Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Neurostim dry eye startup backed by Kleiner Perkins, NEA readies for CE mark

Dry eye implant maker Oculeve is working toward a CE mark with its venture round from last spring. It's also in the process of recruiting for an initial U.S. clinical trial; the trial started in December and is expected to collect final data this month.

Ready to spar with Pfizer's meningitis B jab, Novartis gets FDA green light for Bexsero

Novartis has long pinned its hopes on meningitis B shot Bexsero to revitalize its lagging vaccines unit. Now, the company is celebrating the product's FDA approval, even as it prepares to hand off the jab to GlaxoSmithKline in a blockbuster asset swap.

Australia's TGA issues updated guidelines on drug supply chain releases

SINGAPORE-- Australia's Therapeutic Goods Administration (TGA) has updated guidance on the release of medicine products from the last manufacturer in the supply chain responsible for certifying the quality before the products are released onto the Australian market.

UPDATED: Rockwell's dialysis drug wins an FDA OK, despite lingering doubts

Rockwell Medical has overcome some hard questions and lingering doubts about its iron-replacement drug for dialysis patients, winning a long-sought FDA approval for Triferic and providing the biotech a green light to begin its marketing campaign.