Pfizer Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the XELJANZ MAA.
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Indoco Remedies Ltd. has received the Establishment Inspection Report (approval) from US Food and Drug Administration (USFDA) for its solid dosages manufacturing facility at Goa (Plant I), thereby confirming the closure of inspection in October, 2015.
AstraZeneca announced the top-line results of the SOCRATES trial, assessing the efficacy of Brilinta/Brilique (ticagrelor) 90mg tablets twice daily, when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient ischaemic attack (TIA). The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart attack) and death was not met. Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population but the trend did not reach statistical significance.
Janssen Research & Development, LLC announced it has entered into a clinical trial collaboration agreement with Genentech, a member of the Roche Group, to initiate two studies to determine the safety and tolerability of daratumumab (DARZALEX®), the first CD38-directed monoclonal antibody (mAb), in combination with atezolizumab, an investigational mAb designed to bind with a protein called programmed cell death-ligand 1 (PD-L1).
Sun Pharma and AstraZeneca Pharma India Limited announced a partnership for the distribution of dapagliflozin, an innovative Type 2 diabetes medicine, in India. Dapagliflozin is AstraZeneca India’s leading diabetes medicine.
Teva Pharmaceutical Industries Ltd., announced the launch of the generic equivalent to CAMPRAL®1 (acamprosate calcium) delayed-release tablets, 333 mg, in the United States. Acamprosate calcium delayed-release tablets are used for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the start of treatment.
Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat® Oral Solution, 10 mg/mL of UCB, Inc. Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Orange Book for Vimpat® Oral Solution, 10 mg/mL is scheduled to expire on March 17, 2022.
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC). This product is expected to be launched in Q1 FY16-17.
Albumedix announced that its albumin-based VELTIS® half-life extension technology is being used by CSL Behring in IDELVION®, a therapy recently authorized for the treatment of haemophilia B in the U.S. The application of Albumedix’s VELTIS technology in the drug delivers an extended half-life which will improve the lives of patients living with the condition by reducing the frequency of injections up to once every 14 days. The U.S. Centers for Disease Control and Prevention, report that the condition affects approximately one in 25,000 male births.
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