Atara's stock plummets 55% following inconclusive phase 2 MS analysis Orion's rebooted R&D strategy pays off with $290M Merck deal for prostate cancer drug Humanigen's COVID-19 prospect flunks NIH trial, sinking stock and raising doubts about its future Sponsored: Ramp up your AAV production with Lonza’s HEK 293 cell line and patented vectors technologies FDA chief says US has 'got to do better' at generating medical product data Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Amgen touts early combo data with Sanofi-backed KRAS partner in a bid to lift Lumakras' prospects Pfizer jumps into bed with Agomab, leading series B extension and lending support to Crohn’s program Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression CRO Inotiv continues M&A strategy with $11M Protypia buy After pivot, Agios names Alexion vet Goff its next CEO as Fouse transitions to board chair Consumers seeking personalized, integrated care post-COVID, CVS survey finds FDA clears Eko’s heart murmur analysis AI for digital stethoscopes Epizyme SEC filing details its desperate days in free fall before $247M sale to Ipsen Featured Story | By Gabrielle Masson Atara Biotherapeutics’ stock plunged following an interim analysis that deemed phase 2 data for its progressive multiple sclerosis candidate to be inconclusive. read more |
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Top Stories By James Waldron Orion’s slimmed-down R&D focus appears to have paid off as the Finnish biotech pockets $290 million from Merck & Co. for a prostate cancer drug. read more By Nick Paul Taylor Humanigen’s COVID-19 program has ended in defeat. After failing to win emergency authorization on the strength of its phase 3 trial, the New Jersey-based biotech has seen its prospect flunk an NIH study, sinking the stock and raising doubts about its future. read more Sponsored by: Lonza AG Advance your AAV-based therapeutics by leveraging Lonza expertise, using the same tools and technologies used for our platform processes. Balance risk and speed, while maintaining high AAV productivity read more By Max Bayer FDA chief Robert Califf, M.D., says the U.S. has "got to do better" at generating medical product evidence to better inform regulators and clinicians. read more Sponsored by: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By Max Bayer Amgen is touting early phase 1 combo data testing Lumakras with a Sanofi-backed KRAS partner as part of a bid to boost the commercial prospects of the lung cancer therapy. Data suggested the combo was more effective in patients that had yet to be treated with a KRAS inhibitor versus those that had. read more By Nick Paul Taylor Pfizer is throwing its weight behind Agomab Therapeutics, leading a $40.5 million extension to a series B round and agreeing to provide expertise in support of a clinical-phase treatment for fibrostenotic Crohn’s disease. read more By Andrea Park Abbott has earned the FDA’s acknowledgement for an ongoing project to apply its deep brain stimulation system to treatment-resistant depression. The designation gives the technology a more expedited pathway toward potential FDA clearance. read more By Gareth Macdonald The non-clinical CRO announced the $11 million acquisition of Tennessee-based Protypia last week, citing its capabilities in protein bioanalysis and tissue-based protein and peptide mass spectrometry as the motivation for the deal. read more By Eric Sagonowsky Agios has had an eventful three-plus years with Jackie Fouse, Ph.D., as its CEO. Now, the company is gearing up for a CEO switch. read more By Paige Minemyer COVID-19 reignited consumers' interest in health and well-being, and they are looking for more personalized care to align with that, according to a new survey from CVS Health. read more By Andrea Park Eko’s smart stethoscopes have been used by U.S. physicians to automatically detect signs of atrial fibrillation and heart murmurs since its first FDA clearance arrived in 2020. A new regulatory OK unveiled this week aims to make the devices even smarter. read more By Kevin Dunleavy As its stock price plummeted early this year, what did Massachusetts biotech Epizyme do to try to stop the bleeding? In a Tuesday SEC filing, Epizyme offered an intriguing blow-by-blow of how it tried to resolve its financial woes on its way to its $247 million sale to Ipsen. read more Resources Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. Sponsored by: Lumanity Check out our 22 on-demand panels, featuring 100+ speakers. 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Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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