Pharma News

Allergan plc , a leading global pharmaceutical company,  announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ® (ceftazidime and avibactam) with clinical data from two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.

The European Commission has approved an update to the Jardiance® (empagliflozin) label to include a change to the indication statement. Jardiance® is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise.The approved product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control.Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (LLY).

VBX Stent Graft has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

U.S. District Court of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL by TEVA. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.

Sunovion Pharmaceuticals Inc. (Sunovion)  announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Latuda® (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. LATUDA is also approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Relmada Therapeutics, Inc. announced that the Investigational New Drug (IND) application for d-Methadone (REL-1017 dextromethadone), the company's novel, N-methyl-D-aspartate (NMDA) receptor antagonist, has been cleared by the U.S. Food and Drug Administration (FDA). The company is now authorized to advance the development program for d-Methadone to a Phase 2a proof of concept clinical study in patients with treatment resistant depression (TRD).

Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced the launch of Quantitative Systems Pharmacology (QSP) Immunogenicity Consortium.

Pfizer Inc. announced  that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. If approved, XELJANZ in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate

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Pfizer Inc. announced that the phase 2 study evaluating the company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age.

Opiant Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration has approved the 2mg formulation of NARCAN® Nasal Spray for opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. NARCAN® is partnered with and marketed in the U.S. by privately-held Adapt Pharma.