pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. Spectrum licensed worldwide rights to poziotinib – excluding Korea and China – from Hanmi in back in 2015.

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Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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World of DTC Marketing

FEBRUARY 4, 2021

million, his first big raise since 2015, thanks to incentive pay that jumped by about $1.2 million in 2020, more than double the number in 2015, according to health data company IQVIA. Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more.

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pharmaphorum

JULY 29, 2022

Patients with end-stage renal disease (ESRD) who are on dialysis often need to be treated with anticoagulants to prevent blood clots, but as a result, can experience bleeding side effects. Now, Ionis and Bayer think they have a new drug that could sidestep that risk. Bayer hasn’t yet revealed whether the results were positive.

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PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. The EMA and the FDA also joined hands to advance precision medicine for rare disease patients. That’s how money is saved and quality of life (QOL) is improved.

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Pharmaceutical Technology

OCTOBER 10, 2022

The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD).

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