Today's Rundown Affimed lands big, backloaded immunotherapy deal with Genentech, sending its stock into overdrive FDA nixes Akcea’s volanesorsen despite favorable AdComm CRISPR biotech Editas to lose CMO as it continues push for clinical trials Second time lucky? Alzheon tries for much-reduced IPO Roivant appoints NEA partner Torti to oversee its ‘vant’ subsidiaries Urovant adds gene therapy to overactive bladder pipeline Roche Diagnostics head Roland Diggelmann to step down Featured Story | | | Tuesday, August 28, 2018 Genentech is handing over $96 million (€82 million) in upfront and near-term payments to work with Affimed on NK and T cell engagers. The deal features $5 billion in milestones and royalties that could land in Affimed’s bank account if the immunotherapies succeed. |
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Top Stories Monday, August 27, 2018 The FDA rejected Akcea Therapeutics’ volanesorsen three months after the drug squeaked past an FDA advisory committee that voted 12-8 to recommend its approval. Tuesday, August 28, 2018 Editas Medicine is to lose Gerald Cox, M.D., Ph.D., its chief medical officer, at the end of the year, as the search is on for a new clinical leader. Tuesday, August 28, 2018 After an aborted attempt earlier this year, Alzheon is having another go at an IPO to help fund new trials of its Alzheimer’s candidate tramiprosate. Tuesday, August 28, 2018 Roivant Sciences named New Enterprise Associates partner Frank Torti, M.D., as Vant investment chair to assist in overseeing its family of biopharma subsidiaries by serving as one of two Roivant-appointed representatives on its companies’ boards. Tuesday, August 28, 2018 Urovant Sciences picked up the global rights to a gene therapy from Ion Channel Innovations for patients with overactive bladder for whom oral drugs do not work. Tuesday, August 28, 2018 The leader of Roche’s diagnostics division, Roland Diggelmann, announced plans to leave the company, effective Sept. 30. Roche Diagnostics accounted for nearly a quarter of the Swiss giant's sales, growing 5% in 2017 to bring in about $12.4 billion. | This week's sponsor is ExL Events. | | Let’s talk about success: Technology transfer with a CMO partner | ExL's 5th Technology Transfer for Biologics Conference
Gain expert insights on how to create successful partnerships with CMOs and the partnership management skills needed to maintain biologics quality at every step of process transfer.
View the full agenda —Save 15% with code FIERCE |
Resources 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. 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. Sponsored by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. Sponsored by: PharmaCord When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients. Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online RESI HealthTech Week September 5-7, 2018 | Boston, MA 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 2018 BIO Investor Forum October 17-18, 2018 | Westin St. Francis, San Francisco, CA 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 Field Service Amsterdam November 27-28, 2018 | NH Collection Amsterdam Grand Hotel Krasnapolsky | 