Legal/Regulatory

Panel votes against painkiller

Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Sunshine data highlights major billers

Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.

FDA won't review Afrezza until July

The regulator has put off the inhaled insulin's PDUFA date by three months.

Health reform spurs Rx growth, data show

Health reform spurs Rx growth, data show

The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.

Massachusetts bans Zohydro

The Bay State is saying no to the controversial prescription painkiller.

Waxman takes aim at Gilead over Sovaldi pricing

Waxman takes aim at Gilead over Sovaldi pricing

Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.

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