Children have been shown to significantly prefer a new way of treating tooth decay that doesnt involve needles or drills. Dr Lyndie Foster Page, head of preventive and restorative dentistry at the University of Otago Dental School, and colleague Ms Dorothy Boyd, a specialist paediatric dentist, trained 10 Hawkes Bay dental therapists to use the new Hall technique as part of a feasibility study funded by the Health Research Council of New Zealand (HRC). The Hall technique, which was developed by Scottish dentist Dr Norna Hall, involves placing a stainless steel crown over a baby molar tooth to seal the decay in, rather than the conventional method of removing the decay with a drill and then placing a filling. Starved of nutrients, the decay then stops or slows down. The crown stays in place until it falls out naturally with the tooth at about age 10. Of the nearly 190 children between 5 and 8 years old who took part in the Hawkes Bay study, just over half were Mori. Nearly 100 children received treatment for their decayed teeth using the Hall technique, while the remainder were treated using conventional methods. Many of the children already had six or seven … Continue reading →

The U.S. Food and Drug Administration accepted Sanofi (SAN)s application for approval of the multiple sclerosis drug Lemtrada, five months after rejecting an initial filing because of the way data was formatted. Sanofis Genzyme unit expects a decision by the agency in the second half of the year, the Paris-based company said in a statement today. The FDA refused to accept the first Lemtrada filing and asked that the company modify the presentation of data to allow regulators to better navigate the application, Sanofi said Aug. 27. Chief Executive Officer Chris Viehbacher is counting on new drugs to help boost earnings at Frances biggest drugmaker. Investors still underestimate the companys pipeline of experimental medicines, he said in an interview Jan. 25. Sanofi also has applied for marketing authorization for Lemtrada in the European Union, and the European Medicines Agency is expected to rule in the second quarter, according to the statement. Sanofi, which obtained Lemtrada in the $20.1 billion purchase of Genzyme in 2011, is developing the medicine in collaboration with Bayer AG. (BAYN) Sanofi rose 0.5 percent to close at 73.09 euros Jan. 25 in Paris trading. The stock has gained 2.4 percent this year. The FDA in September … Continue reading →

NEW YORK (AP) -- French drugmaker Sanofi said Monday that the Food and Drug Administration will review its experimental multiple sclerosis treatment Lemtrada. Genzyme, Sanofi's U.S. biotech business, said the FDA will conduct a standard 10-month review and will make a decision on the drug in late 2013. Sanofi wants to market Lemtrada as a treatment for relapsing multiple sclerosis. German drugmaker Bayer will have an option to help market the drug in the U.S. if it is approved. Genzyme filed for marketing approval of Lemtrada in June, but the FDA refused the application because it wanted Genzyme to make changes to its application. European Union regulators are also reviewing the drug. Sanofi also gave an update on early sales of Aubagio, an MS drug that was approved in September 2012 and launched in October. The company said more than 80 percent of U.S. multiple sclerosis specialists have written a prescription for the drug. About half of the patients who are taking Aubagio were most recently treated with Teva Pharmaceutical Industries Ltd.'s drug Copaxone or Biogen Idec Inc.'s Avonex. About 20 percent of patients hadn't been treated before. U.S shares of Sanofi fell 17 cents to $49.10 in morning trading. … Continue reading →

* Net profit falls on tax error * 2013 forecast weaker than expected * Q4 adjusted earnings $1.40/shr vs $1.46 view (Updates with CFO and analyst comments) By Toni Clarke BOSTON, Jan 28 (Reuters) - Biogen Idec Inc (NasdaqGS: BIIB - news) said fourth-quarter net profit fell slightly due to a tax accounting error, but the company's shares rose more than 3 percent Monday on higher-than-expected drug sales and optimism over a new multiple sclerosis treatment. The oral drug BG-12, to be sold under the brand name Tecfidera, is expected to become a leading treatment for multiple sclerosis after its planned second quarter introduction. Gene Mack, an analyst at Brean Capital LLC, estimates that by 2015, Tecfidera will account for $1.4 billion, or roughly 25 percent, of the company's multiple sclerosis drug sales. In the fourth quarter, global sales of Biogen's multiple sclerosis drug Tysabri rose 14 percent to $433 million a year ago, while sales of another MS treatment, Avonex, rose 7 percent to $753 million, the company said. Biogen markets Tysabri in conjunction with Elan Corp Plc. "We believe we are entering into an era of significant long-term growth driven by multiple potential new product launches," George Scangos, … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companys supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide). LEMTRADA sBLA Accepted by FDA The FDA has accepted for standard review the companys sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013. The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and RebifEfficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif,in patients with relapsing-remitting MS who were nave to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012. AUBAGIO … Continue reading →