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WHO validates Sinovac-CoronaVac Covid-19 vaccine for emergency use
WHO validated the Sinovac-CoronaVac Covid-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac
Redcliffe Lifetech introduces mucormycosis multiplex RT-PCR test to detect DNA of Mucorales species
Redcliffe Lifetech, a leading molecular diagnostics company, has introduced a non-invasive (serum/fluid) RT-PCR test to detect the DNA of Mucorales species. As a part of the diagnostic process, BAL samples will be used to directly detect the infection, with sample-to-result collection in less than 24 hours
Trivitron Healthcare launches advanced diagnostic solutions for HbA1c based on HPLC technology
Trivitron Healthcare has launched two new products "NANO H5 and NANO H110" for HbA1c- and Hb- variant detection. These products are High Performace Liquid Chromatography (HPLC) analysers for HbA1c detection in less than three minutes. These will be used for monitoring diabetes, thalassemia and haemoglobin variants, a company statement said
Haffkine Biopharma to produce 22.8 crore Covaxin doses per annum
Haffkine Biopharma, a Maharashtra state PSU proposed to produce 22.8 crore Covaxin doses per annum under technology transfer arrangement with Bharat Biotech. The production will take place at the Parel complex of the company in Mumbai
Glenmark Pharma launches generic Banzel tablets
Glenmark Pharmaceuticals has launched rufinamide tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for rufinamide tablets USP, 200 mg and 400 mg, with a paragraph IV certification and received final approval
UK MHRA approves one-dose Janssen Covid-19 vaccine
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted regulatory approval for the Janssen's Covid-19 vaccine. This is the fourth Covid-19 vaccine to be authorised by the UK's independent regulator and is the first to be approved for protection against Covid-19 with a single dose
Zydus Cadila receives US FDA approval for fluphenazine HCl tablets
Zydus Cadila has received final approval from US FDA to market fluphenazine hydrochloride tablets in the strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg (Prolixin tablets). This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia)
Novartis reported the first interpretable year one results of the phase III MERLIN study, a two-year study initiated in H2 2018, assessing the efficacy and safety of Beovu 6 mg versus aflibercept 2 mg given every four weeks following the loading phase in patients with wet age-related macular degeneration
IIL to produce drug substance for Covaxin from June
Indian Immunologicals Ltd (IIL) has announced its plans to begin the production of drug substance meant for COVID-19 vaccine Covaxin from June 15, and despatch the first batch to Bharat Biotech by July
Biohaven's Nurtec ODT receives US FDA approval for preventive treatment of migraine
Biohaven Pharmaceutical Holding Company Ltd, a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Nurtec ODT (rimegepant 75 mg) for the preventive treatment of migraine
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