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    Glenmark Gets CDSCO panel nod for Phase IV CT of COPD drug

    New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol. However, this approval is subjected to […] More

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    Drug regulators cancel licences of drug manufacturing units over quality concerns

    New Delhi: The central and state drug regulatory bodies have banned the licences of numerous production facilities and revoked the product approvals of a few others, all on the grounds of quality concerns. Regulators investigated dozens of medication manufacturing plants in Himachal Pradesh, Uttarakhand, Haryana, Madhya Pradesh, and Maharashtra in response to allegations of the […] More

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    Study: drug may delay earliest symptoms of multiple sclerosis

    MS is a disease in which the body’s immune system attacks myelin, the fatty white substance that insulates and protects the nerves. Symptoms of MS may include fatigue, numbness, tingling or difficulty walking. A drug called teriflunomide may delay first symptoms for people whose magnetic resonance imaging (MRI) scans show signs of multiple sclerosis (MS) […] More

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    Amgen wins patent appeal on psoriasis drug Otzela against Zydus Pharma, Sandoz

    Thousand Oaks: Amgen has announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the District of New Jersey in a patent infringement lawsuit against Sandoz Inc. and Zydus Pharmaceuticals (USA), Inc. The decision affirms the permanent injunction entered by the district court prohibiting Sandoz and […] More

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    Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

    Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg). Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD). It is used to […] More

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    Novartis bid to revive multiple sclerosis drug Gilenya patent rebuffed by US Supreme Court

    Novartis bid to revive multiple sclerosis drug Gilenya patent rebuffed by US Supreme Court

    Washington: The U.S. Supreme Court on Monday declined to hear Novartis Pharmaceuticals Corp’s bid to revive a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China’s HEC Pharm Co Ltd. The justices turned away an appeal by Novartis of a lower court’s decision to cancel the patent, a […] More

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    GSK oral antibiotic drug to treat uncomplicated urinary tract infections meets main goals in late stage trials

    GSK oral antibiotic drug to treat uncomplicated urinary tract infections meets main goals in late stage trials

    London: British drugmaker GSK said on Saturday its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults and adolescents met the main goals in late-stage trials. The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for […] More

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    Indian standards of drug regulation should be on par with global standards, recommends NITI Aayog

    Indian standards of drug regulation should be on par with global standards, recommends NITI Aayog

    New Delhi: The NITI Aayog has recommended that Indian standards of drug regulation should be on par with global standards as well as aligned with the International Council for Harmonisation guidelines while promoting ease of doing business. The apex public policy think tank of the central government also suggested creating a separate authority to regulate […] More

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    Teva, Viatris win US appeal in patent fight over Parkinson’s drug

    Teva, Viatris win US appeal in patent fight over Parkinson's drug

    New Delhi: Belgian biopharmaceutical company UCB on Wednesday lost its U.S. court appeal seeking to revive a patent covering its Parkinson’s disease drug Neupro, clearing an obstacle for Teva’s Actavis Laboratories UT Inc and Viatris‘ Mylan Technologies Inc to sell generic versions of the drug. The U.S. Court of Appeals for the Federal Circuit agreed […] More

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