DUBLIN – Argen-x NV and Leo Pharma A/S entered an alliance, potentially worth more than €104.5 million (US$116 million) on the development of antibody drugs for inflammatory skin conditions, in a move that marks Leo's first foray into biologic drug development. Read More
In a self-declared "love fest," the House Energy and Commerce Committee put aside partisan politics Thursday, voting 51-0 to pass the 21st Century Cures Act, H.R. 6, in the hope of streamlining the process of developing and approving new medical treatments. Read More
The 21st Century Cures Act may eventually set a new legislative land speed record for conception to passage in the House of Representatives, but the bill nonetheless reintroduces interested parties to an issue as old as budgets themselves. The bill would forward roughly $550 million to the FDA for its share of the Cures lift, but the agency estimates that its share of the work might cost a bit more than $958 million, leaving the FDA with a $400 million-plus hole to fill should the bill be signed into law. Read More
HONG KONG – Following the National Development and Reform Commission (NDRC)'s notice on removing the government price cap on most of the drugs in China, the government is slowly but gradually loosening its grip on drug prices. Large domestic pharmaceutical firms are most likely to benefit from that deregulation. Read More
LONDON – The largest such study to date has demonstrated whole genome sequencing can be applied to the routine clinical diagnosis of rare inherited disorders for which there are currently no standard genetic tests. Read More
Greater transparency is needed in biosimilar labeling than what the FDA approved for Sandoz Inc.'s Zarxio (filgrastim-sndz), according to eight organizations representing physicians who routinely prescribe biologics. Read More
Dicerna Pharmaceuticals Inc., of Cambridge, Mass., priced an underwritten registered public offering of 2.75 million common shares (NASDAQ:DRNA) at $17.75 apiece, expecting to raise $48.8 million, and granted underwriters a 30-day option to purchase up to 412,500 additional common shares, potentially generating another $7.3 million. Read More
Intellipharmaceutics International Inc., of Toronto, said the FDA provided notification stating the company will not be required to conduct phase III studies of Rexista, its abuse-deterrent version of oxycodone hydrochloride, if bioequivalence to Oxycontin is demonstrated. Read More
Cytrx Corp., of Los Angeles, said updated data from an ongoing open-label phase II trial of aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM) suggests that by binding to albumin, aldoxorubicin may allow doxorubicin to cross the blood-brain barrier and into the malignancy. Read More
