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Rx Drugs

October 18, 2017 | Daily News

A source tells Inside Health Policy that rumored potential HHS secretary nominee, former Lilly president and HHS official Alex Azar, has been interviewed for the job and wants it with conditions -- but those conditions remain unknown as of press time.

October 18, 2017 | Daily News

FDA approved Wednesday (Oct. 18) Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma.

October 17, 2017 | Daily News

The executive order that the president signed last week could drive healthy people to buy short-term and association health plans that are not required to cover drugs, but Pharmaceutical Research and Manufacturers of America Executive Vice President Lori Reilly declined Tuesday (Oct. 17) to take a position on the policy.

October 17, 2017 | Daily News

The American Civil Liberties Union (ACLU) Foundation and ACLU of Hawaii Foundation, representing a medical professional and other health organizations, have sued HHS and FDA for what the plaintiffs say are inappropriate and unnecessary Risk Evaluation and Mitigation Strategies (REMS) restrictions on Danco Laboratories' Mifeprex -- also known as the “abortion pill” -- that limit patient access.

October 17, 2017 | Daily News

Senate health committee Chair Lamar Alexander (R-TN) questioned the merit of drug rebates at a hearing Tuesday (Oct. 17) on drug prices.

October 16, 2017 | Daily News

Watchdog group Democracy Forward sued the White House Office of Management and Budget for information on the role OMB Associate Director of Health Programs Joseph Grogan played in the delays of the Obama administration's 340B drug ceiling price and manufacturer penalty rule.

October 16, 2017 | Daily News

The White House next week will declare the opioid epidemic a national emergency, President Donald Trump said Monday (Oct. 16).

October 16, 2017 | Daily News

President Donald Trump on Monday (Oct. 16) renewed his promise to rein in the cost of prescription drugs.

October 13, 2017 | Daily News

FDA's final guidance on the use of emerging technology in pharmaceutical manufacturing remains largely unchanged from the 2015 draft guidance, despite the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) calling for the agency to list suitable technologies and detail the criteria for being accepted into the program.

October 13, 2017 | Daily News

FDA Commissioner Scott Gottlieb announced Wednesday (Oct. 11) that the agency will establish a patient affairs team that will “be responsible for the coordination of certain agency-wide and multi-center projects related to patient engagement.”

October 13, 2017 | Daily News

During the first meeting of FDA’s Patient Engagement Advisory Committee (PEAC) on Wednesday (Oct. 11), patients and patient advocates, industry, and FDA discussed a need to craft regulatory policy around patient engagement in clinical trials and provided solutions for increasing and possibly incentivizing patient participation and retention in studies.

October 12, 2017 | Daily News

An FDA expert panel unanimously voted Thursday (Oct. 12) to recommend approval of Spark Therapeutics' Luxturna (voretigene neparvovec) -- a gene therapy used to treat patients with a rare form of genetically-inherited blindness -- that some analysts say could cost nearly $1 million per patient.

October 12, 2017 | Daily News

A coalition that includes the trade groups for the generic, hospital, health insurance and pharmacy benefit manager industries are the latest to call on Congress to investigate Allergan's deal with a Mohawk tribe to skirt inter partes review of its patents.

October 12, 2017 | Daily News

A federal circuit judge has reversed a lower court's recent controversial decision to order a biologic cholesterol medication to be taken off the market in response to a patent challenge.

October 11, 2017 | Daily News

Top pharmaceutical trade groups haven't yet said they will sue over California’s newly signed drug pricing law, but the generics trade group tells Inside Health Policy it is weighing its options.

October 11, 2017 | Daily News

House Energy & Commerce Democrats on Wednesday (Oct. 11) touted 340B providers and the programs run off of savings received through that drug discount program, but committee Chair Greg Walden (R-OR) said he was worried about the lack of transparency and dearth of data on how the providers use the program.

October 11, 2017 | Daily News

More than half of the Senate signed on to a letter asking CMS to make sure proposed cuts to hospitals' 340B drug reimbursement don't affect the long-term success of the program, though the bipartisan group says reforms to the 340B drug discount program are needed.

October 11, 2017 | Daily News

FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.

October 11, 2017 | Daily News

More Medicare beneficiaries with drug coverage are expected to be in plans with high performance ratings next year compared to this year, according to a CMS release.

October 11, 2017 | Daily News

While courts have struck down FDA's prohibition on off-label promotion based on First Amendment grounds, the agency has good standing to prohibit such actions when considering various canons of statutory construction, one law professor argues in a recently published University of Chicago Law Review article.

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