| Editor’s Note: Just a week left to nominate the Fiercest Women in Life Sciences! Nominations close at 11:59 p.m. EDT on Friday, Aug. 26. WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Bluebird scored its first U.S. gene therapy approval, and with it comes a $2.8 million price tag that the company is prepping to defend. In other gene therapy news, with two patients dying after taking Novartis’ Zolgensma, the safety debate has come to the surface once again. And amid a biotech market downturn, execs have been forced to make tough decisions about their pipelines. In the medtech world, Illumina has set aside more than $450 million to prep for potential fines in Europe over its Grail acquisition. Those headlines, plus news from Merck, Pfizer, AstraZeneca and more made this week’s top news. | |
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Featured Story | By Fraiser Kansteiner Ahead of a much awaited FDA decision deadline Friday, the agency endorsed bluebird bio's gene therapy Zynteglo. It'll carry a $2.8 million price tag and is the first gene therapy for this rare disease. read more |
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Top Stories Of The Week By Angus Liu Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention. read more By Annalee Armstrong We’re seeing a seemingly unprecedented reckoning from biotech C-suites, where executives are making tough calls about continuing to keep the lights on or cutting once-promising candidates. read more By Conor Hale The rainy day money for potential legal troubles dragged Illumina's quarterly income into the red, while sales slumped due to global macroeconomic challenges and the company cut back its financial outlook for the year. read more By Fraiser Kansteiner Angling to keep trade secrets out of a local rival’s hands, AstraZeneca has asked a London court to enforce and extend a noncompete agreement, Bloomberg reports. read more By Teresa Carey This week on "The Top Line," we discuss Novartis’ gene therapy Zolgensma—and the two deaths following treatment. We also hear from AstraZeneca on its strategy to get into the CAR-T space with off-the-shelf cancer cell therapies. read more By Nick Paul Taylor Orna Therapeutics is in the money. Tuesday morning, the developer of fully engineered circular RNA therapies revealed a double dose of good news, simultaneously taking the lid off an alliance with Merck & Co. worth $150 million upfront and a $221 million series B financing. read more By Nick Paul Taylor Sanofi is stopping development of its oral selective estrogen receptor degrader amcenestrant. A failed phase 3 interim analysis dealt the death blow to the program, which Sanofi once saw as the future “endocrine backbone therapy” in breast cancer. read more By Kevin Dunleavy Despite a bevy of economic challenges in the second quarter, the biopharmaceutical industry got through the period with solid sales as 15 of the top 24 companies saw a revenue increase over the second quarter of 2021. Pfizer, AstraZeneca and Merck were the top gainers while Regeneron and BioNTech took the largest hits. read more By Andrea Park After years of urging from both the government and the public, the FDA has established a new device category that’ll allow certain hearing aids to be sold over the counter, directly to consumers. read more By Max Bayer Checkpoint is calling it quits on a phase 3 combo trial of its lead cancer med because of the ongoing war in Ukraine. The company had the majority of its trial sites in Russia and says it's dealt with a "substantially longer" enrollment period than expected. read more By Fraiser Kansteiner Reported pandemic staffing shortfalls within GSK’s manufacturing network have temporarily scuttled supplies of a crucial childhood vaccine in four African countries. read more By Andrea Park "This algorithm could help to find more of these hidden lesions in children and adults with epilepsy and enable more patients with epilepsy to be considered for brain surgery that could cure the epilepsy and improve their cognitive development,” Konrad Wagstyl, Ph.D., co-senior author of the study, said in a statement. read more By Ben Adams "When you look me in the eyes, I hope you don’t see crow’s feet." Not exactly the words of the Jonas Brothers’ hit single, but Joe Jonas—one-third of the U.S. super band—may be re-thinking whether to add that second line for his next gig. read more By Angus Liu A research team led by the University of California, San Francisco has identified genetic regulators of microglia’s disease states in the brain. The hope is to identify drugs that act on relevant genes or proteins to revert diseased microglia back to a healthy state to treat neurodegenerative diseases. read more Resources Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. 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 Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities 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 Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. | 