FDA's Hahn defends pace of Pfizer COVID-19 vaccine review Merck KGaA pens major cancer drugs biobucks pact with DNA damage biotech Artios Pharma AbbVie pays Frontier $55M to pursue hard-to-drug targets Sponsored: Biotech IPOs: New Steps to Success on the Road to Going Public In a first, Janssen submits lung cancer bispecific hopeful amivantamab to the FDA 4D hires a trio of area heads as it ramps up its gene therapy pipeline Zimmer Biomet picks up chest surgery toolmaker A&E Medical for $250M cash Who's your pick for the next FDA chief? Nominate now, start voting next week Featured Story | By Nick Paul Taylor FDA Commissioner Stephen Hahn, M.D., has defended the pace of the review of Pfizer’s COVID-19 vaccine on the grounds that a thorough assessment is needed to reassure a skeptical public. read more |
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| | The Challenge of Keeping Cool Pharmaceutical drugs must be maintained within strict temperature guidelines to protect the efficacy of the product. Learn about end-to-end temperature management for the clinical supply chain. |
Top Stories By Ben Adams Germany’s Merck is signing up to a small upfront but potentially huge biobucks pact with U.K.-U.S. biotech Artios. read more By Nick Paul Taylor AbbVie has teamed up with Frontier Medicines to develop molecules against hard-to-drug targets. The collaborators will use Frontier’s technology for uncovering hidden binding pockets to develop protein degraders and small molecules against oncology and immunology targets. read more Sponsored By: RBC Capital Markets 2020 is on track to post the highest number of biotech IPOs in five years. But the pandemic and today’s shifting market have rewritten the rulebook. What are the new best practices for going public? read more By Ben Adams Janssen has sent off its mutation-specific non-small cell lung cancer drug amivantamab to the FDA. read more By Amirah Al Idrus 4D Molecular Therapeutics raised $75 million in June to get several gene therapy programs into and through the clinic. Now, it’s adding a trio of executives to spearhead its work in heart, eye and lung diseases as it looks to shepherd treatments in those focus areas forward. read more By Conor Hale Zimmer Biomet has signed a deal to buy A&E Medical, maker of open chest surgery tools, for $250 million in cash. Separately, the company launched a new charitable foundation, and started a partnership with the NAACP in support of its public health and justice efforts. read more By Beth Snyder Bulik Before President-elect Biden announces his own choice for FDA commissioner, Fierce Pharma wants to know what readers think. Who's the best man or woman to be the nation’s next top drug regulator? Nominate your picks for our bracket and stop by to vote starting Monday. read more Resources 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. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. 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: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. 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 | 