Biolife4d, of Chicago, filed a $50 million IPO with the SEC under Regulation A+ rules, allowing individual investors help crowdfund its cardiac tissue regeneration and organ replacement process. The company is seeking to leverage advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant. Proceeds will be used to bolster working capital and fund key corporate initiatives, including hiring additional employees, procuring laboratory space and developing and licensing related technology. Read More
Vivus Inc., of Campbell, Calif., said the EMA granted orphan designation to tacrolimus, a calcineurin inhibitor, for the treatment of pulmonary arterial hypertension. Vivus plans to hold a pre-IND meeting with the FDA by the end of this year. Read More
U.S. Sen. Claire McCaskill (D-Mo.) released a report this week that shows how a drug company can manipulate an insurer's prior authorization requirements to boost sales of highly addictive opioid painkillers. Read More
"I'd hate for people to just assume, 'Oh, this is another cancer vaccine, therefore it's going to fail like so many others have failed in big clinical trials,'" Gritstone Oncology Inc. CEO Andrew Allen told BioWorld. Investors in the company's individualized, tumor-specific neoantigen strategy – able to sort the plethora of mutations in cancer for key ones – apparently made no such assumption, as they put a handsome $92.7 million into the series B round. Read More
Japanese researchers have identified a potent novel enhancer of neural stem cells (NSCs) and, hence, neurogenesis, with its prenatal administration having been shown to normalize both brain structure and function in mouse models of Down syndrome. Read More
The FDA user fee agreements were signed into law earlier this year despite the Trump administration's expressed preference for a fully user fee-funded agency, but the new user fee agreements are all new programs, and hence the agency's ability to spend those monies could be hampered by the use of a new three-month continuing resolution to fund government operations. Read More
Erring on the side of caution, the FDA may take its education efforts up a notch by requiring a new label warning for gadolinium-based contrast agents (GBCAs) commonly used in MRIs. Read More
Alnylam Pharmaceuticals Inc. suspended dosing in ongoing studies of fitusiran following the report of a fatal thrombotic event in a patient with hemophilia A without inhibitors that occurred during the therapy's phase II open-label extension (OLE) study. In July, the antithrombin-targeting RNAi therapy developed by Alnylam with partner Sanofi Genzyme, entered phase III territory with the launch of the three-part ATLAS program in hemophilia A and B. (See BioWorld, July 10, 2017.) Read More
Adaptimmune Therapeutics plc CEO James Noble said Glaxosmithkline plc (GSK) exercised its option "much earlier than they needed to," exclusively licensing rights to research, develop and commercialize Adaptimmune's NY-ESO SPEAR T-cell therapy program. Read More
Flexion Therapeutics Inc., of Burlington Mass., plans to present a pooled analysis of three phase II/III trials testing Zilretta (FX006), triamcinolone acetonide with a poly lactic-co-glycolic acid matrix, in 586 patients with osteoarthritis knee pain, at PAINWeek 2017 in Las Vegas. The findings showed that patients receiving an injection of Zilretta only used 0.86 daily tablets of rescue medication after 12 weeks, compared to 1.23 tablets for patients who received a saline-placebo injection. Read More
