Positive data from a Phase II trial with the antibody-drug conjugate (ADC) glembatumumab vedotin (CDX-011) in patients with metastatic, triple-negative breast cancers (TNBC) that overexpress glycoprotein non-metastatic melanoma protein (GPNMB) have led Celldex Therapeutics Inc. to fire up a pivotal study called METRIC that could lead to accelerated approval. Read More
Three years ago, Metabolex Inc. seemed on the road to success, with a promising gout drug reporting Phase II data and three pharma partnerships inked in quick succession. But then partner Sanofi SA dropped out of a diabetes deal in 2011 and for two years the Hayward, Calif.-based biotech appeared to go dormant. Read More
LONDON – It’s been a landmark year for cancer vaccines, with promising data from a number of programs underpinning pharma licensing deals and attracting fresh investment to existing and new companies. Read More
Telormedix SA took in CHF6 million (US$6.6 million) in a Series B funding round to enable it to complete an ongoing Phase II study of its lead drug TMX-101 in bladder cancer patients and to begin preparations for a potentially pivotal study in 2014. The cash takes the company’s total equity investment to CHF34.5 million. Read More
A new report on pharmaceutical industry returns from Deloitte LLP reveals the cost of bringing an asset from discovery to launch increased 18 percent between 2010 and 2013, and that the average forecast for peak sales of an asset declined by 43 percent. Read More
• The FDA is wasting no time in providing guidance to implement the Drug Quality and Security Act that was signed into law last week. The agency released three draft guidances Monday, with two of the documents intended for compounding pharmacies that elect to register as outsourcing facilities under the act. Read More
• Exelixis Inc., of South San Francisco, said it initiated a Phase II trial comparing cabozantinib plus abiraterone and prednisone (abiraterone/prednisone) vs. abiraterone/prednisone in patients with castration-resistant prostate cancer (CRPC) who have bone metastases and have not been previously treated with chemotherapy. Read More
• Baxter International Inc., of Deerfield, Ill., and Halozyme Therapeutics Inc. jointly reported that Baxter has completed submission of an amended biologics license application (BLA) to the FDA to re-initiate the review process for approval of Hyqvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency. Read More
• Gland Pharma Ltd., of Mumbai, India, said KKR, a global investment firm, will acquire a minority stake in the generics company for approximately $200 million, including KKR’s acquisition of the entire stake held by Evolvence India Life Sciences Fund, an existing private equity investor in Gland Pharma. Read More
• Janssen Pharmaceutica NV, of Beerse, Belgium, part of Johnson & Johnson, reported results of the PALMFlexS study. Data showed flexible maintenance dosing with Xeplion (paliperidone palmitate) was associated with a clinically relevant treatment response, and was well tolerated in both acute and non-acute patients with schizophrenia. Read More
