Despite a phase IIb miss this time last year for lead compound CRLX101 in advanced non-small-cell lung cancer (NSCLC), Cerulean Pharma Inc. vowed to plow forward with its nanopharmaceutical platform.
Newlink Genetics Corp. said Friday its phase III IMPRESS trial of algenpantucel-L in patients with surgically resected pancreatic cancer will continue without modification on the recommendation of the independent data safety monitoring board (DSMB) following the first of two planned interim analyses.
Synageva Biopharma Corp. priced the largest underwritten public offering for a biotech so far in 2014, seeking to raise $211.5 million and leaving no doubt that the public markets continue to lavish capital on the rare disease space.
Biogen Idec Inc. and Eisai Co. Ltd. are joining forces to tackle Alzheimer’s disease (AD), initially focusing on two candidates from the Japanese company with an option to jointly develop and commercialize two early stage Biogen assets. The deal marshals the talents of a pharma behind the blockbuster AD drug Aricept (donepezil) and a big biotech with a solid track record in neurodegenerative disease.
Shares of Oxygen Biotherapeutics Inc. (NASDAQ:OXBT) climbed as much as 35 percent Tuesday after the company reported the FDA lifted the clinical hold on Oxycyte, clearing the path for the company to resume U.S. studies.
Roche AG unit Genentech Inc. said it was halting the phase III METLung study of onartuzumab, or Metmab, in combination with Tarceva (erlotinib, Roche and Astellas Pharma Inc.) in MET-positive, advanced non-small-cell lung cancer (NSCLC) on the recommendation of an independent data monitoring committee after a planned interim analysis showed the drug did not meet its primary endpoint of overall survival (OS).
Radius Health Inc. expanded the circle of biotech initial public offerings (IPOs), filing to raise up to $86.25 million. In its preliminary prospectus, the Cambridge, Mass.-based company took a different angle than most recent biotech IPOs, becoming one of the first – perhaps the only – since the passage of the Jumpstart Our Business Startups Act of 2012 that did not file as an emerging growth company.
Talk about a great Act One. After six years quietly developing Laminin-111, a protein replacement therapy for ultra-rare merosin-deficient congenital muscular dystrophy (MDC1A), privately held Prothelia Inc. snagged leading rare disease firm Alexion Pharmaceuticals Inc. as its first strategic partner earlier this month in a three-way deal with the University of Nevada, Reno, where the technology was developed.
Metreleptin, the biologic developed by Bristol-Myers Squibb Co.’s (BMS) wholly owned subsidiary Amylin Pharmaceuticals LLC, received an FDA green light on its PDUFA date of Feb. 24 as a replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with ultra-rare congenital generalized or acquired generalized lipodystrophy (LD).
