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ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle Abbott’s imaging catheter recall hit with FDA’s Class I designation Senate Finance Committee details telehealth 'Bill of Rights' for mental health care services ASCO: J&J, Legend reveal more CAR-T data and a look at Carvykti for earlier myeloma in a difficult population Iovance sinks 50% as pivotal cell therapy data disappoint investors, but approval plan pushes ahead anyway Cleveland Clinic reports $283M loss, deferred care and high expenses in Q1 2022 Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod Moderna CEO pledges to donate most of his $4B fortune: Bloomberg Addex's eyelid data fail to make clear case for spasm expansion ASCO: Seagen, Takeda think Adcetris can become a force as a lymphoma combo drug AWS for Health launches accelerator with a focus on health equity startups 'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines Featured Story | By Annalee Armstrong Mirati seems to have gotten what it needed in terms of efficacy for its KRAS inhibitor, notching an objective response rate of 43% in non-small cell lung cancer, compared to Amgen’s 37% for its already approved med Lumakras. But the problem lies with how long the effect lasts. On that measure, Amgen appears to have taken the win. read more |
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Top Stories By Andrea Park The recall covers more than 14,500 Dragonfly OpStar imaging catheters that had been distributed around the world, including 4,800 that were sold in the U.S. alone. read more By Robert King The Senate Finance Committee released details on what telehealth flexibilities should be made permanent as part of an effort to increase mental health coverage. read more By Angus Liu Johnson & Johnson and Legend Biotech showed that their closely watched CAR-T therapy, Carvykti, sustained an effect in heavily pretreated multiple myeloma patients and shrank tumors when given earlier in a population with otherwise unyielding disease. read more By Nick Paul Taylor Iovance Biotherapeutics trumpeted a 29% response rate and a 10.4-month median duration of response in a pivotal advanced melanoma trial of its tumor-infiltrating lymphocyte candidate—and saw its stock plummet almost 50% on an unfavorable comparison to earlier data. read more By Dave Muoio A -3.4% operating margin and heavy investment losses places Cleveland Clinic right in line with other nonprofit systems buffeted by the omicron surge. read more By Andrea Park A new artificial intelligence algorithm may be the key to slashing the drawn-out period between when pulmonary hypertension symptoms first arise and a definitive diagnosis is reached. read more By Eric Sagonowsky Moderna's efforts to develop, manufacture and market its massively successful COVID-19 vaccine have made CEO Stéphane Bancel a billionaire. Eventually, the helmsman plans to give away most of his fortune, he told Bloomberg. read more By Nick Paul Taylor Addex Therapeutics’ attempt to expand use of dipraglurant into muscle spasms has stumbled at the first hurdle. A phase 2a clinical trial of the mGluR5 negative allosteric modulator has delivered “inconclusive” data in an eyelid disorder, raising doubts about a broader push beyond Parkinson’s disease. read more By Kevin Dunleavy During the American Society of Clinical Oncology (ASCO) conference, Seagen and Takeda presented trial data that show Adcetris could become at growing force in the treatment of various forms of lymphoma. read more By Anastassia Gliadkovskaya For- or nonprofit U.S.-based startups with existing customers and revenue looking to use AWS services and focused on solving health equity challenges will be considered, the company said. read more By Teresa Carey This week on "The Top Line," we discuss the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. We also talk about Dexcom's potential megamerger with Insulet, the upcoming ASCO meeting and the week's other big headlines. Plus, we have a special announcement about the prestigious Fierce 15 competition. read more |
