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Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.

Painkiller maker Acura gets NIH grant

The $300,000 grant will go towards an abuse-deterrent technology.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, August 27

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.

Eli Lilly and BI's Jardiance hits shelves

Eli Lilly and BI's Jardiance hits shelves

The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.

Biologics have higher psoriatic arthritis adherence

A study of psoriatic arthritis patients found greater adherence among patients whose initial treatment was a biologic, compared to those who started with a non-biologic treatment.

IRS struggles with device tax

A Treasury report says the IRS is having trouble identifying who owes it money.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds

Five things for Pharma Marketers to know: Tuesday, August 26

Five things for Pharma Marketers to know: Tuesday, August 26

Merck and Pfizer pursue new pembrolizumab research, black box warnings are linked to fewer court visits, and the WHO says it needs $430M to fight Ebola.

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