Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA reviewers raise red flags for Amgen cancer vaccine ahead of AdComm

Wednesday's a big day for Amgen, whose dual-acting cancer vaccine/viral therapy is coming up for review by an FDA panel of experts.

UPDATED: FDA review challenges Amgen on a questionable T-Vec study

An internal FDA review of Amgen's study of its cancer-killing virus talimogene laherparepvec (T-Vec), released Monday morning, raises red flags for this drug, presenting some thorny questions for the company's regulatory team to answer.

Japan MHLW panel names 11 unapproved/off-label drugs for fast-track reviews

A special panel at Japan's Ministry of Health, Labour and Welfare designated 11 unapproved and off-label drugs as applicable to unmet medical needs, putting them in line for fast-track review in Japan by the Pharmaceuticals and Medical Devices Agency.

India's Stempeutics says China IP office grants process patent on stem cell ischemia candidate

Cipla-backed Stempeutics, an Indian advanced clinical stage biotech company based in Bangalore, said it is the first company in the world to be granted a process patent by the State Intellectual Property Office of China for a stem cell drug treatment based on pooling technology that could potentially be used in the treatment of critical limb ischemia.

Sumitomo Dainippon says Latuda for schizophrenia in Japan misses PhIII aims

Sumitomo Dainippon Pharma said the results of Phase III clinical trials for its Latuda schizophrenia treatment in Japan disappointed and it would evaluate the next steps forward, but noted that a separate clinical trial on a bipolar disorder candidate would proceed.

China's artemisinin-based malaria therapy gets a big hand

China got international plaudits on the recent World Malaria Day not so much for handling its own cases of the disease but for providing the world with what one expert called "the best" treatment, artemisinin-based combination therapies.

China hopes to learn ins and outs of regulation from U.S. FDA

China's FDA is laying plans to work directly with its U.S. counterpart to learn the secrets of drug and medical-device regulation and bring China drug-making and other regulated industries up to international standards.

China FDA wants to end use of intermediaries on drug approval process

China's cabinet, the State Council, has circulated a proposal to tighten up the practice of using insiders and others as intermediaries to get access to drug and other regulators and their approval processes.

BMS scores positive EMA opinion for Opdivo in advanced melanoma patients

Bristol-Myers Squibb's immuno-oncology med Opdivo is racking up positive data and earning regulatory gold stars in record time. Now, the drug is poised to gain even more ground after the European Medicines Agency gave Opdivo its marketing thumbs-up as a first-line treatment for advanced melanoma--an approval it has yet to earn in the U.S.--and in previously treated patients.

Western firms form band of brothers, but welcome others, in Asian medical device association

Major Western device and medical technology firms launched Asia Pacific Medical Technology Association, or APACMed, pledging the association would unite a fragmented effort to work with regulators across a region that is both lucrative and frustrating on issues ranging from import rules to public tender guidelines.