Topic:

Regulatory

Latest Headlines

Latest Headlines

Boehringer grabs 'breakthrough,' plots pivotal trials for rival to AstraZeneca, Clovis

The FDA is putting an oral lung cancer drug from Boehringer Ingelheim on its inside track, promising to accelerate development of a new EGFR mutation-specific tyrosine kinase inhibitor that could quickly rival competing therapies from AstraZeneca and Clovis Oncology. And Boehringer is promising to hustle its way through a pivotal program with an eye to a near-term launch.

AB Science's Kinavet cancer drug for dogs loses FDA marketing authorization

France's AB Science suffered another setback in its years-long effort to gain traction for its lead compound, masitinib, which it has been developing for both veterinary and human medicine.

Shift in law helps local pharma groups in the Philippines

A law passed in 2008 that imposed price caps on brand-name drugs and imposed stiff fines on doctors who prescribed those drugs instead of cheaper generics has boosted the fortunes of domestic drugmakers in the Philippines.

U.S. lawmakers push FDA to increase China, India oversight

Two American congressmen have written to the U.S. Government Accountability Office asking the agency to investigate the U.S. Food and Drug Administration's inspection work for pharma manufacturing plants in India and China.

Sun Pharma warned again over Halol plant

India's Sun Pharmaceutical Industries got knocked again by the U.S. Food and Drug Administration over its plant in Halol in western India. The FDA sent another warning letter to highlight quality problems at the plant.

FDA hits tight timeline for start of precisionFDA open beta

FDA has hit the tight timeline it set itself for the start of the precisionFDA open beta program. The system went live this week, just as the regulator forecast when it started a closed beta program last month.

FDA CTO admits security shortcomings are holding back data sharing

The FDA's Chief Technology Officer has admitted the regulator's security isn't "mature enough" to support the sharing of data, Nextgov reports. The FDA has been assessing its capabilities as part of its push to use IT to improve the way it interacts with the public and the industry.

Hep C spending in Australia to top $1 billion

The government of Australia said it will spend $1 billion over 5 years to provide "groundbreaking" treatments for hepatitis C sufferers and that it hopes the work will eliminate the disease from down under within a generation, according to a report by ABC News.

Shkreli resigns from Turing Pharma, replaced by a longtime associate with Retrophin ties

Martin Shkreli, arrested yesterday on charges of securities fraud, has resigned from his CEO post at Turing Pharmaceuticals. In his stead, Turing appointed Chairman Ron Tilles, a longtime Shkreli associate who allegedly played a role in what the FBI called a "Ponzi-like" scheme at the pair's former company.

FDA approves fecal incontinence system via Humanitarian Exemption

The FDA approved Torax Medical's Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.