European Medicines Agency

The move would allow the European Medicines Agency to advise countries that wanted to use the US pharma giant's promising antiviral treatment ahead of formal approval across the EU.

Covid restrictions: Travelling to the US, or applying for a Green Card? Here's what you need to know

More travel updates: Up to $3,000 fine for not wearing a mask in the US, Australia may allow fully vaccinated travellers by Christmas, and Italy recognises all versions of AstraZeneca vaccine now.

EU regulator finds link between heart inflammation and mRNA COVID vaccines

Heart conditions myocarditis and pericarditis must be listed as possible side effects of the two mRNA vaccines, the safety committee of the European Medicines Agency (EMA) said on Friday.

Double COVID-19 jab seems to curb Delta variant: EMA

The upbeat assessment came as the World Health Organization warned that the variant first spotted in India could fuel a new wave of cases in Europe. The EMA's head of vaccine strategy, Marco Cavaleri, said the Amsterdam-based watchdog was "aware of concerns caused by the rapid spread of the Delta variant."

COVID-19 vaccine | UK approves single shot Johnson & Johnson vaccine

The government hopes the single-dose jab "will play an important role in the months to come", he added, as young people come forward for their vaccinations amid concern over the rise of the so-called Indian variant.

More data needed before COVID-19 vaccine booster decisions: EU regulators

Speaking at the first of planned regular fortnightly media briefings on the coronavirus pandemic, the European Medicines Agency's head of biological health threats and vaccines strategy Marco Cavaleri cautioned against making "premature" moves to deploy booster COVID-19 shots.

EMA opens review of China's Sinovac coronavirus jab

The EMA's human medicines committee's "decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies," the Amsterdam-based agency said.

AstraZeneca vaccine benefits increase with age: EMA

The European Medicines Agency (EMA) was presenting its findings after the European Commission asked it to look into concerns that prompted several countries to restrict its use to older people.

COVID-19 Update | Clear link between AstraZeneca vaccine and rare blood clots in brain: EMA official

The regulator has consistently said the benefits outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the AstraZeneca vaccine.

COVID-19 update | EU drug watchdog reaffirms no particular clot risk factor linked to AstraZeneca vaccine

Investigations by EMA and several national authorities in the EU continue, after initial probes deemed the vaccine safe for use following reports of a brain clotting ailment known as cerebral venous sinus thrombosis (CVST).

COVID-19 Vaccine update | EU pressures AstraZeneca to deliver vaccines as promised

AstraZeneca's announcement that it will deliver fewer vaccines to the EU early on has only increased pressure on the 27-nation bloc, especially since Pfizer-BioNTech, the first vaccine to get EU approval, failed last week to keep up its promised deliveries to the EU.

COVID-19 vaccine update | Europe's medicines regulator clears way for use of Pfizer in EU

European Union countries including Germany, France, Austria and Italy have said they plan to start vaccinations from December 27 as Europe tries to catch up with the United States and Britain, where inoculations began earlier this month.

Biocon pins hopes on emerging markets to deliver in FY19

The company said the growth in the coming quarters will be boosted by two key approvals it received for its long acting insulin glargine in Russia and cancer biosimilar Trastuzumab from Brazilian regulatory authorities.

EU rapid drug approval plan worries some national agencies

A push by the European Medicines Agency to speed up the approval of new drugs that show promise is running into resistance from some of the national agencies that will ultimately decide whether the medicines are worth buying.

EU regulator recommends suspending 300 drugs tested by Indian CRO firm

The European Medicines Agency (EMA) said that the suspension has been ordered for all drugs for which the bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.

EU recommends suspending hundreds of drugs tested by Micro Therapeutic Research Labs

The decision, announced by the European Medicines Agency (EMA) on its website, is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent year

Sun Pharma gets European Medicines Agency nod for Tobramycin

The approval for the product was received by company's wholly owned subsidiary firm from the European Medicines Agency, Sun Pharmaceutical Industries said in a filing to BSE.

Biocon well-poised to be a frontrunner in biosimilars: MD

Attributing the strong show in Q3FY17 to robust performance in biologics, Biocon Chairperson and MD Kiran Mazumdar-Shaw told CNBC-TV18 that Biocon is well poised to be front-runner in biosimilars. The acceptance of biosimilar Trastuzumab by the USFDA is a huge milestone for Mylan and Biocon, she said.

EMA accepts marketing application of Biocon, Mylan product

Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease, Biocon said in a regulatory filing.

Biosimilars to lead growth; generics to be a small part: Biocon

Biotechnology major Biocon reported 19.8 percent rise in revenue to Rs 796.2 crore year-on-year and margins grew to 25.2 percent from 21.2 percent in the second quarter of FY17. The company‘s standalones sale grew 17 percent in Q2.

EMA accepts Mylan, Biocon Trastuzumab biosimilar for review

This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe, global pharma major Mylan and Biocon said in a statement today.

Biosimilar insulin Glargine to make $100 m from FY18: Biocon

Biocon R&D team is working on the second phase of the development of oral insulin, and Kiran Mazumdar-Shaw, Chairman & MD, Biocon, hopes that it becomes an approved product in the next 2-3 years.

Alkem Labs falls 7% as German regulator accuses of data fudge

Alkem informed exchanges that the company will be submitting a suitable clarifications to the European Medicines Agency within the stipulated timelines to enable the Committee for Medicinal Products for Human Use (CHMP) take a balanced risk-benefit view with respect to these two products.

Will submit clarification to EMA on clinical study data:Alkem

Drug maker Alkem Laboratories today said it will submit 'suitable clarifications' to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.

EU bans 700 generic drugs for manipulation of trials by GVK

The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences.