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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Thursday pharma headlines

World of DTC Marketing

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

Pharma 180
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The future of targeted alpha therapy development and manufacture

European Pharmaceutical Review

percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy). Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

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For rare disease patients in Mainland China, hope of greater access to treatment

Clarivate

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.