Former Pfizer staffers counter pharma giant's ‘belated and ill-founded’ trade secrets case After ‘masterful’ development of Keytruda, Merck’s CMO follows Roger Perlmutter to Eikon 2seventy bio's honeymoon phase is over as job cuts hit 6% of staff Sponsored: Bridging the preclinical to clinical divide: practical considerations for biomarker success Despite 0% response rate, 4D hits primary endpoint in Keytruda combo trial, sending stock skyward Sponsored: Unlocking the power of AI-driven pathology in drug development: An Interview with Bristol Myers Squibb LifeMine locks down $70M 'dream scenario' fungi partnership with GSK—and a fundraising, too Pfizer's $7B bet delivers phase 3 success, advancing bid to establish new drug in ulcerative colitis Arena Ocelot Bio gets a cool $36M series A and a new CEO to boot NIH-backed HDT Bio sues Indian partner for $950M, alleging it stole trade secrets Moderna seeks FDA nod for COVID vaccine in children under 6, starts delayed filing for older kids Anthony Fauci predicts uptick in US COVID cases from BA.2 subvariant: 'We can't claim absolute victory' UK watchdog slaps AZ, Allergan, GSK, Sanofi and Brittania for marketing breaches FDA clears Quantum Surgical's liver-cancer-focused ablation robot NAMSA buys Spain's AKRN Scientific Consulting in 4th deal in 2 years Featured Story | By Annalee Armstrong Denied, denied, denied—and a countersuit. That’s the response Regor Therapeutics has offered to Pfizer’s lawsuit claiming two former employees who now run the Chinese biotech committed “treachery” by claiming the Big Pharma’s work on a diabetes and obesity program as their own. read more |
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Top Stories By Annalee Armstrong Not only does Roger Perlmutter, M.D., PhD., have the pull to lock down a fundraising round worth a half a billion dollars, he's now poached a former Merck & Co. colleague over to his new biotech Eikon Therapeutics. read more By Max Bayer Slimmed-down 2seventy bio is getting even slimmer, with 6% of its workforce heading out the door less than five months after formally spinning off from bluebird. 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 Can a 0% response rate represent success in an oncology clinical trial? Investors said yes on Wednesday, sending shares in 4D pharma up 30% after enough patients in its Keytruda combination trial had stable disease for the study to hit its primary endpoint. 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 Annalee Armstrong GlaxoSmithKline’s scientific champions, Hal Barron and Tony Wood, were with LifeMine Therapeutics before the small, fungi-focused biotech knew what it does now. But those early conversations, which began two years ago, have led to today: a $70 million upfront deal to develop three candidates based on LifeMine’s fungi-based drug discovery engine. read more By Nick Paul Taylor Pfizer’s $6.7 billion bet on Arena Pharmaceuticals has delivered a phase 3 success. The late-phase trial of S1P receptor modulator etrasimod in ulcerative colitis patients met its primary endpoint, although the drug’s prospects will only come into focus once details of the data and results from an ongoing study are available. read more By Sophia Sorensen With a new CEO and a phase 2 trial ready to go, Ocelot Bio has snagged $36 million in a series A financing led by RA Capital Management, Venrock and Vivo Capital. read more By Max Bayer Seattle-based biotech HDT Bio is suing its manufacturing partner Emcure Pharmaceuticals for $950 million, alleging that the Indian company stole trade secrets and co-opted HDT's COVID vaccine as its own. Emcure says it's been wrongly added to the suit and is looking to get it dismissed. read more By Angus Liu Moderna has new data backing the use of its COVID-19 vaccine Spikevax at a low dose in the youngest children under the age of 6. The mRNA specialist is moving forward with global regulatory submissions in that age group, and it's advancing a delayed FDA filing in children ages 6 to 11. read more By Heather Landi It's likely the U.S. will see an uptick in COVID-19 cases similar to a current surge in Europe as a result of the spread of a more contagious subvariant of omicron called BA.2. "The extent of it and the degree to which it impacts seriousness of disease like hospitalizations and death remains to be seen," Anthony Fauci, M.D., said Tuesday. read more By Natalie Missakian AstraZeneca and Allergan are among five pharma companies in hot water with the UK's Prescription Medicines Code of Practice Authority for marketing activities that ran afoul of industry standards. read more By Conor Hale The company’s Epione system helps plan and perform minimally invasive ablation surgery as an outpatient procedure by deploying computer-guided needles through the skin to single out and destroy tumors. read more By Gareth Macdonald Medtech contractor NAMSA has shown it is still on the takeover trail by buying Madrid-based medical device services organization AKRN Scientific Consulting. 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 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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