LONDON – An official investigation into the phase I trial of BIA 10-2474, in which one person died and four others suffered severe neurological complications, has found that administration of the endo-cannabinoid continued even though the volunteer who died had been taken to hospital. Read More

The composition of the microbiome influenced whether animals infected with the malaria parasite developed severe disease, researchers from the University of Louisville have reported in the Feb. 8, 2016, online version of the Proceedings of the National Academy of Sciences. Read More

The FDA's plan to get tough on opioid abuse is a good first step, but it isn't enough to get two Democrat senators to lift their holds on Robert Califf's nomination as the next FDA commissioner. Read More

The FDA placed a partial clinical hold on trials of CTI Biopharma Corp.'s lead candidate, pacritinib, citing fatal and life-threatening safety issues in patients treated with the drug vs. those provided best available therapy other than JAK inhibitors in the control arm of PERSIST-1, a phase III study of primary myelofibrosis (MF). The hold also impacts PERSIST-2, an ongoing study extending pacritinib treatment to patients with post-polycythemia vera MF and post-essential thrombocythemia MF. Read More

LONDON – The EMA has released new guidelines for companies developing drugs to treat Alzheimer's disease, reflecting increased understanding of disease pathology and the availability of new diagnostic tools and biomarkers. Read More

NEW YORK – Thousands of failed cancer trials and only a smattering of cancer drug approvals prompted the FDA to adopt draft guidance in 2010 to allow for adaptive study designs and, while a number of studies such as the public-private Lung-MAP study are ongoing, still more work needs to be done to improve the cost efficiency and success rate of oncology drug development. (See BioWorld Insight, July 28, 2014.) Read More

Diamedica Inc., of Minneapolis, said it is undertaking a non-brokered private placement of up to 4.68 million units at an issue of $0.16 per unit for gross proceeds of up to $750,000. Each unit will consist of one common share and one-half common share purchase warrant, with each warrant entitling the holder to acquire an additional common share at an exercise price of $0.25. Read More

Biogen Inc., of Cambridge, Mass., said it joined the Centre for Therapeutic Target Validation (CTTV), a public-private collaboration to improve the success rate for discovering new medicines. The CTTV fosters ongoing interactions between academic and industry members for the purpose of developing open, transformative approaches to selecting and validating novel targets in drug development. The company said its new membership follows the launch of the CTTV target validation platform, which helps researchers identify therapeutic targets for new medicines. Read More

Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, completed a preliminary analysis of its AURION (Aurinia early Urinary protein Reduction Predicts Response) study. Read More