Pharma News

Eagle Pharmaceuticals, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its KANGIO™ (bivalirudin injection), 505(b)(2) New Drug Application for a ready-to-use (“RTU”), stable liquid intravenous formulation of 5 mg/mL bivalirudin in a 50-mL vial intended for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention (“PCI”) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (“HIT”) and thrombosis syndrome (“HITTS”), and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (“PTCA”).

PneumaCare Ltd announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device.Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen.

Researchers, including one of Indian-origin, have created a new molecule for prostate cancer that has shown great efficacy when tested in mice.The findings suggest that the new therapeutic might be a viable treatment for prostate cancer in humans too if it is found effective the future clinical trials.

The central government on Monday asked the Delhi High Court to vacate the interim stay on ban on some fixed dose combinations (FDC) medicines sold by pharma majors saying they "endanger patient safety".

The government on Monday launched Bedaquiline, an exclusive drug to tackle drug resistant TB cases in the country, among several other initiatives against the disease.

India's AYUSH Minister Sripad Yesso Naik on Sunday said the ministry will ink an agreement with the World Health Organization to popularise AYUSH system of medicine at a global level.

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Using antibiotics as the primary treatment for appendicitis does not increase the risk for complications at least in the first year and can significantly reduce the number of surgeries by 92 percent within the first month of diagnosis, finds a new study.

Women who take the birth control pill, which lessens and stabilises estrogen levels, are less likely to suffer serious knee injuries, suggests new research.

Researchers have found that ketamine, often abused as a recreational drug, has the potential to damage the bladder permanently and in worst cases it will lead to its removal.

The U.S. Food and Drug Administration has approved Bayer's KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which supported the approval of KOVALTRY for routine prophylaxis to reduce the frequency of bleeding episodes.