Induced pluripotent stem cells (iPSCs) had more mutations when they were generated from older donors, and retained an epigenetic signature that was typical of aged cells, but both issues can be addressed. Read More
Flamel Technologies SA, of Lyon, France, said the first patient was dosed in its Rest-On phase III trial of FT218, a once-nightly formulation of sodium oxybate using the company's Micropump technology, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients. Read More
Merck & Co. Inc., of Kenilworth, N.J., said the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the first-line treatment of metastatic non-small-cell lung cancer in adults whose tumors have high PD-L1 expression (tumor proportion score of 50 percent or more) with no EGFR or ALK-positive tumor mutations. Read More
Antibe Therapeutics Inc., a Toronto-based company developing medicines for pain and inflammation, raised about $2.4 million with completion of the first tranche of a private placement. Read More
DUBLIN – The constellation of therapeutic development and tools companies that has grown out of the work of two CRISPR/Cas9 co-inventors, Emmanuelle Charpentier and Jennifer Doudna, has entered a global intellectual property agreement under which each signatory will recognize the other's IP rights and IP licensing deals they have entered. The companies involved will also cooperate on maintaining the patent estate and will co-ordinate their efforts on prosecuting, defending and enforcing their shared IP rights. Read More
DUBLIN – Evotec AG is banking $45 million up front and stands to earn up to $250 million more in per-program milestones from a drug discovery pact in neurodegenerative disease with Celgene Corp. Read More
Manufacturing issues. New trials. Miscommunications. Unclear expectations. So go company conversations following the often unexpected receipt of the much-dreaded complete response letter (CRL). Read More
HONG KONG – A new study at Duke-National University of Singapore Medical School (Duke-NUS) has identified a novel network of genes in the brain that, when disrupted, causes epilepsy, offering a new target for developing new antiepileptic drugs. Read More
SHANGHAI – Acea Biosciences Inc. presented efficacy, safety and tolerability data from its China phase I/II dose-escalation and expansion study of AC0010, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) at the World Conference on Lung Cancer (WCLC) 2016 in Vienna. Read More
The CDC said drug overdose deaths, including opioid overdose deaths, continued to increase in the U.S. last year. Of more than 52,000 people who died from a drug overdose, 33,091 (63.1 percent) involved a prescription or illicit opioid. Read More
