| 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 | | | Monday, September 10, 2018 The FDA has told Amicus Therapeutics it cannot file for accelerated approval of Pompe disease drug AT-GAA using its existing data. Amicus must now continue adding to its existing phase 1/2 data with a view to sitting down again with the agency next year. |
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Top Stories Of The Week Monday, September 10, 2018 Takeda’s Shire buyout has driven a wedge between the deal’s mastermind, CEO Christophe Weber, and the founding Takeda family, as a senior member of the family publicly voiced his opposition to the $62 billion deal, calling it a potential disaster. Tuesday, September 11, 2018 After serving as Gilead’s CMO for just six months, Andrew Cheng has taken the top spot at Akero Therapeutics not long after the biotech raised $65 million to move its lead NASH candidate into phase 2 trials. Monday, September 10, 2018 A mutation in a gene regulator called TERT is the most common mutation in glioblastoma, and it gives cancer cells the ability to divide and spread indefinitely. Researchers at the University of California, San Francisco, have discovered a new way to target the mutation and are working with GlaxoSmithKline to develop a drug based on the finding. Friday, September 7, 2018 Teva executives continue to express confidence the drugmaker's novel migraine drug will get an FDA nod next week, but with questions lingering about the Celltrion manufacturing plant that will produce it, at least one analyst is writing it off for now. Tuesday, September 11, 2018 Weather is again taking a toll on the U.S. supply of injected drugs. Pfizer is idling its Hospira sterile injectables plant in Rocky Mount, North Carolina, ahead of Hurricane Florence. Wednesday, September 12, 2018 The latest iteration of Apple’s smartwatch includes an FDA-cleared electrocardiogram, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. Friday, September 7, 2018 It hasn’t been an easy summer for AstraZeneca in the respiratory department, but the British drugmaker has finally come up with a win. On Friday, the FDA bestowed its breakthrough therapy designation on candidate tezepelumab, a severe asthma drug. Thursday, September 13, 2018 New research out by the BMJ shows that half of tracked clinical trials across Europe “have not reported trials,” but biopharmas are doing much better than their academic peers when it comes to disclosing data. Monday, September 10, 2018 Without additional funding, the world won't see new "highly efficacious" vaccines against HIV, tuberculosis and malaria, according to a new study. Resources Sponsored by: Veeva A top 20 pharma and growing biotech re-engineer regulatory processes. Sponsored by: Sciformix Are automation, big data and artificial intelligence (AI) a key part of your company’s pharmacovigilance strategy? Read this whitepaper to know what they should be! Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Sponsored by: Patheon, part of Thermo Fisher Scientific When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. Sponsored by: Baxter Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale. Sponsored by: Blue Matter A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them. Sponsored by: Catalent In this case study, an unknown leachable species was detected by GC-MS analysis of an alkaline drug product (pH approximately 10.5) that was packaged in a novel self- contained plastic Blow Fill Seal (BFS) vial. Sponsored by: AWS and Tableau Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. Sponsored by: Catalent Catalent provides world class stability services to ease your critical path to success. Presented by: AWS and Druva Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data. Sponsored by: Health Strategies Group The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. | 
