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Eli Lilly's Alzheimer's drug donanemab approved in India, but neurologists flag cost, access barriersA new drug for Alzheimer's, donanemab, has arrived in India. It aims to slow the disease's progression by clearing brain plaques. While off...- EU drug regulator starts reviewing new coronavirus vaccineA rolling review is an accelerated way of assessing new drugs that allows European Medicine Agency experts to look at data from ongoing stu...
- EU Green Pass: SII applies to EMA for inclusion of Covishield in approved jabs listThe EMA, which is the agency of the European Union responsible for the evaluation and supervision of medicinal products, has approved only ...
- 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 ...
- 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...
- 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...
- 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 ...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 ...
- 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...
- 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...
- 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...
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