Icosavax's COVID-19 shot fails to deliver in early data, spurring debate about 'fatal flaw' in platform AN2 upsizes IPO, teeing up bid to revitalize antibiotic let go by GSK and Pfizer 89bio gains a little more confidence in NASH treatment with new hormone data Sponsored: Bridging the preclinical to clinical divide: practical considerations for biomarker success MEI rocked as FDA request for randomized data on cancer drug ends hopes of accelerated approval Sponsored: Unlocking the power of AI-driven pathology in drug development: An Interview with Bristol Myers Squibb Biogen sets up network to leverage real-world data for neurological disease drugs Moderna weighs private market debut for COVID shot as federal funding flounders Roche, Bristol Myers partner to develop digital pathology AI to analyze clinical trial assays Google unveils smartphone-based AI for diabetic retinopathy, heart valve disorders Gilead, after 11% revenue increase in 2021, rewards CEO O'Day with $19.2M pay package Wisconsin, Utah governors sign bills penalizing violence, threats against healthcare workers Chutes & Ladders—After 9 years at Merck, Roy Baynes follows Roger Perlmutter to Eikon Fierce Pharma Asia—Chinese biotech's Pfizer trade secret suit; Lilly, Innovent's FDA rebuff; Aurobindo's New Jersey closure Featured Story | By Max Bayer Early underwhelming data from Icosavax's COVID-19 vaccine has sent investors sprinting towards the exits, bringing into question whether the biotech's entire platform has a "fatal flaw." read more |
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Top Stories By Nick Paul Taylor AN2 Therapeutics has found public investors willing to bet on biotech, enabling it to upsize its IPO and reel in $69 million for a pivotal trial of an antibiotic it picked up from Pfizer’s Anacor Pharmaceuticals. read more By Annalee Armstrong 89bio has gained a little more confidence in its non-alcoholic steatohepatitis therapy after new data showed the treatment increased levels of a key hormone linked to anti-inflammatory and anti-fibrotic activity in the liver. read more Sponsored by: Precision for Medicine To successfully advance preclinical biomarker assays from the bench to the bedside, it is crucial to develop a clear plan for delivering assays that can be used within the clinical trial setting. Learn strategies for assessing and optimizing biomarker feasibility and utility to support study success. read more By Nick Paul Taylor The FDA has crushed MEI Pharma’s hopes of winning accelerated approval for its PI3K inhibitor on the strength of phase 2 data, delivering another blow to a class of cancer drugs that has been reshaped by a series of shifts in recent months. read more Sponsored by: PathAI Learn how Bristol Myers Squibb is unlocking new insights in translational research and development by transforming pathology with artificial intelligence read more By Gareth Macdonald Aduhelm maker Biogen has set up a data network to track how neurological disease medicines perform in the real world after clinical trials. read more By Fraiser Kansteiner As Congress gridlocks over new funding for COVID-19 therapies and vaccines, mRNA bigwig Moderna is setting its sights on the endemic market for its wildly successful shot. read more By Andrea Park It’s only been a few months since Roche started inviting artificial intelligence developers like PathAI into its cancer-focused digital pathology platform, but it’s already going all-in on the technological team-up. read more By Andrea Park At its second annual The Check Up event this week, Google Health introduced new research projects that would use artificial intelligence to turn smartphones into stethoscopes and other at-home disease screening tools. read more By Kevin Dunleavy After a good news, bad news year for Gilead, CEO and board chairman Daniel O’Day nabbed a $19.2 million pay package, a slight increase from his 2020 pay of $19.0 million. read more By Dave Muoio Newly signed legislation protects healthcare workers and helps limit the number of providers choosing to leave short-staffed hospitals, Wisconsin Hospital Association President and CEO Eric Borgerding said in a statement. read more By Max Bayer After nine years at Merck, Roy Baynes is taking the CMO role at Eikon Therapeutics, following former colleague Roger Perlmutter. Months after leaving Biogen, former R&D chief Al Sandrock will take the helm of Voyager Therapeutics. Phillip Krause joins Mesoblast board after departing FDA amid bungled booster rollout. read more By Angus Liu The co-founders of a Chinese biotech have countersued their former employer Pfizer in a legal battle over alleged trade secrets theft. Eli Lilly and Innovent Biologics have received bad news for their China-made cancer drug. Aurobindo is shutting down a New Jersey facility. And more. 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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