je.st
news
Tag: astrazenecas
Premarket Biotech Digest: Harvoni's Label Expansion, AstraZeneca's...
2015-11-16 15:58:38| Biotech - Topix.net
Click this link to find out how much you can save.) Last week, Gilead Sciences announced that its Harvoni has been approved by the FDA in new indications. The FDA approved the blockbuster drug for expanded use in patients with genotype 4, 5 and 6 chronic HCV infections and in patients co-infected with HIV.
Tags: label
expansion
digest
biotech
FDA Ad Comm backs AstraZeneca's lesinurad for gout-associated hyperuricemia
2015-10-26 03:18:05| Biotech - Topix.net
The FDA's Arthritis Advisory Committee votes 10-4 recommending approval of AstraZeneca's lesinurad 200 mg tablets, in combination with a xanthine oxidase inhibitor , for the treatment of hyperuricemia associated with gout. The FDA's date is December 29. Lesinurad inhibits a protein called urate transporter which is responsible for most of the renal reabsorption of uric acid.
Tags: comm
backs
fda
astrazenecas
FDA: AstraZeneca's diabetes drug showed increased death risk
2015-04-11 13:08:02| Biotech - Topix.net
AstraZeneca PLC's type 2 diabetes drug Onglyza showed an increased risk of death in an analysis by U.S. regulators of a clinical trial on the heart effects of the treatment. Food and Drug Administration staff said their analysis of deaths in the trial suggested patients using Onglyza experienced "significant or near-significant" increases in death from all causes, not just heart problems.
Tags: death
increased
risk
drug
AstraZeneca's patent on asthma drug invalidated by US court
2015-02-16 06:34:56| Biotech - Topix.net
A U.S. federal judge ruled late on Friday that AstraZeneca PLC's patent on its Pulmicort Repsules treatment for asthma was invalid, opening up the market to a second, cheaper generic version. NEW YORK: A U.S. federal judge ruled late on Friday that AstraZeneca PLC's patent on its Pulmicort Repsules treatment for asthma was invalid, opening up the market to a second, cheaper generic version.
FDA approves Teva's generic version of AstraZeneca's Nexium
2015-01-27 00:13:34| Biotech - Topix.net
The U.S. Food and Drug Administration said it approved Teva Pharmaceutical Industries Ltd's generic version of AstraZeneca Plc's blockbuster heartburn drug Nexium, the agency's first such approval for the drug. The approval comes as generic drugmakers scramble to get their versions to the market and AstraZeneca is taken to court over so-called "pay-for-delay" settlements to delay the launch of generics to protect its drug's exclusivity.
Tags: version
generic
fda
approves