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Category Archives: Safety
Weight-Loss Drug Qnexa Loses in FDA Committee Ruling
Vivus’ Qnexa may help in weight loss, but it also now risks losing its place in the market following FDA’s Advisory Committee’s ruling July 15. The panel of medical experts did not question the effectiveness of the drug, but rather voiced its concerns over safety of the medication.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee [...]
Also posted in FDA Tagged Anti-obesity medication, Drug, FDA, Fen-phen, Food and Drug Administration, Health, Qnexa, Weight loss 1 Comment
HTA Concerns From European Drug Agency
The EMA’s Thomas Lönngren has gone public with his disquiet over organizations such as NICE. But pharma still needs more allies in fighting what it sees as the failings of the health technology assessment bodies, says Pharm Exec Europe’s Brussels correspondent, Reflector.
Europe’s pharmaceutical firms were never very keen on Britain’s influential National Institute for Health [...]
Also posted in Europe, Global, Guest Blog, Regulatory, Strategy Tagged EU, European Medicines Agency, European Union, NICE, Regulatory Leave a comment
FDA to Review Prostate Cancer Meds
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FDA, on Monday, announced that it was reviewing whether a certain class of prostate cancer drugs could lead to diabetes, stroke, death, or heart problems.
The drugs in question are gonadotropin-Releasing Hormone (GnRH) agonists, marketed under a number of monikers, including Vantas and Lupron. These treatments are used to slow the growth of prostate [...]
Also posted in FDA Tagged Cancer, Conditions and Diseases, Diabetes mellitus, Food and Drug Administration, Genitourinary, Health, Heart disease, Prostate cancer Leave a comment
Takeda Changes Dexlansoprazole Brand Name From Kapidex to Dexilant
Takeda’s US subsidiary launched its proton pump inhibitor dexlansoprazole last February under the name Kapidex. No one thought they’d have to find a new name a year later.
But shortly after the launch, the company began getting reports of dispensing errors. Some were due to prescription misreading, others to simple, honest mistakes. The two drugs causing [...]
Also posted in Corporate Responsibility, FDA, Marketing, News, Strategy Tagged Casodex, chronic pain, Dexilant, dexlansoprazole, dispensing error, FDA, Kadian, Kapidex, Prostate cancer, proton pump inhibitor, Takeda 2 Comments

Advisory Panel Rejects Avastin For Breast Cancer Treatment