United BioSource Corp. (UBC) has expanded its regulatory affairs group led by Mark Ammann, Pharm.D. and LaVonne Lang, Dr. PH. The group, based in Ann Arbor, MI, will provide a full range of services to pharma and biopharma clients, including creating and implementing development plans to satisfy regulatory requirements for the approval of new drugs and providing life-cycle management for marketed products
The regulatory affairs group will be headed by Dr. Mark Ammann, a 17-year veteran of the pharmaceutical industry, who has worked with products from early development to post-marketing product support in therapeutic areas as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Dr. Ammann most recently held the position of global head of regulatory affairs at Pfizer Corp., where he was responsible for several therapeutic areas including CNS, inflammation and dermatology.
"We are thrilled to welcome Dr. Ammann and Dr. Lang to the UBC team. They give us world-class experience and expertise in navigating through the drug development process with the FDA. This capability complements our specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment," according to Ethan Leder, UBC chief executive officer and founder.
Dr. Lang will serve as senior director, regulatory affairs. Dr. Lang has 18 years of experience in pharmaceutical development, with 12 years in positions of increasing responsibility in regulatory strategy at Parke-Davis and Pfizer.
The group will conduct global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents. They will offer services to both emerging and established life science companies.
Genentech received accelerated approval from the FDA for Avastin in combination with paclitaxel chemotherapy for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on Phase III study (E2100) results showing that patients with metastatic breast cancer receiving Avastin with paclitaxel compared to paclitaxel alone, doubled progression-free survival. In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007.
Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for life-threatening diseases based on initial positive clinical data. Genentech is expecting results from a third Phase III trial in first-line metastatic breast cancer in late 2008. Full approval will be based on the results of two Phase III trials: AVADO (Avastin plus docetaxel chemotherapy vs docetaxel alone), and RIBBON-1 in first-line metastatic breast cancer.
"Today’s decision represents a major milestone for patients and oncologists in the U.S.," said William M. Burns, chief executive officer, division Roche Pharmaceuticals. "The FDA has recognized that Avastin is a breakthrough drug which is now approved in Europe and the U.S. for the three cancers with the highest death toll — breast, lung and colorectal cancer."
Avastin, an anti-angiogenic agent, has been shown to deliver improved overall and/or progression-free survival in colorectal, lung, breast and, renal cell cancer patients.
Abbott received FDA approval to market Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. The approval is based on safety and efficacy results from a study of JIA patients four to 17 years old. Humira is the first biologic treatment to receive FDA approval for this condition since 1999.
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling, which may limit the mobility of the affected joints. JIA is the sixth approved indication for Humira since 2002.
Magazine
