Today's Big News Sep 15, 2022 In the wake of the Inflation Reduction Act, newer and smaller biotechs may find it increasingly difficult to succeed on their own, Amgen CEO Robert Bradway told Bloomberg. Industry experts predict as CVS, Walgreens and Amazon invest in home health and primary care, there will be major disruptions for more traditional providers, such as hospitals. After generating early evidence of efficacy, Alnylam and Regeneron have outlined plans to kick off a phase 2 trial of their RNAi candidate in the tricky NASH indication. - Gabrielle Masson | Lumanity’s research scientists and data luminaries can identify fit-for-purpose RWD and design studies to generate the strongest evidence to meet stakeholder needs. Learn more.
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Featured | | By Fraiser Kansteiner In an era of abundant pharma buyouts, small and midsized biotechs may find it increasingly difficult to go their own way, Amgen’s CEO Robert Bradway figures. And new drug cost legislation in the U.S. certainly won’t help, the helmsman added. |
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Top Stories By Heather Landi CVS, Walgreens and Amazon are ramping up their focus on in-home medical services and primary care and it will cause major disruptions for more traditional brick-and-mortar providers, industry experts say. By Nick Paul Taylor Alnylam and Regeneron have hit the gas on their RNAi nonalcoholic steatohepatitis program, outlining plans to kick off a phase 2 clinical trial of the drug candidate after generating early evidence of efficacy. By Conor Hale The postage stamp-sized Regeneten implant is designed to trigger the tissue’s healing response and be fully absorbed by the body in about six months. By Fraiser Kansteiner On the heels of Merck & Co. rival Keytruda’s green light as an adjuvant treatment for earlier-stage melanoma, Bristol Myers Squibb’s Opdivo has ginned up data suggesting it won’t be locked in advanced disease for long. By Dave Muoio Many consumers who fall on hard times will be able to maintain their coverage in the marketplace, a luxury the industry hadn't seen in prior recessions, HCA Healthcare's Bill Rutherford said Tuesday during Morgan Stanley’s 20th Annual Global Healthcare Conference. By Gabrielle Masson Are we witnessing the return of SPACs? It's worth considering as Apollomics merges with Maxpro Capital Acquisition Corp.—the second such transaction in recent weeks. By Kevin Dunleavy After lots of trial and error, the FDA has finally signed off on Mallinckrodt's Terlivaz as the first approved treatment for hepatorenal syndrome (HRS) with rapid reduction in kidney function. The condition affects between 30,000 and 40,000 annually in the U.S. By Conor Hale Researchers at NYU have developed a single test they say can help determine which patients may see their cancer return after treatment with immunotherapies, as well as who may be at risk for severe side effects. By Frank Diamond Blue Cross and Blue Shield of North Carolina touted major savings thanks to improved outcomes racked up by providers and the insurer through its Blue Premier program that relies heavily on value-based healthcare. By James Waldron It’s been a turbulent first year for IMV’s CEO Andrew Hall. In July, the company was threatened with Nasdaq delisting. Now, IMV has initiated a significant strategic reorganization that will allow the biotech to focus on its lead, oncology asset at the expense of a third of his workforce. By Fraiser Kansteiner In a write-up of Alvotehc's Reykjavik, Iceland, manufacturing facility, the FDA laid out 13 observations, including chidings related to procedural controls, management of manufacturing deviations, the presence of bacteria and mold, plus more. By Max Bayer New phase 3 data of Pfizer's pentavalent meningococcal vaccine has the big pharma gearing up to go to regulators before the end of the year. The company found its new shot held up against alternatives, including GSK's offering. Fierce podcasts Don't miss an episode | | This week on "Podnosis," we talk about how the emotional toll from gun violence impacts care in hospitals. We also chat about how investors are approaching the current market. |
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| Wednesday, September 28, 2022 | 2pm ET / 11am PT Explore the top line items every SMB marketer should focus on when commercializing new-to-market products, including shifts in the way that HCPs interact with pharma companies post-pandemic, and more. Register now.
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Sponsored by: Catalent Industry Events Virtual U.S. Healthcare Compliance Certificate Program October 10-13, 2022 European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 20-22, 2022 | San Diego, CA Fierce New Product Planning Summit September 19-20, 2022 | Boston, MA Medical Affairs Strategic Summit West (MASS West) September 20-22, 2022 | San Diego, CA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Good Clinical Practice Summit (GCP): Part of the Fierce Clinical Collective October 24-26, 2022 | Philadelphia, PA | Presented by Fierce Pharma Clinical Quality Oversight Forum: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia PA | Presented by: Fierce Pharma Decentralized Clinical Trials Summit: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia, PA | Presented by: Fierce Pharma Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event | 