Topic:

Regulatory

Latest Headlines

Latest Headlines

Australia, pharmacy body near agreement on budget subsidies for medicines

Australia's government reportedly has reached an agreement with the nation's pharmacists, nearing an end to a long-fought battle over a budget to cover subsidized medicines.

FDA advisory panel recommends sterilization after each use of duodenoscope

In a recommendation often followed by the U.S. FDA, an advisory panel asked that the agency require sterilization after each use of a duodenoscope, directly affecting at least three Japan makers.

India's top court orders temporary halt to Glenmark's production of Merck diabetes drugs

India's Supreme Court has called a temporary halt to Glenmark's production of generics of two Merck diabetes drugs but allowed continued sales of the local drugmaker's inventory through October or November.

AbbVie nabs FDA's orphan drug tag for Humira in HS

AbbVie is working to lessen its reliance on blockbuster Humira, which is already facing biosimilar competition in India. But it's also working to broaden the drug's label, and on that front, it got a boost from the FDA on Friday.

FDA creates openFDA developer challenge

The FDA has challenged developers to create algorithms that identify spikes in adverse event data automatically. The challenge is one of several posted by the regulator to encourage developers to use the data made available through the openFDA initiative and share their work on Reddit.

Wockhardt heart drug and Fujifilm, Mitsubishi Heavy devices in FDA recall notices

India-based Wockhardt's U.S. unit has ordered a national recall of 93,393 bottles of its Captopril heart and hypertension drug for being of the wrong thickness. The U.S. FDA also announced recalls of two Japan-made devices.

Japan's Daiichi Sankyo still on the hook for Ranbaxy bills?

Think Daiichi Sankyo set itself free of Ranbaxy Laboratories when it sold its stock in Sun Pharmaceuticals Industries? Think again. It remains possibly liable until 2022 for another $325 million as the Ranbaxy mess is cleaned up in the United States.

Regenerative push grows as Green Cross, POSCO Capital buy stake in U.S.-based Juventas

South Korea's Green Cross Holdings and POSCO Capital joined to buy a $7.5 million stake in U.S.-based Juventas Therapeutics, pushing a regenerative and biologics growth strategy that has seen recent deals in China and Russia.

Here's a lucrative idea: Turn a drug into an orphan med, reap 6 months extra exclusivity

Would-be makers of rare disease meds, rejoice: A 6-month exclusivity extension, proposed last year in Congress, has returned. The 21st Century Cures Act, now under consideration in the House of Representatives, once again includes a measure that would prolong competition-free marketing for some meds repurposed to treat rare diseases.

Troubled Wockhardt recalls blood pressure med in U.S.

India's Wockhardt may have two of its plants banned by the FDA from shipping to the U.S. but it still has product on the market and it says some of it needs to be recalled. The drugmaker is retrieving nearly 95,000 bottles of blood pressure tablets because they are out of spec for thickness.