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Rx Drugs

May 14, 2019 | Daily News

The House Energy & Commerce Committee will hold a hearing next week on a package of bipartisan drug-pricing bills, sources say.

May 14, 2019 | Daily News

Hospitals are asking the federal D.C. district court to make CMS propose a way to fix 340B pay rates by June 28 to ensure that the agency doesn’t cut hospitals’ reimbursement for 340B drugs in the 2020 outpatient pay rule.

May 14, 2019 | Daily News

House Oversight Committee Chair Elijah Cummings (D-MD) and Sen. Bernie Sanders (I-VT) are looking into reports in a newly filed lawsuit that allege generic drug companies obstructed the lawmakers’ 2014 investigation into price fixing.

May 14, 2019 | Daily News

Biologic maker Eli Lilly is calling for FDA to consider an insulin product’s entire ecosystem -- from delivery devices to monitors to mobile apps in addition to the insulin itself -- when deciding whether products are interchangeable, an unexpected stance that an FDA official and the generic drug and biosimilars lobby suggested could delay the availability of interchangeable insulin.

May 13, 2019 | Daily News

Progressive Democrats have made clear they do not want an arbiter to mediate disputes between drug makers and Medicare over drug prices, but their opposition to arbitration goes beyond the pharmaceutical space.

May 13, 2019 | Daily News

The pilot CMS is using to artificially lower Medicare Advantage and drug-plan premiums next year will not apply to group MA plans, which means that 4.3 million retired union workers and state and local government employees could be hit with drastically higher premiums if HHS follows through on its proposal to ban drug rebates that aren’t shared at the point of sale.

May 13, 2019 | Daily News

FDA on Tuesday (May 7) sent a notice to the White House budget office about the agency’s plan to work with large research universities to evaluate whether a clinical need exists for certain bulk drug substances to be compounded at outsourcing facilities.

May 10, 2019 | Daily News

Acting FDA Commissioner Ned Sharpless predicts the agency’s biosimilar interchangeability guidance will bring down insulin prices by triggering interchangeable biosimilar competition.

May 10, 2019 | Daily News

Former FDA Commissioner Scott Gottlieb on Friday (May 10) bashed a bill passed by Florida lawmakers to import Canadian drugs a day after the president endorsed state-level drug importation.

May 10, 2019 | Daily News

FDA finalized guidance to help drug applicants know when they should submit an abbreviated new drug application (ANDA) or a 505(b)(2) application for their products.

May 10, 2019 | Daily News

In a final guidance document released Thursday (May 9), FDA lays out ways for sponsors of over-the-counter (OTC) topical drugs to conduct in vivo absorption trials that will help the agency determine whether a product is eligible to be included in OTC monograph.

May 10, 2019 | Daily News

FDA on Thursday (May 9) finalized guidance that aims to help sponsors evaluate reproductive toxicity related to embryo-fetal development (EFD) for anticancer drugs, and to help sponsors figure out what labeling they should use to minimize the potential risk to a developing embryo or fetus.

May 10, 2019 | Daily News

FDA issued two draft guidance documents that lay out ways for drug makers to design clinical lactation studies and leverage real-world data to gauge the effects of pending and agency-approved therapies on pregnant or nursing women.

May 10, 2019 | Daily News

FDA has reversed policy and now says it will allow sponsors to use non-U.S.-licensed reference biologics in studies to support biosimilar interchangeability.

May 09, 2019 | Daily News

President Donald Trump said Thursday (May 9) that his administration would allow prescription drug importation from foreign countries if the programs would create significant cost savings.

May 09, 2019 | Daily News

The Government Accountability Office (GAO) said it still hasn’t received documents from the White House Office of National Drug Control Policy (ONDCP) needed to adequately assess the administration’s national drug policy strategy, while some House Democrats said the goals outlined by the drug control office on medication-assisted treatment (MAT) are too modest.

May 09, 2019 | Daily News

FDA issued draft guidance explaining how drug and biologic sponsors can document their use of real-world evidence in drug and biologics applications, in a bid to encourage industry use of such evidence to seek product approvals or labeling changes.

May 08, 2019 | Daily News

House Speaker Nancy Pelosi’s (D-CA) office is working on a drug-price negotiation bill that would use arbitration as a backstop to price negotiations between HHS and drug makers on high-cost drugs, and the resulting price could be available to other payers, not just to Medicare plans, sources briefed on the plan told Inside Drug Pricing.

May 08, 2019 | Daily News

The government and major lobby groups oppose FDA’s biologic naming convention, which says that all new biologics, biosimilars and interchangeable biosimilars must have a nonproprietary name followed by a non-meaningful suffix.

May 08, 2019 | Daily News

The head of FDA’s biologics staff said she is not a fan of the agency’s biologics and biosimilars naming convention but that she understands the rationale behind it -- chiefly, a need to bolster active pharmacovigilance and to help distinguish between small molecule drugs and biologics.

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