Among Novartis' key growth drivers, MS drug Kesimpta surges as Kisqali sees 'positive trend' in breast cancer: CEO Sci-fi no more: Synchron implants mind-reading device in first US patient in paralysis trial Top 10 game-changing biotech layoffs in H1 Hospital, physician groups push back on CMS payment rules as COVID-19 assistance dwindles Incyte's topical JAK Opzelura nabs landmark vitiligo nod after brief delay this spring Inovio cuts workforce as COVID program weighs down future growth In another Lynparza flop, AstraZeneca, Merck pull the plug on a colorectal cancer trial Olive cuts 450 staff as CEO cites 'missteps' with fast growth, lack of focus Gilmore O'Neill picked a bad time to become a biotech CEO. He's confident Editas has the goods Delfi Diagnostics scoops up $225M from Lilly, Illumina and more for its cancer blood tests Axel Hoos wants to take small molecules further at Scorpion, leaving Big Pharma in the dust Centene completes sale of PANTHERx subsidiary Roche's Alzheimer's blood test earns breakthrough label from FDA Featured Story | By Angus Liu Novartis is highlighting six products as key engines for the company’s mid-term growth. Among them, new multiple sclerosis drug Kesimpta and relatively slow-ramping breast cancer med Kisqali earned a special call-out from CEO Vas Narasimhan. read more |
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Top Stories By Andrea Park In a milestone that could turn sci-fi into fact, the first U.S. clinical trial of a brain implant that returns the power of communication to severely paralyzed people has begun. read more By Annalee Armstrong At the halfway point for the year, Fierce Biotech looks back at some of the most important layoff events that have hit the industry in 2021. read more By Robert King Several hospitals and physician groups are sharply criticizing recent CMS payment rules as inadequate in light of inflation and labor shortages, as pandemic relief starts to erode. read more By Fraiser Kansteiner Late Monday, the FDA gave the all-clear to Opzelura, also known as ruxolitinib cream 1.5%, for topical treatment of nonsegmental vitiligo in adults and teens ages 12 and older. The green light makes Opzelura the first FDA-approved treatment for repigmentation in vitiligo patients. read more By Annalee Armstrong Inovio is reducing its workforce by 18% in a restructuring that will extend the biotech’s cash runway into 2024 and allow for prioritization of its lead DNA medicine programs. The cuts are in concert with previously announced changes to the biotech’s troubled COVID program. read more By Zoey Becker As AstraZeneca and Merck try to prove Lynparza across tumor types, the companies stopped a phase 3 trial investigating the drug in colorectal cancer after the study was found unlikely to succeed. read more By Heather Landi Healthcare automation startup Olive has laid off 450 employees as the CEO cited tough economic conditions as well as "missteps" in the company's strategy. read more By Annalee Armstrong Editas' new CEO Gilmore O'Neill has already checked off a few items on his to do list in his first six weeks, including hiring a chief medical officer. Fierce Biotech caught up with him and his new CMO to find out what's next. read more By Andrea Park With the funding, Delfi said it plans to ramp up the development and global rollout of its blood tests for early cancer detection and treatment monitoring. read more By Gabrielle Masson Axel Hoos, M.D., Ph.D., left GSK almost a year ago, setting off to reinvent small-molecule drugs as CEO of Scorpion Therapeutics. It's a type of drug that's ripe for innovation, he figures, as other companies shift to new, hotter treatments like CAR-T. read more By Paige Minemyer The company expects to receive $2.8 billion from the two transactions. read more By Andrea Park In the wake of the FDA handing down its first clearance for an in vitro test for early-stage Alzheimer’s disease in May, the floodgates have been opened. read more Resources Sponsored by: NetApp Could cloud be the cure for your EHR headaches? See our infographic on how moving to the cloud can slash financial and administrative burdens. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. 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 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 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 Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. | 