FDA briefing documents posted ahead of Wednesday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee (adcom) meeting to review the approvability of cangrelor were sufficiently positive to give shares of The Medicines Co. (NASDAQ:MDCO) a modest boost Monday.
Partnering with patient advocacy organizations is an increasingly attractive avenue to speed drugs for rare indications into clinical development. For the smallest of biotechs, the strategy also can keep a company afloat.
Lead candidate EG-1962, a polymer-based microparticle formulation of the FDA-approved calcium channel inhibitor nimodipine, more than piqued the curiosity of investors, who plowed approximately $72.5 million into Edge Therapeutics Inc. in two follow-on C rounds.
Mylan NV disclosed Wednesday that it issued what it called "a preliminary proposal" to acquire Perrigo Co. plc for $205 per share, paid in an undisclosed combination of cash and Mylan stock, to create a global powerhouse across branded, generic and over-the-counter (OTC) pharmaceuticals.
One of the hottest companies in the sizzling cancer immunotherapy space, Adaptimmune Ltd., filed its F-1 with the SEC, seeking a $150 million IPO and a Nasdaq listing for its American depositary shares under the ticker ADAP.
"If the truth were known, mothers would really not want their children to be entrepreneurs," observed Hugh Young Rienhoff Jr., surmising that such a path – which he called part decision, part fate – suggested difficulties conforming to the corporate or academic worlds.
Having resolved issues with its manufacturing supply chain and conducted an additional phase III study over and beyond requirements set by the FDA in two previous complete response letters (CRLs), Heron Therapeutics Inc. is confident the finish line is in sight for lead product Sustol (granisetron injection) to prevent delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of moderately or highly emetogenic chemotherapy (MEC/HEC) agents.
KPI-121, Kala Pharmaceuticals Inc.'s topical nanoparticle formulation of loteprednol etabonate (Lotemax, Bausch & Lomb), emerged with flying colors from a phase III study evaluating the lead program for the treatment of inflammation and pain following cataract surgery.
Horizon Pharma plc is looking to add approved drugs Ravicti (glycerol phenylbutyrate) and Buphenyl (sodium phenylbutyrate) to its orphan drug business by acquiring the outstanding shares of developer Hyperion Therapeutics Inc. for $46 apiece in cash, or approximately $1.1 billion.
