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From risk mitigation to program-level country and site strategy, IQVIA helped help this sponsor prove operational feasibility for six concurrent global studies. Download the case study.
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| By Angus Liu The FTC has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, raising an argument that serves as an alarming sign for M&A scrutiny to come. The move comes just as biopharma's dealmaking prospects seemed to be improving. |
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By Helen Floersh Novo Nordisk’s Ozempic and Wegovy may have benefits beyond helping patients shed pounds: They appear to reverse the impairments in cancer-fighting natural killer cells seen in people with obesity, independent of weight loss. |
By Max Bayer FDA advisers have narrowly voted in favor of Sarepta’s gene therapy for patients with Duchenne muscular dystrophy, a stunning decision that runs counter to regulators who expressed skepticism heading into the meeting. |
By James Waldron Whether it’s returning to CAR-Ts, swooping in to pick up a Parkinson’s asset from a sinking biotech or setting up a spinout company to pursue its neuroscience ambitions, Janssen has been busy in recent months. |
By Zoey Becker The decision came nearly three months after the drug's original FDA decision date. |
By Helen Floersh The world’s second-ever private astronaut mission to the International Space Station will ferry a first-of-its-kind experiment that will test whether scientists can create induced pluripotent stem cells in microgravity. |
By Fraiser Kansteiner Johnson & Johnson's COVID-19 vaccine is “no longer available in the U.S.,” the Centers for Disease Control and Prevention (CDC) said. The last remaining doses in the U.S. stockpile expired on May 7, 2023, with the CDC now giving instructions to “[d]ispose of any remaining Janssen COVID-19 vaccine in accordance with local, state and federal regulations.” |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Zoey Becker After AbbVie and Teva scratched their memberships with the influential trade group, AstraZeneca is now the latest to ditch PhRMA. |
By Gabrielle Masson Nido Biosciences is exiting stealth mode with $109 million in hand to develop new precision medicines for neurological diseases, with a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder. |
By Fraiser Kansteiner On the heels of an FDA citation and export halt at Sun Pharma’s Mohali, India, manufacturing operations, the U.S. drug regulator is making clear that its demands for corrective actions are nonnegotiable. |
By Joseph Keenan Flatiron Health debuted the latest offering of its real-world evidence platform to include data and end-to-end services focused on growing needs in the arena of oncology clinical trials. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines. |
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Thursday, May 4, 2023 | 2pm ET / 11am PT Join us for an important look at how insights into the complete patient journey can be used to maximize commercial success and health equity. We'll explore how to: measure the volume of patient referrals to specific treatment sites, leverage data that identifies underserved and at-risk patient populations, create value-based compensation plans that align with patient outcomes, and more. Register now.
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| Whitepaper Modern software development and its impact on addressing clinical trial complexity. Sponsored by: YPrime |
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