InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million since the first sale of the offering occurred on Oct. 20, 2017, according to yesterday’s filing. Get the full […]
West Pharmaceutical Services launches two elastomer products
West Pharmaceutical Services (NYSE:WST) yesterday said it launched two new elastomer products, the 4040/40 formulation elastomer and an extension of its AccelTRA component program. The 4040/40 formulation was created using customer insights to improve performance and reliability. It comes in two stopper designs in 13mm and 20mm sizes with a universal design to deliver high functionality […]
Insulet Q3 earnings beat The Street despite bottom-line slide
Insulet (NSDQ:PODD) shares are rising today on third-quarter results that topped the consensus forecast, despite a dip in profits. The Acton, Mass.–based company posted profits of $852,000, or 1¢ per share, on sales of $192.1 million for the three months ended Sept. 30, for a 48.6% bottom-line slide on sales growth of 27.1%. Adjusted to exclude […]
Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod
Surmodics (NSDQ:SRDX) shares plummeted today despite third-quarter results that topped Wall Street projections. Eden Prairie, Minn.-based Surmodics posted profits of $3.55 million, or 26¢ per share, on sales of $30.8 million for the three months ended Sept. 30, moving from red to black on revenue growth of 33.8% compared with Q3 2018. Adjusted to exclude one-time […]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions. The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin
Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]
FDA approves Flowonix’s Prometra II programmable pump
Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that […]
Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Bausch agreed to […]
Phillips-Medisize wins contract for wearable combination product
Phillips-Medisize said today that it entered into an agreement with an unnamed biotechnology company to manufacture a wearable, electronic-enabled combination product for subcutaneous drug delivery. The hockey puck-sized product is designed as a disposable, single-use combination device that can be worn near the infusion site for two days or adhere to the patient’s body with […]
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