Moderna finally cracks into gene editing with Metagenomi pact thanks to 'irresistible' data Legend's status put on hold as FDA delays Janssen-partnered CAR-T decision Pfizer sells midphase inflammatory drugs to mystery startup, exiting race against Bristol Myers Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success 6 weeks in, Mirati CEO shows CMO, COO the door ahead of key FDA filing for KRAS drug Sponsored: Intranasals in Clinic Now Positioned for $71 Billion Nasal Delivery Market Pfizer, GSK present dueling maternal vaccine data in RSV, as an analyst predicts 'the year of RSV' is ahead Aldeyra’s dry eye drug helps with redness but misses other important phase 2 goals Novartis makes protein degrader play, inking deal with new British startup to access fruits of novel tech AbbVie-backed Nitrome adds BMS as investor in $45M series A, snags Nurix CBO as CEO and rebrands to Nitrase The top 10 highest-paid medtech CEOs Federal judge rules HHS' efforts to punish pharma over 340B restrictions 'arbitrary and capricious' Featured Story By Annalee Armstrong We finally know who Moderna has been courting behind the scenes to make the big jump into gene editing. The famed biotech has signed a research partnership with CRISPR gene editing company Metagenomi. read more |
| |
---|
| Top Stories By Ben Adams Legend Biotech and Johnson & Johnson have been hit by an FDA delay for their cell therapy blood cancer hopeful ciltacabtagene autoleucel. read more By Nick Paul Taylor Pfizer is getting out of TYK2. Having studied its lead inhibitor in a raft of inflammatory diseases, the Big Pharma is offloading the portfolio to a new company in return for a 25% stake in the startup. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Kyle LaHucik In the lead up to asking the FDA for its first drug approval, Mirati Therapeutics is making another leadership shuffle, parting ways with its chief medical officer and chief operating officer six weeks into the new CEO's tenure. read more Sponsored By: Avance Clinical the Australian CRO for global biotechs Australia’s Avance Clinical: how intranasal biotechs can expedite trials with rapid approval processes - including no IND and a 43.5% incentive rebate - to tap $71 billion market read more By Annalee Armstrong The head-to-head Big Pharma battle for a respiratory syncytial virus vaccine is heating up, with Pfizer reporting 85% efficacy in protecting babies born to vaccinated mothers from infection or hospitalization. read more By Annalee Armstrong Aldeyra Therapeutics’ dry eye drug helped relieve ocular redness in a phase 2 trial but merely “approached statistical significance” on a secondary endpoint of wetness in the eye. We know you’re here for the unspun version of this story, and this is it: the secondary goal was not met. read more By Nick Paul Taylor The search for an edge in the hot protein degrader space has led Novartis to Dunad Therapeutics. By putting up $24 million and committing to $1.3 billion in biobucks, Novartis has secured the chance to option candidates against up to four targets worked on by its new partner. read more By Kyle LaHucik Nitrome Biosciences rebranded to Nitrase Therapeutics to represent the new class of enzymes it discovered and added Bristol Myers Squibb as an investor. The biotech's refresh was completed by poaching former Nurix Therapeutics Chief Business Officer Pierre Beaurang as CEO. read more By Conor Hale,Andrea Park The COVID-19 pandemic presented a once-in-a-generation challenge for the medtech industry, and many of the CEOs on this list met it head-on. read more By Dave Muoio Although the court turned aside HHS efforts to penalize drugmakers restricting discounted 340B products from contract pharmacies, the judge took a shot at the the restrictions themselves and opened the door for legislators to settle the issue. read more | LabConnect is the leader in innovative central laboratory services for advanced therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. | Resources Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored by: Informa Pharma Intelligence and Oracle Health Sciences New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic. Sponsored by: TransPerfect Life Sciences Every detail is important when selecting a new eCOA solution; learn more about the current eCOA landscape, best practices, and crucial considerations for successful eCOA solution deployment in this white paper. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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. Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Drug Development Boot Camp® 2021 VIRTUAL November 17-18, 2021 Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online New Product Planning Summit December 1-2, 2021 | Boston, MA 2nd Annual Symposium on Translational Medicine and Biomanufacturing December 2—3, 2021 Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Pharma Drug Safety Summit February 2022 | Location TBD Fierce Biotech Forum 2022 | Virtual Event May 2022 | Location TBD |