uniQure pauses part of Huntington's trial after 3 patients hospitalized—1 of whom hasn’t fully recovered Pfizer’s $5.4B GBT buy adds potential sickle cell disease ‘cure’ and former Sanofi candidates Genentech didn't get it right on diversity for critical Graduate Alzheimer's program. They're trying again Karuna’s resurrection of Lilly drug delivers phase 3 schizophrenia success, teeing up 2023 filing Kodiak matches Regeneron’s Eylea in macular edema phase 3, lighting Beacon of hope after flop The most significant FDA citations of 2021-2022 Senate Democrats pass major healthcare deal that includes drug price reforms MIT engineers develop shape-shifting artificial pancreas that brushes off the immune system’s rejections With COVID vaccine demand in free fall, BioNTech's revenue plummets nearly 50% in second quarter Troubled testmaker Talis Biomedical drops COVID plans, lays off 35% of remaining staff Eli Lilly says Indiana's abortion ban will force it to hire more outside the state Featured Story | By Max Bayer Three patients treated with the higher dose of uniQure's Huntington's disease gene therapy have been hospitalized, including one who has yet to fully recover. read more |
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Top Stories By James Waldron The $5.4 billion Pfizer coughed up to acquire Global Blood Therapeutics was worth it to get the Big Pharma’s hands on a pipeline of exciting sickle cell disease treatments, if analysts’ predictions are anything to go by. And those gains will come well before GBT’s preclinical pipeline, from the likes of Sanofi, enter the clinic. read more By Annalee Armstrong Roche's Genentech unit tried and failed to recruit a diverse population for its critical late-stage Alzheimer's disease program for gantenerumab. They're trying again, armed with lessons learned. read more By Nick Paul Taylor Karuna Therapeutics’ multi-year mission to resurrect an old Eli Lilly drug has ended in clinical success. The biotech has emerged from the phase 3 Emergent-2 trial with evidence showing its therapy works in schizophrenia, positioning it to seek FDA approval next year. read more By Nick Paul Taylor Kodiak Sciences has bounced back from the failure of its eye disease drug candidate, noting that it has matched Regeneron and Bayer’s blockbuster Eylea in one phase 3 in macular edema due to retinal vein occlusion. read more By Fraiser Kansteiner Given the nature of warning letters and 483s as well as the dangers tied to manufacturing snafus, it doesn't make sense to rank worst offenders. Instead, we're providing a glimpse of FDA write-ups that are significant for different reasons. read more By Robert King,Heather Landi The Senate on Sunday passed the Inflation Reduction Act, which includes major reforms to drug prices and extends ACA subsides by three years. read more By Conor Hale Researchers at MIT have developed a method that could be used to ensure long-lasting diabetes implants do not trigger an immune response, allowing them to keep working without being rejected by the body. read more By Kevin Dunleavy After four consecutive quarters in which revenue topped 5 billion euros ($5.1 billion), BioNTech is coming to grips with a decline in demand for the shot, known commercially as Comirnaty. And the fall is coming quicker than expected. read more By Conor Hale The point-of-care testmaker Talis Biomedical is undergoing a second wave of layoffs this year after struggling to get its COVID-19 diagnostic off the ground. It will make another 35% reduction in its headcount and is walking away from COVID testing altogether, pivoting instead to screeners for sexually transmitted diseases. read more By Fraiser Kansteiner Despite Indiana's inability to reach a consensus on the issue of abortion, the state "opted to quickly adopt on the most restrictive anti-abortion laws in the United States,” Eli Lilly said over the weekend. Now, the company is warning of its economic consequences. read more Resources Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? 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: 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 What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 