The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important … Continue reading
Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this … Continue reading
As often discussed, market entry of biosimilars, in general, brings a new hope not just for many patients, but also to biosimilar drug manufacturers – planning to get marketing approvals of these drugs in the United States, the El Dorado … Continue reading
India continues to be one of the fastest growing pharmaceutical market of the world with its over 40 percent of the total pharmaceutical produce is exported around the world. Over half of the total exports constitute of formulations, and the … Continue reading
“In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened,” said the Secretary of the Department of Pharmaceuticals (DoP) – V K Subburaj at an event in New-Delhi on April … Continue reading
Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were … Continue reading
On November 06, 2015, the District Court of Delaware of the United States (US) passed a temporary restraining order barring Dr. Reddy’s Laboratories (DRL) from selling in the US its generic version of AstraZeneca’s blockbuster anti-ulcerant drug Nexium, with immediate … Continue reading
India has already achieved a staggering number In terms of quantity or volume of generic medicines that it produces not just for India, but for many developed, developing and poorer countries, across the world. For this reason, India is popularly … Continue reading