Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

EMA wants more than 700 drugs suspended over GVK data scandal

The European Medicines Agency is recommending its member states stop selling drugs tied to improprieties at a GVK Biosciences facility in India.

Sanofi, Regeneron capture a shot at first-mover advantage in the PCSK9 market

Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.

EMA posts guide to help IT teams with its new pharmacovigilance database

The European Medicines Agency (EMA) has taken another step toward the creation of a database of all suspected adverse reactions reported within its jurisdiction. The EMA laid out the technical details of the system and how it will affect biopharma companies in a 100-page guide it published this week.

Analyst: FDA guidance will slow near-term adoption of wearables

Juniper Research analyst James Moar told Outsourcing-Pharma the placing of limits on the types of information that can have medical uses will slow uptake.

India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.

India's Biocon keeps many irons in the fire, Malaysian plan on schedule

India's Biocon held a busy earnings call on Jan. 23 that highlighted extensive spending on research and keeping several deals rolling, though tight-lipped on a possible license to make Gilead's chronic hepatitis C products and said it will sell a 10% to 15% stake in its research services arm Syngene through an initial public offering.

Celgene's Abraxane wins another OK in Europe

Celgene's Abaxane is one of those cancer fighters that has proven effective against many forms of cancer, and so the company has sought approvals far and wide, sometimes successfully and other times not. Now it has been recommended in Europe to treat lung cancer.

Novo hopes for European Saxenda launch this year after CHMP nod

Novo Nordisk's obesity therapy Saxenda is on a roll. Just over a month after snagging FDA approval, the drug scored a positive recommendation on Thursday from Europe's Committee for Medicinal Products for Human Use (CHMP). But by the time it gets to the regulatory finish line, the med may have some competition on the continent.