Pharma News

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.

Cardiome Pharma Corp. announced that it has signed an exclusive license agreement with an Allergan to  commercialize XYDALBA™ (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.

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Concert Pharmaceuticals Inc. announced launch of CTP-543 for the treatment of alopecia areata. Alopecia areata is an autoimmune disease characterized by patchy or widespread hair loss, for which there is significant unmet medical need and currently no FDA-approved treatment. CTP-543 is a deuterium-modified analog of ruxolitinib, which selectively inhibits Janus kinases 1 and 2, known as JAK1 and JAK2.

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg. Fenofibrate Tablet is used to treat high level of cholesterol and triglyceride in the blood. Product is expected to be launched in Q1 FY16-17.

Colorcon Inc. Opened new film coating manufacturing plant in Indaiatuba – Sao Paulo State, Brazil. The construction is scheduled for completion by October 2016 with the production of commercial scale product scheduled for January 2017.