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Rx Drugs

February 08, 2019 | Daily News

Five Democratic senators, including a presidential candidate and another potential candidate, introduced a bill to let the government condition drug exclusivity on companies keeping price increases in the single digits.

February 08, 2019 | Daily News

FDA on Friday (Feb. 8) updated its public list of brand drugs for which generic drug makers complain they can’t get a hold of the samples needed for generic development.

February 07, 2019 | Daily News

NEW ORLEANS -- Senate Finance Committee Chairman Sen. Chuck Grassley (R-IA) and Sen. Patrick Leahy (D-VT) introduced a bill Tuesday (Feb. 5) that they say would lower drug prices by blocking tactics brand-drug makers use to delay generic drug development by withholding drug samples.

February 07, 2019 | Daily News

Johnson & Johnson announced Thursday (Feb. 7) that it would be the first drug maker to disclose list prices in its television advertisements, the Associated Press first reported.

February 07, 2019 | Daily News

The Senate health committee will hold a hearing next Tuesday (Feb. 12) to discuss progress in developing non-addictive pain therapies, how health care providers can better treat pain patients and potential federal barriers to improving care for people with pain.

February 06, 2019 | Daily News

A group of drug makers and other health care stakeholders wrote to Senate health and Finance committee leaders on Tuesday (Feb. 5) asking them to pass a package of incentives to boost antibiotic development, saying pharmaceutical companies and investors are losing interest in the field due to a lack of return on new product development.

February 06, 2019 | Daily News

Despite warnings from the medical device industry that FDA would be slammed by a backlog of medical product applications that piled up during the shutdown, a former FDA advisory told Inside Health Policy the agency’s user fee-funded activities should return to normal operations and workload shortly.

February 06, 2019 | Daily News

FDA on Wednesday (Feb. 6) finalized guidance detailing the types of clinical studies and novel endpoints that can be used to support approval of depot buprenorphine products and how sponsors should design efficacy trials.

February 06, 2019 | Daily News

Democrats were not impressed with the president’s pledge during his State of the Union address to lower drug prices because he didn’t mention government price negotiation.

February 06, 2019 | Daily News

The American Cancer Society Action Network (ACS CAN) applauded President Donald Trump’s call in his State of the Union address for Congress to provide $500 million over the next 10 years to fund research for new childhood cancer therapies.

February 06, 2019 | Daily News

Patient advocates and health care experts welcomed President Donald Trump’s pledge Tuesday night to end the HIV epidemic by 2030, but also stressed the administration must make policy shifts that embrace comprehensive health care and reject discriminatory actions in order for the ambitious project to succeed. Democrats argued the administration’s previous actions have undermined, not supported, the battle against the disease.

February 05, 2019 | Daily News

In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products.

February 05, 2019 | Daily News

The House Ways & Means Committee next Tuesday (Feb. 12) will hold a drug-pricing hearing, which will be the fourth hearing on the topic over the course of a few weeks.

February 04, 2019 | Daily News

The Senate Finance Committee asked seven brand drug makers to testify Feb. 26 on rising drug prices after some of those companies refused to testify at a Jan. 29 hearing.

February 04, 2019 | Daily News

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

February 04, 2019 | Daily News

HHS wants Congress to ban drug rebates, and Senate Special Committee on Aging Chair Susan Collins (R-ME) said she’d like to work with the president on rebate legislation.

February 04, 2019 | Daily News

FDA will hold a public workshop on May 1 to weigh potential barriers to generic drug development and alternative ways to evaluate product equivalence outside of in vivo bioequivalence (BE) studies, the agency announced in the Federal Register Monday (Feb. 4).

February 01, 2019 | Daily News

HHS Secretary Alex Azar on Friday (Feb. 1) challenged congressional Democrats, who are critical of the administration’s proposal to eliminate drug rebates, to suggest an alternative.

February 01, 2019 | Daily News

FDA’s Leah Christl, head of the agency’s biologics and biosimilars staff in the Office of New Drugs (OND), will leave FDA on Feb. 22, after 16 years of working with the agency, drug center director Janet Woodcock announced in an email to center staff on Friday (Feb. 1).

February 01, 2019 | Daily News

The HHS proposal to eliminate drug rebates would increase government spending up to $196 billion over a decade, CMS actuaries estimate.

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