Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Taiwan drug regulator plans online database after drug recall spate

Taiwan's Ministry of Health and Welfare has had enough after 46 recalls the past two weeks from 32 different pharmaceutical companies. MHW is taking its case to the cloud.

Data in hand, Merck shoots for Keytruda approval for lung cancer

Hot on the heels of Bristol-Myers Squibb, Merck announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer.

FDA approves new device for surgical sealing during cranial procedures

The FDA approved HyperBranch Medical Technology's Adherus AutoSpray Dural Sealant to provide watertight closure during cranial procedures, according to a March 30 approval letter. Approval came via the stringent PMA pathway, which included a clinical trial, after which Adherus was deemed noninferior to Integra LifeSciences' surgical sealant system.

Second OTC drug recall within a week in Taiwan

Taiwan drug authorities issued their second drug recall within a week for use of lower-grade ingredients in over-the-counter drugs, this time targeting 23 products of 19 Taiwan companies.

AdvaMed supports Senate move to speed along free trade agreements with Asia, Europe

Democrats and Republicans just agreed to send "fast track" Trade Promotion Authority legislation to the Senate for a vote. Granting the president fast-track authority allows Congress to vote on free trade agreements on a yes, no basis; if passed, Congress would not have the authority to make amendments to the agreements.