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Rx Drugs

September 10, 2019 |

The White House on Tuesday welcomed House Speaker Nancy Pelosi’s ideas on drug pricing, hiking President Donald Trump’s pressure on Senate Republicans and the drug industry to back a less aggressive, but strongly pharma-opposed, drug-pricing bill passed by the Senate Finance Committee.

September 10, 2019 | Daily News

The White House on Tuesday welcomed House Speaker Nancy Pelosi’s ideas on drug pricing, hiking President Donald Trump’s pressure on Senate Republicans and the drug industry to back a less aggressive, but strongly pharma-opposed, drug-pricing bill passed by the Senate Finance Committee.

September 10, 2019 | Daily News

FDA denied a petition from Public Citizen that called for a moratorium on new opioid approvals until the agency’s regulation and review of opioids are revamped.

September 09, 2019 | Daily News

A draft of House Speaker Nancy Pelosi’s Medicare price negotiation bill circulating among lobbyists calls for using international prices as an upper limit for what Americans pay for drugs and imposing harsh penalties to keep drug makers at the negotiating table, instead of relying on a third-party arbitrator as a backstop to negotiation.

September 09, 2019 | Daily News

The Healthcare and Public Health Sector Coordinating Council has issued a list of information-sharing organizations as a resource for assisting hospitals, physicians, drug and device makers, and others within the healthcare industry to defend against cybersecurity threats, with additional guidance expected to come.

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.

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