| Today's Big NewsNov 15, 2022 |
| By Annalee Armstrong,James Waldron,Max Bayer Another failure of an amyloid medicine for Alzheimer’s disease has companies, analysts and patient advocacy groups circling the wagons to once again defend the theory and the future of research into the devastating neurological disorder. |
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By Kevin Dunleavy After 41 years, ImmunoGen has scored its first approval for a solely owned drug. On Monday, the FDA signed off on Elahere to treat advanced ovarian cancer. Elahere (mirvetuximab soravtansine) becomes the first FDA-approved antibody drug conjugate for platinum-resistant disease. It also is the first approval in eight years for advanced ovarian cancer. |
By Conor Hale Dubbed Platform_Validate, the program is designed to put an algorithm’s credibility to the test, and act as a third party to confirm the AI’s efficacy in meeting its intended clinical purpose. |
By Annie Burky SonderMind acquired neuroscience company Total Brain to expand mental healthcare to a broader population and offer more personalized services. Total Brain’s mental health monitoring and support platform will be integrated into SonderMind’s therapeutic platform so therapists and patients can better understand thought patterns, triggers and the efficacy of treatment plans. The acquisition was announced publicly at the HLTH 2022 conference. |
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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now. 
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By Nick Paul Taylor If anyone needed a reminder of the toll that the bear market continues to take on biotech, then the wave of layoffs announced by companies post-market yesterday should leave them in no doubt. |
By Zoey Becker A protracted legal fight over an alleged "pay-for-delay" deal on AbbVie's Alzheimer's disease drug Namenda may be nearing its end as the sides have reached a preliminary settlement. |
By Robert King Retail giant Walmart agreed to a $3.1 billion settlement framework surrounding allegations it didn't do enough to halt suspicious prescriptions of opioids, helping fuel the nationwide epidemic. |
By Andrea Park In a tongue-twisting new prospect for the medtech industry, researchers from MIT have developed devices that can disintegrate on demand. |
By Nick Paul Taylor The pile of discarded biotech R&D programs is getting bigger and bigger. Hutchmed, NightHawk Biosciences and NexImmune are among the latest companies to add to the pile, tossing out programs in response to cash constraints and strategy shifts. |
By Fraiser Kansteiner In briefing documents published Monday, staff reviewers from the FDA’s cardiology and nephrology division questioned the overall efficacy of Ardelyx’s NHE3 inhibitor tenapanor. The development follows an FDA rejection last year. |
By Dave Muoio General Catalyst's "health assurance" network offers its portfolio tech startups a window into health systems' operations and needs for potential collaborations. Today's addition of Universal Health Services, Banner Health and other hospitals brings the investment firm's total number of partner systems to 15. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we share some highlights from Fierce Biotech's Cell and Gene Therapy Forum in case you missed it. |
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Tuesday, November 29, 2022 | 2pm ET / 11am PT Process development of RNA-LNPs can be time consuming, cost prohibitive and require deep expertise in a field that is very dynamic and accelerating fast. Outsourcing gives you direct access to infrastructure, experience, and a team who has done this before and can quickly generate meaningful data taking the guesswork out of process development. Register now. 
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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Whitepaper This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
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Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent |
Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper 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 Biologics |
Webinar 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 |
Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent |
Whitepaper 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: Catalent |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
Whitepaper 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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