Novartis AG has proposed buying radiopharmaceuticals specialist Advanced Accelerator Applications SA (AAA) in a deal valuing the company at $3.9 billion. The transaction would add the EU-approved neuroendocrine tumor therapy Lutathera (lutetium [177Lu] oxodotreotide) to the company's portfolio, as well as a new technology platform that Novartis said has potential applications across a number of early oncology development programs. Read More
Serving as a cautionary tale for other drug companies, Insys Therapeutics Inc. is trying to right its ship after John Kapoor – its founder, former CEO and majority owner – was arrested last week on federal racketeering and fraud charges related to the off-label distribution of Subsys, a fentanyl spray approved for cancer patients with breakthrough pain. Read More
LONDON – Poxel SA has landed an all-embracing deal in Asia for Imeglimin with new partner Sumitomo Dainippon Pharma Co. Ltd. taking on the costs of conducting phase III development and commercializing the first-in-class, oral, type II diabetes treatment in Japan, China and 11 other countries. Under the terms of the agreement Poxel receives an upfront payment of $42 million, plus future development and sales-based milestones of $257 million. In addition, the Lyon, France-based company will be eligible for double-digit royalties on net sales. Read More
With her company "in the hunt for a series B" that could "unfold in the coming few months," X4 Pharmaceuticals Inc. CEO Paula Ragan told BioWorld that the latest data with X4P-001-IO, a C-X-C receptor type 4 (CXCR4) inhibitor, should give clear-cell renal cell carcinoma cancer patients new hope. Read More
PHILADELPHIA – Understanding the evolution of cancer and discovering the most specific, immunogenic targets are crucial prerequisites for the discovery of effective therapeutics, especially when tumors continually evade immune surveillance. Read More
PHILADELPHIA – A growing number of therapeutics, upon showing signs of early efficacy, are moving directly into seamless registration trials, replacing the age-old phase I, II and III continuum, speeding the time to approval and potentially reaching ill patients faster. Read More
Six quarters after it was co-founded, seeded and incubated by Atlas Venture, Kymera Therapeutics LLC debuted with a $30M series A round led by Atlas, with participation from Lilly Ventures and Amgen Ventures. In the words of Atlas partner Bruce Booth, co-founder and chairman, the Cambridge, Mass.-based firm is seeking to "drug the undruggable" by harnessing the power of targeted protein degradation to deliver therapeutic benefits. Read More
VBI Vaccines Inc., of Cambridge, Mass., said the underwriters of its underwritten public offering have exercised their option to purchase an additional 2.1 million shares. Read More
Bristol-Myers Squibb Co., of New York, reported that the EMA validated the type II variation application for Opdivo (nivolumab) to expand the current indications. The company seeks to include treating those with melanoma at high risk of disease recurrence after undergoing complete surgical resection. Read More
Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported post-hoc analysis of a phase III trial, as well as interim data from a long-term open-label extension study testing Latuda (lurasidone HCI) in children and adolescents with major depressive episodes associated with bipolar I disorder at a scientific meeting in Washington. Read More
OBI Pharma Inc., of Taipei, Taiwan, reported preclinical results from a study of OBI-3424 in a patient-derived xenograft model of T-cell acute lymphoblastic leukemia. OBI-3424, which targets aldo-keto reductase 1c3 and releases a DNA alkylating agent, produced objective responses in eight of nine mice with a significant reduction in bone marrow infiltration at day 28 in four of six evaluable mice. Read More
Medicinova Inc., of La Jolla, Calif., reported top-line results from the SPRINT-MS phase IIb trial of MN-166 (ibudilast) in patients with progressive multiple sclerosis. Read More
