Today's Rundown Regeneron, Bluebird ink anti-cancer cell therapy pact Pain Therapeutics hit with yet another CRL, plots ‘reorganization,’ Alzheimer’s pivot Boehringer Ingelheim lands option on cystic fibrosis gene therapy Ovid posts results from midstage rare disease test, plots registrational path Pfizer contracts with Antares to build a rescue auto-injector for an unnamed drug Featured Story | Monday, August 6, 2018 Regeneron and Bluebird bio have teamed up to develop anti-cancer cell therapies. The collaboration combines Regeneron’s antibody expertise with Bluebird’s cell therapy toolkit in a bid to expand the list of tumors modified T cells can treat. |
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| Top Stories Monday, August 6, 2018 With little surprise, Pain Therapeutics has been hit with a complete response letter from the FDA for Remoxy ER, its extended-release, capsule gel form of the opioid oxycodone. Monday, August 6, 2018 Boehringer Ingelheim has secured the option to license a cystic fibrosis gene therapy. The agreement will see Boehringer work with British academics and Oxford BioMedica to develop an inhaled, lentiviral vector-based gene therapy treatment for cystic fibrosis. Monday, August 6, 2018 Ovid Therapeutics has posted a batch of topline data out of its midstage STARS trial in Angelman syndrome as it seeks out a path to approval. Monday, August 6, 2018 Pfizer has tapped Antares Pharma for the development of a self-administered combination drug-device rescue pen for an undisclosed medicine, shortly after investing $465 million in a new sterile injectables plant. Resources 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: 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: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. 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 |