Series of Recall: Lupin, Sun pharma, Glenmark recall products in US Farhat Nasim21 Jan 2019 11:09 AM ISTThe ongoing voluntary nationwide recall has been classified as Class-I and Class-II recall.New Delhi: Indian drug majors Lupin, Sun Pharma and...
Shilpa Medicare gets USFDA approval for Imatinib Mesylate Tablets Farhat Nasim21 Jan 2019 9:30 AM ISTImatinib Mesylate is a generic equivalent of the reference-listed drug (RLD) Gleevec (100mg and 400mg), which is used in the treatment of leukaemia as...
Lilly Lartruvo fails key trial, will no longer be prescribed Farhat Nasim21 Jan 2019 9:15 AM ISTLartruvo will continue to be available to patients who appear to be benefiting from it as global regulators determine the next steps for the...
HUL expects to complete merger with GSK Consumer Healthcare in 2019 Medical Dialogues Bureau20 Jan 2019 9:45 AM IST"Once we get the court's approval, GSK Consumer India would merge into HUL. That process, we expected to take between 6 to 9 months because we require...
Teva Pharma receives US FDA approval for generic Sabril Garima20 Jan 2019 9:30 AM ISTTeva’s generic Sabril(vigabatrin) tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program.U.S: The U.S. Food...
Sandoz launches SYMJEPI epinephrine syringe in the US Medical Dialogues Bureau20 Jan 2019 9:15 AM ISTSYMJEPI will be rolled out through a phased launch, first in the institutional setting – an established channel where Sandoz Inc. has significant...
Valeo Pharma and Zambon announces the approval of Onstryv for treatment of Parkinsons disease Medical Dialogues Bureau20 Jan 2019 9:00 AM ISTThere is a growing need for new treatments to manage Parkinson’s Disease and Onstryv provides an important option for patients that require better...
Aurobindo arm to acquire 7 oncology drug from Spectrum for $300 million Medical Dialogues Bureau19 Jan 2019 9:45 AM ISTThe portfolio is expected to generate a revenue of around $100 million for the first 12 months after completion of the transaction for Aurobindo. The...
Dr Reddy's gets four observations from USFDA for Andhra plant Medical Dialogues Bureau19 Jan 2019 9:30 AM IST"The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....
Biomunex signs licensing agreement with Sanofi for development of antibodies Medical Dialogues Bureau19 Jan 2019 9:15 AM ISTUnder the terms of the agreement, Sanofi will have access to Biomunex proprietary technology to generate and optimize bi- and multi-specific antibody...
Immunomedics sacituzumab fails to win accelerated approval from the FDA Farhat Nasim19 Jan 2019 9:00 AM IST"The issues related to approvability in the CRL (complete response letter) were exclusively focused on Chemistry, Manufacturing and Control matters...
More trouble for Sun Pharma: Tumbles after fresh allegations by whistleblower Garima18 Jan 2019 1:52 PM ISTA whistleblower had approached SEBI late last year with a document alleging various irregularities by Sun Pharma, its promoter Dilip Shanghvi and...
