European Medicines Agency Ema

The European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of Covishield, a COVID-19 vaccine.

The European Union's medicines watchdog said Wednesday two jabs by approved vaccine makers were "vital" to provide maximum protection against the highly-infectious coronavirus Delta variant, urging countries to speed up their inoculation drives.

Vaccine major Serum Institute of India (SII) is confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, the company's Chief Executive Officer Adar Poonawalla said today.

There is a link between AstraZeneca's COVID-19 vaccine and very rare blood clots in the brain but the possible causes are still unknown, a senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday.

Why have several countries in Europe suspended use of the AstraZeneca vaccine, citing fears of blood clots, even as the European Union's top regulator insists there is no evidence of a link and calls for the inoculations to continue?

The coronavirus vaccine developed by AstraZeneca and Oxford University, which was approved Wednesday in Britain, is unlikely to get a green light in the European Union in the next month, according to the European Medicines Agency (EMA).

Russia and China have not requested authorisation from the European Medicines Agency (EMA) for their COVID-19 vaccines and the agency is not under political pressure to speed up vaccine approvals, the regulator's chief said in remarks published on Wednesday.

The European Medicines Agency (EMA) on Tuesday said it would hold an extraordinary meeting on December 29 "at the latest" to consider emergency approval for a Covid-19 vaccine developed by Germany's BioNTech and US giant Pfizer.

Biocon's Malaysia facility was inspected by the European Medicines Agency (EMA) in April 2017.

US drug maker Pfizer Inc's breast cancer drug, Ibrance, should be given marketing approval, an advisory committee at the European Medicines Agency recommended.

Mylan and Biocon anticipate that this may be the first marketing authorisation application (MAA) for a Trastuzumab biosimilar accepted by the EMA for review, it added.

Alkem was found to have engaged in "intentional misrepresentation" of data and duplicated results of electrocardiogram (ECG) readings of patients in trials, the German regulator said in a notice sent to the EMA on March 24, 2016.

The Mumbai-based firm along with many other companies had received communication from EMA for suspension of Trimetazidine MR 35 mg and Cefpodoxime 200 mg tablets in January 2015.

The European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of Covishield, a COVID-19 vaccine.

The European Union's medicines watchdog said Wednesday two jabs by approved vaccine makers were "vital" to provide maximum protection against the highly-infectious coronavirus Delta variant, urging countries to speed up their inoculation drives.

Vaccine major Serum Institute of India (SII) is confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, the company's Chief Executive Officer Adar Poonawalla said today.

There is a link between AstraZeneca's COVID-19 vaccine and very rare blood clots in the brain but the possible causes are still unknown, a senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday.

Why have several countries in Europe suspended use of the AstraZeneca vaccine, citing fears of blood clots, even as the European Union's top regulator insists there is no evidence of a link and calls for the inoculations to continue?

The coronavirus vaccine developed by AstraZeneca and Oxford University, which was approved Wednesday in Britain, is unlikely to get a green light in the European Union in the next month, according to the European Medicines Agency (EMA).

Russia and China have not requested authorisation from the European Medicines Agency (EMA) for their COVID-19 vaccines and the agency is not under political pressure to speed up vaccine approvals, the regulator's chief said in remarks published on Wednesday.

The European Medicines Agency (EMA) on Tuesday said it would hold an extraordinary meeting on December 29 "at the latest" to consider emergency approval for a Covid-19 vaccine developed by Germany's BioNTech and US giant Pfizer.

Biocon's Malaysia facility was inspected by the European Medicines Agency (EMA) in April 2017.

US drug maker Pfizer Inc's breast cancer drug, Ibrance, should be given marketing approval, an advisory committee at the European Medicines Agency recommended.

Mylan and Biocon anticipate that this may be the first marketing authorisation application (MAA) for a Trastuzumab biosimilar accepted by the EMA for review, it added.

Alkem was found to have engaged in "intentional misrepresentation" of data and duplicated results of electrocardiogram (ECG) readings of patients in trials, the German regulator said in a notice sent to the EMA on March 24, 2016.

The Mumbai-based firm along with many other companies had received communication from EMA for suspension of Trimetazidine MR 35 mg and Cefpodoxime 200 mg tablets in January 2015.