FDA clears Pfizer's coronavirus vaccine for young kids, moving US to next stage of rollout

The authorization makes the shot available to nearly 28 million kids between the ages of 5 and 11, though a CDC panel next week could hold significant sway over who among them should be vaccinated.

By Shoshana Dubnow • Oct. 29, 2021

Drug price restraints dropped as Biden prioritizes other measures

Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.

By Jonathan Gardner • Oct. 29, 2021

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Labor

Hospitals are navigating persistent labor shortages with the need to cut costs — a source of contention that could leave patients caught in the middle.

By Healthcare Dive staff

FDA advisers support using Pfizer's coronavirus vaccine in young children

The expert panel pressed Pfizer and the FDA on the shot's safety, but ultimately were convinced by the potential for significant benefit in 5- to 11-year-olds.

By Ned Pagliarulo • Oct. 27, 2021

Regulatory burdens strapped medical practices over the past year, MGMA finds

Prior authorization requirements were the most frequently cited hurdle, while requirements for Medicare's Quality Payment Program and COVID-19 workplace mandates tied for second, a survey by the medical practices group found.

By Hailey Mensik • Oct. 27, 2021

Merck agrees to license COVID-19 pill widely through pact with patent group

The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.

By Kristin Jensen • Oct. 27, 2021

A look at Teladoc's primary care strategy from its head of US group health

In an interview, Kelly Bliss teased upcoming clients for a new virtual-first primary care product and parsed out Teladoc's growth strategies for 2022 and beyond.

By Rebecca Pifer • Oct. 27, 2021

CARES funding to hospitals hit hard by COVID-19 was unevenly distributed, study finds

Larger academic medical centers received a significantly larger proportion of federal coronavirus relief funds than smaller and more rural hospitals, a study of more than 950 facilities concluded.

By Ron Shinkman • Oct. 22, 2021

CDC panel backs COVID-19 boosters for Moderna, J&J vaccine recipients

Advisers' recommendations followed the FDA's clearance of additional doses for certain people vaccinated with Moderna's and J&J's shots, while also endorsing a mix-and-match approach.

By Jonathan Gardner , Shoshana Dubnow • Updated Oct. 22, 2021

What to watch at FDA meeting on COVID-19 vaccines for kids

The outcome of a high-stakes advisory panel Tuesday could open the door for millions of kids to receive Pfizer's coronavirus vaccine. Here's what we know.

By Ben Fidler , Ned Pagliarulo • Oct. 22, 2021

CMMI wants every Medicare beneficiary in an accountable care plan by 2030

Officials acknowledged provider concerns that current models are too burdensome and benchmarks too complex, which the innovation center aims to fix.

By Hailey Mensik • Oct. 21, 2021

FDA authorizes additional Moderna, J&J shots, broadening booster rollout

The agency also cleared booster shots of all three currently available vaccines to be used interchangeably, a so-called mix-and-match approach that recent study results showed could boost immune responses.

By Shoshana Dubnow • Oct. 21, 2021

Biden administration rolls out plan for vaccinating children as FDA weighs clearance

The plan is dependent on FDA authorization and CDC recommendation of Pfizer's vaccine for children aged 5 to 11 by early next month.

By Shoshana Dubnow • Oct. 20, 2021

Over-the-counter hearing aids proposed by FDA

The policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by a few companies, a Cowen analyst said.

By Greg Slabodkin • Oct. 19, 2021

Anatomy of a medical device recall: How defective products can slip through an outdated system

A fragmented system has medtechs notifying hospitals via mail or FedEx, leading to missed notices, putting patients at risk, critics say.

By Ricky Zipp • Oct. 19, 2021

Zelis helps address new NSA and TiC regulations

Learn more about innovative solutions that can help you comply with new regulations.

Oct. 18, 2021

FDA panel endorses second shot for adults who received J&J vaccine

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

By Ben Fidler • Oct. 15, 2021

Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload." 

By Greg Slabodkin • Oct. 15, 2021

Biden circling former FDA chief Califf to again lead agency: report

The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

By Ricky Zipp • Oct. 15, 2021

FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon.

By Shoshana Dubnow • Oct. 14, 2021

FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

By Nick Paul Taylor • Oct. 13, 2021

AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?

The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.

By Ben Fidler • Oct. 12, 2021

Medicare Advantage, Part D plans with 4 or more stars soaring, CMS says

About 90% of people currently enrolled in MA plans offering prescription drug coverage are enrolled in a plan that will earn four stars in 2022.

By Hailey Mensik • Oct. 11, 2021

Merck, Ridgeback seek US clearance of first oral COVID-19 drug

The two partners have officially filed for emergency authorization of their antiviral pill, a milestone in the fight against COVID-19. It's not yet clear whether vaccine recipients will be eligible for treatment, however.

By Ben Fidler • Oct. 11, 2021

The 21st Century Cures Act update: where we've been and where we're going

Learn what's changed and how you can leverage technology and data to shape the healthcare of tomorrow.

Oct. 11, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

For years, FDA has talked about the need for an electronically readable inventory of third-party components in devices, as a way to address the problem of widespread cyber vulnerabilities.

By Greg Slabodkin • Oct. 8, 2021