Liquid biopsy company Guardant Health has revealed that 1,100 patients’ information was stolen in a phishing attack in July. The Redwood City, Calif. company said in an SEC filing that an unauthorized user hacked an employee’s email account and accessed patients’ names, contact information, birth dates, medical diagnosis codes, and, in a very limited number […]
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Get the full story at our sister site, Drug Delivery Business News. […]
Smiths Group (LON:SMIN) said yesterday that it’s spiking merger talks with ICU Medical (NSDQ:ICUI) after rejecting a nearly $4 billion offer earlier this month. The British company and San Clemente, Calif.-based ICU revealed negotiations in May about a possible union with Smiths Medical. Smiths, said to be eyeing the exit door last month, reportedly rejected a cash-and-stock offer worth $3.67 billion […]
DarioHealth (NSDQ:DRIO) said today that it closed a private placement offering with institutional and private investors, bringing in roughly $10.3 million for the Israel-based company. As part of the private placement, DarioHealth issued 4,266,800 shares of common stock at 90¢ apiece and 1,806,923 shares of Series D convertible preferred stock at $3.60 apiece. The company also offered […]
Vital Therapies (NSDQ:VTL) saw share price drop 91.3% this week after the company announced that the leading clinical trial of its ELAD cell-based therapy for treating liver failure failed to meet its primary and secondary endpoints and that it was “ceasing any further development” of the product. The San Diego-based company’s ELAD cell-based therapy was intended […]
Hologic (NSDQ:HOLX) today lowered the revenue expectations for its Cynosure division by $15 million to take into effect lost and reduced sales associated with an FDA warning from last month which raised concerns about the validity and functionality of “vaginal rejuvenation” products and procedures. Last month the company said that Cynosure will suspend the marketing and […]
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy. The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019. Get the full story at our sister site, Drug Delivery Business News.
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. Get the full story at our sister site, Drug Delivery Business News.
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions it […]
Neovasc (NSDQ:NVCN) said today that holders of its senior secured convertible notes, originally due May 17, 2019, have agreed to extend the maturity of the notes from next year to May 17, 2020, and said yesterday it will initiate a reverse stock split as it looks to regain compliance with minimum bid price requirement of the […]
AirXpanders (ASX:AXP) said today that it closed funding rounds worth approximately $15 million in total, including an approximately $11.2 million (AUD $15.7 million) rights offering and US-based private placement with approximately $3.4 million (AUD $4.6 million). The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch […]