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Rx Drugs

October 02, 2017 | Daily News

Specialty doctors are lobbying Congress to exclude the cost of drugs they administer from the calculation of their Medicare bonuses and penalties because the therapies are often expensive and would result in volatile swings in reimbursement.

September 29, 2017 | Daily News

Amgen will not market its biosimilar of Humira until 2023, according to the terms of a settlement with Humira maker AbbVie.

September 29, 2017 | Daily News

A top lawyer in HHS’ Office of Inspector General says the office’s priorities have not shifted since the change in administration, and highlighted kickback issues, promotional practices and government price reporting as three continuing risk areas for life science companies.

September 29, 2017 | Daily News

FDA said there are currently no drug shortages resulting directly from the spate of hurricanes this season, but 40 high-priority drugs are at risk of shortage due to Hurricane Maria and Puerto Rican firms are still accessing damages.

September 28, 2017 | Daily News

A bipartisan group of 228 House lawmakers urged CMS on Wednesday (Sept. 27) to scrap proposed cuts to hospitals' reimbursement for 340B drugs because they say it isn't clear the proposal would reduce drug costs for Medicare beneficiaries and it could hurt hospitals.

September 28, 2017 | Daily News

The Health Resources and Services Administration again delayed, this time until July 2018, a rule that sets civil money penalties and ceiling prices for drugs in the 340B discount program.

September 28, 2017 | Daily News

FDA seeks public input on how to exercise its existing authorities to address the opioid epidemic, the agency announced in the Federal Register and in an FDA Voice blog Thursday (Sept. 28).

September 28, 2017 | Daily News

At least six opioids that appear to be subject to Risk Evaluation and Mitigation Strategies with restricted distribution systems are currently being compounded by outsourcers, according to Inside Health Policy’s review of newly released FDA data.

September 28, 2017 | Daily News

FDA should implement expedited pathways and provide incentives, such as exclusivity, for pharmaceutical companies that develop non-opioid pain treatments and for those that develop medications for opioid use disorders, industry stakeholders and government agency heads said at the Wednesday (Sept. 27) meeting of the President's Commission on Combating Drug Addiction and the Opioid Crisis.

September 28, 2017 | Daily News

A top FDA official told state regulators Tuesday (Sept. 26) that FDA is actively working to finalize a number of policy documents meant to regulate the growing compounding outsourcing sector, but multiple related regulations cited by the official are also on the inactive list of FDA’s most recent regulatory agenda.

September 27, 2017 | Daily News

AbbVie denies reports that CEO Richard Gonzalez said the company might break its pledge to keep annual price hikes under 10 percent, according to a statement posted on the company's website on Tuesday (Sept. 26).

September 27, 2017 | Daily News

The Pharmaceutical Research and Manufacturers of America (PhRMA) on Wednesday (Sept. 27) announced its support for federal and state policies that would limit the supply of opioids for acute pain to seven days.

September 26, 2017 | Daily News

The House Energy & Commerce health subcommittee announced Tuesday (Sept. 26) it will hold a hearing Oct. 3 to examine patient access to investigational drugs and to “discuss legislation related to access to unapproved therapies.”

September 26, 2017 | Daily News

FDA Commissioner Scott Gottlieb announced Monday (Sept. 25) that the agency will create a “hurricane shortages task force” to identify potential drug shortages and implement solutions in the wake of the damage to Puerto Rico's pharmaceutical manufacturers by Hurricanes Irma and Maria.

September 25, 2017 | Daily News

FDA officials tell Inside Health Policy they dispute allegations that the agency's decision to put certain compounding regulations on the most recent regulatory agenda's inactive list means the agency is no longer working to implement portions of the Drug Quality and Security Act.

September 22, 2017 | Daily News

FDA Commissioner Scott Gottlieb made the business case Sept. 13 that regardless of where one comes down on the debate over the true cost of drug development, the costs are too high and may chill investment in biotech and ultimately may stifle drug development.

September 22, 2017 | Daily News

FDA is updating its existing warnings on the dangers of combining addiction medications and certain anxiety and insomnia drugs to emphasize that despite the potential for potentially deadly interactions, medication-assisted treatment (MAT) for opioid addiction should not be withheld from patients already taking these anxiety medications.

September 22, 2017 | Daily News

FDA Commissioner Scott Gottlieb will testify at an Oct. 5 Senate health committee hearing on the federal response to the opioid crisis.

September 21, 2017 | Daily News

FDA calls for biosimilar sponsors to use a risk-based approach when choosing statistical methods to demonstrate analytical similarity to a reference product, laying out the policy in a long-awaited draft guidance released Thursday (Sept. 21).

September 21, 2017 | Daily News

FDA will publish guidance detailing how drug developers can use real-world evidence to satisfy FDA’s pre- and post-market requirements, agency head Scott Gottlieb said during an RWE workshop held at the National Academies of Sciences, Engineering, and Medicine on Tuesday (Sept. 19).

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