The prospects for Remoxy, the twice-rejected, investigational, extended-release oral formulation of oxycodone, look bleak. Pfizer is pulling out of a partnership with Durect to commercialize the candidate, after reviewing the results of 5 clinical trials conducted in response to the FDA's second complete response letter, issued in 2011.
Pfizer is popping the confetti on earnings that beat analysts' expectations, bolstered by sales of cancer drugs and growth in emerging markets. But as for that much-talked about deal with AstraZeneca? No word for now.
Pfizer had hung on to high hopes for the drug Remoxy long after the tamper-resistant pain therapy endured its second rejection at the hands of the FDA in 2011. It even officially re-upped for the late-stage comeback try last fall, committing to see it through a third try. But today Pain Therapeutics says that the pharma giant has finally thrown in the towel, handing back rights to the long-delayed treatment and washing its hands of any further development work.
Pfizer execs can sigh with relief now that a federal court has backed the company's patents on kidney cancer drug Sutent. The med has become increasingly important to Pfizer as sales of off-patent drugs have faded, and so it was alarming to the U.S. drugmaker when generics maker Mylan challenged the patent in 2010 and filed to make its own copy.
Pfizer's $11 billion share buyback, announced late Thursday, gave investors something to focus on, rather than fretting about whether the company would renew its pursuit of AstraZeneca once the required cooling off period lapses in November. But some of them immediately started worrying about whether the buyback meant it was less likely Pfizer would do a big deal.
Will Pfizer come back at AstraZeneca? That's been the question of the summer, especially since the U.S. Treasury Department rolled out new rules for tax-inversion deals.
Pfizer's controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts.
The acquisition of dialysis company Gambro last September continues to fuel Baxter International's sales growth as it preps to spin off its biopharma division in 2015. But despite some stop-gap measures, it's not likely that Baxter will actually be able to meet the demand for its dialysis products until additional manufacturing capacity opens up in 2016.
FDA staffers aren't as impressed with new safety data on Chantix as Pfizer wants them to be. In briefing documents filed in advance of Thursday's advisory committee meeting, reviewers say the stop-smoking remedy should keep its black-box warning about potential psychiatric side effects.
Pfizer's pipeline could use a big approval, and it may have one coming in palbociclib.