CEO Glenn Sblendorio told BioWorld that, except for a phase I/II trial in Von Hippel-Lindau syndrome that was prompted by "a request we had a while back" from the National Eye Institute, the latest failure with Fovista (pegpleranib) "closes the book" on the anti-platelet-derived growth factor (PDGF) therapy, and Ophthotech Corp. will focus instead on complement 5 inhibitor Zimura (avacincaptad pegol) in eye diseases along with shopping for new assets.

LONDON – Cellact Pharma GmbH has sealed a $250 million plus royalties deal with Mundipharma International Ltd. for its phase II anticancer prodrug, Cap7.1.

The odds of getting a complete response letter (CRL) from the FDA citing manufacturing problems are about as good these days as getting a closeout letter stating that a company has adequately resolved all the manufacturing concerns raised in a warning letter.

The FDA has removed a clinical hold on Cel-Sci Corp.'s primary clinical program, a global phase III test of its immunotherapy candidate Multikine (leukocyte interleukin injection) in advanced primary head and neck cancer. The 928-patient study had been in limbo ever since the agency expressed concerns about matters of risk communication and trial design in late 2016.

The FDA issued a guide Friday that takes doctors step-by-step through the process of requesting expanded access to an investigational drug for a single patient in a nonemergency situation.

Fortress Biotech Inc., of New York, said it launched a new subsidiary, Aevitas Therapeutics Inc. The new company's goal is to develop gene therapy approaches for complement-mediated diseases using a technology that has been licensed from a leading university.

Aytu Bioscience Inc., of Englewood, Colo., said it received subscriptions of approximately $11.5 million in a private placement of equity units. The issued class A units consist of one share of common stock and a warrant to purchase 1.5 shares of common stock at $0.15 per unit; class B units consist of one share of series A preferred stock and warrants to purchase 1.5 shares of common stock for each share of common stock into which the series A preferred stock is convertible and were sold at $1,000 per unit to those who, together with their affiliates and certain related parties, would beneficially own more than 9.99 percent of the company's outstanding common stock following the offering. The exercise price of the warrants is $0.18 per share, subject to adjustment. Proceeds are expected to be used for sales and marketing expenses to further advance the commercialization of Natesto (testosterone), a nasal gel approved as a replacement therapy for men diagnosed with hypogonadism, and for working capital and general corporate purposes.

That effort by Regeneron Pharmaceuticals Inc. to get a toehold in the potentially lucrative respiratory syncytial virus (RSV) market with a candidate that had FDA fast track status? It's kaput, after the Tarrytown, N.Y.-based company said the phase III study of suptavumab (previously REGN-2222) missed the primary endpoint of preventing medically attended RSV infections in infants.

Qu Biologics Inc., of Vancouver, British Columbia, reported positive feedback from the FDA in response to Qu's first pre-IND meeting package submission.

New flexible belt- and fiber-shaped electrodes in sodium ion-containing batteries (SIBs) with aqueous electrolytes, which have promising potential applications as safe power sources for wearable or implantable medical devices, have been developed by Chinese researchers.