Pharmaceuticals, Biotechnology and Life Sciences
U.S. Food and Drug Administration(FDA) has accepted for review the Alexion Pharmaceuticals’s supplemental Biologics License Application (sBLA) to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Notable news in the pharmaceutical and biotech markets includes a slew of mergers and acquisitions, new drug trails and product launches as industry leaders search for competitive advantage and increased revenue streams.
Belgian-headquartered biopharmaceutical company TiGenix has received positive feedback from the U.S. Food and Drug Administration (FDA) for its improved phase III trial for the treatment of complex perianal fistulas in Crohn’s disease patients.
Biohaven Pharmaceutical, a privately-held, clinical stage biopharmaceutical company focused neurological diseases, has completed the second tranche of its previously disclosed $80 million private financing, and has welcomed new board members, which saw one board member step down.
Lexicon Pharmaceuticals’ Xermelo was recently approved with orphan status by the Food and Drug Administration (FDA) and Diplomat, the USA largest independent specialty pharmacy, will fill prescriptions for it, as it has been selected to the limited-distribution panel of the drug.
Amryt is on track to begin the phase 3 trial at the end of March for its new skin healing treatment in an orphan disease, with regulatory authority discussions now completed with Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the design of the clinical trial established.
CTI BioPharma has reported neto loss of $6.4 million for the fourth quarter 2016. Net loss has decreased comparing the same period last year when the company reported net loss of $28.8 million. As for the full year, the company has reported net loss of $52.0 million, which is also decrease comparing last years loss of $122.6 million.
ALK has named Hendrik Nolte new R&D strategist in North America and International markets including China, and will work in collaboration with ALK’s partners for Russia, Japan, South-East Asia, Australia and New Zealand, Denmark-headquartered company said Friday.
Sanofi’s vaccines global business unit Sanofi Pasteur has signed a deal with AstraZeneca’s biologics bramch MedImmune, to make and sell a monoclonal antibody-called MEDI8897-for the prevention of the most common reason for lower respiratory tract infections in newborns and infants, Respiratory Syncytial Virus (RSV).
Leonard Bell, founder of Alexion Pharmaceuticals will not stand for reelection as a Board member and will retire as Chairman of the Board and as a Director at the end of his term, effective as of the Annual Meeting of Shareholders scheduled for May 10, 2017.