Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. AbbVie reported a 22.7% Bristol Myers Squibb (BMS) documented a 9.1%

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Vaccines Drug Pricing Biosimilars Documentation 108

Big Molecule Watch

NOVEMBER 6, 2023

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.

Drug Pricing 53

Drug Pricing Biosimilars 53

Express Pharma

OCTOBER 20, 2023

Under an agreement with the government, the drug will also stay free of charge for patients insured under the Medicare and Medicaid programs through the end of 2024, and to uninsured and underinsured patients through 2028. Influential U.S.

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Express Pharma

MARCH 26, 2025

Sahu adds, Japan had started reviewing its lengthy regulatory approval processes and time to reduce drug lag and supply shortages to lessen reliance on imported medicines and improve patient access to critical treatments. The amendments further aim to streamline approvals and strengthen domestic production to mitigate these challenges.

Drug Development 66

Drug Development Drug Pricing 66

Pharmaceutical Technology

MAY 16, 2023

increase in market capitalisation over Q1 2023, fuelled by its robust portfolio of diabetes and obesity treatments – in particular, its line of glucagon-like peptide 1 receptor agonist (GLP-1) Type 2 diabetes drugs Ozempic, Rybelsus and Victoza. Novo Nordisk reported an 18.2%

Diabetes 52

Diabetes Vaccines Drug Pricing 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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Labelling Drug Pricing Compounding Payment Processing 105

Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

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Biosimilars Drug Pricing Documentation Labelling 130