Today's Rundown DBV loses regulatory, R&D executives ahead of peanut drug refile Alessandro Riva to leave Gilead to lead Glenmark spinoff Alnylam’s givosiran hits the mark in phase 3 porphyria test, NDA to follow midyear [Sponsored] Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials Gene-editing startup Beam bags $135M in series B top-up Pfizer licenses AnTolRx's immune tolerance nanomedicine for Type 1 diabetes Gottlieb's quick goodbye triggers investor panic, biopharma bewilderment and at least one good riddance Pacira Pharma to add devicemaker Myoscience to its pain-relief portfolio in $220M deal Featured Story | | | Wednesday, March 6, 2019 Two of the leaders responsible for regulatory and product development at DBV Technologies are set to leave the company this month. The departures deprive DBV of senior members of its regulatory team as it gears up to refile for FDA approval of its peanut allergy drug. |
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Top Stories Wednesday, March 6, 2019 Alessandro Riva is set to leave Gilead to take up the CEO role at Glenmark Pharmaceuticals’ new spinoff. The Indian drugmaker’s hiring coup leaves Gilead without the oncology leader that oversaw its takeover of Kite Pharma and push into CAR-T. Wednesday, March 6, 2019 Alnylam's givosiran reduced the rate of porphyria attacks in patients with acute hepatic porphyria. The company will file a rolling NDA for givosiran in mid-2019. Tuesday, March 5, 2019 Modern clinical trials increasingly rely on technologies to help accelerate startup, capture endpoints, and facilitate recruitment. In the midst of this technological revolution, it becomes increasingly important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications in clinical research. Wednesday, March 6, 2019 Beam Therapeutics has raised a healthy $135 million in second-round financing that will be used to advance its single-base approach to gene editing. Tuesday, March 5, 2019 Two years after leading AnTolRx's $4 million series A, Pfizer is pulling the trigger on an option to take over the development of the upstart's lead candidate, an immune tolerance therapy for Type 1 diabetes. Wednesday, March 6, 2019 FDA chief Scott Gottlieb will be gone within a month. Biotech investors are selling. Biopharma faces an uncharted regulatory landscape, with no idea which Gottlieb initiatives will survive his exit. Even Silicon Valley is mourning. And the big question is: Who's next? Tuesday, March 5, 2019 Pacira Pharmaceuticals has moved to acquire pain-relief device developer Myoscience in a deal worth up to $220 million. The specialty pharma plans to fold Myoscience’s Iovera device system into its nonopioid painkiller portfolio. Resources Sponsored by: Patheon, part of Thermo Fisher Scientific The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: ON24 Which HCP Touchpoints and channels are yielding the best results in today’s digital world? Sponsored by: Blue Matter White paper outlining the key types of cell-based immunotherapies in oncology, as well as the development and commercial outlook for each. Sponsored by: AlphaSense It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies. Sponsored by: Cofactor Genomics Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens. Sponsored by: Outer Edge Technology With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market. 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. BioBasics: Biotech For The Non-Scientist March 28-29, 2019 | Boston, MA Drug Development Immersion April 3-4, 2019 | Philadelphia, PA 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! Calling Europe – Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 