Pharma News

Asia's premier biopharmaceutical company, today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine.  This is a significant achievement for Biocon and its commercial partner, FUJIFILM Pharma Co. Ltd (FFP) as it endorses our endeavor to bring high quality, yet affordable, world class products to diabetes patients in Japan.

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

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.

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).

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.

Spending on programmes to control India’s three main communicable diseases malaria, tuberculosis and leprosy increased seven percent over five years while cases reported, taken together, increased 32 percent, according to an IndiaSpend analysis of government data.

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