Featured Story | By Nick Paul Taylor The FDA gave Protagonist Therapeutics’ rusfertide breakthrough designation last year. Now, the agency wants to take it back “based on observed malignancies,” triggering a 30% drop in Protagonist’s stock as investors scrambled to figure out the implications of the news. read more |
| |
|---|
|
Top Stories By Annalee Armstrong Editas is bringing on Sarepta’s Chief Medical Officer Gilmore O’Neill, M.B., but not to fill that empty role at the gene editing biotech. He will instead replace Chairman, President and CEO James Mullen, who is taking on the executive chairman role. read more By Nick Paul Taylor AbbVie has fired back in the fierce fight for the CD20 bispecific market. Phase 1/2 data show AbbVie and Genmab’s epcoritamab triggers responses in heavily pretreated blood cancer patients, although the first report of grade 3 cytokine release syndrome (CRS) could dent hopes of delivering best-in-class safety. read more By James Waldron One of Merck’s next generation of pneumococcal vaccines has been granted breakthrough therapy status by the FDA, as the Big Pharma races rival Pfizer to market. read more By Gabrielle Masson Move over, A: B is taking the lead now, with Be Biopharma closing out a $130 million financing round backed by several industry leaders that will fuel its engineered B cells platform. read more By Max Bayer Magenta Therapeutics is cutting 14% of its workforce and trimming early R&D work as the stem cell-focused biotech shifts focus towards its targeted conditioning program. The company hopes these moves will help extend its cash runway to the second quarter of 2024. read more By Fraiser Kansteiner U.S. bankruptcy judge Michael Kaplan this week denied J&J’s bid to block a lawsuit accusing the company of hiding evidence that its industrial talc operations exposed workers to asbestos, Bloomberg first reported. read more By Conor Hale By using a device that shows how tiny amounts of drugs perform inside the body, Takeda is examining two therapies that could help break down the barriers protecting solid tumors from the body's immune system. read more By Heather Landi More than 200 healthcare executives, 217 to be exact, are now in the “three comma club,” as Forbes calls it, and are among the 2,668 billionaires on Forbes’ 2022 list. There are 32 American business leaders on Forbes' list who made their fortunes in healthcare. Meet 20 of this year's healthcare billionaires. read more By Angus Liu Just as Regeneron’s COVID-19 antibody combination, REGEN-COV, is sidelined in the U.S. thanks to omicron, the drug has hit a hiccup on its quest for a full FDA nod. read more By Andrea Park Boston Scientific is banking on the luck of the Irish to help expand its sustainable manufacturing efforts. read more By Gareth Macdonald Educating patients and physicians about drug studies will boost enrollment, according to the organization behind the new Clinical Trial Guide website. read more Resources Sponsored by: Nethealth Net Health, experts in wound care and dermatology clinical trials, have a new eBook: 5 Rules to Enhance Clinical Trials in 2022, find out how to recruit the right participants, connect patients and researchers with technology, manage costs and more. 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. Presented By: Springer Nature The journey of drug development in 2021 delivered to your inbox: top 10 AdisInsight drug profiles viewed, new drug profiles released, overview of drug launches, key deals, research trends in 2021 and much more (free of charge). Sponsored by: Blue Matter, strategic consultants in the life sciences What’s in store for the oncology market in 2022 and beyond? This paper looks at 5 trends driving the market. Sponsored by: Thermo Fisher Scientific Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific. 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: 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. Cancer Progress 2022: Hear from Leading Oncology Innovators May 10-12, 2022 | Virtual Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Accelerating Immuno-Oncology and Oncology Drug Development Using Humanized Mice Live & Recorded on: Thursday, April 21, 2022 | 12pm ET / 9am PT Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 
