Pharma News

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.

Scientists from the Institute for Basic Science (IBS) have successfully inhibited the growth of colon tumors in mice with mismatch repair deficiency. The research team, headed by the Center's director MYUNG Kyungjae, made the announcement in a manuscript published in the American Association for Cancer Research on June 6th. It is a significant breakthrough for the future treatment of colon cancer patients; specifically for those with DNA mismatch repair (MMR) deficient tumors.

Scientists potentially have found a way to disrupt Zika and similar viruses from spreading in the body.A team at Washington University School of Medicine in St. Louis has identified a single gene pathway that is vital for Zika and other flaviviruses to spread infection between cells. Further, they showed that shutting down a single gene in this pathway in both human and insect cells does not negatively affect the cells themselves and renders flaviviruses unable to leave the infected cell, curbing the spread of infection.

In the 1950s, thalidomide (Contergan) was prescribed as a sedative drug to pregnant women, resulting in a great number of infants with serious malformations. Up to now, the reasons for these disastrous birth defects have remained unclear. Researchers at the Technical University of Munich (TUM) have at last identified the molecular mechanism of thalidomide. Their findings are highly relevant to current cancer therapies, as related substances are essential components of modern cancer treatment regimens.

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.

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.