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Rx Drugs

December 01, 2017 | Daily News

FDA will set out in guidance a policy of allowing complex generics and the brand product they are copying to have different labels so long as those changes reflect solely design differences, Commissioner Scott Gottleib said this week.

December 01, 2017 | Daily News

FDA has fulfilled a promise it first made in 2016 to list patent submissions dates in the Orange Book, making it easier for generic companies to discern whether the patent will trigger certain required Hatch-Waxman steps.

November 30, 2017 | Daily News

FDA is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30).

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar said Wednesday (Nov. 29) he wants to stop brand drug companies from thwarting generic competition by gaming the patent system and drug-approval policies; he'd consider applying design aspects of Part D to Part B drug coverage; and he opposes gag orders that keep pharmacies from telling customers when drugs are cheaper out of pocket than when bought with insurance.

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar declined to commit to pushing Congress to appropriate at least $45 billion to fight the opioid epidemic during a Senate health committee hearing Wednesday (Nov. 29) on his nomination.

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar sidestepped a question on whether he would support increasing access to birth control drugs by giving them over-the-counter (OTC) status when the issue came up at his Senate health committee nomination hearing Wednesday (Nov. 29).

November 29, 2017 | Daily News

HHS' Office of Inspector General Tuesday (Nov 28) rescinded an advisory opinion that allowed Caring Voice Coalition, a charitable entity that receives donations from the drug industry, to help consumers with drug expenses without violating federal anti-kickback statute after discovering the group apparently allowed its donors greater influence than it had disclosed.

November 29, 2017 | Daily News

The Cato Institute is urging the government to stop promotion of abuse-deterrent formulations (ADFs) of opioids, saying they do more harm than good and promoting their use is unethical.

November 28, 2017 | Daily News

The U.S. Supreme Court heard oral arguments Monday (Nov. 27) in a highly watched case set to determine whether the inter partes review process commonly used by generic drug stakeholders to clear the way for generic competition is unconstitutional given such cases are not subject to the same guardrails placed on federal courts.

November 28, 2017 | Daily News

In the wake of arguments over whether the inter partes review process is constitutional, the Supreme Court also heard Monday (Nov. 27) another IPR case that one justice claimed is an attempt to get around precedent that bars parties from challenging the Patent Trial and Appeal Board's non-institution decisions, and counsel for the government argued could be used to stall district court patent litigation -- although one attorney cautioned that this may have less of an effect in Hatch-Waxman cases.

November 28, 2017 | Daily News

Rare disease advocates, who have been embraced by President Donald Trump in the past, remain hopeful the president will back their efforts to remove the orphan drug tax credit cuts from the tax reform package heading for a Senate vote, even though Trump was on Capitol Hill Tuesday (Nov. 28) lobbying for passage of tax legislation that would scale back the tax credit.

November 28, 2017 | Daily News

Rare disease patient advocates, who have been embraced by President Donald Trump in the past, remain hopeful the president will back their efforts to remove the orphan drug tax credit cuts from the tax reform package heading for a Senate vote, even though Trump was on Capitol Hill Tuesday (Nov. 28) lobbying for passage of tax legislation that would scale back the tax credit.

November 28, 2017 | Daily News

FDA Commissioner Scott Gottlieb and National Institutes of Health (NIH) Director Francis Collins will testify in front of the Senate health committee on Thursday (Dec. 7) regarding progress being made by FDA and NIH in implementing the 21st Century Cures Act.

November 28, 2017 | Daily News

Sen. Elizabeth Warren (D-MA) told HHS Secretary-nominee Alex Azar to bone up on drug-reimbursement policy the day before the Senate health committee’s courtesy hearing Wednesday (Nov. 29) on Azar’s nomination.

November 28, 2017 | Daily News

The HHS Inspector General recommends a legislative change that would lower beneficiary spending on drugs and save taxpayers money, but CMS opposes the change because on rare occasion it would make it difficult for doctors to infuse the drug of their choice.

November 27, 2017 | Daily News

The House Energy & Commerce health subcommittee will examine FDA and the National Institutes of Health's implementation of the 21st Century Cures Act at a hearing Thursday (Nov. 30) where the heads of both agencies will testify.

November 22, 2017 | Daily News

The head of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the CEO of a major opioid manufacturer are on the defensive over a New York Times editorial lambasting the recently announced public-private partnership between the pharmaceutical industry and the National Institutes of Health (NIH), which aims to support the development of non-addictive pain treatments.

November 22, 2017 | Daily News

The Senate Finance Committee's move to scale back the orphan drug tax credit instead of repealing it as part of the chamber's tax bill has appeased the biologics lobby, but rare disease patient advocates continue to oppose any proposal to cut the credit.

November 22, 2017 | Daily News

Knowledge Economy International and Doctors Without Borders (MSF) are once again sounding the alarm over a plan to issue an exclusive license for a government-developed Zika vaccine candidate.

November 22, 2017 | Daily News

As CMS considers testing approaches to curb rising drug prices, the Pharmaceutical Research and Manufacturers of America is trying to stop the agency from turning those pilots into national programs.

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