EU reviews Johnson & Johnson COVID-19 vaccine for blood clots, expands AstraZeneca probeFour serious cases of rare blood clots with low platelets, one of which was fatal, have been reported after inoculation with J&J's vaccine ...
09 Apr, 2021, 05.13 PM IST
EU drug agency: No indication AstraZeneca shot caused clotsEmer Cooke said Tuesday that the agency is "firmly convinced" that the benefits of the AstraZeneca shot outweigh the risks, but an evaluati...
16 Mar, 2021, 07.11 PM IST
UK drugs regulator defends fast pace of the Pfizer-BioNTech vaccine approvalWith Britain transitioning out of the European Union, the UK regulator obtained an exemption from the EU's medicines agency, which has stre...
04 Dec, 2020, 04.46 PM IST
EU defends vaccine trials as UK gives first OKBritish ministers claimed Brexit has allowed them to adopt the Pfizer-BioNTech vaccine ahead of their neighbours, who are still awaiting a ...
02 Dec, 2020, 09.38 PM IST
EU warns of risks of COVID-19 vaccine race after UK approval of Pfizer shotThe European Medicines Agency which is in charge of approving COVID-19 vaccines for the EU, said its longer procedure to approve vaccines w...
02 Dec, 2020, 04.36 PM IST
India engaging with EU to sort out pharma issues: GovernmentIndia is engaging with EU to sort out regulatory issues and strengthen manufacturing practices following the 28-nation block's ban on aroun...
01 Mar, 2016, 02.54 PM IST
Germany suspends marketing of 54 drugs tested by GVK BiosciencesGermany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.
22 Aug, 2015, 11.22 AM IST
EU hoping for solution after FTA talks stalled over drug banEU defended its decision to ban around 700 generic drugs clinically tested by GVK Biosciences which had prompted India to defer the talks o...
07 Aug, 2015, 07.21 PM IST
EU bans 700 generic drugs for manipulation of trials by GVK BiosciencesMedicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...
25 Jul, 2015, 02.40 PM IST
India examines WTO option over EU drug suspension orderEMA's Committee for Medicinal Products for Human Use had looked at over 1,000 pharmaceutical forms and strengths of medicines studied at th...
15 Apr, 2015, 06.14 PM IST
German regulator hails European Medicine Agency's drugs suspension on GVK Bio dataThe German watchdog said it will take a decision shortly on whether to add more medicines to the list of banned drugs in the wake of the EM...
24 Jan, 2015, 01.03 PM IST
EU regulator recommends suspension of drugs over GVK Bio dataThe recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on be...
23 Jan, 2015, 10.06 PM IST
GVK Biosciences may redo studies doubted by European drug regulatorKantipudi also opined that some of the customers may even ask GVK Bio to pay damages in the event of drug recalls related to the studies co...
08 Dec, 2014, 08.28 PM IST
Four European Union countries suspend authorisation of 25 drugs studied at GVK BiosciencesEuropean Medicines Agency (EMA) said in a statement that it is reviewing findings of non-compliance with good clinical practise at the GVK ...
06 Dec, 2014, 07.44 PM IST
EU lifts drug export ban from Ranbaxy's Toansa plantThe assessment of the Toansa facility by EMA followed an inspection by the USFDA, which revealed areas of non-compliance with GMP at the si...
05 Jun, 2014, 08.23 PM IST
Exports to Europe from Ranbaxy's two plants to remain suspendedExports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as probes are continuing, European health regulator EMA sai...
09 Apr, 2014, 04.47 PM IST
EU, UK evaluating FDA findings on Ranbaxy's Toansa facilityDays after US FDA banned import of Ranbaxy products to America from its Toansa plant, health regulators of EU & UK have said they are evalu...
29 Jan, 2014, 05.05 PM IST