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Regulatory

Latest Headlines

Latest Headlines

How much would you pay for FDA special treatment?

Knight Therapeutics intends to find out how much drugmakers are willing to pay for the FDA's attention, putting its priority review voucher up for sale and shining a light on a program designed to encourage neglected disease R&D.

Syria broadens corruption accusations against GlaxoSmithKline

Last month, a whistleblower sent a letter to GlaxoSmithKline alleging "multiple corrupt and illegal practices" in the company's Syrian consumer health operation before it was shut down in 2012. Now it appears the problems may have extended to GSK's prescription drug business in Syria, which is still in operation.

Lenox MacLaren's grinding court battle with Medtronic will continue

A federal appeals court panel ruled that Lenox MacLaren Surgical has sufficient grounds to take Medtronic ($MDT) back to court over monopolization claims against the Minnesota-based medical device giant.

Pakistan indicts 76 customs officers in fake drug probe

The spotlight is back on Pakistani customs officials. With the force having previously been accused of accepting bribes to facilitate global counterfeiting operations, the Pakistani Federal Investigation Agency (FIA) has now indicted 76 customs officials as part of an investigation into the unlawful clearance of raw materials.

Recalls overseen by FDA soar in 2013, 2014

The number of recalls overseen by the FDA has surged over the past two years, Regulatory Focus reports.

J&J's diabetes combo wins FDA nod in a fast-crowding space

Johnson & Johnson's canagliflozin was the first to win FDA approval among a new class of diabetes therapies, and now it's the star of the first such combination therapy to pass agency muster, helping the drug stand out in an increasingly cluttered market.

New use for Bayer's Eylea in EU gives it more market power against Novartis' Lucentis

The European Commission has approved Bayer's Eylea (aflibercept) for the treatment of diabetic macular edema, the most common cause of vision loss among people with diabetes.

Sunshine Act payments database offline, rollout of initiative delayed

The Centers for Medicare & Medicaid Services took offline the payments database used by drug and device makers to disclose payments to doctors and teaching hospitals under the Sunshine Act, a part of the Affordable Care Act. CMS's action came in response to complaints that some doctors could see the payments made by other doctors.

Ipca joins list of Indian drugmakers accused of data falsification

When the FDA issued a Form 483 to Ipca Laboratories late last month, the Indian API manufacturer voluntarily suspended shipments to the U.S. Now the release of details about the 483 has shown why Ipca acted swiftly, with the company joining the list of Indian drugmakers accused of data falsification.

Four unanswered questions about the looming LDT regulations

The FDA described the contents of its proposed regulatory framework to Congress, but the details of its plan remain a mystery. Following the July 31 notification to Congress, the agency must wait at least 60 days before the release of its draft guidance on the topic.