The death of a woman in a study combining Advaxis Inc.'s lead immunotherapy candidate, axalimogene filolisbac (axal), and Astrazeneca plc's Imfinzi (durvalumab) to treat two types of carcinoma has triggered an FDA clinical hold, halting further dosing and enrollment in the study. Although the final cause of death is still under investigation, a spokesperson for Advaxis told BioWorld that initial reports point to respiratory failure.
Biogen Inc. has moved to buy a midstage neuropsychiatric drug from Pfizer Inc. for $75 million up front, up to $515 million in potential milestones, and tiered royalties in the low to midteens.
Less than three months after an $111 million December offering, Global Blood Therapeutics Inc. has launched an upsized $216 million public offering that will fund two crucial studies of its hemoglobin-modulating sickle cell candidate, voxelotor, including a pivotal trial, the first part of which is expected to read out before the end of June.
A new joint development program testing Eisai Co. Ltd.'s Lenvima (lenvatinib mesylate), an oral tyrosine kinase inhibitor, both alone and together with Merck & Co. Inc.'s anti-PD-1 therapy, Keytruda (pembrolizumab), across a dozen cancers could yield a multibillion-dollar payout for the Tokyo-based company while opening up new markets for both partners.
Novartis AG and Science 37 Inc., a virtual trials specialist long backed by dRx Capital, the drugmaker's joint investment company with Qualcomm Inc., have agreed to initiate up to 10 new clinical trials over the next three years.
Allena Pharmaceuticals Inc., a company negotiating a challenging path to develop an enzyme therapy for severe cases of the rare kidney disorder enteric hyperoxaluria, has started the first of two planned phase III trials in support of a potential biologic license application for the candidate, ALLN-177.
Twin failures in a pivotal phase III test of Dermira Inc.'s lead acne candidate, DRM-01 (olumacostat glasaretil), have left the company expecting to discontinue the drug's development more than six years after initially acquiring it through the purchase of Canada's Valocor Therapeutics Inc.
Planning for a global market withdrawal of the multiple sclerosis (MS) drug Zinbryta (daclizumab) is underway after reports of seven cases of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, triggered "an urgent review" by the EMA of the medicine.
Inscripta Inc., a company developing a full suite of gene editing tools that it hopes will democratize access to CRISPR-based research and development, has landed a $55.5 million series C funding that it said will help accelerate the development and commercialization of its platform. The financing follows a $23 million series B round in February 2017 and a $6 million series A round in February 2016.
Rubius Therapeutics Inc., a Cambridge, Mass.-based company developing red blood cell-based therapies, has completed an oversubscribed $100 million crossover financing.
