Vium Inc., of San Mateo, Calif., said it closed a $24 million series B financing led by existing investors Lux Capital and Data Collective, with participation from Dolby Family Ventures, Founders Fund and Tony Fadell's Future Shape LLC. Read More
Citing comments addressing a range of issues that could impact the cost and efficiency of developing biosimilars, the FDA Thursday withdrew the draft guidance "Statistical Approaches to Evaluate Analytical Similarity," issued in September, that was intended to help biosimilar sponsors. Read More
Meiragtx Holdings plc, of London, was granted a manufacturer's authorization for investigational medicinal products from the U.K.'s Medicines and Healthcare Products Regulatory Agency. The license allows the firm to manufacture gene therapy product candidates in its current GMP-compliant facility. Read More
SHANGHAI – Alpha Biopharma Inc., of Shanghai, closed the first tranche of its $65 million series A fund, having received $37 million from Qiming Venture Partners, TF Fund and Lyzz Healthcare Venture Fund. According to Alphabio's chief operating officer, James Liu, the remaining $28 million is expected to close in the next few months. Read More
DUBLIN – Scottish startup Adorx Therapeutics Ltd. is the latest contender to tackle the knotty problem of immunosuppression in the tumor microenvironment through adenosine receptor inhibition. The Edinburgh-based firm raised $10 million to take forward an adenosine receptor A2A antagonist and a dual blocker of the A2A and A2B receptors. Read More
Reporting positive and eagerly anticipated, potentially wider label-enabling data from a pair of phase IIb trials, Heron Therapeutics Inc.'s non-opioid HTX-011 took another leap forward on the road to marketing approval in postoperative pain, leaving farther behind any concerns regarding the recent add-on indication for Exparel (bupivacaine liposome injectable suspension) from Pacira Pharmaceuticals Inc. Read More
In voting Thursday to send H.R. 6142 to the House floor, the Ways and Means Committee took a baby step toward requiring drug and device companies to rethink the delivery mechanism and packaging of single-use drugs so as to cut down on the amount of drugs being discarded in the U.S. Read More
For the first time since BioWorld began tracking the biotech industry's public financings in 1999, five U.S. companies priced their IPOs within a 24-hour period and made their U.S. market debuts on a single day. Ironically, they picked June 21, the Northern Hemisphere's summer solstice. Whether the date was coincidental or a metaphor for long workdays ahead remains to be seen, but all five companies – Aptinyx Inc., Avrobio Inc., Kezar Life Sciences Inc., Magenta Therapeutics Inc. and Xeris Pharmaceuticals Inc. – started in the plus column. Eidos Therapeutics Inc., which priced a day earlier, began that trend when its shares (NASDAQ:EIDX) gained $6.12, or 36 percent, Wednesday to close its first trading day at $23.12. Read More
