Sector News

EU, U.S. and Japanese regulators join forces on antibiotic trials

June 13, 2017
Life sciences

The three drug regulators from Europe, the U.S. and Japan have come together in a data share program aimed at boosting antibiotic development.

Long held as one of the most overlooked but potentially devastating areas of development, antibiotic resistance and a lack of new meds in this area have increasingly become a major concern for governments.

Now, too, regulators are looking to help stimulate biopharmas in getting new meds in the clinic, something they are typically reluctant to do as they have little to no ROI, especially when compared the industry’s work on oncology and rare diseases.

To this end, the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Food and Drug Administration (FDA) have, according to a statement, “agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.”

Reps from across all three agencies sat down in a recent meeting in Vienna, Austria, to come up with new plans to help design studies to test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms.

The results showed a number of areas where data requirements in the three regions “could be streamlined,” according to the EMA.

All three will now be working to update their respective guidance documents. While the updates are ongoing, the agencies added that they will provide advice to individual biopharma companies.

By Ben Adams

Source: Fierce Biotech

comments closed

Related News

October 17, 2021

Colorcon acquires a majority share in Ideal Cures Pvt. Ltd., India

Life sciences

Ideal Cures will operate as a fully independent entity within Colorcon. Their business complements Colorcon’s position in the Indian pharmaceutical market with a strong presence in the domestic generic sector comprised of long-standing customer relationships sustained by innovative and customized solutions.

October 17, 2021

Barriers exist, but participation urgent in breast cancer clinical trials: report

Life sciences

Across four new breast cancer treatments approved by the FDA last year, 2% to 9% of patients in clinical trials for the drugs were Black Americans and 0% to 9% were Hispanic, according to a new report from Breastcancer.org.

October 17, 2021

Danish consortium acquires part of Jernbanebyen to create one of the world’s healthiest urban villages

Life sciences

The southern section of Jernbanebyen in central Copenhagen has a new owner. The Baneby Consortium, comprising NREP, Novo Holdings and Industriens Pension, has bought the land from Freja Ejendomme. The ambition is to create a green, partly car-free environment that will also be one of the healthiest in the world. 

Send this to a friend