FDA signs off on Pfizer, Moderna COVID-19 vaccines for kids 6 months and older Intrivo CEO on how medtech startups can band together to help Ukraine: 'This is a call to action' FTC notches another antitrust win as HCA Healthcare, Steward Health Care call off 5-hospital sale Will we ever land the Alzheimer's moonshot? Genentech's crenezumab partners reflect on failure FTC puts drugmaker and PBM rebates in the crosshairs over mounting insulin prices Bausch Health pulls the plug on Solta Medical IPO and 3-way company split Trial site staff shortages, sluggish patient recruitment force Addex to scrap phase 3 Parkinson's study MedPAC is recommending a new method to make Medicare Advantage risk adjustment more accurate. Here's how Eli Lilly taps Sidekick Health to tailor smartphone apps for breast cancer patients Dilution be damned: Scholar Rock raises $205M as 24-month data point to durability of SMA efficacy Paige, Janssen team up to launch AI-powered bladder cancer test CMS expands Medicaid postpartum coverage in 3 states, District of Columbia Merck eyes Seagen purchase amid quest to diversify from star cancer drug Keytruda: WSJ 'The Top Line' podcast: The top 10 list of pharma profits turns up some surprises, bluebird bio's gene therapies win over FDA's expert panel, plus this week's headlines Featured Story | By Kevin Dunleavy Eighteen months after authorizing adults to use COVID-19 vaccines from Pfizer and Moderna on an emergency basis, the FDA has done the same for preschoolers who are at least 6 months old. The endorsement comes two days after an independent FDA advisory committee voted unanimously—though with some reservations about efficacy—to recommend the shots. read more |
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Top Stories By Andrea Park “There’s a lot of power in a lot of people coming together to do tiny little things that add up to something really big," Intrivo CEO Ron Gutman told Fierce Medtech. read more By Dave Muoio Would it have gone through, the sale of five Steward Health Care System hospitals to HCA Healthcare would have combined the second- and fourth-largest systems in the Salt Lake City and Utah’s Wasatch Front region. read more By Annalee Armstrong In a moment of public reflection, the partners on Genentech's failed Alzheimer's disease therapy consider what happened, what they learned and what happens next. read more By Fraiser Kansteiner With FTC's latest enforcement policy statement, the regulator warns that it’s putting pharma companies and prescription intermediaries “on notice” that rebates and anti-competitive fees to exclude cheaper drug alternatives from prescription formularies could run afoul of competition and consumer protection laws. read more By Conor Hale Amid fears of a looming recession, Bausch Health put the brakes on the final piece of a long-running plan to split its company into three. read more By Nick Paul Taylor Addex Therapeutics waited more than a decade for the chance to learn whether dipraglurant is effective in dyskinesia associated with Parkinson’s disease (PD-LID), suffering delay after delay after delay as it tried to get a late-phase trial started. After all that, the phase 2b/3 trial has crashed out before delivering data. read more By Robert King MedPAC recommended installing a reinsurance approach to redistribute uneven spending in Medicare Advantage to make risk adjustment and payments more accurate. read more By Conor Hale Eli Lilly has joined forces with the digital therapeutics developer Sidekick Health to offer tailored apps that help patients with breast cancer stick to their medication regimens. read more By Nick Paul Taylor Stuck in a hard place, Scholar Rock has raised $205 million while its stock is at an all-time low to secure the cash it needs to survive through to the delivery of phase 3 spinal muscular atrophy (SMA) data. The biotech disclosed the financing alongside 24-month data from its phase 2 trial of apitegromab in SMA. read more By Andrea Park The test was developed by Janssen Research & Development, and the Johnson & Johnson subsidiary has tapped digital pathology powerhouse Paige to help bring it into pathology labs and clinical trial sites around the world. read more By Robert King CMS has extended Medicaid and CHIP postpartum coverage for up to 12 months to three states and the District of Columbia, part of a larger effort to improve maternal health outcomes. read more By Angus Liu Merck & Co. already owns a stake in antibody-drug conjugate specialist Seagen. But now, the New Jersey pharma appears to want the whole thing, according to The Wall Street Journal. read more By Teresa Carey This week on "The Top Line," we discuss our special report on the top 10 most profitable pharma companies in 2021. We also talk about the two bluebird bio gene therapy candidates that won expert recommendations for FDA approvals. Plus, we're back in person (and on billboards) at BIO. read more | 