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SkyePharma
Latest Headlines
Latest Headlines
SkyePharma's inhaler takes step toward EMA approval
After years of delays and rejections, SkyePharma is finally getting some good news on Flutiform.
New year brings new delay for SkyePharma's Flutiform asthma inhaler
It's likely that SkyePharma isn't having a "Happy New Year" just yet. That's because the British drug delivery company now stands to face an additional delay of between 6 and 9 months in the approval
Pacira's FDA nod marks win for extended-release tech
Pacira Pharmaceuticals ( $PCRX ) has gotten a green light from the FDA to begin sales of its long-acting pain drug Exparel, making the treatment for post-surgical pain the third approved product that
SkyePharma hit with European delay on Flutiform app
SkyePharma's troubles persisted with its combo asthma product Flutiform, with European regulators unable to meet the drug-delivery specialist's approval timeline. Investors reacted to the news and
SkyePharma stumbles after AstraZeneca decision on asthma drug
SkyePharma's ( $SKP.L ) share price dropped March 7 on bad news from the company's partner, AstraZeneca ( $AZN ). AstraZeneca announced it would no longer make a hydrofluoroalkane (HFA) pressurized
AZ discontinues inhaler on 'technical issues'
AstraZeneca is giving up on a hard-to-manufacture inhaler. The company will stop making Pulmicort pMDI, a form of the asthma drug delivered through a pressurized inhaler, because of "manufacturing
Abbott bows out of Flutiform pact
Following the FDA's decision in June to require more clinical trials of SkyePharma's asthma drug Flutiform, partner Abbott has returned U.S. marketing rights to the British drugmaker. Under an
SkyePharma shares blitzed after FDA spurns Flutiform app
SkyePharma's long-troubled attempt to gain FDA approval for the asthma drug Flutiform officially hit a brick wall today, with the agency demanding what the developer termed significant new clinical
FDA rejects SkyePharma's NDA for Flutiform
The U.K.'s SkyePharma says the FDA has officially rebuffed its NDA for the asthma drug Flutiform, its lead drug prospect, spelling out "substantive" issues that need to be resolved ahead of an
In setback, FDA demands new work on SkyePharma's Flutiform
The FDA is throwing a hurdle in the way of SkyePharma's experimental asthma therapy Flutiform. As the U.K. developer had feared, the agency is demanding new clinical work on dosing before it will
