Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Rx Drugs

February 28, 2018 | Daily News

A bipartisan group of senators on Tuesday (Feb. 27) introduced updated opioid legislation that builds on the Comprehensive Addiction and Recovery Act signed into law in 2016.

February 27, 2018 | Daily News

The Department of Justice has launched a task force aimed at holding opioid manufacturers accountable for unlawful marketing practices and ensuring distributors, including pharmacies and physicians, obey Drug Enforcement Administration rules designed to prevent diversion and improper prescribing, DOJ announced Tuesday (Feb. 27).

February 27, 2018 | Daily News

The Pew Charitable Trusts says ensuring Medicare and Medicaid programs cover all approved medication-assisted treatment (MAT) and levels of care as laid out by the American Society for Addiction Medicine (ASAM) is one way Congress could help improve access to opioid use disorder treatment.

February 26, 2018 | Daily News

HHS Secretary Alex Azar on Saturday (Feb. 24) pledged to expand the use of medication-assisted treatments (MAT) to treat opioid addiction, telling the National Governor's Association that FDA will soon release two pieces of draft guidance aimed at boosting development of new therapies.

February 26, 2018 | Daily News

FDA has launched a pilot program aimed at streamlining the process for requesting orphan drug designation, and has scheduled a public meeting on regulatory issues associated with granting orphan drug designation -- and possibly applying orphan drug incentives -- to tissue-agnostic therapies, the agency announced Monday (Feb. 26).

February 26, 2018 | Daily News

The Pew Charitable Trusts and the National Association of Boards of Pharmacy in a report released Monday (Feb. 26) praise states for implementing what they believe are best practices in overseeing compounding, but they say more can be done to increase inspection frequency and develop a risk-based inspection framework.

February 21, 2018 | Daily News

State officials and the National Academy for State Health Policy compiled policies to help states negotiate cheaper drug prices that include closed formularies, specialty pharmacy networks and a joint federal-state Medicaid Technical Advisory Group.

February 21, 2018 | Daily News

Nearly 20 Democratic lawmakers wrote to HHS Secretary Alex Azar last week urging the department to consider issuing compulsory licenses for high-priced hepatitis C treatments, naming Gilead’s Harvoni and AbbVie’s Mavyret as two prime targets.

February 20, 2018 | Daily News

The Biotechnology Innovation Organization (BIO) in a newly released report found that development of and investment in novel pain medicines has been sorely lacking over the past decade, with only two novel chemical entities -- those with no prior approval history -- entering the market since 2007.

February 16, 2018 | Daily News

House and Senate lawmakers worry about the effects of pharmacy benefit manager consolidation, and nominees to the Federal Trade Commission said they expect FTC to review past PBM mergers.

February 14, 2018 | Daily News

Patients for Biologics Safety & Access is calling on FDA to rework portions of its newly released web page meant to educate prescribers about biosimilars, with the group suggesting changes aimed at downplaying the agency's safety assurances.

February 13, 2018 | Daily News

The president’s budget proposes $16 million in user fees to help the Health Resources and Services Administration administer the 340B drug discount program, a proposal one lobbyist said could end up serving as an offset if lawmakers look to make changes to the program.

February 13, 2018 | Daily News

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

February 12, 2018 | Daily News

The Trump administration's newly released fiscal 2019 budget allocates $10 billion across HHS to address the opioid epidemic, $10 million of which would be dedicated to FDA investment in regulatory science and tools for stemming opioid abuse and misuse.

February 12, 2018 | Daily News

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

February 12, 2018 | Daily News

The White House is taking on what it views as anticompetitive behavior by some generic drug companies that stave off additional generic entrants by being first to file and then “parking” exclusivity by failing to market their product.

February 12, 2018 | Daily News

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

February 09, 2018 | Daily News

Nonprofit hospitals say a new report on drug pricing that is critical of the 340B program, along with a reported proposal from HHS Secretary Alex Azar to tie 340B reimbursement to charity care, shows the administration doesn't understand the 340B drug discount program, while other lobbyists say the report may be setting up both the president's upcoming budget request and 340B reform bills on Capitol Hill.

February 09, 2018 | Daily News

A newly released Council of Economic Advisors report on drug pricing, which is expected to inform HHS' fiscal 2019 budget request, is angering both public health advocates and those favoring sweeping drug pricing reforms, given it suggests FDA can lower drug prices by speeding FDA approvals of brand drugs and making FDA's approval standards easy to comply with, all while making no mention of brand industry-opposed reforms, including those that have been floated by FDA Commissioner Scott Gottlieb, such as cracking down on abuses of FDA-mandated safety programs.

February 09, 2018 | Daily News

HHS Secretary Alex Azar’s plan to curb rising drug prices includes reforms to hospital 340B drug discounts and cuts to Medicare doctor pay similar those that the Obama CMS withdrew in the face of rabid attacks by drug companies, according to a lobbyist.

Pages