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Technology News- BioPharm News
- Shire Gains European Approval for its Gaucher Disease Treatment
- Mtech Bioprocess Scale-Up Facility to Double in Staff and Size
- ImClone Closes Plant in New Jersey, Consolidating Erbitux Manufacture
- EMA and FDA Seek Applicants for Joint GMP Inspections
- ATMI Expands Bloomington, Minnesota Manufacturing Facility
- Clinical Trials News
- CRF Health Achieves EXACT ePRO Vendor Certification for Windows Mobile Systems
- ACR Image Metrix Establishes Global Presence
- BioPharm Systems Named to the 2010 Inc. 500|5000 List of Fastest-Growing Companies in the U.S.
- CRF Health Doubles North American Headquarters
- Oracle Completes Acquisition of Phase Forward
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