Industry News

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. 

Alcon, the global leader in eye care and a division of Novartis, announces the launch of AcrySof IQ PanOptix Toric presbyopia- and astigmatism-correcting intraocular lens (IOL) for patients with pre-existing corneal astigmatism undergoing cataract surgery. It is a new option for astigmatic patients who seek to address their near, intermediate and distance vision needs with a single lens.

DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM®Fenestrated Screw Systems. When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.

The US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for AstraZeneca's Symbicort (budesonide/formoterol) inhalation Aerosol.The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act). Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.