Merck, Roche and J&J among pharma players weighing Russian operations amid humanitarian tightrope walk UnitedHealth to acquire home health provider LHC Group in $5B deal Sanofi pulls IGM into dealmaking whirlwind, paying $150M upfront to form 6-target R&D pact Pfizer, Moderna win over FDA for second round of COVID-19 boosters in older adults Pear Therapeutics ripens after SPAC pact, predicts quintupling of revenue in 2022 ImmunoGen files ovarian cancer ADC with FDA, a week after scaring investors with iffy survival data Cleveland Clinic expands into Europe with opening of private London hospital near Buckingham Palace On a roll, Sanofi raises Dupixent's peak sales target to €13B-plus Staar Surgical scopes out FDA approval for LASIK alternative implantable lens Karyopharm hoping for some Keytruda stardust as former Merck & Co. exec joins as CMO 4 healthcare items to watch in Biden's budget proposal LetsGetChecked expands at-home testing with bid for George Church's Veritas companies Featured Story By Fraiser Kansteiner While scores of Western corporations have quit Russia in protest of its invasion of Ukraine, the pharmaceutical industry has been caught in a philanthropic juggling act: Most drugmakers have condemned the war and promised to halt new investments in Russia—but few have stopped operations altogether in the aggressor nation. read more |
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| | Webinar: Comparing the FDA, EMA & PMDA In Vitro DDI Guidance Thursday, April 14, 2022 | 11am ET / 8am PT In January 2020, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Taylor will offer his expert perspectives on major changes, challenges and impacts to development strategies that resulted, compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three. Register Now. | Top Stories By Paige Minemyer UnitedHealth Group will acquire home healthcare provider LHC Group for $170 per share in cash, or about $5.4 billion, the healthcare giant announced Tuesday. read more By Nick Paul Taylor Sanofi has continued the breakneck pace of dealmaking activity, paying $150 million upfront to make IGM Biosciences the third partner added in a hectic month for its business development team. read more By Eric Sagonowsky Amid the ongoing debate over the need for another round of COVID-19 boosters, the FDA has acted quickly on the matter. Pfizer and Moderna each scored FDA nods for another round of boosters in people 50 and older plus certain immunocompromised people. read more By Andrea Park In its first year-end financial report after going public via reverse merger last December, Pear Therapeutics inched past nearly all of its predictions for 2021—and planted the seeds for a much, much bigger 2022. read more By Annalee Armstrong Last week, ImmunoGen’s investors scattered on underwhelming survival data from a late-stage trial of its antibody-drug conjugate for ovarian cancer. But that was last week. This week, the company is filing an application for FDA approval based on the “positive results.” read more By Heather Landi Marking the latest step in its international expansion, Cleveland Clinic today opened a new, private 184-bed hospital in London across the street from the Buckingham Palace Garden. read more By Eric Sagonowsky Over the years, as Sanofi and Regeneron's Dupixent racked up new indications and approached the French pharma giant's 10 billion euro peak sales goal, analysts had started to wonder whether the drug might end up overshooting the target. With Dupixent now well on the way, Sanofi is raising its peak sales ambitions on the star drug to more than 13 billion euros. read more By Andrea Park Years after initially setting its sights on FDA approval for the latest version of its implanted vision-correcting lens, Staar Surgical has finally reached the regulatory milestone. read more By Gabrielle Masson Karyopharm Therapeutics has tapped Reshma Rangwala, M.D., Ph.D., to serve as the company's chief medical officer. She previously served as Merck & Co.'s executive clinical director and was involved in the development of Keytruda. read more By Paige Minemyer The White House has released its proposed budget for fiscal year 2023, and it highlights multiple healthcare priorities for the administration. read more By Andrea Park In side-by-side acquisitions, LetsGetChecked has struck a pair of deals to buy Veritas Genetics and Veritas Intercontinental, which share the at-home testing company’s mission of expanding access to comprehensive health screening. read more |