Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has filed a citizens petition with the US Food and Drug Administration (FDA) not to approve any new drugs for multiple sclerosis until their safety risks have been evaluated by outside advisers, the US media reports. Teva's multiple sclerosis drug, Copaxone, has billions of dollars in annual sales. "Dow Jones News Wire" reports that Teva's petition targets Biogen Idec Inc. (Nasdaq: BIIB), which expects an FDA decision by late March on Biogen's application to market a new multiple sclerosis treatment, known as BG-12, an orally administered pill that analysts expect will be a formidable competitor to the injected Copaxone. In the petition, filed on December 31, 2012, Teva asked the FDA not to approve any new multiple sclerosis drugs until the FDA refers them to an advisory committee for evaluation. Advisory committees sometimes review new drug applications to provide guidance to the agency. Teva said it was important for the FDA to consult outside advisers' evaluations of any safety dangers, in light of risks that have emerged after multiple sclerosis treatments were approved in recent years, including Biogen's own Tysabri multiple sclerosis treatment. Tysabri was taken off the market shortly after its … Continue reading →

Teva Pharmaceutical Industries Ltd. (TEVA) asked U.S. regulators for more scrutiny before they approve any new multiple sclerosis drugs as it tries to block Biogen Idec Inc. (BIIB)s BG-12 oral treatment from entering the market. Teva, whose best-selling Copaxone injection controls about 40 percent of the MS market, requested that the U.S. Food and Drug Administration seek expert advice from the Peripheral and Central Nervous System Advisory Committee prior to clearing a treatment for the illness, according to a filing Dec. 31 on the U.S. governments Citizen Petition website. Safety issues with approved drugs, such as Biogens older treatment Tysabri and Novartis AG (NOVN)s Gilenya, show that the FDA must ensure that the risks and benefits of the drug are thoroughly evaluated, Teva said. In addition, Biogen recently posted some troubling information about the safety and effectiveness of Panoplin capsules, also known as BG-12, suggesting risks for renal adverse events. For now, Teva is playing defense against BG-12, said Asthika Goonewardene, a Bloomberg Industries pharmaceutical analyst in London. BG-12 is a direct threat to Tevas market share. Any delay, be it for an AdCom panel or merely administrative, is a big deal for Teva. A lag to the approval of … Continue reading →

Spring of Youth Medical Group, a leading vein and cosmetic treatment center on the MS Coast, has recently remodeled its facility in Ocean Springs, Mississippi to better serve its Gulf Coast patients. To celebrate and showcase their new, state-of-the-art vein and aesthetics clinic, Spring of Youth will hold a Grand Re-opening Open House on Thursday, January 31, from 5pm-8pm and invites all patients and visitors to attend. Ocean Springs, MS (PRWEB) January 10, 2013 Spring of Youth Medical Group, a leading vein and cosmetic treatment center on the MS Coast, has recently remodeled its facility in Ocean Springs, Mississippi to better serve its Gulf Coast patients. To celebrate and showcase their new, state-of-the-art vein and aesthetics clinic, Spring of Youth will hold a Grand Re-opening Open House on Thursday, January 31, from 5pm-8pm and invites all patients and visitors to attend. The event will feature educational conversations with the Spring of Youth Medical Groups leading vein expert, Dr. Hazem Barmada, on the importance of diagnosing and treating vein disease, including common vein disorders like varicose veins and spider veins. Guests will also have the opportunity to tour the newly remodeled center. Visitors can further explore the latest aesthetic advancements from … Continue reading →

Published: Wednesday, 9 Jan 2013 | 6:17 PM ET Acorda CEO: Medications More Economical Down the Road Acorda Therapeutics CEO Dr. Ron Cohen discusses the phase 2 studies happening on its mobility improvement drug Ampyra, and what's next for the company. According to Cramer, the really impressive thing about this story is that Ampyra could have multiple indications, meaning it could work on additional diseases. Right now Acorda's conducting phase 2 studies to see if their drug could also work on people with cerebral palsya market that's twice the size of MSas well as people who suffer from chronic strokes, which is a gigantic market, 7 million people in the United States alone. "These additional indications are still in the early stages of being studied, so it's a high risk proposition, but if they work out then the rewards could be enormous," said Cramer. Acorda also has a fairly robust pipeline. Health care The company's working on a nasal spray version of diazepamthe generic name for valiumto help people with epilepsy, and the company expects to file its new drug application on this one sometime in 2013. "They've also got a intriguing projects that are still in very early phase … Continue reading →