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Gain expert advice on navigating the stakeholder ecosystem—from payers and policymakers to patients and community oncologists. Download the eBook now to drive commercial success and outcomes in cancer care.
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Today's Big NewsJul 21, 2023 |
| By Max Bayer Cidara Therapeutics has yet to hear whether Janssen is formally ending a collaboration on flu prophylaxis, saying it intends to trudge ahead with development until hearing otherwise. Janssen no longer lists the partnered asset in its pipeline. |
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By Fraiser Kansteiner Some four years after Daiichi Sankyo's quizartinib scored its initial green light in Japan—and suffered a slap-down from drug regulators stateside—the acute myeloid leukemia medicine has won the FDA’s blessing. It becomes the U.S.' first FLT3 inhibitor approved across three phases of the common blood cancer. |
By Andrea Park After use of its surgical robotics systems all but ground to a halt at the height of the COVID-19 pandemic, Intuitive Surgical has seen its fortunes reverse in recent months, as hospital procedures steadily return to pre-pandemic levels. |
By Zoey Becker After severe respiratory events and seven deaths held up ADC's Zynlonta study in unfit or frail patients with previously untreated diffuse large B-cell lymphoma, the company has scrapped the trial altogether. |
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Tuesday, July 25, 2023 1pm ET / 10am PT New methods in scalable compute cloud environments not only accelerate drug discovery in a cost-effective manner, but benefit from reduced deployment time, accelerated GPU speed, and reduced infrastructure costs. Register now to learn more.
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By James Waldron Up to 500 roles at Idorsia are at risk as the Swiss biotech tries to halve its cash burn while it waits for its approved insomnia treatment Quviviq to pay off. |
By Conor Hale A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market. |
By Fraiser Kansteiner Friday, Mirati said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati “disagrees with the opinion” and intends to file for a formal re-examination, the company said. |
By James Waldron In a tricky financial climate, we’re increasingly used to hearing about biotechs reducing head count for their early-stage R&D work. But Passage Bio has decided to go in the other direction, laying off employees in its chemistry, manufacturing and controls group to prioritize its development strategy. |
By Andrea Park Proving once and for all that you can, indeed, teach an old dog new tricks, the University of Utah has earned its first-ever 510(k) clearance from the FDA at the ripe old age of 173. |
By Max Bayer,Gabrielle Masson Marc Tessier-Lavigne has resigned from his post as president of Stanford University after months of sidestepping allegations that select research he oversaw was manipulated. |
By Zoey Becker Eisai showed off "promising" results from a modeling and bioavailability study of its subcutaneous Leqembi formulation. Astellas joined the growing list of drugmakers taking on the Inflation Reduction Act with legal action. GSK pulled two batches of its Nucala in Taiwan after glass particles were found in one vial. Plus more. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the state of digital phenotyping, plus the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines. |
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Thursday, August 3, 2023 | 11am ET / 8am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now.
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