Page 2 - Us Drug Approvals

US officials authorize emergency use of antibody-drug Actemra from Roche

US health officials have granted emergency use for another antibody-drug to help hospitalised patients with the most dangerous cases of Covid-19.

Cost, timeline: Facts about Pfizer-BioNTech's '90% effective' Covid vaccine

The companies said the vaccine was more than 90% effective and they have so far found no serious safety concerns, priming it for possible speedy regulatory approvals

FDA new drug approval run rate down in FY20 for most Indian pharma majors

According to analysts, companies are skeptical about entering crowded opportunities

Govt mulls faster drug approval process, regulatory system overhaul

The industry, which has been lobbying for faster approvals for quite some time now, says the current pandemic should help expedite the reforms process

Healthy trend: Indian pharma firms see rise in USFDA drug approvals in FY18

As the 2017-18 financial year enters the final quarter, a look at formulation approvals by the US Food and Drug Administration (FDA) in the year till date (YTD) period shows an improvement over last year. Deepak Malik, associate director at Edelweiss Securities, says 750-800 approvals had come in 2016-17. In 2017-18, around around 1,000 approvals for Abbreviated New Drug Applications (ANDAs) to FDA are likely to get approval. "So far, around 700 or so approvals have come for ANDAs, and the last quarter is expected to see another 300 or so," he said. Of the major companies that sell drugs in that country, Ahmedabad-headquartered Cadila Healthcare (Zydus) has received the largest number of approvals, at 76, so far in FY18. There were only 14 for the company in all of FY17. Aurobindo Pharma had done well in FY17, securing 73 approvals, followed by Actavis at 40. FY17 had seen Sun Pharmaceutical, this country's largest drug major by valuation, launch generic cancer drug Gleevec that had .