Topic:

Regulatory

Latest Headlines

Latest Headlines

Roche nabs FDA OK for drug-resistant bacteria test

Roche got an FDA green light for its drug-resistant MRSA/SA test, chalking up another regulatory win and expanding the company's offerings on its cobas 4800 system.

Med tech chalks up solid year of new device approvals in 2014

Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process.

Samsung Bioepis advances its Enbrel biosimilar to an EMA review

The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.

France's Vygon puts boots on the ground in Singapore in Asia push

Boots on the ground underlies the expansion of Vygon, the specialist single-use medical devices group, into Singapore as Southeast Asia heads toward a regional economic pact and public and private hospitals mushroom in China and Indonesia.

Singapore's MerLion eyes partner for Phase III of Finafloxacin urinary infection trials

MerLion Pharmaceuticals said it is in sustained talks with potenial investors to take its successful Phase II trials of a urinary tract infection application for its finaloxacin antibiotic into Phase III as it moves into a competitive landscape for the fluoroquinolone class of antibiotics with approval for an ear infection treament by the U.S. FDA.

U.S., India make incremental IP headway during Obama visit

The summit meeting between President Barack Obama and India Prime Minister Narendra Modi resulted in no breakthroughs, such as on intellectual property, but did lead to about a dozen smaller agreements on various issues affecting the pharmaceutical industries.

FDA slaps down another Indian plant, adding to the industry's woes

The FDA has banned imports to the U.S. from another Indian drugmaker, adding to a substantial list of Indian companies whose drugs are now prohibited from being sold in the U.S.

FDA picks Duke's Califf as deputy chief, spurring succession rumors

FDA Commissioner Margaret Hamburg appointed a Duke cardiologist with ties to biopharma as the agency's deputy commissioner for medical products and tobacco, stoking speculation that she's lining up a successor.

Obesity player USGI raises $19.5M to complete U.S. pivotal trial, FDA submission

USGI Medical expects that its latest infusion of $19.5 million in cash and debt will enable it to complete a U.S. pivotal trial and to submit for FDA approval. The pivotal trial is currently in the follow-up phase; the financing will also enable a crossover study of patients who previously had received sham treatment in the trial.

FDA approves NPS Pharma's drug, burnishing Shire's $5.2B bet

NPS Pharma picked up FDA approval for the rare disease-treating Natpara, capping a lengthy review process and supporting Shire's decision to spend $5.2 billion on the company.