With positive phase III data in hand and another study under way, Allergan plc with partner Gedeon Richter plc could be on their way to the first non-invasive, long-term option for women with uterine fibroids in the U.S., as the therapeutic space gains momentum. Read More
Nordic Nanovector ASA, of Oslo, Norway, said its investigational new drug application for a new phase I study of Betalutin in a second non-Hodgkin lymphoma indication is now open with the FDA. The company plans to investigate Betalutin in relapsed diffuse large B-cell lymphoma patients who are ineligible for stem cell transplant. Betalutin comprises a tumor-seeking anti-CD37 antibody conjugated to a low-intensity radionuclide (lutetium-177). Read More
VBI Vaccines Inc., of Cambridge, Mass., and Scivac Therapeutics Inc., of Rehovot, Israel, completed their merger, with VBI surviving as a wholly owned subsidiary of Scivac, which is changing its name to VBI Vaccines. Read More
Aptinyx Inc., an Evanston, Ill.-based spinout of Allergan plc-acquired Naurex Inc., has completed a $65 million series A financing that will carry the company's lead candidate through initial clinical proof of concept in a yet-to-be chosen CNS indication, while also funding discovery in its specialty, small-molecule modulators of the N-methyl-D-aspartate (NMDA) receptor. Read More
DUBLIN – AC Immune SA closed a CHF42.7 million (US$43.5 million) series E round, taking to CHF126.7 million the total investment it has raised since its inception in 2003 and taking the year's running total for private equity financing of European biopharma to $725 million. Read More
An experimental Zika diagnostic can rapidly and inexpensively detect Zika virus and determine its specific strain, opening up the possibility of much improved monitoring of the virus as it spreads through the Americas. Read More
LONDON – Two years after it was instituted, the U.K.'s Early Access to Medicines Scheme (EAMS) has succeeded in getting drugs to patients in advance of a formal marketing approval, but the aim that therapies arrive a year beforehand has not been met, and the fact the scheme is not funded makes it hard for small biotechs to participate. Read More
SHANGHAI – Several weeks ago a 21-year-old man named Wei Zexi, diagnosed with terminal synovial sarcoma, a rare form of cancer of the soft tissue, died. In the weeks since his death, public debate and outrage have hit upon various elements of his story, illustrating a volatile mix of distrust in online transparency, lax oversight of regulations governing cell treatments and commonplace greed. It is also giving immunotherapy, a promising form of cancer treatment, a bad reputation in China. Read More
The U.S. Federal Trade Commission approved a modified final order giving London-based Hikma Pharmaceuticals plc 20 more days to complete divestitures required for its $2 billion acquisition of Roxane Laboratories Inc. and Boehringer Ingelheim Roxane Inc. from Boehringer Ingelheim GmbH, of Ingelheim, Germany. Read More
Horizon Pharma plc, of Dublin, reported first quarter net sales of $204.7 million. In its orphan drug franchise, sales of urea cycle disorders drug Ravicti (glycerol phenylbutyrate) totaled $37.1 million, while Actimmune (interferon gamma-1b) reached sales of $25.5 million. Read More
