An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]
Business/Financial News
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]
Pulmatrix announces 1-for-10 reverse split, $1m offering
Pulmatrix (NSDQ:PULM) this week announced both a 1-for-10 reverse split of its stock and the closing of an offering which brought in approximately $905,000. On Tuesday, the Lexington, Mass.-based company said that it initiated a 1-for-10 reverse split of its common stock, putting a single share in the hands of each shareholder for each 10 shares they […]
Bigfoot Biomedical, Owen Mumford ink deal for pen needles
Bigfoot Biomedical said today that it inked a commercial supply deal to include Owen Mumford‘s Pentips line of pen needles with Bigfoot’s injection system subscription bundles. Milpitas, Calif.-based Bigfoot is working on monthly subscription packages for people with insulin-requiring diabetes. The company said it selected Owen Mumford’s pen needle because of the needle’s compatibility with […]
Reva Medical cuts 44% of workforce
Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction. “While we continue to see strong interest in Fantom Encore and are excited about […]
Senseonics extends distribution agreement with Roche Diabetes Care
Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had […]
Surmodics posts Street-beating FY2019 Q1 earnings
Surmodics (NSDQ:SRDX) today posted fiscal year 2019 first quarter earnings that beat expectations on Wall Street. The Eden Prairie, Minn.-based company posted profits of $1.3 million, or 9¢ per share, on sales of approximately $22.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew […]
Circassia inks exclusive ventilator commercialization deal with AIT Therapeutics
Circassia Pharmaceuticals said last week that it inked a deal for the exclusive commercialization rights to AIT Therapeutics’ nitric oxide device, AirNOvent, in the U.S. and China. Using an electric voltage, the portable AirNOvent system produces nitric oxide from the nitrogen and oxygen in the air. According to the terms of the deal, Circassia is […]
Bellerophon closes $7m round
Bellerophon Therapeutics (NSDQ:BLPH) last week closed an underwritten public offering of 10,000,000 shares of common stock at 70¢ apiece. The Warren, N.J.-based company also gave underwriters a 45-day option to buy up to an additional 1,500,000 shares of common stock at the same price. The gross proceeds of the offering were $7 million, Bellerophon reported. Earlier […]