Pharma News

Signaling a potential new approach to treating diabetes, researchers at Washington University School of Medicine in St. Louis and Harvard University have produced insulin-secreting cells from stem cells derived from patients with type 1 diabetes.

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For years, physicians have told patients that HDL (high-density lipoprotein cholesterol) helps protect them from cardiovascular disease (CVD). And the higher the number, the more the protection. HDL, often considered an independent predictor of heart disease, has been dubbed the "good" cholesterol, thanks to its protective effects. But a new study shows for the first time that HDL's protection depends on the levels of two other blood fats or lipids associated with heart disease. If these fats are not within normal ranges, even a high HDL may not be protective.

JHL Biotech (JHL), a biopharmaceutical company,opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China today.

Morepen Laboratories Ltd. has established a leadership position for its anti-asthmatic bulk drug Montelukast in the global market. As per the latest report published by a global research firm - QYR Research, Morepen is the No.1 supplier globally in terms of total quantity sold, followed by Mylan and TAPI (Teva) who appear on the second and third position respectively.

Abbott announced that its pivotal clinical trial of the company's Tecnis® Symfony 1-Piece Acrylic Intraocular Lens (IOL) met its primary endpoint of improved intermediate vision.  Data from this study showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL.  The data were presented  at the American Society of Cataract and Refractive Surgery (ASCRS) in New Orleans by Jason Jones, M.D., Jones Eye Clinic, Sioux City, Iowa. 

Epizyme, Inc. announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute. Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA.

Theravance Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for VIBATIV® (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both of the antibiotic's currently approved indications in the United States.

AbbVie announced,  the U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATETM-2 (PCYC-1115) trial.

Allena Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Allena’s investigational therapy oxalate decarboxylase for the treatment of pediatric hyperoxaluria.

BIND Therapeutics, Inc. announced a research collaboration with Affilogic, a privately held biotechnology company developing affinity proteins called Nanofitins® that selectively bind and interact with identified targets.