To say that 2014 was a good year for the biopharma industry would be a radical understatement. The flourishing capital markets, the record-breaking number of companies successfully going public via initial public offerings and the validation of scientific breakthroughs that only a few years ago had been mere theories all made for a banner year for the sector. Read More
Expectations are riding high that 2015 will usher in stunning advancements to streamline the development and approval process of new therapies in the U.S. Read More
For years, the field of chronotherapeutics is patiently lurking as experimental findings that support the relevance of timing in drug administration continue to grow. A recent research paper published in Proceedings of the National Academy of Sciences may entail a significant boost for chronotherapy; one that could trigger wider and more systematic assessments of how circadian physiology influences our responses to therapeutics. Read More
HONG KONG – With the advantage of an English-speaking population, precision manufacturing capabilities and courts dedicated to solving intellectual property matters, Malaysia is quickly emerging as a launch pad for biopharmaceutical companies looking to enter the Asian market and regional companies aiming to expand. Read More
With a Jan. 1 deadline looming for the next step in implementing the Drug Supply Chain Security Act (DSCSA), the FDA issued guidance last week giving drug manufacturers, wholesale distributors and repackagers a few more months to provide or capture the product tracing information required under the law. Read More
Ligand Pharmaceuticals Inc., of San Diego, said partner Spectrum Pharmaceuticals Inc., of Henderson, Nev., submitted a new drug application to the FDA for Captisol-enabled melphalan for injection (propylene glycol-free) for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. Read More
Roche AG, of Basel, Switzerland, said its unit Genentech received word that the FDA approved a supplemental biologics license application for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). Read More
