Clarus Ventures, which has been shifting iteratively from traditional venture investing to structured financings, completed its transformation with the close of Clarus IV LP, which topped its $750 million goal by attracting $910 million in assets. The size of the fund pushed the firm, which has offices in Cambridge, Mass., and South San Francisco, beyond $2.6 billion in assets invested across 50 private and public life sciences companies.
Two years after its formation by Ionis Pharmaceuticals Inc., Akcea Therapeutics Inc. planted its own flag on the public markets, opening Friday as AKCA on Nasdaq. The Cambridge, Mass.-based company raised $125 million in its IPO by offering 15.625 million common shares – up from its expected offering of 9.62 million shares – at $8, below its intended range of $12 to $14.
Mayo Clinic is expanding its clinical territory into drug discovery and development for the first time by partnering with artificial intelligence (AI) firm Nference to create Qrativ. Virtual for now, the startup plans to forge collaborations with third parties and to in-license drug candidates – either way, applying a data-driven approach that combines a range of AI techniques.
The decision by Johnson & Johnson (J&J) to use a priority review voucher for the submission of the biologics license application for guselkumab apparently paid off. The drug, branded Tremfya, gained FDA approval late Thursday, four months prior to its estimated PDUFA date of Nov. 17.
As promised last year during its merger with Scivac Therapeutics Inc., VBI Vaccines Inc. is seeking to move Sci-B-Vac, a third-generation hepatitis B virus (HBV) vaccine licensed in Israel and 14 other countries, onto the world stage. After gathering input from the FDA, EMA and Health Canada, the Cambridge, Mass.-based company is preparing to conduct a 15-month phase III program that will include two concurrent studies – the safety and immunogenicity PROTECT study and lot-to-lot consistency CONSTANT study – with combined enrollment of approximately 4,800 participants across some 40 sites in the U.S., Europe and Canada.
The FDA's green light for the submission of Amicus Therapeutics Inc.'s new drug application (NDA) for migalastat in Fabry disease followed what John Crowley, chairman and CEO, called a "data-driven, science-based discussion" with "largely the same reviewers" within the same FDA review division who previously looked askance at the company's data package.
The next chapter in the tale of Inotek Pharmaceuticals Corp. is all about “something strategic,” David Southwell, president and CEO, said after the phase II fixed-dose combination (FDC) trial of lead candidate trabodenoson and standard-of-care therapy latanoprost failed to move the needle in treating glaucoma.
If Qu Biologics Inc. CEO Hal Gunn was dismayed at presenting the company's poster in the back of the colossal exhibit hall at Chicago's McCormick Place during Digestive Disease Week (DDW) in May, he didn't complain.
"This is why you do a phase II," H.C. Wainwright & Co. analyst Corey Davis headlined his note assessing top-line data posted by Cara Therapeutics Inc. on its phase IIb trial of the oral formulation of its peripherally selective kappa opioid agonist, CR-845, in patients with osteoarthritis (OA) of the knee or hip.
