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Home » Newsletters » BioWorld

BioWorld

June 20, 2017

View Archived Issues

Melinta Therapeutics's I.V., oral delafloxacin wins an FDA nod in skin infections

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

In the clinic

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

Other news to note

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

SCOTUS stops states expanding jurisdiction over drug, device firms

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

Rubraca hits PFS high notes in ARIEL3 across ovarian cancer populations

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

Angels sing similar chorus: Don't wing it, prepare first when making case for cash

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

Gamida Cell raises $40M for pivotal trial of cord stem cell expansion therapy

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

Stem cell treatment shows promise in severe spina bifida

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

Financings

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

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