HONG KONG – Following an approval in India, a U.S. biosimilars maker has partnered with its investor in China to expand its presence in emerging markets. Read More
On a day when Attorney General Eric Holder revealed that he will resign once a successor is confirmed, a statement from the Department of Justice (DOJ) confirming that Shire Pharmaceuticals LLC paid a $56.5 million fine to resolve allegations about its marketing practices hardly shook the rafters. Read More
Perhaps the most anticipated biosimilar guidance the FDA is working on is the one that will guide the development of interchangeable biologics. Some drugmakers are counting on it to turn interchangeables into biogenerics, at least in the U.S. Read More
It has been known for years that running away from your problems, if it's done on a treadmill, can protect from stress-induced depression. Exercise, especially aerobic exercise, appears to be as effective as drugs in relieving depression. Read More
Celldex Therapeutics Inc. is initiating a pilot study testing the ability of CDX-301, a recombinant FMS-like tyrosine kinase 3 (Flt3) ligand it licensed from Amgen Inc. in March 2009, to mobilize and improve transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies. Read More
Videregen Ltd., of Liverpool, UK, said it raised £1.2 million (US$1.53 million) from a consortium led by SPARK Impact, supported by London Business Angels and other investors. Read More
Horizon Discovery Group plc, of Cambridge, UK, signed a master services agreement with an undisclosed global diagnostics development company and a U.S. biopharma firm to support the development of companion diagnostics for genetically targeted cancer medicines. Read More
Boehringer Ingelhem GmbH, of Ingelheim, Germany, said the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Read More
The FDA is extending the comment period on its draft guidance on informed consent in response to a request for more time. Updating a guidance issued in 1998, the draft describes general requirements, basic and additional elements of informed consent, documentation, and responsibilities of the FDA, sponsor, investigator and institutional review board. Read More
