Today's Rundown Astellas absorbs U.K. ocular gene therapy player Quethera Vernalis, weakened by FDA rejections, accepts £33M Ligand bid Artios bags $84M to trial next-generation DNA damage response drugs Gemphire pulls the plug on gemcabene fatty liver disease trial UC Berkeley backs oral gene therapy company targeting the gut in $1.5M seed round EuroBiotech Report—Brexit, Boehringer, Therachon, Cellectis and Sensyne FiercePharmaAsia—Lenvima growth; China’s drug invite; Samsung’s biologics commitment Chutes & Ladders—Off-the-shelf CAR-T player Cellectis poaches Novartis executive Featured Story | Friday, August 10, 2018 Japan’s Astellas Pharma has delved deeper into the gene therapy sector, picking up U.K. specialist Quethera for around $109 million. |
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| Top Stories Friday, August 10, 2018 Ligand Pharmaceuticals is set to acquire Vernalis for the knockdown price of £33 million ($42 million). The takeover agreement comes one year after Vernalis was left reeling by a second FDA rejection in quick succession. Friday, August 10, 2018 Artios Pharma has raised $84 million (£65 million) to take DNA damage response (DDR) programs to clinical proof of concept. The series B round sees more big-name investors give cash to researchers whose earlier work on PARP inhibitor Lynparza put DDR on the map. Friday, August 10, 2018 Things were looking up for Gemphire in June, when its lead drug gemcabene aced a midstage hypertriglyceridemia trial. Now, the company is halting its phase 2a trial in pediatric nonalcoholic fatty liver disease because some patients’ disease got worse. Friday, August 10, 2018 A UC Berkeley-backed preclinical company, DNAlite Therapeutics, has gathered $1.5 million in seed money to pursue oral gene therapies that can slip through the mucus barrier that typically blocks access to the gastrointestinal tract. Friday, August 10, 2018 In this week's EuroBiotech Report, the U.K. downplays the risk of Brexit disruption, Boehringer inks a gene therapy deal, Therachon raises $60 million and more. Friday, August 10, 2018 Eisai's Lenvima enjoys strong sales growth as Keytruda combo presses ahead; China invites the makers of 48 drugs approved abroad to use foreign clinical data for Chinese approval; Samsung plans to invest $22 billion across several promising fields, including biologics; and more. Friday, August 10, 2018 Off-the-shelf CAR-T player Cellectis poached Novartis oncology executive Stefan Scherer, M.D., Ph.D.; GlaxoSmithKline recruited a new CFO to spearhead cost-cutting; and Thomas Hughes, Ph.D., left Zafgen to take the CEO role at Navitor. Those moves plus more hirings, firings and retirings throughout the industry. Resources 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: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. 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. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA 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 |