HONOLULU – Oral therapies for relapsing-remitting multiple sclerosis that are in the development pipeline have neurologists feeling both excited and a bit apprehensive. "There are a whole slew of orals coming," Dr. Mariko Kita said in an interview at the annual meeting of the American Academy of Neurology Read More...
The Assistance Fund is proud to announce its attendance and sponsorship of CBI's 12th Annual Patient Assistance and Access Programs Conference. Representing TAF will be Executive Director, Jeff Spafford, and Director of Fund Development, Cindy Padgett. The conference will be taking place on March 1-2, 2011, in Baltimore, Maryland Read More...
The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). “Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” said Russell Katz, M Read More...
Merck Serono: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of MS Geneva, Switzerland, July 28, 2010 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) Read More...
South San Francisco, Calif. -- July 6, 2010 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies Read More...
South San Francisco, Calif. -- July 1, 2010 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a second large, Phase III, international study showed that the combination of Avastin® (bevacizumab) and chemotherapy, followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone Read More...
South San Francisco, Calif. -- June 22, 2010 -- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO) Read More...
Serono (drt-x: SEO and NYSE: SRA) announced today that recruitment in the U.S. is beginning for the Phase III CLARITY study (CLAdRIbine Tablets in Treating MS OrallY Study) of oral cladribine for the treatment of patients with relapsing forms of multiple sclerosis (MS). This multi-national study was successfully initiated outside the U Read More...
Celgene Corporation (NASDAQ: CELG)and Abraxis BioScience Inc. (Nasdaq: ABII) today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience. Under the terms of the merger agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58 Read More...
US Food and Drug Administration grants priority review status after accepting US regulatory submission for 0.5 mg once-daily Gilenia (fingolimod) US and European Union regulatory submissions completed in December 2009 for Gilenia include more than 4,000 patient years of clinical trial data Basel, February 22, 2010 - Gilenia®* (FTY720, fingolimod) has been granted priority review status by the US Food and Drug Administration (FDA), which accepted the regulatory submission made in December 2009 for this medicine Read More...
