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Home » Newsletters » BioWorld

BioWorld

Oct. 24, 2016

View Archived Issues

Other news to note

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

In the clinic

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

Appointments and advancements

Lion Biotechnologies Inc., of New York, named Gregory T. Schiffman chief financial officer. Read More

Bench Press: BioWorld looks at translational medicine

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

Financings

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

South Korea's push to develop industry strong despite hiccups

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

VC funding in hand, Cstone files China IND for PD-L1 antibody

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

Neutrophil 'traps' help tumor cells metastasize

Researchers have identified "a new way that cancer cells are hijacking innate immune cells to promote metastasis," Mikala Egeblad told BioWorld Today. Read More

Access to EMA's new open data trial portal restricted to EU residents

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

Blackthorn secures $40M series A, seeks to pierce neurobehavioral field

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

Alkermes lucky threes open door for Cerecor; Street wave crest after last test in depressed

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

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