Editas Medicine Inc. and Bluerock Therapeutics LP have agreed to combine their respective genome editing and cell therapy technologies to discover, develop and manufacture a set of new off-the-shelf cell therapies targeting a broad array of indications. Editas will focus on oncology, including solid tumors and blood cancers, while Bluerock will work on neurology, cardiology and immunology indications. Potential products based on the approach are likely several years away. But Cindy Collins, interim CEO of Editas, said she is optimistic about their value. Read More
Dyne Therapeutics Inc., founded and seeded last year by Atlas Venture, has completed a $50 million series A along with Forbion and MPM Capital. Cambridge, Mass.-based Dyne will target therapies for patients suffering from myotonic dystrophy type 1 (DM1), a rare and inherited disorder with life-limiting complications that affects about 40,000 people in the U.S. alone. Read More
Nearly 50 bills dealing with some aspect of taming drug prices have been introduced so far this year in the U.S. Senate or House, but the six bills slated for markup Wednesday in the House Energy and Commerce Committee are likely to be the first of the lot to come up for a floor vote in either chamber. Read More
With the recent granting of the IND for trials to begin with CG-806 in the hands of Aptose Biosciences Inc., the rich and busy field of Bruton's tyrosine kinase (BTK) inhibitors may be set to further evolve. Read More
The swan song of FDA Commissioner Scott Gottlieb in the U.S. House Appropriations Committee came with the not-unexpected rueful farewells from both sides of the political aisle, but Gottlieb said one of his hopes for the agency is that it would push some compounding pharmacies operating under Section 503A of the Food, Drug and Cosmetic Act to register as 503B pharmacies. That would create more regulatory liability for those pharmacies, but Gottlieb said the FDA stands ready to assist any pharmacies with the tools and knowledge to make that transition. Read More
DUBLIN – By the end of the year, Adrenomed AG will have a pretty good idea whether its lead drug candidate, adrecizumab, is a runner in what is one of the most challenging of all indications. A phase II trial of the drug in patients with early septic shock has already passed an interim efficacy analysis in half of the 300 patients the study is enrolling. The company aims to complete the study this year – and it could then be in a position to contemplate applying for conditional marketing authorization in Europe. Read More
Cellgen Diagnostics Inc., of Irvine, Calif., and Genomic Testing Cooperative are collaborating to accelerate global development of companion tests for various oncology therapeutics, using GTC's next-generation sequencing, artificial intelligence-based biomarker discovery services and Cellgen's companion diagnostics platform. Financial terms were not disclosed. Read More
Geron Corp., of Menlo Park, Calif., appointed Dawn C. Bir and Elizabeth G. O'Farrell to its board. Bir will serve on its nominating and corporate governance committee and O'Farrell will serve on its audit committee. Read More
Santhera Pharmaceuticals AG, of Pratteln, Switzerland, said it entered a CHF15 million (US$15.04 million) credit line facility. It is also preparing for the issuance of up to 500,000 registered shares in a private placement managed by Mirabaud Securities (Geneva). In addition, Santhera is considering various options to monetize certain assets, which would provide for additional nondilutive funding. Read More
