After suspending EUA request, Brazil now shelves import authorisation of CovaxinAccording to a statement issued by the National Health Surveillance Agency of Brazil, Anvisa its Collegiate Board on Tuesday took a decisio...
Brazil’s health regulator scraps Bharat Biotech’s EUA application of CovaxinThe move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent...
Brazil suspends clinical trials of Bharat Biotech's Covaxin“The Coordination of Clinical Research at Anvisa (Copec/GGMED) determined this Friday (23/7) the precautionary suspension of clinical studi...
European efforts to assess Russia’s Sputnik V vaccine stymied by data gapsSeparately, an assessment of Sputnik V by a French delegation of scientists in advance of the EMA review found that the vaccine developers ...
Decks cleared for import of Bharat Biotech's Covaxin, Russia's Sputnik V into BrazilNational Health Surveillance Agency of Brazil-Anvisa had earlier denied permission to import Covaxin after authorities found that the India...
Bharat Biotech submits new request to Brazilian regulator on GMP issues for CovaxinAccording to the National Health Surveillance Agency of Brazil Anvisa, Bharat Biotech made the request on May 25 and a day before the Minis...
Russia’s Gamaleya Center defends production facilities for Sputnik V jabIndia is one of the countries that has approved the Sputnik V vaccine, and the country is set to receive 50 million doses of the vaccine fr...
Brazilian regulator says Bharat Biotech's Covaxin manufacturing facility fails to meet CGMP standardsReacting to it, the city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 2...
Brazil gives final approval for AstraZeneca vaccine, sees domestic manufactureThe AstraZeneca vaccine is already being administered in Brazil, but is registered only for emergency use, and the doses have been imported...
Brazil drug agency questions 'transparency' of China vaccineThe Brazilian health regulator Anvisa on Monday accused China of using criteria that "are not transparent" to win emergency approval of its...
Halted Brazil trials of Chinese-made coronavirus vaccine cause surpriseThe potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo's st...
Brazil suspends Sinovac COVID-19 vaccine trial due to adverse eventThe health regulator, Anvisa, said on Monday the event took place on Oct. 29 but did not specify if the incident took place in Brazil or in...
AstraZeneca COVID-19 vaccine trial Brazil volunteer dies, trial to continueThe Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said the volunteer was Brazi...
Mylan-Biocon's breast cancer biosimilar gets ANVISA nodBiosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan.
Shasun Pharmaceuticals shares surge over 7% on completion of regulatory inspectionShares of Shasun Pharmaceuticals surged in trade today after the company announced that it successfully completed the USFDA inspection.
- Claris Lifesciences yet to get USFDA clearance
Claris Lifesciences said its consolidated net profit rose 9% for the first quarter of calendar year 2012 to Rs 21.7 crore.
- Marck Biosciences plans to enter Latin American market
Drug manufacturer Marck Biosciences is planning to enter the Latin American market and has got the nod from the Brazilian healthcare watchd...