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Rx Drugs

September 06, 2019 | Daily News

After health organizations and former FDA heads, including former FDA chief Scott Gottlieb, urged the White House to tap Acting FDA Commissioner Ned Sharpless as the permanent FDA chief, another contender for the role appeared: Stephen Hahn, chief medical executive of MD Anderson’s Cancer Center.

September 06, 2019 | Daily News

The prospect of Congress passing drug pricing legislation may depend in large part on the outcome of Texas v Azar, the GOP lawsuit to repeal the Affordable Care Act, according to former congressional and administration staff.

September 06, 2019 | Daily News

Acting FDA Commissioner Ned Sharpless defended the agency’s expedited approval policies, saying the agency can speed up approvals while also preserving the standards of safety and efficacy.

September 06, 2019 | Daily News

In a few weeks, FDA will announce plans to update its technology infrastructure, Acting FDA Commissioner Ned Sharpless told stakeholders at a Research!America event Thursday (Sept. 5).

September 05, 2019 | Daily News

FDA denies allegations in an ongoing lawsuit with drug pricing undertones that two drugs approved to treat Lambert-Eaton myasthenic syndrome (LEMS), Firdapse and Ruzurgi, are the same even though they are indicated for different populations.

September 04, 2019 | Daily News

Four former FDA commissioners and a host of patient advocacy, research and physician groups on Tuesday (Sept. 3) called on President Donald Trump and HHS Secretary Alex Azar to nominate Acting FDA Commissioner Ned Sharpless as the agency’s permanent chief.

August 30, 2019 | Daily News

The senior director of health programs at The Pew Charitable Trusts doesn’t expect a dramatic upheaval at FDA’s Office of Antimicrobial Products after its longtime director, Ed Cox, departed on Sunday (Aug. 25) to become vice president of regulatory affairs at drug maker Regeneron.

August 30, 2019 | Daily News

EPA staff have clarified that under the agency’s new pharmaceutical waste rule, healthcare facilities can manage over-the-counter (OTC) medications as hazardous waste and send them to a reverse distributor, easing significant logistics issues that otherwise would likely have arisen for the facilities, according to an attorney tracking the issue.

August 29, 2019 | Daily News

Surgeon General Jerome Adams issued an advisory on Thursday (Aug. 29) warning about the dangers of marijuana use to adolescents and pregnant women, and urging more research and awareness on the long-term effects of marijuana use across different user populations.

August 28, 2019 | Daily News

Senior FDA officials on Tuesday (Aug. 27) took on critics who say the agency’s increased use of expedited approval pathways is a move toward more lax approval standards.

August 28, 2019 | Daily News

Patients who were exposed to contaminated blood pressure drugs are at a much lower risk of cancer over their lifetime than FDA originally estimated, agency drug center director Janet Woodcock said Wednesday (Aug. 28).

August 27, 2019 | Daily News

Several Republican senators in tough re-election races haven’t been playing up the upper chamber’s accomplishments on drug-pricing over lawmakers’ August recess, analysts say, though the most impactful bill would save taxpayers more than $100 billion.

August 27, 2019 | Daily News

The government is putting up new barriers to drug copay coupons, and pharmacy benefit managers say the new rules will help control drug spending.

August 27, 2019 | Daily News

The Drug Enforcement Administration (DEA) will review more than 30 pending applications from entities interested in growing marijuana for research purposes, the agency announced Monday (Aug. 26).

August 26, 2019 | Daily News

An Oklahoma judge determined that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals played a role in the opioid crisis, and he ordered the company to pay more than $572 million based on public nuisance claims.

August 26, 2019 | Daily News

Large employers are increasingly open to the government negotiating prices of high-cost drugs, a notable change from previous years that reflects ongoing concern over skyrocketing costs, according to a new survey by the National Business Group on Health (NBGH).

August 26, 2019 | Daily News

FDA issued a draft guidance Monday (Aug. 26) encouraging drug sponsors to include men in clinical trials of breast cancer therapies.

August 23, 2019 | Daily News

House Ways & Means Democrats are scheduled to meet Sept. 10 and 11 to talk about drug pricing and surprise billing legislation, and the committee might even mark up a bill mid-month, but it’s unclear which measures might be marked up or what they might entail.

August 23, 2019 | Daily News

A new group led by the Biotechnology Innovation Organization (BIO) is urging Congress to create additional incentives for drug and biologic makers to develop innovative antibiotics, starting with passage of the Medicare add-on payments included in the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019.

August 23, 2019 | Daily News

Three former FDA commissioners are calling for CMS to test using data from multiple sources to gauge outcomes of value-based pay models for high-cost drugs and biologics.

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