Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Ranbaxy faces U.S. racketeering suit for blocking launch of Roche, Novartis generics

Ranbaxy Laboratories and its new parent, Sun Pharmaceutical Industries, have been named in a U.S. district court suit accusing Ranbaxy of racketeering by blocking generics of two drugs, one each by Roche and Novartis.

Japan readies to sign new IP law it sees as win-win

Japan is due to sign off on an international intellectual property patent treaty that would require it to make some reforms in its own laws to make it easier for foreigners to apply. But its own exporting companies also stand to benefit.

Australia budget promises more digging on reimbursement, fees

An analysis of Australia's federal budget released this week showed that healthcare remains a sharp cost focus, though a bit less compared with the aggressive reforms proposed by the government last year.

Japan's MHLW sets Sovaldi price, hep C competition heats up

Gilead and its controversially expensive Sovaldi (sofosbuvir) hepatitis C drug is set to gain a major new market, Japan and its half-million people with the type the drug treats, though other major drugmakers are in or eyeing the same market.