Regulatory
The Alliance for Regenerative Medicine released a Therapeutic Developers’ Statement of Principles, setting forth a bioethical framework for the use of gene editing in therapeutic applications.
Adocia announced that the American Arbitration Association Tribunal governing Adocia’s arbitration claims against Eli Lilly & Company dismissed both parties’ claims in the second and final phase of the arbitration between Adocia and Lilly.
More Women May Benefit from Hereditary Cancer Risk Assessment and Genetic Testing
Motif Bio plc announced that the Company will be utilising NIAID’s1 suite of preclinical services through JMI Laboratories to evaluate iclaprim against Listeria monocytogenes, a Gram-positive bacteria causing food-borne, life-threatening infections.
Philadelphia, PA – Oncoceutics, Inc., announced that it has signed an exclusive, world-wide license for US patent #10,239,877, entitled “Pharmacophore for trail induction”, from The Scripps Research Institute, covering the composition of matter of ONC201 as well as other molecules in the imipridone family.
The regulatory agency expressed concern regarding the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides, Sarepta said.
WuXi Biologics (Cayman) Inc. announced its unaudited interim results for the six months ended June 30, 2019.
PharmaMar announced that the FDA agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of second-line SCLC.
Current rules set by the FDA allow companies to assess whether or not long-term follow-ups are required based on risk factors determined by the company.
Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration reevaluates its policies regarding opioid pain medications. Here’s a look.
PRESS RELEASES