Three 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 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...
The 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.
The 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.
During 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 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 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.
A 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.
A 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.
The 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, 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.
The 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.
Shares 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.
Dr. 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 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...