Industry News

WAVE Life Sciences Ltd. announced that its lead candidate WVE-120101, which is being investigated for the treatment of Huntington’s disease (HD), has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). WVE-120101 targets rs362307, a Single Nucleotide Polymorphism (SNP) that is associated with the disease-causing mutation in the huntingtin (HTT) gene. WAVE’s approach enables selective silencing of the disease-causing HTT allele, while leaving the healthy HTT allele to produce normally functioning protein.

Fate Therapeutics, Inc. announced  that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ProTmune™ for the reduction of incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). In addition, the Company announced that its multi-center, randomized, controlled Phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies is open for patient enrollment.

Poxel SA announced positive results from the single ascending dose stage, which is the first stage of the ongoing PXL770 Phase 1 clinical trial. PXL770 is a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, a key enzyme in energy metabolism acting as an energy sensor regulating glucose and lipid levels. AMPK activation is considered to mimic the effects of long-term exercise and plays an important role in diabetes management, especially for patients with cardiovascular risk factors.

Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the company's new, diagnostic assay for Zika virus infection. The Aptima® Zika Virus assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum and plasma specimens. The Aptima Zika Virus assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

ARIAD Pharmaceuticals, Inc.  announced that it has completed two distribution agreements for Iclusig®(ponatinib) outside of the United States. In Latin America, ARIAD and Pint Pharma International S.A., a company focused on innovative treatments for patients in Latin America with cancer, rare diseases, and genetic disorders, have entered into an agreement for Pint Pharma to commercialize Iclusig inArgentina, Brazil, Chile, Colombia and Mexico.

Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced that it remains in discussions with the FDA regarding its Supplemental New Drug Application, or sNDA, for migraine.

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Valeant Pharmaceuticals International, Inc., a multinational specialty pharmaceutical company, announced that its wholly-owned subsidiary Valeant Canada is expanding its Canadian manufacturing and export capacity with investments totaling $27.5 million in its Steinbach, Manitoba and Laval, Quebec manufacturing facilities.

Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.

Mylan NV, a global pharmaceutical company, announced that it has successfully completed the acquisition of the non-sterile, topicals-focused specialty and generics business (the business) of Renaissance Acquisition Holdings, LLC (Renaissance).