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India Drug Regulator Allows Serum Insititute To Export Its Malaria Vaccine To UK
India's drug regulator has allowed the export of the first produced-in-India vaccine against malaria, developed by scientists at the University of Oxford and manufactured by Serum Institute to the UK.
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UK Approves An Updated Moderna Vaccine Which Targets Omicron Variant
The UK's drug regulator said Monday it has approved an updated Moderna vaccine against the coronavirus that targets the Omicron variant as well as the original form.
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UK Approves GlaxoSmithKline Drug, Appears Effective Against Omicron
British regulators on Thursday approved GlaxoSmithKline drug sotrovimab to treat those at high risk of developing severe Covid-19 symptoms, with the manufacturer saying it "retains activity" against the new Omicron variant.
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Serum Institute Seeks India Trial Of A Second Covid Vaccine
The Serum Institute of India, the world's biggest vaccine makers, has sought the drug regulator's permission to conduct a small domestic trial of the Novavax Inc COVID-19 vaccine that was found to be 89.3% effective in a UK trial, its CEO told Reuters on Friday.
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Oxford Vaccine Likely To Be First To Get Approval In India, Say Officials
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.
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Oxford-AstraZeneca Covid Vaccine Submitted For UK Approval
The University of Oxford and drug manufacturer AstraZeneca have applied to the UK health regulator for permission to roll out their Covid-19 vaccine, Health Minister Matt Hancock said Wednesday.
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UK Asks Regulator To Study AstraZeneca Vaccine
The British government said on Friday it has asked its independent medicines regulator to assess AstraZeneca's coronavirus vaccine as part of the formal approval process for the drug to be rolled out by the end of the year.
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UK Suspends Hydroxychloroquine Trial For COVID-19
Britain's drug regulator on Tuesday instructed scientists trialling the use of malaria drug hydroxychloroquine for the treatment or prevention of COVID-19 to suspend the recruitment of participants.
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Wockhardt Rises As UK Regulator Completes Inspection Of Key Plant
Shares of drug manufacturer Wockhardt rose as much as 4.46 per cent to hit intraday high of Rs 945 after the UK's drug regulator completed inspection of one of its key manufacturing unit without any critical observations.
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UK Drugs Regulator Halts Approvals For Indian Clinical Trials Firm
The UK's healthcare regulator has suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data.
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Alkem's Taloja Facility Cleared By UK Health Regulator
Drug firm Alkem Laboratories on Tuesday said the UK health regulator has given a clean chit to its Taloja facility in Maharashtra after going through the corrective and preventive steps submitted by the company.
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UK's Drug Regulator Issues Restricted GMP Certificate to Marksans Pharma
The company has received communication from UK's MHRA informing that they are issuing a 'Restricted GMP Certificate' allowing the company to continue manufacture and marketing of critical products for the UK markets, Marksans Pharma said in a BSE filing.
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Marksans Pharma's Goa Plant Under UK Regulator Scanner
Marksans Pharma on Wednesday said UK health regulator has issued "certain observations" regarding the company's Goa facility, after inspecting it in November.
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Wockhardt's Chikalthana Plant Gets GMP Certificate From UK Regulator
In a major relief to drug firm Wockhardt, its Chikalthana plant at Aurangabad in Maharashtra has received a good manufacturing practice (GMP) certificate from the UK health regulator post-inspection.
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Claris Lifesciences Gets Nod From UK Regulator for New Plant
Drug firm Claris Lifesciences has received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for its newly commissioned plant in Ahmedabad.
-
India Drug Regulator Allows Serum Insititute To Export Its Malaria Vaccine To UK
India's drug regulator has allowed the export of the first produced-in-India vaccine against malaria, developed by scientists at the University of Oxford and manufactured by Serum Institute to the UK.
-
UK Approves An Updated Moderna Vaccine Which Targets Omicron Variant
The UK's drug regulator said Monday it has approved an updated Moderna vaccine against the coronavirus that targets the Omicron variant as well as the original form.
-
UK Approves GlaxoSmithKline Drug, Appears Effective Against Omicron
British regulators on Thursday approved GlaxoSmithKline drug sotrovimab to treat those at high risk of developing severe Covid-19 symptoms, with the manufacturer saying it "retains activity" against the new Omicron variant.
-
Serum Institute Seeks India Trial Of A Second Covid Vaccine
The Serum Institute of India, the world's biggest vaccine makers, has sought the drug regulator's permission to conduct a small domestic trial of the Novavax Inc COVID-19 vaccine that was found to be 89.3% effective in a UK trial, its CEO told Reuters on Friday.
-
Oxford Vaccine Likely To Be First To Get Approval In India, Say Officials
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.
-
Oxford-AstraZeneca Covid Vaccine Submitted For UK Approval
The University of Oxford and drug manufacturer AstraZeneca have applied to the UK health regulator for permission to roll out their Covid-19 vaccine, Health Minister Matt Hancock said Wednesday.
-
UK Asks Regulator To Study AstraZeneca Vaccine
The British government said on Friday it has asked its independent medicines regulator to assess AstraZeneca's coronavirus vaccine as part of the formal approval process for the drug to be rolled out by the end of the year.
-
UK Suspends Hydroxychloroquine Trial For COVID-19
Britain's drug regulator on Tuesday instructed scientists trialling the use of malaria drug hydroxychloroquine for the treatment or prevention of COVID-19 to suspend the recruitment of participants.
-
Wockhardt Rises As UK Regulator Completes Inspection Of Key Plant
Shares of drug manufacturer Wockhardt rose as much as 4.46 per cent to hit intraday high of Rs 945 after the UK's drug regulator completed inspection of one of its key manufacturing unit without any critical observations.
-
UK Drugs Regulator Halts Approvals For Indian Clinical Trials Firm
The UK's healthcare regulator has suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data.
-
Alkem's Taloja Facility Cleared By UK Health Regulator
Drug firm Alkem Laboratories on Tuesday said the UK health regulator has given a clean chit to its Taloja facility in Maharashtra after going through the corrective and preventive steps submitted by the company.
-
UK's Drug Regulator Issues Restricted GMP Certificate to Marksans Pharma
The company has received communication from UK's MHRA informing that they are issuing a 'Restricted GMP Certificate' allowing the company to continue manufacture and marketing of critical products for the UK markets, Marksans Pharma said in a BSE filing.
-
Marksans Pharma's Goa Plant Under UK Regulator Scanner
Marksans Pharma on Wednesday said UK health regulator has issued "certain observations" regarding the company's Goa facility, after inspecting it in November.
-
Wockhardt's Chikalthana Plant Gets GMP Certificate From UK Regulator
In a major relief to drug firm Wockhardt, its Chikalthana plant at Aurangabad in Maharashtra has received a good manufacturing practice (GMP) certificate from the UK health regulator post-inspection.
-
Claris Lifesciences Gets Nod From UK Regulator for New Plant
Drug firm Claris Lifesciences has received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for its newly commissioned plant in Ahmedabad.
