Regarding the stopped phase III glioblastoma trial with Rintega (rindopepimut), Celldex Therapeutics Inc. CEO Anthony Marucci said the firm is "well positioned to weather this temporary setback," and during the weeks ahead will ransack data from ACT IV for clues to why control arm patients did just as well as those on the drug. Read More
Abbvie Inc. agreed to pay Boehringer Ingelheim GmbH $595 million up front for the opportunity to co-develop and later sell BI 655066, a phase III anti-IL-23 monoclonal antibody for psoriasis that could eventually help the North Chicago-based company replace revenue losses that it will face as its largest product, Humira (adalimumab), begins to lose patent protection and incur competition from biosimilars. Read More
DUBLIN – DBV Technologies SA reported further progress from its patch-based peanut allergy therapy, Viaskin Peanut, at the American Academy of Allergy, Asthma and Immunology (AAAAI) congress in Los Angeles over the weekend, including 52-week data from a phase II trial conducted by the Consortium of Food Allergy Research (Cofar) and sponsored by the National Institute of Allergy and Infectious Disease. Read More
LONDON – The EMA has launched its latest scheme for accelerating the assessment of drugs, promising support tailored to the stage of development, ongoing access to its approvals committee and more help with plotting a route through to approval. Read More
Two years after inking an agreement to provide manufacturing services and clinical development assistance for GT038, the lead program at Genable Technologies Ltd., Spark Therapeutics Inc. is acquiring the Dublin-based company and its technology, now known as Rhonova. Read More
LONDON – The U.K.'s latest antibody company, Capella Biosciences Ltd., announced the closing of an £11 million (US$15.5 million) series A round, providing the funding to take the lead program through to phase IIa development by the end of 2018, and to complete preclinical development of four other products. Read More
The National Cancer Institute (NCI) is considering the development of a specimen bank for tube and ovary tissues from women undergoing surgery for benign conditions, risk reduction and early stage cancer. Collecting tube and ovary tissues containing clinically unsuspected precursors or early stage cancer has been challenging, especially from women who are not at increased genetic risk, according to an NCI notice to be published in Tuesday's Federal Register. Read More
VBI Vaccines Inc., of Cambridge, Mass., reported that manufacturing characterization data confirmed the purity and quality of its therapeutic vaccine candidate against glioblastoma multiforme (GBM). Read More
International Stem Cell Corp., of Carlsbad, Calif., said it is enrolling patients in the phase I trial if ISC-hpNSC, human parthenogenetic stem cell-derived neural stem cells, for the treatment of moderate to severe Parkinson's disease. Read More
ITM Isotopen Technologien Muenchen AG, of Garching, Germany, said it raised €20 million (US$22 million) in equity from Medtech Focused Family Office. ITM plans to use the funds to further develop its pipeline of targeted radionuclide therapies for therapeutic and diagnostic purposes. Read More
