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In new editorial, FDA's Califf says biomedical field should prioritize chronic illness, addiction Takeda returns two inflammatory bowel prospects back to Finch's nest Blanchard abseils down from Everest, walking out as CEO with immediate effect ACRO posts diversity and inclusion principles to tackle age-old clinical trial problem Role-shifting enzyme could be potential treatment target in sepsis Clash of the titans: Moderna sues Pfizer, BioNTech for mRNA patent infringement Fitbit debuts afib detection in health-tracking smartwatch Merck and Seagen can't agree on a price for their rumored merger: Bloomberg Brain Scientific's EEG headset caps off regulatory push with European approval Chutes & Ladders—Former Takeda exec takes reins at Tessa 'The Top Line': Genentech's candid conversation about diversity, a report's surprising findings on diabetes brand recall and more Fierce Pharma Asia—Takeda dengue vaccine's first nod; Eisai's new US HQ; US-China audit inspection deal Featured Story By Max Bayer FDA Commissioner Robert Califf says the biopharma industry and researchers should redouble its efforts to treat common chronic diseases and addiction. His comments came in a new editorial published in Science. read more |
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| Top Stories By Max Bayer Takeda is handing the rights of two assets back over to Finch, including one that the two have collaborated on for more than five years. Finch says it will try and find new partners for the programs. read more By Nick Paul Taylor Kerry Blanchard has resigned as CEO of Everest Medicines with immediate effect. While the Chinese drug developer only shared the news on Thursday evening, it has spent the past few months searching for a CEO, putting it on course to appoint a successor to Blanchard in the coming month. read more By Nick Paul Taylor The Association of Clinical Research Organizations (ACRO) is stepping up its efforts to address the age-old problem of the lack of diversity in clinical trial populations. With its principles statement, the trade group has set out what its members will do to make clinical trials—and their own workforces—more diverse. read more By Helen Floersh Sometimes, finding out that an enzyme doesn’t work the way you thought it did means you have to go back to the drawing board. Then there are times when it turns out to be a fortuitous discovery that could pave the way for treatments for one of medicine’s most challenging conditions— in this case, sepsis. read more By Zoey Becker It's shaping up to be the patent fight of the pandemic era as Moderna files lawsuits in the United States and Germany accusing Pfizer and BioNTech of infringing its patents that date back to 2010. read more By Andrea Park Just a few months after Fitbit roped in FDA clearance for an algorithm that could be embedded into its eponymous health-tracking wearables to detect atrial fibrillation, the technology is ready to hit the ground running. read more By Kevin Dunleavy An anticipated merger between Merck and Seagen has stalled because the companies can’t agree on a price, Bloomberg reports. The potential deal—which was rumored to be valued at around $40 billion—remains on the table and could still happen soon, the new outlet reports. read more By Andrea Park With a device that’s now been cleared in both the U.S. and Europe, preparing a patient for an EEG test is almost as easy as strapping on a bike helmet. read more By Gabrielle Masson,Max Bayer Former Takeda exec Willemsen takes reins at Tessa. Former bluebird regulatory chief jumps aboard gene editing-focused Flagship company Tessera. Aeglea CEO departs after the company is stymied by FDA. read more By Teresa Carey This week on "The Top Line," we discuss Genentech’s Greg Rippon's remarks on missing the mark in terms of diverse trial recruitment and how the company hopes to get it right in the future. We'll also chat about a new report on brand awareness for diabetes drugs. read more By Angus Liu Takeda's dengue shot has won its first approval anywhere. Eisai has debuted its new U.S. headquarters . In relief for several New York-listed Chinese biotechs, U.S. and Chinese authorities have reached a deal that would allow American accounting watchdogs access to Chinese companies’ audit records. And more. read more Resources Sponsored by: Ferma.AI, a Product of ZoomRx Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Bio-Techne Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Simply load, scan, and insert your cartridge and come back to fully analyzed results in 75 minutes. Rethink your ELISA, with Ella. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. 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Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Events European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Drug Development Boot Camp® 2022 November 16-17, 2022 |