Pfizer/BioNTech COVID-19 shot sails through FDA panel after staffers sing its praises Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine Savara says sayonara to pipeline programs, doubles down on Molgradex, cuts staff Sponsored: From Conquering COVID-19 to Curing Cancer, New York City Charts the Future of Life Sciences Sanofi delays hemophilia filing 18 months amid safety concerns Sponsored: Biotech IPOs: Navigating the New Landscape Oncolytic immunotherapy biotech CG Oncology nabs $47M round for late-stage cancer push Rani Therapeutics nets $69M to transform injections into its easy-to-swallow 'robotic pill' Fending off heart attacks by getting at their genetic roots FiercePharmaAsia—Takeda's CMV, leukemia data; COVID-19 vaccines from Sinovac, Clover and Sinopharm Chutes & Ladders—Arena Pharma R&D chief Cabell leaves post after 6 months Featured Story | By Amirah Al Idrus Pfizer and BioNTech’s COVID-19 vaccine is one step closer to an emergency nod after an expert panel voted in favor of its emergency use Thursday evening. The Vaccines and Related Biological Products Advisory Committee voted 17-4, with one panel member abstaining, that the benefits of the vaccine outweighed its risks for use in people 16 and older. read more |
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| | Balancing Cost, Time and Quality When you support many clinical studies, one thing is certain—you gain experience. Explore critical factors in the packaging design process that can help to deliver the best possible outcome for your study. |
Top Stories By Nick Paul Taylor Sanofi and GlaxoSmithKline’s COVID-19 vaccine has failed to trigger the desired immune response in people aged 50 years and older, forcing the partners to rethink the antigen formulation. The setback is expected to delay the availability of the vaccine from mid-2021 to near the end of next year. read more By Ben Adams Texas-based biotech Savara is killing off much of its pipeline work amid a staffing cull as it sets its focus on troubled lung disease therapy Molgradex. read more Sponsored By: NYCEDC The life sciences sector in New York City is on pace to raise $1B in venture funding in 2020, up from just $40 million ten years ago. In addition to NYC’s outstanding talent and funding, the city is rich with life science real estate offerings across the five boroughs. read more By Nick Paul Taylor Sanofi’s response to nonfatal thrombotic events in a phase 3 hemophilia program has delayed its plans to seek approval for RNAi drug fitusiran by 18 months. The delay will “allow for the appropriate collection and assessment of safety and efficacy data under the amended protocols.” read more Sponsored By: RBC Capital Markets Biotech IPO markets are booming. But even in a boom, identifying the right time to go public and telling your post-IPO story for how capital deployment translates to value for investors is critical. read more By Ben Adams Californian immuno-oncology biotech CG Oncology has reeled in a $47 million series D—and, surely, an IPO isn’t far behind—as it looks to phase 3 trials. read more By Conor Hale Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream. read more By Arlene Weintraub University of Virginia researchers found several naturally occurring gene variants—as well as one specific gene—that influence the formation of the fatty plaques in blood vessels that can cause heart attacks or strokes. The findings could inspire new methods for preventing heart attacks in people with genetic risk factors, they believe. read more By Angus Liu Takeda touted its cytomegalovirus candidate's phase 3 win and Iclusig's five-year chronic myeloid leukemia survival data. Sinovac snagged a $515 million investment to double COVID-19 vaccine capacity. Clover Biopharma kicked off a pivotal trial of its COVID-19 shot paired with a GSK adjuvant. And more. read more By Kyle Blankenship Arena Pharma R&D chief Cabell leaves company after six months on the job; Zai Lab appoints Roche vet Sandler to research post; 4D hires executive trio. read more Resources Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. 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 Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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 Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. 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. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event | 