FDA shares advice on bioequivalence studies for different dosage forms Xeris, a rival to Lilly and Novo, gets FDA nod for glucagon kit CRISPR pioneer helps create gene-editing delivery system Magnetic pills deliver insulin to refill implanted reservoir Inching closer to buyout, Philip Morris grabs stake in respiratory specialist Vectura as health groups push back Featured Story | By Nick Paul Taylor The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after the FDA released the first version of the document for consultation. read more |
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Top Stories By Nick Paul Taylor Xeris Pharmaceuticals has opened another front in its fight to win market share from Eli Lilly and Novo Nordisk with the FDA approval of its Gvoke Kit for the treatment of severe hypoglycemia. read more By Nick Paul Taylor CRISPR pioneer Feng Zhang and his colleagues have come up with a new way to get gene editing and other molecular therapeutics to target cells. The approach uses a protein found naturally in humans, potentially avoiding the immune attacks that prevent repeat dosing using viral vectors. read more By Nick Paul Taylor It is now more than 40 years since the first diabetic received an implantable insulin pump. Yet, the concept never took off, with Medtronic pulling the plug on R&D back in 2007. Now, a group of Italian researchers is trying to revitalize the approach with an implant refilled using magnetic capsules. read more By Fraiser Kansteiner Marlboro maker Philip Morris has largely swayed Vectura in its bid to acquire the U.K.-based inhalation specialist. The tobacco giant just firmed up its position ahead of the deal’s Sept. 15 deadline, too. Outside Vectura, though, resistance to the proposed takeover is mounting. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored by: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule 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: 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: Catalent Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes. Sponsored by: Catalent This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. 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. 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) September 13-15, 2021 | New Brunswick, NJ Promotional Review Committee Compliance & Best Practices September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Digital Pharma East September 28-30, 2021 | Pennsylvania Convention Center, Philadelphia | October 5-8, 2021 | Virtual Event Fierce Pharma Marketing Awards September 29, 2021 | Philadelphia, PA Pharma PR & Communications Summit Jersey City, NJ | October 4-5, 2021 TMF Summit October 25-27, 2021 | New Orleans, LA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event | 