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
A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.
Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.
Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”
