Newron Pharmaceuticals SpA., of Milan, Italy, and its partners, Milan-based Zambon SpA and U.S. Worldmeds LLC, of Louisville, Ky., reported that the FDA considers the September 2016 resubmission of their new drug application for the Parkinson's disease candidate Xadago (safinamide) by Newron to be a complete, class 2 response to the agency's March 28 complete response letter and has set a PDUFA date of March 21, 2017. Read More
Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, said the American Journal of Pharmacy Benefits published results from a real-world analysis comparing health care resource utilization data among nearly 4,000 recently diagnosed nonvalvular atrial fibrillation patients newly treated with direct thrombin inhibitor Pradaxa (dabigatran etexilate mesylate) or warfarin. Read More
N6-methyladenosine or m6A plays an important role in viral infection, according to two separate studies published back to back in the Oct. 20, 2016, issue of Cell Host & Microbe. Methylation is an important epigenetic tag on RNA, and m6A in particular is the most abundant methyl tag found on eukaryotic genomes and plays a role in many biological processes. Read More
Northwest Biotherapeutics Inc., of Bethesda, Md., said it would hold a registered direct offering with gross proceeds of about $5 million, which will be used in connection with upcoming phase II trials to test Dcvax-Direct for the potential treatment of inoperable solid tumor cancers. Read More
HONG KONG – Aspiring South Korean pharmaceutical companies had a reality check when Hanmi Pharmaceutical Co. Ltd. faced an abrupt end in its license deal with German pharma giant Boehringer Ingelheim GmbH. Read More
SHANGHAI – Starting out with a bang, newly formed biopharma Cstone Pharmaceuticals Co. Ltd. has filed an investigative new drug application with the Jiangsu FDA for its recombinant anti-PD-L1 monoclonal antibody (WBP3155). The firm now awaits approval from the regulators before it can study the PD-L1 antibody in Chinese patients. Read More
Researchers have identified "a new way that cancer cells are hijacking innate immune cells to promote metastasis," Mikala Egeblad told BioWorld Today. Read More
DUBLIN – After a protracted period of fiery debate, several lawsuits and no end of bureaucratic convolutions, the EMA finally made good on its promise of four years ago, to make clinical data openly and proactively available. But only those who can supply an address in the European Union will have access to the new site, according to the EMA's terms of use. Read More
Quietly launched three years ago, Blackthorn Therapeutics Inc. declared its intention to tackle neurobehavioral disorders in a big way, closing a $40 million series A led by founding investor Arch Venture Partners with support from Johnson & Johnson Innovation (JLABS)-JJDC Inc., Altitude Life Science Ventures, Mercury Fund, Alexandria Real Estate Equities and an undisclosed crossover fund. Read More
Cerecor Inc.'s chief medical officer (CMO), Ronald Marcus, acknowledging that upbeat phase III data from Alkermes plc in major depressive disorder (MDD) whetted appetites for his firm's pair of earlier-stage candidates, told BioWorld Today that tweaks in trial design can "dramatically improve your probability of success," as Alkermes showed and Cerecor may, too. Read More
