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Second Thoughts on Avandia’s Safety Stir a Dispute
June 2, 2013 12:41 pm | by By KATIE THOMAS and SABRINA TAVERNISEAssociated Press | News | CommentsThree years ago, in one of the more notable drug-safety scandals in recent history, the diabetes drug Avandia was all but banned from use in the United States after researchers found that thousands of people had heart problems after taking it. Today, it is a...
Depomed Abandons Sefelsa Plans on FDA Letter
May 31, 2013 6:31 pm | by The Associated Press | News | CommentsDepomed Inc. said Friday that it will not invest further in its drug Sefelsa after the U.S. Food and Drug Administration said that it cannot approve its application in the current form. The drug was designed to treat hot flashes and other symptoms of menopause. It hit a major road block in March...
Fully Integrated Mass Directed Flash System
May 31, 2013 4:59 pm | Product Releases | CommentsThe Isolera™ Dalton is a fully automated miniaturized mass directed flash purification system. It raises the bar for flash purification by integrating a miniaturized mass detector and an advanced flash chromatography system into one commercially available platform.
Conveying and Pre-Mixing Dry Solids into a Slurry
May 31, 2013 4:46 pm | Product Releases | CommentsThe powder and liquid delivery system automatically and precisely delivers dry bulk ingredients into a motive liquid stream to convey slurries, solutions or suspensions into users mix tank, blender or other process equipment.
IPS Technology Tours at INTERPHEX 2013
May 31, 2013 3:11 pm | Videos | CommentsDuring INTERPHEX 2013 Integrated Project Services (IPS) again held their technology tours on the floor of the show. Tour participants, guided by IPS subject matter experts, visited leading providers of equipment in the areas of Advanced Aseptic technologies, Biomanufacturing technologies, Oral Solid Dosage technologies and new this year, Modular Construction technologies.
Aegerion Gets EU Vote on Cholesterol Disorder Drug
May 31, 2013 10:10 am | by The Associated Press | News | CommentsAegerion Pharmaceuticals Inc. said Friday that a European Union advisory panel recommended its drug Lojuxta be approved as a treatment for a rare inherited disease that causes extremely high levels of bad cholesterol. Regulators are expected to make a decision on the drug during the third...
BioMarin Says US, EU Now Reviewing Vimizim
May 31, 2013 8:55 am | News | CommentsBioMarin Pharmaceutical Inc. said Thursday that regulators in the U.S. and Europe are reviewing its drug Vimizim and are expected to make decisions on the drug in early 2014. BioMarin said European Union regulators could approve Vimizim in the first quarter of 2014.
NM Clinic Says it Received Drug in Fed Probe
May 31, 2013 8:52 am | News | CommentsA New Mexico health clinic has confirmed that some of its patients received potentially tainted anti-inflammatory injections prepared by a compounding manufacturer in Tennessee, but it says no negative reactions have been reported. Roswell Family Care said around 50 patients received an injectable steroid involved in a U.S. Food and Drug Administration investigation.
New AIDS Vaccine Trial Launched
May 31, 2013 8:43 am | Videos | CommentsA new vaccine in the war against HIV could be a step closer as scientists begin a new clinical trial in London and Africa. Initially the trial will enroll 64 volunteers between the ages of 18 and 50 who are at low risk for contracting HIV.
EMA Recommends Restricting Trobalt to Last-Line Therapy in Partial Epilepsy
May 31, 2013 8:29 am | News | CommentsThe EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of the anti-epileptic medicine Trobalt (retigabine) only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
Curis Appoints New Vice President of Corporate Strategy and Investor Relations
May 31, 2013 8:25 am | News | CommentsCuris, Inc., today announced the appointment of Dr. Mani Mohindru as Vice President of Corporate Strategy and Investor Relations. Prior to joining Curis, Dr. Mohindru spent several years as a Wall Street equity research analyst covering the biotechnology sector, including analyst roles at ThinkEquity LLC, Credit Suisse Securities and UBS Securities.
EMA Recommends Approval of Pomalidomide for the Treatment of Multiple Myeloma
May 31, 2013 8:20 am | News | CommentsThe European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Pomalidomide Celgene (pomalidomide) to treat patients with multiple myeloma. Multiple myeloma is a rare and incurable cancer of the bone marrow that primarily affects older adults. In Europe, approximately 27,800 new cases are diagnosed each year.
Ironwood Pharma Rises Following Analyst Upgrade
May 31, 2013 8:09 am | News | CommentsShares of Ironwood Pharmaceuticals Inc. rose Friday after a Wedbush analyst upgraded the stock, saying growth in prescriptions for the company's bowel drug Linzess has been better than he expected. Linzess is a treatment for irritable bowel syndrome with constipation and for chronic constipation. It is Ironwood's only approved product.
Doctor’s Doubts Imperil A Lucrative Diabetes Drug
May 31, 2013 8:05 am | by By ANDREW POLLACK; New York Times News Service | News | CommentsDr. Peter C. Butler initially declined a request by the drugmaker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats. “I said, I’m not interested in your money, go away,” Butler recalled. Merck no doubt now wishes it had.
Endo Says FDA Wants More Information on Aveed
May 30, 2013 5:33 pm | by The Associated Press | News | CommentsEndo Health Solutions Inc. said Thursday the Food and Drug Administration wants more information about its long-acting testosterone injection Aveed before it will approve the drug. Endo said the FDA is concerned about risks and severe complications related to post-injection reactions. Endo said...
