The president of the Society for Cardiovascular Angiography and founder of the Children with Diabetes Foundation made their case for faster approvals at a July 17 AdvaMed hearing in Washington, DC.
The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.
Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.
Former FDA associate commissioner Peter J. Pitts added his voice to calls for the need to regulate animal drug compounders who put together illegal animal drug combos, accusing the FDA of doing nothing while animals are dying from the practice.
The FDA is continuing to push ahead with its openFDA initiative, with this week's rollout of an application programming interface (API) for recall data coming a month after its adverse event system went live. And the regulator plans to maintain the pace throughout the rest of the summer.
FDA Commissioner Margaret Hamburg has urged India's drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But efforts are being hampered by the exit of top officials.
China has abruptly changed course on its plans to prosecute private investigator Peter Humphrey and his wife Yu Yingzeng in a closed trial. Now Humphrey and Yu, who were arrested last summer as part of China's investigation of bribery charges involving GlaxoSmithKline, will be tried in a public proceeding.
InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.
Salix Pharmaceuticals picked up FDA approval for an orphan therapy, giving the company another revenue source as it plots a tax-saving move to Ireland.
Australia's dorsaVi just received 510(k) clearance from the FDA for its wearable biosensor for assessing movement in the spine and lower back.