Drug Industry Daily

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GlaxoSmithKline’s (GSK) investigational integrase inhibitor dolutegravir bested Gilead’s dominant HIV therapy Atripla in a late-stage trial, setting the drug up to compete with both Atripla and Gilead’s Quad, which is likely to get approval soon.

Eli Lilly’s schizophrenia candidate has failed in a Phase IIb trial but Lilly will continue with a second similar trial for the drug, it says.

An Ohio District Court ruling that the FDA can approve generics on a withdrawn brand product could spell bad news for brand drugmakers trying to ward off generic competition.

House Republicans, joined by a handful of Democrats, voted Wednesday to repeal the 2010 Affordable Care Act (ACA) — the 31st time the GOP has tried to take down or truncate the law, House Democrats said.

Exemplar Pharmaceuticals, a contract manufacturer of nasal sprays and other aerosol-based drugs, was handed a Form 483 for process control deficiencies tied to filling foul ups.