Pfizer halts BCMA trial amid safety woes, hit by DMD delay Novartis loses 2nd oncology R&D exec as Hammerman leaves through the door left open by Engelman Lilly takes variant-busting COVID-19 antibody into the clinic Sponsored: Mitotech brings novel approach to treating eye disorders Sarepta thinks it may have a more effective DMD drug, but new side effects could be a problem Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials MoonLake debuts with Cosentyx challenger from Merck KGaA How new 'lung-on-a-chip' models from Harvard are advancing COVID-19 drug discovery Apple Watch could gain long-sought glucose tracking with Rockley Photonics deal: report Featured Story | By Nick Paul Taylor Pfizer has paused enrollment in a pivotal trial of its anti-BCMA bispecific antibody after seeing three cases of peripheral neuropathy in an earlier-stage study. The Big Pharma shared the news alongside details of a delay to the start of the U.S. part of its Duchenne muscular dystrophy (DMD) phase 3. read more |
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Top Stories By Ben Adams Days after Novartis lost Jeff Engelman M.D., Ph.D., ex-director of cancer drug discovery at the Novartis Institutes for BioMedical Research, Peter Hammerman, M.D., Ph.D., has followed his boss out the exit as both answer the call of biotech. read more By Nick Paul Taylor Eli Lilly has begun clinical development of an anti-SARS-CoV-2 antibody designed to work against all currently known circulating variants of concern. The action comes weeks after the FDA revoked the single use emergency authorization of Lilly’s first COVID-19 antibody due to the rise of variants. 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 Sarepta Therapeutics says its RNA therapy for Duchenne muscular dystrophy, SRP-5051, could be more effective than the company’s existing therapies, but a dose-escalation study also dug up some new—and serious—adverse events in patients. 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 Amirah Al Idrus MoonLake Immunotherapeutics launched on Monday with backing from BVF Partners and a mission to develop single-domain antibodies, or “nanobodies” for several inflammatory diseases. Its first program? A nanobody licensed from Merck KGaA that’s already been tested in phase 2. read more By Arlene Weintraub Pitting COVID-19 drug candidates against the virus in cell cultures doesn’t accurately predict how effective they’ll be in the human respiratory tract. Now more accurate models of the human lung airway are uncovering new treatment candidates. They include the antimalarial drug amodiaquine, which reduced viral load in animal models of the virus by 70%. read more By Conor Hale While the Apple Watch has evolved from a fashionable phone accessory to a high-tech health monitor—capable of scanning for heart conditions and calling for help after injuries—future generations may tap into a deeper set of features to track the body’s inner workings. 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. Sponsored By: ClearView Healthcare Partners As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. 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 | 