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Rx Drugs

October 04, 2019 | Daily News

FDA on Friday (Oct. 4) called for groups to submit research proposals for the agency’s Safe Use Initiative, which fosters collaborations with the health care community to reduce preventable harm from medication use.

October 04, 2019 | Daily News

FDA approved the second HIV prevention drug, Descovy, Gilead said Thursday (Oct. 3), setting the stage for difficult coverage decisions as Gilead touts Descovy as safer than its other HIV prevention drug, Truvada, a year before Truvada goes generic.

October 03, 2019 | Daily News

President Donald Trump said Thursday (Oct. 3) that his administration will “soon” allow states to import drugs from Canada.

October 03, 2019 | Daily News

A prominent Canadian patient advocate alleged a U.S.-based biologics industry group is engaging in “fearmongering” in her country as part of a bid to reduce confidence in biosimilars, but the targeted group, the Alliance for Safe Biologic Medicines, told Inside Health Policy it is merely raising legitimate concerns over Canada’s new policy that requires biosimilar switching without the involvement of physicians.

October 03, 2019 | Daily News

Senate Finance Chair Chuck Grassley (R-IA) could lose leverage if the panel’s bipartisan drug pricing package is delayed until early 2020, but he would gain political maneuvering time, sources said.

October 03, 2019 | Daily News

FDA awarded a grant to the National Association of Boards of Pharmacy to set up an information-sharing system for drug compounding activities that are primarily overseen by states, the agency announced Wednesday (Oct. 2).

October 02, 2019 | Daily News

President Donald Trump tweeted Wednesday (Oct. 2) that House Speaker Nancy Pelosi (D-CA) is “incapable” of working on legislation to lower drug prices and is using the issue to distract from House Democrats’ impeachment inquiry.

October 02, 2019 | Daily News

House Energy & Commerce Committee Democrats are considering changes to a measure in their drug pricing bill that would hurt many nonprofit hospitals by eliminating 340B discounts on drugs that are subject to government price negotiation.

September 30, 2019 | Daily News

The proposed 2021 Notice of Benefit and Payment Parameters, which will lay out exchange-related policies and is expected to include revised guidance on drug co-pay coupons that was delayed for 2020, is now under review by the White House Office of Management and Budget.

September 30, 2019 | Daily News

FDA on Monday (Sept. 30) issued a draft guidance detailing the methods and best research practices stakeholders, especially drug makers, can use to find out what’s important to patients, including identifying the burdens of living with and treating a disease, as well as the benefits and risks in managing a disease.

September 27, 2019 | Daily News

FDA is creating new Sentinel Coordination Centers via a five-year contract as part of its bid to grow the agency’s flagship Sentinel System into a vigorous national scientific resource, the agency announced Friday (Sept. 27).

September 26, 2019 | Daily News

FDA’s plan to streamline its reviews of new drugs through a major reorganization effort has been approved by Congress, agency drug center director Janet Woodcock announced Thursday (Sept. 26).

September 25, 2019 | Daily News

Senate Finance Chair Chuck Grassley said he hopes to rally support from the president and more lawmakers for the drug pricing package he sponsored with Finance ranking Democrat Ron Wyden (OR) after the full bill text’s expected release Wednesday (Sept. 25) evening.

September 25, 2019 | Daily News

FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.

September 24, 2019 | Daily News

The House Democrats’ impeachment inquiry all but kills the chances of House Speaker Nancy Pelosi (D-CA) striking a deal on drug pricing with President Donald Trump, lobbyists and analysts say, though they had always said there was little prospect in government drug price negotiation becoming law.

September 24, 2019 | Daily News

The use of medical devices in combination with biologic medicines is emerging as a way to ease burdens on patients and reduce health care costs, but the products pose regulatory challenges to FDA, agency drug center director Janet Woodcock told stakeholders Monday (Sept. 23).

September 24, 2019 | Daily News

FDA officials are encouraging developers of drugs to treat amyotrophic lateral sclerosis (ALS) to get the word out about their research and offer access to their investigational products to patients through the agency’s Right to Try and expanded access pathways.

September 23, 2019 | Daily News

In a brief two-page report, the Government Accountability Office highlights the potential for opioid vaccines and lays out the challenges and policy questions surrounding their development, including what standards FDA should set for clinical trials and what resources would be needed.

September 23, 2019 | Daily News

Compounding company Athenex has withdrawn its appeal of a recent D.C. federal district court ruling that upheld FDA’s ban on bulk compounding of vasopressin.

September 23, 2019 | Daily News

FDA wants input from stakeholders on the development of abuse-deterrent formulations (ADFs) of central nervous system stimulants, which are widely prescribed to treat attention deficit hyperactivity disorder and sometimes narcolepsy.

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