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Today's Big NewsJun 28, 2023 |
| By Max Bayer,Gabrielle Masson The Inflation Reduction Act's drug pricing reforms have sent shock waves through the drug development world, with executives arguing the legislation stands to stymie the development of innovative new medicines. |
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By Nick Paul Taylor Bayer has early evidence that its Parkinson’s disease cell therapy is safe. Now, with a phase 2 clinical trial on course to open enrollment next year, the German drugmaker is set to start showing whether the candidate can undo damage and restore motor function. |
By James Waldron Foghorn Therapeutics isn’t having much luck with FHD-286. Only weeks after the FDA released a trial of the drug in two blood cancers from a clinical hold, the biotech has abandoned plans for the candidate in an eye tumor after taking a look at phase 1 data. |
Sponsored by Context Therapeutics Inc. In the ongoing search for new cancer treatments, companies including Context Therapeutics are developing potential therapies focused on the emerging novel oncology target Claudin 6. |
By James Waldron Novo Nordisk insists its rival to Roche's Hemlibra will make a “good offering” for hemophilia patients even though mixed phase 3 data suggest that Pfizer’s own candidate could have an edge in the race to market. |
Sponsored by Sciensus Are you considering expanding your orphan drug in Europe? Discover key strategies to identify, engage and support rare disease patients, ensuring treatment adherence that makes a real difference. |
By Nick Paul Taylor Cognition Therapeutics has released data on the effect its Alzheimer’s disease drug candidate had on an exploratory endpoint in a small clinical trial, offering another look at how the molecule acts on the brain as the biotech heads toward more important readouts. |
By Helen Floersh The results of a new study show that it's possible to target the enzyme CaMKII in the heart without affecting it in the brain. They also suggest that ruxolitinib, a JAK1/2 inhibitor commercialized by Novartis as Jakavi, stops arrhythmias in their tracks. |
By Zoey Becker In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety. |
By Kevin Dunleavy Retiring from Emergent BioSolutions in 2010 didn’t take for Robert Kramer. He was wooed back to the company a year later and eventually became the contract manufacturer’s president, CEO and a member of its board. Now, Kramer has done it again, announcing his retirement, effective immediately. Kramer will be replaced as CEO on an interim basis by Haywood Miller. |
By Andrea Park Tandem Diabetes Care’s insulin pumps already make up more than a third of those used by people with Type 1 diabetes in the U.S., according to Elizabeth Gasser, an executive VP at Tandem and its chief strategy officer—but the company wants an even bigger piece of the pie. |
By Nick Paul Taylor Bristol Myers Squibb went big on display ads at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023. That is one of the takeaways of ZoomRx’s analysis of the online activities of oncologists, which showed promotions of Bristol Myers’ cell therapies Abecma and Breyanzi were the most seen ads. |
By Teresa Carey This week on "Podnosis," we talk about the role commercial insurers play in Medicaid eligibility determinations. Also under discussion is healthcare for the LGBTQ+ community. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines. |
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September 26-28, 2023 | Philadelphia, PA Hear how to drive greater sponsor-CRO-site collaboration and communication, and the latest on oversight approaches for external stakeholders. Save $400 on Registration with the Early Bird Rate!
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| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperAutoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
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| WhitepaperThis paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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