Today's Rundown FDA kills off Amicus’ 2018 accelerated approval plan Kodiak Sciences preps $100M IPO to advance AMD drug Medivir names Linda Basse as CMO, adding Darzalex R&D experience to its clinical team Oxford regenerative medicine spinout brings on GlaxoSmithKline drug hunter as CSO Glythera rebrands as Iksuda, pledging to solve ADC problems Top cancer researcher called out for not disclosing conflicts in medical journals Roche raises outcry as cost watchdogs spurn Ocrevus—again—in tough-to-treat MS 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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| This week's sponsor is Synteract, Inc. | | | |
Top Stories Monday, September 10, 2018 Kodiak Sciences has filed to raise up to $100 million in its IPO to support the development of its anti-VEGF drug for wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema. Monday, September 10, 2018 Medivir has named Linda Basse, M.D., Ph.D., as chief medical officer. The appointment puts a leader who played a starring role in the development of Darzalex in charge of ushering Medivir’s clinical pipeline through a critical period. Monday, September 10, 2018 The University of Oxford’s regenerative drug discovery spinout OxStem Limited has appointed Georg Terstappen as chief scientific officer, to lead development work across its portfolio of six programs that aim to stimulate progenitor and stem cell repair mechanisms within the body. Monday, September 10, 2018 Despite their promise, antibody-drug conjugates have been tricky to bring to market, but the U.K. biotech formerly known as Glythera wants to change that. Monday, September 10, 2018 José Baselga, M.D., who heads up research at Memorial Sloan Kettering Cancer Center, failed to disclose his financial ties to industry in academic papers about 60% of the time since he joined the cancer center in 2013. Monday, September 10, 2018 England’s cost watchdogs are standing by their controversial decision to reject Roche’s Ocrevus in a form of multiple sclerosis for which it's the only approved treatment. Roche says pricing isn't to blame—and patient advocates are helping stir up a backlash. Resources 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: 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: Blue Matter A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them. 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: Catalent Catalent provides world class stability services to ease your critical path to success. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. 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. Drug Approval, Manufacturing Quality & Regulation 2018 | Online 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL Fierce Innovation Awards: Life Sciences Edition 2018 FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Understanding Commercialization Within Biopharma Nov 7-8, 2018 | Boston, MA Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Drug Development Immersion December 5-6, 2018 | San Diego, CA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA | 