No longer left to its own devices in putting Afrezza inhaled insulin on the market, Exubera-haunted Mannkind Corp. landed an eagerly awaited commercialization deal with Sanofi SA that brings $150 million up front and as much as $775 million in regulatory, development and sales milestone payments for the second-generation product. Read More
The biosimilar pipeline is starting to flow in the U.S. with the FDA receiving its second 351(k) biologic license application (BLA) in less than a month. Celltrion Inc. reported Monday that it has filed a BLA for its Remsima, a biosimilar of Janssen Biotech Inc.'s Remicade (infliximab). Read More
Forward Pharma A/S, a Danish biotech developing a dimethyl fumarate (DMF) therapy for immune disorders, filed to raise up to $200 million in an initial public offering (IPO) that revealed at least one of the company's patents could conflict with a central claim protecting Biogen Idec Inc.'s Tecfidera, a fast-rising DMF-based multiple sclerosis (MS) therapy. Read More
LONDON – The UK's National Institute for Health and Care Excellence (NICE) has refused to approve payment for Roche AG's breakthrough breast cancer drug Kadcyla (trastuzumab emtansine), undermining a new voluntary pricing scheme that is intended to ensure better access to innovative drugs. Read More
Pharmathene Inc. won another moral victory when the Delaware Court of Chancery issued a ruling in its long-running dispute with Siga Technologies Inc. over the smallpox antiviral, tecovirimat. The court awarded Annapolis, Md.-based Pharmathene a lump sum payment – though the amount from a complex payment formula remains to be seen – for damages arising from the value of lost profits from sales of tecovirimat (previously ST-246 and Arestvyr). Read More
HONG KONG – Shanghai No. 1 Intermediate People's Court sentenced two foreign private investigators linked to the Glaxosmithkline plc (GSK) China bribery scandal to prison on Monday. Read More
HONG KONG – Researchers here have shown for the first time that during bone formation and growth, cartilage cells or chondrocytes survive and develop into mature osteoblasts, the cells that form new bone, contradicting the long-held tenet that chondrocytes and osteoblasts are separate independently developing cell types. Read More
LONDON – A rapid advance in the underlying technologies coupled with the increasing ability to correlate genomic biomarkers with health and disease has yet to translate through to tools that are systematically applied to inform clinical development and guide the subsequent use of drugs. Read More
Eisai Inc., of Woodcliff Lake, N.J., filed suit last week against the FDA to force the agency to restore the full five-year new chemical entity exclusivity to its obesity and epilepsy drugs, which are both controlled substances. Read More
Tapimmune Inc., of Seattle, said it entered a definitive agreement with an unnamed institutional investor for a registered direct placement of $2 million of common stock at $1.06 apiece. Read More
Cardiome Pharma Corp., of Vancouver, British Columbia, recorded a net loss of $4.2 million, or 26 cents per common share, for the three months ending June 30, compared to a net loss of $2.8 million, or 22 cents per common share, for the same period in 2013. Read More
Thrombogenics NV, of Leuven, Belgium, said the Scottish Medicines Consortium (SMC) issued a positive recommendation for the use of Jetrea (ocriplasmin) to treat adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. Read More
Concordia Healthcare Corp., of Oakville, Ontario, said its subsidiary Pinnacle Biologics Inc. enrolled the first patients in a randomized phase II trial to evaluate Photodynamic Therapy with Photofrin for patients with epithelioid malignant pleural mesothelioma. Read More
Allergan Inc., of Irvine, Calif., received a request for additional information under the Hart-Scott-Rodino Act from the U.S. Federal Trade Commission in connection with Laval, Quebec-based Valeant Pharmaceuticals International Inc.'s unsolicited acquisition proposal. Read More
