Delcath Systems (NASDAQ:DCTH) said Thursday that subsequent to recent talks with the FDA, its management will modify the label indication it is seeking in its New Drug Application for its proprietary chemosaturation system with melphalan hydrochloride for injection. Though the firm’s Phase 3 trial exhibited a very positive signal in patients suffering from liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath will focus its NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver.
In a Thursday release, Medgenics (MDGN) said it has received a Notice of Allowance from the Japanese Patent and Trademark Office for key claims protecting its Infradure Biopump tech for the delivery of interferon alpha. The firm is developing Infradure as a new method to supply sustained and patient compliant interferon therapy to address unmet needs in the treatment of hepatitis B, C, and D. Medgenics is a developer of a novel tech for the sustained output and delivery of therapeutic proteins in patients using their own tissues.
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Curis (NASDAQ:CRIS), in a Thursday release, said that the United States Patent and Trademark Office has issued a patent that covers a genus of compounds that includes Debio 0932, an orally-administered Heat Shock Protein 90 (HSP90) inhibitor, which is currently being developed by Curis’ licensee Debiopharm. The company develops drugs, seeking to develop next generation targeted small molecule drug candidates for the treatment of cancer.
TheStreet Ratings cuts St Jude Medical (NYSE:STJ) from Buy to Hold, but investors seemed to pay little attention. The analyst remarked that St Jude’s strengths can be observed in multiple areas, such as its reasonable valuation levels, mostly solid financial position with reasonable debt levels by most measures, and expanding profit margins. “However, as a counter to these strengths, we also find weaknesses including deteriorating net income, weak operating cash flow and disappointing return on equity.”
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