| 11.15.22 | Roche flop casts pall over Alzheimer’s R&D; Arde lyx’s kidney disease prospect t akes FDA flack ahead of hearing

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Today's Big News

Nov 15, 2022

Roche's 'high risk' failure has industry circling the wagons on future of Alzheimer's research

Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect

Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs

HLTH22: SonderMind picks up neuroscience company Total Brain to build out data-driven mental healthcare

AbbVie inks $54M settlement to resolve Namenda 'pay-for-delay' lawsuit

Adamis, Harpoon, Neoleukin and Tricida add to biotech layoff wave as pipeline setbacks spur cuts

MIT study finds new way to dissolve stents, staples—potentially replacing surgical removal


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Roche's 'high risk' failure has industry circling the wagons on future of Alzheimer's research

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.

Four decades in, ImmunoGen gets landmark green light in advanced ovarian cancer

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.

Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs

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.

HLTH22: SonderMind picks up neuroscience company Total Brain to build out data-driven mental healthcare

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.

Webinar: How an open, collaborative network of life-science vendors is transforming biopharma

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.

Adamis, Harpoon, Neoleukin and Tricida add to biotech layoff wave as pipeline setbacks spur cuts

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.

AbbVie inks $54M settlement to resolve Namenda 'pay-for-delay' lawsuit

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.

Walmart agrees to $3.1B multistate opioid settlement framework and will install new requirements

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.

MIT study finds new way to dissolve stents, staples—potentially replacing surgical removal

By Andrea Park

In a tongue-twisting new prospect for the medtech industry, researchers from MIT have developed devices that can disintegrate on demand.

Hutchmed, NightHawk and NexImmune are latest biotechs to drop R&D programs in Q3 cleanout

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.

Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect

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.

HLTH22: General Catalyst adds 10 new health system partners including UHS, Banner Health

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.

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Webinar: Accelerate development by outsourcing MRNA –LNP formulations to a CDMO

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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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Enhance the cost-effectiveness of your chemical supply chain

Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific.

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Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

Sponsored by: Thermo Scientific Production Chemicals and Services

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Webinar: Writing the Future of Antibody Discovery Solutions

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

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Commercializing Gene Therapies – Supply Chain Considerations

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Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

The Faster Path From Pre-Filled Syringe to Auto-Injector

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Softgel Formulation Enables Oral Delivery of Testosterone

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

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Today's Big News

Featured

Roche's 'high risk' failure has industry circling the wagons on future of Alzheimer's research

Top Stories

Four decades in, ImmunoGen gets landmark green light in advanced ovarian cancer

Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs

HLTH22: SonderMind picks up neuroscience company Total Brain to build out data-driven mental healthcare

Webinar: How an open, collaborative network of life-science vendors is transforming biopharma

Adamis, Harpoon, Neoleukin and Tricida add to biotech layoff wave as pipeline setbacks spur cuts

AbbVie inks $54M settlement to resolve Namenda 'pay-for-delay' lawsuit

Walmart agrees to $3.1B multistate opioid settlement framework and will install new requirements

MIT study finds new way to dissolve stents, staples—potentially replacing surgical removal

Hutchmed, NightHawk and NexImmune are latest biotechs to drop R&D programs in Q3 cleanout

Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect

HLTH22: General Catalyst adds 10 new health system partners including UHS, Banner Health

Don't miss an episode

'The Top Line': Fierce Biotech's Cell & Gene Therapy Forum

‘The Top Line’: Philips' plans to cut costs amid ongoing recalls

'Podnosis': Charity care policies, Fierce's Women of Influence

Webinar: Accelerate development by outsourcing MRNA –LNP formulations to a CDMO

Resources

Enhance the cost-effectiveness of your chemical supply chain

Plan for scalable process liquid and buffer preparation

Webinar: Writing the Future of Antibody Discovery Solutions

Commercializing Gene Therapies – Supply Chain Considerations

Discover why you should choose the Gibco™️ Efficient-Pro™️ system

The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

Formulation Strategies When Transitioning From Vial to PFS

The Faster Path From Pre-Filled Syringe to Auto-Injector

Softgel Formulation Enables Oral Delivery of Testosterone

Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Intranasal Drug Product Development: Formulation to Manufacturing

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| 11.15.22 | Roche flop casts pall over Alzheimer’s R&D; Arde lyx’s kidney disease prospect t akes FDA flack ahead of hearing

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