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Rx Drugs

November 08, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Nov. 8) called on brand drug makers to “end the shenanigans” of using loopholes to delay generics, while taking a step he said will help stem brand's use of Risk Evaluation and Mitigation Strategies to put off competition.

November 07, 2017 | Daily News

In the wake of hurricane-caused drug shortages, the American Hospital Association is calling on FDA to push manufacturers of small-volume parenteral solutions to invest in ways to prevent future shortages, including moving firms to areas not prone to natural disasters.

November 06, 2017 | Daily News

FDA will work with the Department of Homeland Security and local authorities in Puerto Rico to help a subset of drug and device manufacturers to jump the line for getting back on the electrical grid, FDA Commissioner Scott Gottlieb announced Monday (Nov. 6) at an Association for Accessible Medicines conference.

November 06, 2017 | Daily News

FDA is taking steps to modernize its organizational structure and improve coordination among its expert staff, as well as reconsidering its approach to risk-benefit assessment in pre- and postmarket drug reviews, especially in regards to opioids, FDA Commissioner Scott Gottlieb said at a National Press Club luncheon on Friday (Nov. 3).

November 03, 2017 | Daily News

Pay-for-delay agreements have significantly decreased in the wake of a U.S. Supreme Court decision that found such agreements can run afoul of antitrust law, the Federal Trade Commission said in a new report released Wednesday (Nov. 1).

November 02, 2017 | Daily News

CMS on Thursday (Nov. 2) reversed a policy meant to drive down biosimilars prices -- a reversal that drug makers say overall will save Medicare money but that nonpartisan congressional Medicare advisers say will lead to both higher biosimilars prices and an increase in Medicare spending.

November 02, 2017 | Daily News

The House GOP tax overhaul bill unveiled Thursday (Nov. 2) would slash the orphan drug tax credit, which offers drug developers a 50 percent tax credit for the cost of conducting clinical trials.

November 01, 2017 | Daily News

Experts convened by the White House are urging FDA to fast track review of emerging technologies, including mobile medical apps, to detect -- and in some cases intervene -- in cases of substance abuse, according to a highly anticipated report released Wednesday (Nov. 1).

November 01, 2017 | Daily News

FDA Commissioner Scott Gottlieb recently said that while he laments the federal government regulating the practice of medicine, more federal action is needed -- and mandated by the Controlled Substances Act (CSA) -- to help tackle the opioid crisis.

November 01, 2017 | Daily News

The President’s Commission on Combating Drug Addiction and the Opioid Crisis on Wednesday (Nov. 1) recommended the White House push several policy reforms -- including steps to improve enforcement of mental health and substance abuse disorder insurance coverage parity, eliminate the institution for mental disease (IMD) exclusion and enhance Prescription Drug Monitoring Programs (PDMP) -- among its list of 56 proposals to stem the crisis.

November 01, 2017 | Daily News

An FDA advisory committee on Tuesday (Oct. 31) voted 18-1 to recommend approval of Indivior’s injectable buprenorphine with proposed Risk Evaluation and Mitigation Strategies (REMS) restrictions, but many members questioned the dosing regimen and said it isn't clear how well the drug works compared to others already on the market.

November 01, 2017 | Daily News

Massachusetts is getting national attention for requesting a waiver from CMS to use a “closed” Medicaid drug formulary, limited pharmacy network and tiered copays for prescription drugs.

October 31, 2017 | Daily News

CMS Administrator Seema Verma and her staff are holding roundtable discussions with plans and pharmaceutical benefit managers on ways the public and private sector can work together to tackle the growing opioid crisis.

October 31, 2017 | Daily News

FDA announced Tuesday (Oct. 31) that it has formally recognized the good manufacturing practice inspections of eight European Union countries -- roughly one third of the countries FDA is seeking to certify as part the Mutual Recognition Agreement the agency inked with the European Medicines Agency (EMA) last year.

October 31, 2017 | Daily News

The Biotechnology Innovation Organization and over 20 drug companies wrote to House Speaker Paul Ryan (R-WI) and Ways & Means Chairman Kevin Brady (R-TX) Friday (Oct. 27) urging them to retain the orphan drug tax credit when pursuing tax reform.

October 31, 2017 | Daily News

Orphan drugs represented 7.9 percent of drug spending in 2016, up from roughly 3 percent in 1993, and contributed about $15 billion, roughly 19 percent, of overall drug spending growth over the last five years, according to a newly released report from QuintilesIMS sponsored by the National Organization for Rare Disorders (NORD).

October 30, 2017 | Daily News

Generic drug makers are lobbying Congress to require Part D coverage-gap discounts for biosimilars, and congressional Medicare advisers are discussing that policy Friday (Nov. 3).

October 30, 2017 | Daily News

The U.S. International Trade Commission declined Amarin Pharma's request that it investigate alleged unfair competition from what the company alleges are unapproved drugs illegally imported into the United States under the guise of dietary supplements, heeding calls from FDA and lawmakers to let the agency decide whether the products at issue, certain synthetic omega-3 products, are dietary supplements or new drugs.

October 30, 2017 | Daily News

An upcoming public workshop spearheaded by the Federal Trade Commission and FDA will delve into possible incentives for generic market entry, what can be done to address tactics used to stall generic competition, the role intermediaries play in drug pricing and how FTC can address these issues.

October 30, 2017 | Daily News

FDA Commissioner Scott Gottlieb recently outlined FDA’s plan to work with other regulatory bodies with “good inspection histories” to import products in shortage due to recent hurricanes, in the event companies cannot redirect their products being produced overseas for ex-U.S. markets.

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