Today's Rundown Join FierceBiotech in London on October 30th for our Executive Summit. We’ll discuss a post-Brexit world and what this means for U.K. biomedical science. We'll also look at the burgeoning new digital health industry and how new innovations can help research. And we’ll round out the day with a networking cocktail hour. I hope you can join us. Click here to register.– Rebecca Willumson, Publisher Roche sheds clutch of in-licensed drugs in pipeline cull Eiger chalks up one win, one loss in rare disease pipeline Sarepta licenses Lysogene’s Sanfilippo gene therapy in deal worth up to $142M ICER weighs plan to offer trial design advice to pharma companies, for a price FDA puts Affimed's T cell engager on official clinical hold Bayer contemplating outsourcing more R&D as part of restructuring: Reuters Novartis tasks Foundation with companion diagnostic development for cancer treatments Featured Story | Wednesday, October 17, 2018 The most advanced drug to get the chop is RG6125, an anti-cadherin 11 antibody that entered a phase 2 rheumatoid arthritis trial last year. |
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| This week's sponsor is BDO. | Think you’re ready to go public? Make sure you know the genome of the IPO first. Biotech IPOs are on a hot streak this year. But transforming to a public entity is not an easy undertaking. Biotechs should consider four steps ahead of IPO consideration—including bridging the gap between talent and governance. Read our Biotech IPO Checklist. | Top Stories Wednesday, October 17, 2018 Eiger BioPharma has given up on one of its rare disease candidates after a second negative trial, but a midstage win for another drug has more than softened the blow. Tuesday, October 16, 2018 Lysogene is licensing its Sanfilippo syndrome gene therapy to Sarepta Therapeutics for $15 million upfront, a $2.5 million equity investment and up to $125 million in potential milestone payments. Tuesday, October 16, 2018 The Institute for Clinical and Economic Review (ICER)—an independent source for information on the cost-effectiveness of new, cutting-edge drugs and big-ticket therapies—is considering charging biotech companies for early scientific advice and direct guidance in clinical trial design. Wednesday, October 17, 2018 Just a week after Affimed decided to put its T cell engager for blood cancers on hold, the company reported that the FDA has “concurred with Affimed’s decision to stop recruitment” and placed the program on full clinical hold. Tuesday, October 16, 2018 Bayer is contemplating outsourcing more of its R&D as part of an overall restructuring plan, Reuters reported, citing the German pharma giant’s work council. Wednesday, October 17, 2018 Novartis has tapped Foundation Medicine to develop companion diagnostic tests for its cancer treatment portfolio, including multiple precision drugs and immunotherapies. This week's sponsor is the Fierce Innovation Awards – Life Sciences Edition. | | | Enrollment Showcase | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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| | Sponsored by: Biotech Primer Drug Development Immersion is an intensive two-day course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market. Learn from an industry expert who has received drug approvals in both the US and Europe. Register today! |
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| Resources Sponsored by: Veeva Industry Research: Read the 2018 Unified Clinical Operations Report to find out how pharmas and CROs are evolving clinical trial processes. Sponsored by: SAP Collaborate in a digital world to improve patient outcomes. Sponsored by: Patheon, part of Thermo Fisher Scientific Read this whitepaper to learn more about two main areas where a drug developer can face significant obstacles during biologics development. Sponsored by: RWS Life Sciences Examine the linguistic and cultural considerations of global eCOA and BYOD. Sponsored by: Amazon Web Services Download our new eBook to learn how Healthcare and Life Sciences organizations are taking advantage of solutions from AWS and the AWS Partner Network to obtain value from critical data. Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! 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: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Fierce Innovation Awards: Life Sciences Edition 2018 Welcome to the inaugural Neuromuscular Drug Development Summit October 29-31, 2018 | Boston, MA, USA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Immersion November 1-2, 2018 | Boston, MA European Healthcare Compliance Certification Program November 5-8, 2018 | Paris, France Drug Development Boot Camp® 2018 – Registration closes 30 October - Register Now! November 14-15, 2018 | Boston, MA | Registration closes on the 30 of October 2018 due to the need for participants to complete pre-Boot Camp preparations. Register now and start preparing for this intensive training in drug development. BioBasics: Biotech For The Non-Scientist December 5-6, 2018 | Boston, MA Drug Development Immersion December 5-6, 2018 | San Diego, CA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA T Cell Based Immunotherapy: A Deeper Dive III Conference February 28 - March 3, 2019 |