SteadyMed (NSDQ:STDY) said today that 1 of its largest institutional shareholders exercised warrants to purchase additional shares of the company that the investor got in conjunction with the 1st tranche of a previous private placement. Thanks to the exercise, San Ramon, Calif.-based SteadyMed received an additional $5 million in proceeds. The company said it is slated […]
Wall Street Beat
Senseonics prices $41m underwritten offering for Eversense CGM
Senseonics (NYSE:SENS) said today that it priced an underwritten offering of 29 million shares of common stock at $1.41 apiece to a group of institutional investors. Roche (PINK:RHHBY) agreed to purchase 21 million shares and New Enterprise Associates agreed to purchase 7 million shares in the offering, according to the Germantown, Md.-based company. Senseonics said […]
Colorectal cancer patients treated with SIR-spheres more likely to be candidates for resection
Treatment with Sirtex Medical‘s (ASX:SRX) Y-90 resin microspheres and chemotherapy was associated with a statistically significant gain in potentially curative liver resectability, according to data published earlier this week. The results come 1 week after the Australian company reported that its radioactive microspheres had no effect in improving survival in patients with colorectal cancer in its […]
BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy
BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. At […]
FDA approves 1st cancer drug based on genetics, not tissue type
In a landmark decision, the FDA approved Merck‘s (NYSE:MRK) immunotherapy Keytruda yesterday as the 1st cancer treatment indicated for any solid tumor with a specific genetic feature, regardless of tissue type. Traditionally, the location where a cancer originates in a patient’s body determines the course of treatment. The move to treat cancers based on genetic biomarkers […]
Anika onshores manufacturing capabilities with new Bedford facility
Anika Therapeutics (NSDQ:ANIK) opened a new global manufacturing facility today, on the same day that it celebrated the 25th anniversary of its Bedford, Mass.-based headquarters. Anika’s manufacturing operations were previously split between its U.S. headquarters and an Italy-based contract manufacturer. But in a move to onshore manufacturing to the U.S., the company said it hopes […]
UK watchdog accuses Merck of restricting biosimilar competition
Britain’s Competition and Markets Authority accused Merck‘s (NYSE:MRK) European unit, Merck Sharp & Dohme, of conducting an unfair discount scheme that it said was designed to restrict competition from biosimilar copies of the company’s drug, Remicade. Remicade is an antibody drug used to treat rheumatoid arthritis, ulcerative colitis and Chron’s disease. It was the 1st […]
Trump proposes deep cuts to Medicaid, NIH funding
President Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention. The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier […]
Novartis’ Ultibro Breezhaler tops inhaled corticosteroid for COPD in head-to-head study
Novartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts. The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]
