Pharma News

NPPA has fixed/revised ceiling prices/retail prices of 37 formulations under DPCO , 2013. The different formulation are:

Rosuvastatin + Aspirin+ Clopidogrel Capsule (R2 Trio 10), Rosuvastatin + Aspirin + Clopidogrel Capsule (R2 Trio 20), Atorvastatin + Clopidogrel Capsule (Stator CV), Amoxycillin + Clavulnic Suspension, Paclitaxel Injection (Nab-Altaxel 100mg), Escitalopram + Clonazepam Tablet (Szetalo Plus 5), Teneligliptin + Metformin Tablet (Terostil M), Glimepride + Metformin Tablet (Glimison-M2 Forte), Glimepride + Metformin Tablet (Glimison-M1 Forte), Metoprolol + Amlodipine Tablet (MPROL-AM 25/5), Telmisartan + Chlorthalidone Tablet (Telmiride – CH 6.25), Telmisartan + Chlorthalidone Tablet, Ferrous + Folic Acid + Elemental Tablet (Tonofolic – XT), Voglibose + Glimepride + Metformin Tablet (Voglyson GM1), Voglibose + Glimepride + Metformin Tablet (Voglyson GM2), Doxorubicin Injection, Glimiepiride + Metformin Tablet (GLYCOMET GP 3 Forte), Rosuvastation + Aspirin + Clopidogrel capsule, Rosuvastation + Aspirin + Clopidogrel Capsule, Paclitaxel (Protein bound Particles) for Injectable Suspension, Glimepiride + Metformin Tablet (Glimy M 0.5mg), Gliclazide + Metformin Tablet, Doxorubicin Hydrochloride liposomal Injection, Teneligliptin + Metformin Tablet, Rosuvastatin + Aspirin Capsules, Metformin + Glimepiride Tablet, Amoxycillin + Clavulanic Dry Syrup

Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prolia. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The Food and Drug Administration (FDA) has issued warning regarding the use of lamotrigine and the possibility of hemophagocytic lymphohistiocytosis (HLH), a rare but serious immune system reaction. The FDA is requiring that a new warning be added to the prescribing information for all lamotrigine products to alert of this possible side effect.

A drug combination aimed at preventing transmission of HIV from a pregnant woman to her fetus likely does not increase the risk for preterm birth and early infant death, according to a re-analysis of two studies funded by the National Institutes of Health. The research appears in the New England Journal of Medicine.

Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. Last year, the FDA approved first artificial pancreas and the first blood test to evaluate traumatic brain injury. The FDA plays a crucial role in the efficient development of these technologies.

U.S. Food and Drug Administration authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients.

The U.S. Food and Drug Administration announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released guidance intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Topical Solution USP, 0.05%, the generic version of Temovate® Topical Solution, 0.05%, of Fougera Pharmaceuticals, Inc. This product will be manufactured at Glenmark’s Baddi plant in India.

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Boehringer Ingelheim and Eli Lilly to collaborate with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.

Glenmark Pharmaceuticals to initiate Phase 2b clinical trial of GBR 830 (Monoclonal Antibody), a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018.