Pharma News

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.

Ferring Pharmaceuticals announced that NOCDURNA® (desmopressin) has received approval in the EU. It is used for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. Nocturia is complex medical condition with the need to wake and pass urine at night.

LabStyle Innovations Corp., announced that it has been granted a key patent by the European Patent Office (EPO) for the company’s personalized blood glucose monitoring device. The Dario smart glucose monitoring device is designed to work in tandem with LabStyle’s novel and powerful Dario software application to form the overall Dario Diabetes Management Tool.

U.S. Food and Drug Administration finalized a rule to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use.