A look at Lilly’s Alzheimer’s launch plans
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Today's Rundown

Featured Story

GlaxoSmithKline poaches Pfizer vax leader Dormitzer after hemorrhaging vaccine R&D talent

GlaxoSmithKline has seen a host of vaccine research staffers exit the Big Pharma over the past year, but it’s hoping a big name can get its vaccine business back on track.

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Top Stories

ImmunoGen lines up FDA filing as antibody-drug conjugate shrinks tumors in pivotal trial

After toiling for 40 years, ImmunoGen can now see the potential approval of its first wholly owned oncology drug on the horizon. The biotech is preparing to submit mirvetuximab soravtansine for approval after showing the antibody-drug conjugate shrank ovarian tumors. 

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TG tumbles as FDA still hasn’t found what its looking for in U2 leukemia combo, orders advisory committee

The FDA still hasn't found what its looking for in TG Therapeutics’ application for the leukemia and lymphoma combo treatment nicknamed U2, and so the therapy will be examined at an advisory committee meeting.

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Sponsored: Optimize Scale-Up for Vaccine and Therapeutic Manufacturing

Accelerate development by focusing on optimizing an entire biomanufacturing workflow. Thermo Scientific Production Chemicals and Services shares insights on how to achieve successful scale-up.

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'What it takes': As Lilly's Alzheimer's drug approaches FDA, launch leader feels 'amplified' sense of excitement

Fierce Biotech profiles three women breaking barriers in Alzheimer's disease R&D at leading pharmaceutical companies. Today, Eli Lilly's donanemab launch leader Brandy Matthews.

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Mei, with Bayer and Gilead in its sights, posts pivotal data on blood cancer prospect

Mei Pharma’s bid to break into a congested market fought over by Bayer and Gilead has yielded data. The pivotal trial linked zandelisib to a 70% response rate in follicular lymphoma patients but leaves scope to question whether the drug is differentiated enough to crack a competitive space.

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Chinook launches a new biotech with major VCs in China to double down on kidney disease R&D

After merging its way onto the Nasdaq last year, kidney disease biotech Chinook Therapeutics is launching a new joint venture in the form of startup SanReno Therapeutics to deepen its footprint in China.

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Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback

The efficacy data for Pfizer’s oral COVID-19 drug now look so appealing that the Big Pharma company is boosting manufacturing capacity even before an expected emergency use authorization.

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Owlet pulls baby-monitoring Smart Sock from market after FDA warning

Owlet is no longer selling its Smart Sock vital sign monitors for babies and toddlers after the FDA informed the company that the devices had been improperly brought to market.

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RAGE against diabetes complications: Novel drug tamps down tissue damage in mice

NYU researchers have developed a drug that prevent a protein called rage from triggering inflammatory signals in diabetes. The drug reduced the risk of heart attack and sped up the healing of diabetic wounds in mouse models of diabetes.

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The top 10 healthcare M&A targets in 2022

Early in 2020, there was a massive pandemic-induced nosedive in merger and acquisitions deals in healthcare. But the industry rapidly rebounded, and the pace accelerated in 2021. In this report, we’ll take you through some companies that could be in the M&A crosshairs during 2022, such as digital pharmacies and health systems.

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Resources

Guide: Top 10 Considerations When Implementing Machine Translation

If you’re thinking about leveraging the benefits of increased quality, reduced costs, and shortened turnaround times that machine translation (MT) has to offer, check out this quick guide for the top 10 considerations when implementing MT.

Whitepaper: Medable was able to cut costs in multiple clinical trials by over US$25,000,000

Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper.

Webinar: Using Next Best to Elevate your Omnichannel Marketing Strategy

Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making.

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

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: Formulation Strategies When Transitioning From Vial to PFS

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

Whitepaper: How the Chronic Insomnia Market Raises Big Questions About Digital Therapeutics

Paper describing how the chronic insomnia market offers big lessons for any biopharma company thinking about getting into digital therapeutics in any therapeutic area.

2021 Report: Clinical Trial Management in a Post-Pandemic World

New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic.

Whitepaper: Enhance the cost-effectiveness of your cGMP chemical supply chain

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

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

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