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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

One expires next year and the other in 2027, well beyond the original patent expiration date. The move meant that the company, which is now part of Bristol Myers Squibb, won several more years of valuable patent protection than it would have received had it applied for the extra patents when submitting its data to the FDA.

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IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

Big Molecule Watch

Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program. Briefing on dispositive motions has completed in the remaining district court challenges to the Drug Price Negotiation Program. Lead Case No.

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FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

Big Molecule Watch

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program. FDA’s approval of WEZLANA has also been raised as a pertinent fact in one of the pending challenges to the Drug Price Negotiation Program.

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STAT+: Key House panel proposes lowering out-of-pocket drug costs in Medicare

STAT

The House Ways & Means Committee package includes a new provision that would ensure that patients in the Medicare program pay for medicines they pick up at the pharmacy counter based on the discounted price that insurers negotiate with drugmakers, instead of higher sticker prices, starting in 2027.

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South Africa launches ‘unprecedented’ investigation of Johnson & Johnson over TB drug prices

The Guardian - Pharmaceutical Industry

The commission’s investigation was made public last week by the health department and the Health Justice Initiative (HJI) legal organisation at a media briefing of Médecins Sans Frontières (MSF).

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NHC Medicare Drug Price Negotiation Program Comments

Putting Patients First Blog

NHC Medicare Drug Price Negotiation Program Comments April 27, 2023 By: Allen Pinn, Coordinator, Policy April 14, the National Health Council (NHC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

.” Biogen has committed not to raise the price of Aduhelm for four years and said it has agreed access deals with some payers – including the Veterans Health Administration, CVS Health and the National Association of Free and Charitable Clinics (NAFC) – while negotiations are ongoing with Cigna and other groups. billion in 2027.