Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA approves next-gen Medtronic device to treat drug-refractory gastroparesis

The FDA has approved a second-generation Medtronic device to treat gastroparesis patients who are not able to control nausea and vomiting using drugs. The Enterra II System has been approved under a humanitarian device exemption, which is used by the agency to approve devices intended for a population of fewer than 4,000 people in the U.S.

Trans-Pacific Partnership push waits on cue from Obama's India visit

SINGAPORE-- India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.

Nevro gains on FDA pending approval with the resolution of manufacturing, labeling issues

Recent med tech IPO success story Nevro has garnered an approvable letter from the FDA for its Senza spinal cord stimulation system to treat chronic pain, according to the company. Nevro said it needs to address manufacturing and product labeling issues in order to attain FDA approval.

The Medicines Co.'s FDA-rejected cardio drug finds EU success

European regulators are recommending approval for The Medicines Company's cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.