Tag:
Akorn
Latest Headlines
Latest Headlines
FDA announces several approvals
It's a busy Monday morning at the FDA as the agency announced several approvals. Here's the run-down:
The FDA has approved Pfizer and UCB's Toviaz extended-release tablets for the treatment of
Akorn wins FDA OK for topical eye anesthetic
Akorn announced that the FDA has approved its topical eye anesthetic Akten. And the developer says this is the first new FDA approval of an ocular anesthetic in 40 years. The company says it will
FDA halts eye wash and skin cream
The FDA came down on a group of companies that it says is marketing prescription medications without approval. The medications are topical skin creams and eyewashes. One is a skin cream containing a
Akorn anesthesia hits endpoints in Phase III
Akorn announced that its experimental anesthesia for eye surgeries, Akten, achieved both primary and secondary goals for statistically significant duration and ocular anesthesia benchmarks in a late-stage trial. The drug hit those end points in all three doses tested. Akorn executives say they intend to file an NDA on Akten in the second quarter of this year. Akorn says that the drug could be used in up to six million eye surgery procedures each year.
"This is a very important …
ALSO NOTED: Bronchitol gains fast track; Alimera garners $15.9M in second tranche; and much more...
> The FDA has granted fast-track status to Pharmaxis' Bronchitol as a therapy for cystic fibrosis. Investors applauded the news by driving up the value of Pharmaxis' stock about 20 percent on Friday. Pharmaxis has released positive mid-stage data on Bronchitol that demonstrates an improvement in lung function among the patients taking the drug. Pharmaxis plans a complete filing for Bronchitol by 2008. …
ALSO NOTED: Sankyo gains rights to diabetes drug; Ligand slashes interim CEO's salary; and much more...
> Sankyo has gained the exclusive global rights to develop, manufacture and market the new diabetes drug AJD101 and related compounds currently being developed by Ajinomoto. Release
> Ligand has slashed the salary and bonus plan for chairman and interim CEO Henry F. Blissenbach. Report
> …
ALSO NOTED: Akorn inks pact with Sofgen; new cancer start-up; and much more...
> Akorn and Sofgen Pharmaceuticals have inked a development and marketing pact for a new nausea drug. No financial terms were disclosed. Akorn said it expects to launch the drug in 2008. Report
> Affiliates of the European Molecular Biology Laboratory have formed a start-up, Elara Pharmaceuticals GmbH, aimed at developing anti-cancer therapies. …
ALSO NOTED: Takeda wins European approval; Merck wins Vioxx case; and much more...
> European regulators have given Takeda a green light to sell its diabetes drug Competact, a combination of Actos and metformin. Takeda started selling the drug combo in the U.S. last year. Actos directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin HCl acts primarily by reducing the amount of glucose produced by the liver. …
ALSO NOTED: Aphton files for bankruptcy; Akorn wins FDA OK; and much more...
> Philadelphia-based Aphton has filed for bankruptcy. The company is looking for offers to buy its assets. Report
> Akorn shares were on the rise after reporting FDA approval of an ANDA for Orphenadrine Citrate Injection. Report
> Wyeth has developed a new …
ALSO NOTED: NPS shares sink on FDA news; OncoGenex touts Phase I data; and much more...
> Investors turned thumbs down on shares of NPS Pharmaceuticals after the company reported that the FDA suggested a new clinical trial for PREOS, its therapy for post-menopausal, osteoporotic women. NPS believes it can use existing data to gain FDA approval. Report
> Canada's OncoGenex is touting results from a Phase I study of OGX-011 for cancer. …
