AstraZeneca's cancer R&D exec Ferté joins Relay to run its lead asset as another bluebird exec jumps ship Avrobio plans head-to-head Fabrazyme trial after FDA changes path to market Roivant catches the SPAC wave to Wall Street in $611M deal Sponsored: Mitotech brings novel approach to treating eye disorders Gene therapy biotech Affinia prepares for clinic with $110M financing Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials Astellas quietly cuts Cytokinetics R&D pact as $450M-plus in biobucks goes up in smoke KalVista bulks up executive team with CMO addition as angioedema franchise grinds to launch Aceragen bags Enzyvant drug and $35M, plots fast path to market FDA clears augmented reality smartglasses for guiding knee replacement surgeries The top 20 drugs by worldwide sales in 2020 Featured Story | By Ben Adams Last month we found out, via Twitter, that AstraZeneca’s Charles Ferté, M.D., Ph.D., senior director and global project leader of oncology R&D, was leaving the Big Pharma, but we didn’t know for where. read more |
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Top Stories By Nick Paul Taylor Avrobio has updated its Fabry disease gene therapy R&D plans in light of the FDA’s conversion of Sanofi’s Fabrazyme to full approval. The conversion deprives Avrobio of the chance to seek accelerated approval using its current phase 2, leading the biotech to plan to pit AVR-RD-01 against Fabrazyme in a new head-to-head clinical trial. read more By Amirah Al Idrus As Roivant Sciences gears up its “next chapter,” the company is heading for the public markets by merging with a special purpose acquisition company, or SPAC, and raising $611 million in the process. read more Sponsored By: Mitotech S.A. Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases. read more By Annalee Armstrong Affinia Therapeutics, a biotech developing adeno-associated virus vectors and gene therapies, has raked in $110 million through a series B financing to move its programs into the clinic. read more Sponsored By: Catalent Clinical Supply The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes. read more By Ben Adams Japanese pharma Astellas has culled a muscle disease research pact with Cytokinetics, two years after a partnered med between the two flopped in a midstage test. read more By Annalee Armstrong KalVista Pharmaceuticals will bring on Paul Audhya, M.D., as chief medical officer as the Cambridge, Massachusetts-based biotech works to get a clinical trial for its hereditary angioedema franchise back on track. read more By Nick Paul Taylor Enzyvant has sold its preclinical Farber disease therapy to Aceragen. NovaQuest Capital Management is funding the newly founded Aceragen, setting the biotech up to enter the clinic and go on to seek approval. read more By Conor Hale Built into a pair of glasses worn by the surgeon, a camera helps judge the alignment of instruments and the joint itself within their field of view, without requiring changes in conventional surgical techniques. read more By Eric Sagonowsky While the global sales rankings of Big Pharma's superstar drugs naturally feature the biggest names in the business, new meds often pop up or old drugs exit the scene. And the moves within the list from year to year illustrate many of the trends shaping pharma on a daily basis. read more Resources Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. 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Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) Virtual May 5-7, 2021 | Virtual Event TMF Virtual Summit May 18-20, 2021 | Virtual Event Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Biopharma Supply Chain June 29-30, 2021 | Virtual Event | 