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STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India

STAT News

Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.

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Cost of disease-modifying therapies for multiple sclerosis continues to rise in US

Pharmaceutical Technology

DMTs for MS have a high price tag, particularly in the US. A similar trend of price increases was also seen for MS generics and biosimilars. However, they cannot provide a cure and have a very limited impact on halting disease progression.

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Amylyx ALS drug draws criticism over $158,000 price tag

pharmaphorum

The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. Following news of Relyvrio’s $158,000 annual price tag, both ALS advocates and outside observers have voiced outrage at the cost.

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Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Rethinking Clinical Trials

The 4 arms were usual care, generic text message arm, optimized text message arm that used behavioral theories that aligned with “nudge,” and a fourth arm that used a chat bot. More than 13,000 patients were considered eligible for the UH3 trial and more than 9,500 were randomized in the 4 arms, with about 2,300 patients in each of the arms.

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

pharmaphorum

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

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Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

Tagged the “pharma bro” for the cavalier attitude he fronted about his greed, Martin is actually currently behind bars. Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug.

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Drug Pricing Reform: Never Out of the Headlines

Intouch Solutions

Drug pricing, generics and biosimilars, patent laws, and healthcare availability are all specifically identified in the Order as in need of remedy (along with many other issues throughout all sectors of the American economy). The stakes are higher; budgets aren’t getting bigger; and, unfortunately, many patients remain uninsured.

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