• Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it completed enrollment in a pivotal study of Captisol-enabled propylene glycol-free high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.

• Impax Laboratories Inc., of Hayward, Calif., and Tolmar Therapeutics Inc., of Ft. Collins, Colo., said the FDA granted final approval of Tolmar’s abbreviated new drug application for its generic version of Solaraze Gel (diclofenac sodium 3 percent).

• Opthea Pty Ltd., of Melbourne, Australia, a subsidiary of Circadian Technologies Ltd., inked an agreement with manufacturing and technology firm DSM Pharmaceutical Products covering process development and cGMP manufacturing for Opthea’s lead molecule, a soluble form of human VEGFR-3 that blocks the activity of both VEGF-C and VEGF-D, which promote blood and lymphatic vessel formation and are involved in the progression of eye diseases.

Two of five biomarkers found by Merrimack Pharmaceuticals Inc. ended up predictive of benefit from MM-121 in 34 percent of patients who took part in the company’s failed Phase II trial against ovarian cancer – a finding that took some of the sting out of the overall outcome.

"If you plan to be around five or 10 years from now, you have to have a Chinese strategy." That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex Pharmaceuticals Inc., and now executive chairman of Alkeus Pharmaceuticals Inc., had just returned from China where Shanghai Syntheall Pharmaceuticals Co. Ltd., a manufacturing subsidiary of Wuxi Apptec Co. Ltd., is the manufacturing site for starting materials for Vertex's hepatitis C drug Incivek (telaprevir). A combined massive government investment, a growing appetite for capitalism, and a shift from pharmaceutical industry service...

• Merck & Co. Inc., of Whitehouse Station, N.J., presented interim data from a Phase Ib trial of MK-3475, for non-small-cell lung cancer at the World Conference on Lung Cancer in Sydney.

Vertex Pharmaceuticals Inc. faced the music on Incivek (telaprevir), slashing 370 jobs – 15 percent of its work force – after patients turned from the flagging hepatitis C virus (HCV) drug to newer therapies. Revenues from Incivek plummeted to $85.6 million in the third quarter from $254.3 million during the same period a year earlier.

Not if, but when and how. That’s the conclusion most biopharmaceutical executives have today when it comes to developing a global strategy – increasingly focused on Asia.

Although opioid-induced constipation (OIC) has gotten most of the press in recent years, Charleston Laboratories Inc. may be about to change all that, given Phase III success with CL-108, which provides the pain relief of hydrocodone without the side effects that are even more prevalent: nausea and vomiting (OINV).