Elevatebio Inc. CEO David Hallal told BioWorld that the five-member syndicate of investors behind his firm's whopper $150 million series A round "all have been on the other side of the table" in cell and gene therapy, and thus understand the potential value of building a portfolio of new companies in both areas by way of partnerships with academic researchers, medical centers and entrepreneurs. Read More
DUBLIN – Philogen SpA raised €62 million (US$70 million) in new equity investment to fund its internal pipeline of "immunocytokine" therapies and to bolster its cGMP production facilities in advance of a potential first product approval and commercial rollout. Read More
Stockholm-based Karolinska Development AB said that top-line data from portfolio company Modus Therapeutics AB's phase II study of sevuparin did not show a meaningful benefit in the management of acute vaso-occlusive crisis (VOC) in patients with sickle cell disease (SCD), sending company shares (Nasdaq Stockholm:KDEV) down 9.9% to SEK3.90 (US41 cents) Monday. Modus is now considering its options for further development of sevuparin in other indications where its multimodal action may have utility, said Viktor Drvota, CEO of Karolinska Development. Read More
Results from Minerva Neurosciences Inc.'s phase IIb study of seltorexant (MIN-202) announced on Monday bode well for further studies of the drug but couldn't bump the company stock out of the doldrums. Read More
When it comes to insulin, "biosimilars in the absence of interchangeability are of no benefit at all," Robert Ratner, a doctor and volunteer with the American Diabetes Association, told an FDA panel at a workshop Monday on the future of insulin biosimilars. Read More
SAN DIEGO – Almost exactly 10 years ago, on May 28, 2009, Steven Rosenberg was the first person to treat a patient with CAR T cells. That patient, a 48-year-old construction worker with metastatic non-Hodgkin lymphoma, is now 58 and remains in remission, as well as working full time. Two CAR T-cell therapies have been approved, and more than 1,000 patients have been treated with them. Read More
The U.S. FDA's breakthrough devices program is starting to accumulate a significant number of designations, with the latest being an as-yet unnamed diagnostic system from Grail Inc., of Menlo Park., Calif. The company said it has several large studies underway for its next-generation DNA sequencing (NGS) system intended to provide for the early detection of a large number of cancers. This makes the system of interest not just for the FDA, but also for payers keen on diagnosing cancers early, when they are considerably less expensive to treat. Read More
Arch Therapeutics Inc., of Framingham, Mass., said it completed a registered direct offering of approximately 8.6 million units, with each unit consisting of a share of the company's common stock, and a series H warrant to purchase one share of common stock for the combined purchase price of $0.325 per unit. The series H warrants have an exercise price of 40 cents per share and are exercisable for a period of five years. The gross proceeds from the offering are approximately $2.8 million. Read More
Briefing documents released ahead of Tuesday afternoon's meeting of the FDA's Oncologic Drugs Advisory Committee scheduled to review quizartinib tablets signaled a potential uphill battle for Daiichi Sankyo Co. Ltd., of Tokyo, which filed the NDA last year seeking approval for treating adults with relapsed or refractory acute myeloid leukemia (AML) that is FLT3-ITD positive, as detected by an FDA-approved test. Read More
4D Pharma plc, of Leeds, U.K., reported preclinical data on its single-strain live biotherapeutic candidates, MRx-0005 and MRx-0029, at the Neuro4D conference in Frankfurt, Germany. In a Parkinson's disease model, MRx-0005 had reduced neuroinflammation and MRx-0029 protected against the loss of dopaminergic neurons. Read More
