Outgoing NIAID vaccine R&D chief John Mascola reflects on leading 'NASA-type incubator' Roche's lung cancer gamble flames out as TIGIT digits come up short in phase 3 Top Ginkgo execs each nab $364M pay packages thanks to 2021 SPAC deal Sponsored: How creative chemistry and collaboration synthesized a better drug strategy for Enterin GSK, CureVac hope 2nd time's the charm as updated COVID vax launches into clinic Adagio knows its COVID-19 antibody works against old variants. Can it win EUA in the era of omicron? Neuron23 snags $100M and a new Parkinson's disease candidate Karyopharm hoping for some Keytruda stardust as former Merck & Co. exec joins as CMO Give Pease a chance: Charles River Laboratories names new CFO Philips issues cybersecurity warning over e-Alert MRI monitoring system Pfizer mRNA partner BioNTech reaped €19 billion last year but warns of lower prices in 2022 Most hospitals performed well on LGBTQ+ equity, Human Rights Campaign report finds As Lilly, Innovent hit FDA rebuff, another China-made PD-1 cancer drug faces possible delay Featured Story | By Max Bayer John Mascola, M.D., is leaving NIAID's Vaccine Research Center after 22 years, including nine as director of the "NASA-type incubator." He spoke with Fierce Biotech in an exclusive interview about his highs, his lows and what he's learned about vaccine development after 30 years. read more |
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Top Stories By Nick Paul Taylor Roche’s gamble on anti-TIGIT drug tiragolumab in small cell lung cancer has flamed out. Having advanced tiragolumab in SCLC based on little more than a hunch, Roche has now revealed the drug failed to hit its co-primary survival endpoints in a phase 3 clinical trial. read more By Annalee Armstrong Ginkgo Bioworks, the synthetic biology company that was last year referred to by short sellers as 'a hoax for the ages,' rewarded CEO Jason Kelly and President and COO Reshma Shetty more than $364 million in compensation for 2021—each—but mostly in stock. read more Sponsored by: Pfizer Reshaping the understanding of enteric nervous system (ENS) dysfunction and the progression of Parkinson’s, Pfizer CentreOne helped Enterin synthesize a better chemistry for its lead candidate. read more By Max Bayer GlaxoSmithKline and CureVac are hoping their "second-generation" mRNA COVID-19 vaccine is a winner as it launches into a phase 1 trial. The updated shot comes after CureVax was forced to sideline its first attempt following less-than-stellar efficacy data. read more By Nick Paul Taylor Adagio Therapeutics has spied a path to FDA authorization for its tarnished COVID-19 antibody. Having been brought low in an omicron farrago, Adagio is now looking to positive phase 2/3 data against earlier variants to help secure ADG20 a spot among the arsenal of preventive and therapeutic antibodies. read more By Sophia Sorensen Neuron23 has picked a Parkinson’s disease clinical candidate, and, now, the small neurodegenerative-disease-focused biotech will have $100 million more to work with. read more By Gabrielle Masson Karyopharm Therapeutics has tapped Reshma Rangwala, M.D., Ph.D., to serve as the company's chief medical officer. She previously served as Merck & Co.'s executive clinical director and was involved in the development of Keytruda. read more By Gareth Macdonald Charles River Laboratories has named former Johnson & Johnson executive Flavia Pease as its new chief financial officer. read more By Andrea Park While the shift to “smarter,” interconnected healthcare technology has undoubtedly improved the quality of patient care and health outcomes, it has also opened up an entirely new can of cybersecurity worms. read more By Kevin Dunleavy BioNTech reported 2021 sales of €19 billion ($21.1 billion), with nearly all (€18.8 billion) coming from sales of its Pfizer-partnered COVID-19 vaccine. BNT's fourth quarter sales came in at €5.53 billion ($6.2 billion), down from €6.09 billion ($6.8 billion) in the previous period. read more By Anastassia Gliadkovskaya Of 2,200 participating facilities, 82% scored 80 points of 100 or above, while two Texas hospitals received the maximum penalty. read more By Angus Liu After the FDA snubbed Eli Lilly and Innovent Biologics’ cancer immunotherapy because of China-only data, all eyes have turned to the next China-developed PD-1 therapy in line at the FDA. But an FDA decision on that may be delayed. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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