Melinta Therapeutics Inc. won approval from the FDA for Baxdela (delafloxacin), in adults for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible bacteria, and CEO Eugene Sun told BioWorld that the treatment will be made available as soon as possible. Read More
Genexine Inc., of Seongnam, South Korea, said the Ministry of Food and Drug Safety in Korea granted approval to initiate a phase Ib/II trial of GX-188E, an HPV therapeutic DNA vaccine, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) for the treatment of patients with HPV-induced advanced non-resectable cervical cancer. As part of its agreement with Merck, Genexine will run and fund the study, which will enroll up to 46 patients, with Merck providing the Keytruda used in the trial. The agreement includes the potential for further expansion to a phase III study. Read More
Txcell SA, of Valbonne, France, signed a strategic agreement appointing Lentigen Technology Inc. (LTI), of Gaithersburg, Md., a wholly owned subsidiary of Miltenyi Biotec GmbH, as its contract manufacturing organization (CMO) for the GMP production of its HLA A2 CAR lentiviral vector, which will be used to manufacture Txcell's CAR regulatory T cells targeting transplant rejection. Read More
No way, the U.S. Supreme Court told a California court that allowed out-of-state patients to sue a New York-based company under California law for injuries that occurred in 33 other states. Read More
Six months after Rubraca (rucaparib) was granted accelerated approval by the FDA to treat BRCA mutation-associated advanced ovarian cancer in patients previously treated with two or more chemotherapies, Clovis Oncology Inc. basked in the bigger win it predicted all along. Read More
SAN DIEGO – How to approach angel investors and whether startups ought to consider that route at all became two topics among many during a panel at the Redefining Early Stage Investments (RESI) conference, where Bernard Rudnick told attendees that "when you look at a company and you interview the CEO and he wants to grow something of substance over a lengthy period of time, it may not be an angel deal." Read More
DUBLIN – Gamida Cell Ltd. took in $40 million in a new private financing round to enable it to complete an ongoing phase III pivotal trial of its Nicord umbilical cord blood (UCB) expansion technology and to support preparations for its commercialization. Read More
A Japanese study has demonstrated a new management approach for fetuses with myelomeningocele (MMC), one of the most severe forms of spina bifida, employing 3-D skin reconstructed using induced pluripotent stem cells (iPSCs) derived from maternal amniotic fluid cells (AFCs). Read More
Kuros Biosciences AG, of Zurich, Switzerland, said it plans to offer up to 1.6 million shares, in the price range of CHF12.50 to CHF 15.50 per share. It will be conducted as an "at market" rights offering and an offering for shares, for which rights were not exercised, subject to certain limitations based on residency. Read More
