| This week's sponsor is CMIC Group. | | | Partner with Japan’s Largest CRO for your global drug development
CMIC is the largest CRO in Japan, with extended services in drug development and GMP manufacturing, site management, regulatory consulting and contract sales. We have the full end to end solution to help you enter Japan market and fulfill your drug development and manufacturing needs in US, Japan and Asia. To learn more, click here. |
Today's Rundown PTC inks $200M Agilis takeover to snag late-phase gene therapy Roche, PureTech team up to develop oral antisense oligonucleotides Patient death prompts FDA hold on Mersana’s lead cancer ADC EuroBiotech Report—Sanofi, Novartis and Gilead strike deals, Amgen-UCB and Brexit FiercePharmaAsia—Pfizer Indian plant hassle, China-India pharma bond, Sinovant debut Chutes & Ladders—Human Longevity CFO/COO departs after scandal Featured Story | | | Friday, July 20, 2018 PTC Therapeutics is paying $200 million upfront to acquire Agilis Biotherapeutics. The deal gives PTC ownership of a gene therapy treatment for rare neurotransmitter disease AADC deficiency that is set to go before the FDA next year. |
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Top Stories Friday, July 20, 2018 Roche has struck a deal with PureTech Health to develop oral antisense oligonucleotides. The pact gives Roche access to PureTech’s milk-derived exosome technology in return for up to $36 million (€31 million) in near-term payments and milestones that could top out above $1 billion. Friday, July 20, 2018 Another antibody-drug conjugate has been stalled by concerns over safety. The FDA has placed a partial hold on Mersana’s lead candidate XMT-1522 after a patient death in a phase 1 trial, causing its shares to plunge. Thursday, July 19, 2018 In this week's EuroBiotech Report, European drug developers strike a string of deals, UCB refiles romosozumab and more. Friday, July 20, 2018 Pfizer halts production at a legacy Hospira India injectables plant after the FDA cited it for a third time; China is working to grant greater access to Indian drugs amid a U.S. trade war; Vivek Ramaswamy's Roivant Sciences just unveiled Sinovant, a China-focused firm with 11 assets; and more. Friday, July 20, 2018 Human Longevity CFO/COO Nino Fanlo departed after a scandal at his former employer, Sangamo lost another top executive and McCann Health fired its chief creative officer for a conduct code violation. Those moves plus more hirings, firings and retirings throughout the industry. | This week's sponsor is ExL Events. | | | |
Resources Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Patheon, part of Thermo Fisher Scientific Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy. Drug Approval, Manufacturing Quality & Regulation 2018 | Online 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA The Life Science Women's Conference August 8-9, 2018 | Austin, Texas Join 200+ Service and Support Leaders at Field Service Amelia Island this August August 27-29, 2018 | Amelia Island, FL RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program Sao Paulo, Brazil | Sep 24-27, 2018 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 The Advanced Biologic Development Summit at Northeastern University October 9, 2018 | Boston, MA BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation |
