Featured Story | By Annalee Armstrong With CytoDyn's lead drug on FDA clinical hold, the troubled biotech will go searching for partners to rescue key programs and keep afloat. Meanwhile, the board is actively searching for a new CEO to replace Nader Pourhassan, Ph.D., who was ousted in January. read more |
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Top Stories By Annalee Armstrong An FDA advisory panel says the evidence supporting Amylyx’s amyotrophic lateral sclerosis drug, which amounted to just one study, isn't strong enough to warrant FDA approval. The decision came down to 4 yeas and 6 nays, with no abstentions. read more By Max Bayer Eikon Therapeutics continues to reunite former Merck colleagues, this time adding former CEO Ken Frazier to its board. Frazier's appointment is the third former Merck colleague to join this year after the company's former R&D president Roger Perlmutter was tapped as CEO in May 2021. 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 Annalee Armstrong Vertex’s non-opioid painkiller eased pain intensity after surgery in two phase 2 clinical trials, giving the company the proof-of-concept needed to advance to a pivotal study in the second half of this year. read more By Nick Paul Taylor The pink slips keep raining down like confetti in biotech. Taysha Gene Therapies is the latest company to decide to slim down, bidding farewell to 35% of its workers and narrowing its R&D focus to extend its cash runway out to the fourth quarter of next year. read more By Gabrielle Masson Three European agencies have issued initial advice for sponsors about managing clinical trials amid the Russian invasion, noting that certain changes and protocol deviations are “unavoidable.” read more By Nick Paul Taylor Ono Pharmaceutical has pulled the trigger on an immuno-oncology licensing agreement with Numab Therapeutics. After seeing its partner’s work on a “new and very challenging immuno-oncology target,” Ono decided to commit to a $279 million financial package to add the program to its pipeline. read more By Annalee Armstrong Athira Pharma investor Ric Kayne is calling on the company to oust its CEO—months after his business partner was relieved of the role at the Alzheimer's biotech. read more By Angus Liu Under siege from rival drugs by GlaxoSmithKline and AstraZeneca, Clovis Oncology’s Rubraca posted a much-needed win in a broad ovarian cancer patient population, regardless of biomarker status. read more By Andrea Park New results from Synchron’s first human study of its brain-computer interface system found that one year after the device’s placement, none of the four participants had experienced any adverse events that led to disability or death. read more By Angus Liu Preserving insulin-producing pancreatic beta cells—rather than exhausting them—might be a better strategy in the treatment of diabetes. Following that thinking, scientists at the Karolinska Institute found a cancer drug by Seagen holds promise for the metabolic disease. read more By Andrea Park Nearly three years after unveiling its initial series A fundraising efforts—which totaled $6.3 million at the time—Altoida is still adding to the pile. read more By Dave Muoio Hospital E&M charges and negotiated rates have risen more steeply than any of the six areas FAIR Health has been monitoring since 2012, according to the nonprofits latest claims data analysis. 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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