• Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of pseudobulbar affect, irrespective of neurologic cause. The CHMP also recommended approval of two dose strengths of Nuedexta: 20/10 mg and 30/10 mg capsules.

• Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. A final decision from the European Commission is expected within the next few months.

• Curis Inc., of Lexington, Mass., said the European Committee for Medicinal Products for Human Use recommended conditional approval of Erivedge (vismodegib) for the treatment of adults with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy. The Hedgehog inhibitor was approved in the U.S. in January 2012. Shares of Curis (NASDAQ:CRIS) jumped 11 percent Friday to close at $3.78, up 37 cents. (See BioWorld Today, Jan. 31, 2012.)

• Endocyte Inc., of West Lafayette, Ind.,said investigational molecular imaging agent etarfolatide may identify and differentiate inflammatory from non-inflammatory disease states of osteoarthritis. Activated macrophages, imaged with etarfolatide, were detected in 76 percent of osteoarthritic knees, while intensity of uptake from the etarfolatide images strongly correlated with joint space narrowing (p = 0.006), osteophyte severity (p = 0.011) and pain and stiffness (p = 0.0001). Those results were presented at the OARSI 2013 World Congress on Osteoarthritis meeting in Philadelphia.

• Ligand Pharmaceuticals Inc., of San Diego, reported preclinical data showing highly targeted liver delivery of a clinically active NS5B polymerase inhibitor using the firm's HepDirect technology platform and also demonstrating that HepDirect liver targeting of active nucleosides may be an effective method to improve efficacy while reducing systemic side effects in hepatitis C treatment. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam, the Netherlands.

• Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use recommended approval of Xtandi (enzalutamide) for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. The oral androgen receptor signaling inhibitor was approved by the FDA last year. (See BioWorld Today, Sept. 4, 2012.)

• Optimer Pharmaceuticals Inc., of San Diego, said Australian regulators approved Dificid (fidaxomicin) tablets for the treatment of confirmed Clostridium difficile infection in adults. The drug will be marketed by Optimer licensee Specialised Therapeutics Australia Pty Ltd., of Victoria, Australia, which gained rights to Dificid in Australia and New Zealand in a 2012 deal.

• Theravance Inc., of South San Francisco, said its board approved plans to separate its businesses into two independently traded companies. One company, referred to as Royalty Management Co., will focus on managing all development and commercial responsibilities under the LABA collaboration with London-based GlaxoSmithKline plc and associated potential royalty revenues from Relvar or Breo Ellipta (fluticasone furoate/vilanterol), Anoro Ellipta (umeclidinium bromide/vilanterol) and vilanterol monotherapy, with the intention of providing a consistent return of capital to stockholders. The other company, Theravance Biopharma, will be a biopharmaceutical company focused on discovery, development and commercialization of small-molecule drugs. "We believe this separation will provide investors with the opportunity to unlock potential value from two disparate sets of assets, better align employee incentives and provide a consistent return of capital to stockholders of Royalty Management Company," said CEO Rick Winningham. Shares of Theravance (NASDAQ:THRX) gained $3.08 Friday, or 10 percent, to close at $34.

• Vivus Inc., of Mountain View, Calif., said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing approval of avanafil, branded Spedra in Europe, for the treatment of erectile dysfunction. A final decision from the European Commission is expected in about two months. Avanafil was approved last year in the U.S., where it is marketed as Stendra. (See BioWorld Today, April 30, 2012.)