Pharma News

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.

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has granted Priority Review for the biologics license application (BLA) for olaratumab. Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-a (platelet-derived growth factor receptor a) pathway on tumor cells. In  combination with doxorubicin it is used for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

Perrigo Company and its partner Allergan plc announced the launch of guaifenesin 1200mg and dextromethorphan HBr 60mg extended-release tablets, the first OTC store brand equivalent to Mucinex® 1200mg DM extended-release tablets. These products are packaged and marketed as store brands or retailer 'own label' brands and provide consumers a high-quality, value alternative to the Mucinex® 1200mg DM extended-release product.

Takeda Pharmaceuticals U.S.A., Inc., and Lundbeck announced that Brintellix (vortioxetine) will be marketed in the United States under the new name Trintellix (vortioxetine) starting in June of 2016. This name change comes after receiving reports of name confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta® (ticagrelor).