Merck refiles $11.5B Acceleron deal with the FTC. But extending regulators' review time only one benefit Six weeks in, Mirati CEO shows CMO, COO the door ahead of key FDA filing for KRAS drug Fierce Healthcare's 2021 Women of Influence Awards Federal judge rules HHS' efforts to punish pharma over 340B restrictions 'arbitrary and capricious' Zimmer Biomet software error prompts Class I recall of Rosa One robotic neurosurgery platform Novartis keeps the leukemia innovation coming with FDA approval for Gleevec follow-on Scemblix as Tasigna patent cliff nears Teladoc ramping up focus on virtual primary care with plans to take on financial risk BD inks BARDA contract to develop COVID tests for the long future of the pandemic Lengo's hiring spree shows no signs of slowing as it hires Pfizer veteran Murray as VP of research Amid a push to resolve opioid and talc claims, Johnson & Johnson settles Risperdal litigation for $800M Optina Diagnostics nabs Boehringer’s support in $20M VC round for retina-based Alzheimer’s test LianBio snags $325M IPO, slightly bigger than the multi-partnered biotech's 2020 series A Pfizer, GSK present dueling maternal vaccine data in RSV, as an analyst predicts 'the year of RSV' is ahead Featured Story | By Angus Liu Merck & Co.’s $11.5 billion bid for Acceleron Pharma is hitting a delay just as activist investors threaten to derail the deal altogether. The New Jersey pharma is refiling its premerger notification to give antitrust regulators more time. But in doing so, it is also extending the tender offer time for its shareholders. read more |
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Top Stories By Kyle LaHucik In the lead up to asking the FDA for its first drug approval, Mirati Therapeutics is making another leadership shuffle, parting ways with its chief medical officer and chief operating officer six weeks into the new CEO's tenure. read more By Heather Landi We are honoring leaders who have made a measurable impact on healthcare in the past year and who have paved the way forward for women and men alike. These leaders epitomize innovation, passion and ingenuity. read more By Dave Muoio Although the court turned aside HHS efforts to penalize drugmakers restricting discounted 340B products from contract pharmacies, the judge took a shot at the the restrictions themselves and opened the door for legislators to settle the issue. read more By Andrea Park According to the FDA’s recall notice, an error in the latest version of the Rosa One software could cause instruments to be incorrectly placed during stereotactic neurosurgeries. One of the three complaints lodged so far came after the system inaccurately placed an electrode on the brain during a surgical procedure. read more By Angus Liu About two decades ago, Novartis transformed leukemia treatment with the introduction of Gleevec. Now, the Swiss pharma has ushered a third-generation therapy targeted against the blood cancer across the regulatory finish line. read more By Heather Landi Teladoc plans to take on financial risk with its virtual primary care offering as it looks to expand that program to more payers and hospitals. During the company's third-quarter earnings call last week, Teladoc CEO Jason Gorevic said the company will take on degrees of risk, from clinical measures of care to risk corridors to, ultimately, full capitation. read more By Conor Hale BD has inked a public-private partnership with the U.S. government to ready its current lines of COVID-19 diagnostics for the long haul of the pandemic—by developing combination tests that simultaneously screen for the flu and other infectious diseases from a single sample. read more By Ben Adams Lengo Therapeutics has named a slate of new hires in recent months and is back at it again, nabbing Turning Point’s Brion Murray, Ph.D., as its senior vice president of research. read more By Kevin Dunleavy Johnson & Johnson revealed in an SEC filing that it has settled roughly 9,000 liability claims in the U.S. surrounding its antipsychotic drug Risperdal. The $800 million settlement comes amid a flurry of moves to resolve opioid and talc claims against the company. read more By Andrea Park Optina will continue to develop its Retinal Deep Phenotyping platform and accelerate clinical trials of its first Alzheimer’s diagnostic to support the company’s eventual submission for FDA approval of the test. read more By Kyle LaHucik Partner-heavy biotech LianBio secured $325 million in its Wall Street debut to fund a series of trials across cardiovascular, oncology, ophthalmology, inflammatory and respiratory diseases. The Shanghai biotech raised $310 million in a series A last year and has lined up partners like Bristol Myers Squibb's MyoKardia, BridgeBio, Tarsus, Lyra and others. read more By Annalee Armstrong The head-to-head Big Pharma battle for a respiratory syncytial virus vaccine is heating up, with Pfizer reporting 85% efficacy in protecting babies born to vaccinated mothers from infection or hospitalization. read more |
