Topic:

Regulatory

Latest Headlines

Latest Headlines

Japan faces surge in healthcare costs as assessment system challenges loom

Japan can expect the cost of its medical care to increase by more than $33 billion over the next five years, a group of the nation's legislators said, calling it a threat to the government's budget-deficit plans.

India eyes bringing all drugs under NPPA price control system

A committee of India's parliament voted to bring all drugs sold in the country under price controls determined by the National Pharmaceutical Pricing. The NPPA's reach currently is limited to 509 drugs on the nation's list of essential drugs.

India seeks to step up oversight of drugs and devices starting with new department name

India's Department of Pharmaceuticals could soon get a new name to reflect all of its authority: Department of Pharmaceuticals and Medical Devices. The department is a unit of the Ministry of Chemicals and Fertilisers.

Chinese API maker cited with second FDA warning letter

The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.

Teva has to pay a record-setting $512M to settle pay-for-delay case. Who's next?

Teva Pharmaceutical Industries will fork over a record-breaking $512 million to wrap up claims that it paid generics makers to keep cheap copies of Provigil off the market. As a single settlement, it's big news for Teva. As a potential precedent in other pay-for-delay cases, it's a big deal for the rest of the pharma industry.

Teva, Barr in largest ever pay-for-delay settlement

Teva Pharmaceutical Industries and Barr Pharmaceuticals agreed to pay the largest settlement ever for a pharmaceutical "pay-for-delay" deal, $512 million. Fellow defendants Ranbaxy Laboratories and Mylan did not agree to the settlement.

Indian drug firms eye 'paper tiger' status at home, clinical opportunities abroad

Many of the largest pharmaceutical firms operating in India are contemplating becoming "paper tigers," existing there only on paper, with facilities moved to other countries. Regulatory delays get the blame.

China steps up decentralized drug industry regulation, market prices push

China authorities at the highest level are acting on legislation that would, among other things, decentralize drug industry regulation and free some price controls.

Shifting positions, Genervon now admits it has yet to file for ALS drug OK

The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.

'Doc fix' reform bill alters Medicare reimbursement for some oral-only meds

The elimination of the Medicare Sustained Growth Rate formula that threatened large Medicare reimbursement cuts to doctors on an annual basis is the most significant entitlement reform achieved by the new Congress.