| This week's sponsor is Rho. | | | [Webinar] Understanding New Drug Applications (NDAs)
Tuesday, August 14 | 1pm ET / 10am PT
Understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and get tips that can help you avoid common pitfalls in the submissions process. Register Now! |
Today's Rundown Novartis licenses out unwanted GlaxoSmithKline cancer drugs to Chinese biotech CAR-T player Cell Medica names Kite’s European chief as CEO Oncorus poaches Moderna cancer executive Ted Ashburn as CEO ReViral raises $55M to run midphase RSV clinical trials NewLink wields ax, clearing the way for leaner IDO program Medtronic, United receive approval for fully implantable PAH infusion pump WIRB-Copernicus Group snaps up a pair of clinical analytics companies for undisclosed price Special Report—The top 5 vaccine companies by 2017 revenue Featured Story | | | Wednesday, August 1, 2018 Novartis has penned a pact with Shanghai-based biotech Laekna that will see it work on a pair of oral pan-Akt kinase inhibitors. |
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Top Stories Wednesday, August 1, 2018 Cell Medica has appointed Chris Nowers as its CEO. Nowers joins the company from Gilead’s Kite Pharma at a time when Cell Medica is seeking to push CAR and TCR candidates through clinical development and on to the market. Wednesday, August 1, 2018 2016 Fierce 15 winner Oncorus has nabbed Moderna’s head of oncology development, Theodore (Ted) T. Ashburn, M.D., Ph.D., as its new chief executive and president. Wednesday, August 1, 2018 ReViral has raised $55 million (€47 million) to put a treatment for respiratory syncytial virus (RSV) infections through midphase trials. The series B round comes six months after ReViral completed a phase 2a evaluation of RSV fusion inhibitor RV521 in healthy volunteers. Wednesday, August 1, 2018 NewLink has cut its headcount by a third to buy the time it needs to prove that—despite setbacks—its IDO inhibitor indoximod is still worth pursuing. Wednesday, August 1, 2018 Medtronic and United Therapeutics received premarket approval from the FDA for a fully implantable drug delivery system that continuously administers Remodulin (treprostinil) through a cardiac catheter to treat pulmonary arterial hypertension. Tuesday, July 31, 2018 Clinical research helper WIRB-Copernicus Group has acquired KMR Group and Metrics Consortium in a deal that bolsters the company’s market insights and intelligence division. Wednesday, August 1, 2018 Even in an industry dominated by a few huge companies, disruption happens sometimes—and 2017 was one of those times. GlaxoSmithKline surpassed Merck to top the vaccine industry by sales, generating $7 billion compared to Merck's $6.5 billion; and it stands to be a long-term switch, too. Resources 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: 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. Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas 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 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 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 | 