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STAT+: Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say

STAT

1, and the negotiated prices of those drugs take effect in 2027.  Wegovy contains the same active ingredient, semaglutide, as Ozempic and Rybelsus, which help manage blood sugar levels in people with type 2 diabetes. Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs.

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Sanofi investment to enhance antibody bioproduction in France

European Pharmaceutical Review

Supporting production of diabetes medicine Development of the Lyon Gerland site enables internal production of a drug for patients with preclinical type 1 diabetes, previously produced outside the EU and not by Sanofi. These will be available for marketing from 2027, according to Sanofi.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

Clarification on QALY Metrics The NHC appreciates CMS’ commitment to excluding Quality-Adjusted Life Years (QALYs) from the negotiation process as outlined in the 2027 draft guidance. Valuing life differently based on disability status, age, or other special populations is inappropriate.

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Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. The post Provention finally gets FDA nod for type 1 diabetes drug teplizumab appeared first on.

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FDA sets August decision date for Provention’s type 1 diabetes drug

pharmaphorum

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Provention is seeking approval of teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals, hoping the drug can become the first disease-modifying therapy in these patients.

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STAT+: Pharmalittle: We’re reading about Moderna R&D cuts, Lilly plant investments and more

STAT

billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate, STAT writes. So here are some items of interest. Have a great day, everyone. … Moderna plans to cut its annual spending on research and development by 23%, or $1.1

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Lilly surges on positive phase 3 readout from diabetes contender

pharmaphorum

Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase 3 trial readout. More than half (51.7%) of participants in the treatment arm achieved an A1C less than 5.7% – the level seen in people without diabetes.