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Rx Drugs

December 03, 2019 | Daily News

Hospitals are requesting CMS withdraw its proposal to survey 340B hospitals about their drug costs, saying the survey instructions aren’t clear and the agency lacks authority to gather information from a subset of hospitals and on a subset of drugs.

December 02, 2019 | Daily News

FDA is looking into new innovations that could increase the speed and accuracy of clinical trials aimed at addressing antimicrobial resistance, an FDA official said.

November 27, 2019 | Daily News

Global Blood Therapeutics said it is working with public and commercial payers to get broad coverage for its newly approved sickle cell drug Oxbryta (voxelotor) by the end of 2020.

November 27, 2019 | Daily News

As Trump tweets that drug importation is nigh, groups that oppose allowing states to import Canadian drugs are holding meetings with the White House, and the Congressional Research Service says it’s unclear whether expanding legal drug importation would lower drug costs for consumers.

November 27, 2019 | Daily News

The House Judiciary Committee unanimously approved two bills aimed at fighting drug companies’ misuse of patents.

November 26, 2019 | Daily News

FDA on Monday (Nov. 25) indicated it has not concluded that cannabidiol (CBD) is generally recognized as safe (GRAS) to use in human or animal food.

November 25, 2019 | Daily News

FDA has reversed its stance that certain comparative clinical studies, including switching studies, are needed to prove interchangeability for insulin products, in a move that could speed access to less expensive insulin products.

November 25, 2019 | Daily News

FDA on Monday (Nov. 25) granted accelerated approval to Oxbryta (voxelotor), an oral once-daily treatment for sickle cell disease in adults and patients 12 years old and older. The drug inhibits red blood cell sickling, which is the central abnormality in sickle cell disease.

November 25, 2019 | Daily News

When President Donald Trump took to Twitter Friday (Nov. 22) to weigh in on drug pricing reforms, he gave House Republicans cover to vote against House Democrats’ bill to let Medicare negotiate drug prices, instead of leaning on Senate Republicans to support the less-aggressive bipartisan drug pricing legislation in that chamber, even though White House adviser Joe Grogan said recently that the administration backs the Senate bill.

November 22, 2019 | Daily News

A bipartisan group of lawmakers, led by Reps. Cindy Axne (D-IA) and Anthony Gonzalez (R-OH), are pressing HHS Secretary Alex Azar for answers about the ongoing shortage of pediatric cancer drug vincristine.

November 21, 2019 | Daily News

Lawmakers on both sides of the aisle lobbed questions and expressed concerns about issues related to drug pricing, such as drug importation, biologic patent gaming, generic drug exclusivity and insulin access, to FDA commissioner-nominee Stephen Hahn during his Senate confirmation hearing Wednesday (Nov. 20).

November 21, 2019 | Daily News

FDA approved a drug for sickle cell anemia that could pose a significant cost to state Medicaid budgets because a little more than half of the approximate 100,000 Americans living with sickle cell disease are in Medicaid and the annual cost of the drug is $84,852 to $113,136, based on list price.

November 21, 2019 | Daily News

Democratic presidential primary candidate Elizabeth Warren says that during the first 100 days of her presidency she would lower brand drug prices and tackle drug shortages with strict antitrust enforcement, and compulsory licensing and march-in authorities.

November 20, 2019 | Daily News

During the Senate health committee’s confirmation hearing for FDA commissioner-nominee Stephen Hahn on Wednesday (Nov. 20), lawmakers grilled the nominee on myriad issues, including drug pricing, generic drug approvals, drug shortages and e-cigarette regulations.

November 20, 2019 | Daily News

HHS plans to propose this month the controversial International Pricing Index demonstration that the president announced in October of 2018, according to the fall regulatory agenda that the administration published Wednesday (Nov. 20).

November 19, 2019 | Daily News

The House Judiciary Committee will mark up on Wednesday (Nov. 20) a bill to deter patent gaming by allowing the Federal Trade Commission to prosecute pharmaceutical manufacturers that try to engage in product hopping.

November 19, 2019 | Daily News

The Center for Science in the Public Interest (CSPI) is asking FDA and the Federal Trade Commission to take enforcement action against more than 25 companies that market dietary supplements with the claim that they will treat female infertility.

November 18, 2019 | Daily News

Brand and generic drug companies disagree over the usefulness of FDA’s and the Federal Trade Commission’s efforts to address gaming of FDA’s risk mitigation strategies, according to a report published by the Government Accountability Office (GAO) Thursday (Nov. 14).

November 15, 2019 | Daily News

FDA sent Greenbrier International Inc. (Dollar Tree) a warning letter for selling potentially harmful over-the-counter (OTC) foreign drugs, some of which were imported from China.

November 14, 2019 | Daily News

The Consumer Healthcare Products Association (CHPA) says FDA should quickly establish a regulatory pathway to allow dietary supplements containing hemp-derived cannabidiol (CBD) to be legally marketed.