from attacking normal tissues in the body. Monday, June 12, 2017 Industry watchers are predicting GlaxoSmithKline and Sanofi will post strong vaccines growth in the coming years, surpassing Merck in size along the way. But at a recent conference, Merck CEO Ken Frazier told investors not to underestimate his company's presence in the field. Monday, June 12, 2017 Insulet presented new data from the feasibility study of its hybrid closed-loop glucose control system, showing the device performed as well in children and adolescents as it does in adults. Wednesday, June 14, 2017 The place to be in drug sales is biotech. Yet another year’s worth of compensation data show biotech representatives are outearning every category in medical sales save health IT. And once again, pharma reps are collecting average packages that are the lowest of any in the medical rep field. Friday, June 9, 2017 Manufacturing quality and costs always play some part in the price of a new drug, but they are the elephant in the room when looking at CAR-T, personalized cancer medications now under development. That is because of the extensive process to genetically code a patient’s T cells to hunt and kill cancer cells, along with the need for speed. Wednesday, June 14, 2017 Regulus Therapeutics has been suffering with its pipeline since its lead candidate RG-101 was put on clinical hold by the FDA last year. Now, with that candidate officially off the run, the microRNA biotech tapped the help of CRO Aptuit. | This week's sponsor is Rho. | | | [Webinar] Putting Patient-Centric Principles into Practice
Wednesday, June 28 | 11am ET / 8am PT
Learn practical strategies for implementing patient-centered principles that engage patients without sacrificing research quality or adding untenable costs to your trials. Experts share how to design trials that honor patient needs and desires. Register Now! |
Resources Presented by: Veeva Hear three innovative leaders explain how regulatory can “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems. |
