Drug makers Glenmark, Alembic Pharmaceuticals and Sun Pharma are recalling products in the US due to manufacturing issues, according to the US health regulator. Mumbai-based Glenmark is recalling two products in the market, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, is recalling Carvedilol tablets, used to treat heart failure, hypertension, and heart attack, in multiple strengths. The New Jersey-based firm is recalling 55,560 units of the affected lot due to "presence of a nitrosamine, N-Nitroso Carvedilol impurity above the current acceptable intake level," the USFDA stated. The company is also recalling 17,496 bottles of Carvedilol tablets as "results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm," it added. Glenmark initiated the Class II recall in August this year. USFDA said the company is also recalling 2
Gelnmark's India revenue stood at ₹1,239.9 crore, up 3.7 per cent Y-o-Y from ₹1,196.2 crore, driven by growth in cardiac, respiratory, and dermatology segments despite weakness in diabetes portfolio
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Glenmark's $700 million deal with AbbVie for ISB-2001 could unlock significant upside, though analysts note the potential is already priced in, with stock surging post-announcement
At 09:30 AM, Glenmark Pharma shares were trading at ₹2,094.40, up by 10 per cent on the National Stock Exchange.
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IGI Therapeutics, a wholly owned subsidiary of Glenmark, has licensed its cancer and autoimmune drug ISB 2001 to AbbVie for an upfront payment of $700 million
Under the agreement, AbbVie will get exclusive rights to develop, manufacture and commercialize ISB 2001 in North America, Europe, Japan and Greater China
Since June 25, in 12 trading days, the stock has surged 12% after the company launched the lung cancer treatment drug Tevimbra in India, following the approval by the CDSCO.
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Glenmark Pharmaceuticals share price gained in trade after the company announced the launch of Tevimbra (tislelizumab) in India, following approval by the Central Drugs Standard Control Organisation.
Glenmark Pharmaceuticals on Tuesday said it has launched the lung cancer treatment drug Tevimbra in India, following the approval by the Central Drugs Standard Control Organisation. Tevimbra is developed by BeiGene (now BeOne Medicines), a global oncology leader. This launch marks Glenmark's first foray into immune-oncology in India and is a major milestone in expanding its innovative oncology portfolio, the company said in a regulatory filing. "At a time when the cancer burden is rising sharply, we are proud to enable oncologists and patients to access Tevimbra, a therapy with proven efficacy and safety outcomes, strong science, and meaningful impact," Glenmark Pharmaceuticals President and Business Head India Formulations Alok Malik said. Immuno-oncology offers a promising future for the treatment of various types of advanced cancers, which are difficult to treat, he said, adding that "Our foray in this area marks a significant inflection point in our journey to build a world-clas
Glenmark Pharma shares gained 2 per cent in trade as company announced the upcoming launch of zanubrutinib, under the brand name Brukinsa in India
Glenmark will introduce Brukinsa, a BTK inhibitor developed by BeOne Medicines, in India after DCGI approval to treat five B-cell blood cancers with proven safety and efficacy
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In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies
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The US President has predicted that pharmaceutical prices could drop 30 per cent to 80 per cent in America