Allergan (NYSE:AGN) and women’s health nonprofit Medicines360 said today that the FDA approved a supplemental new drug application to extend the duration of use for Liletta, a levonorgestrel-releasing intrauterine device, for up to four years. The hormone-releasing device was first approved in February 2015 and it won additional approval in January last year for a single-handed inserter. Get […]
Kaleo launches program to get Auvi-Q allergy auto-injector into schools
Kaleo said today that it launched a new program to offer its epinephrine auto-injector, Auvi-Q, free-of-charge to all public elementary schools in the U.S. The program is slated to give up to four Auvi-Q cartons per school each academic year. Each carton has two auto-injectors and a training device. Get the full story at our sister […]
Bellerophon shares fall despite Street-beating Q2 results
Shares in Bellerophon Therapeutics (NSDQ:BLPH) fell today even though the company beat expectations on Wall Street with its second quarter results. The Warren, N.J.-based company posted a net loss of -$3.9 million with no sales for the 3 months ended June 30, for bottom-line growth of 23% compared with the same period last year. Get the full […]
FDA approves Jazz Pharmaceutical’s liposomal AML chemotherapy
Jazz Pharmaceuticals (NSDQ:JAZZ) said today that the FDA approved its Vyxeos injectable liposome for the treatment of adults with two types of acute myeloid leukemia. Vyxeos is the first product designed with the Dublin-based company’s CombiPlex technology, delivering a fixed-ratio of daunorubicin and cytarabine to a patient’s bone marrow. Get the full story at our sister […]
Teva wins FDA nod for Qvar RediHaler device
Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved its Qvar RediHaler breath-actuated inhaler for the maintenance treatment of asthma in patients ages 4 and older. The device, which is not indicated for acute bronchospasm, is slated to become commercially available during the first quarter of 2018. Get the full story at our sister site, Drug […]
First patient treated with Biostage’s esophageal implant
Biostage (NSDQ:BSTG) touted today the first patient use of its Cellspan esophageal implant. The Holliston, Mass.-based company said that the regenerative implant was used in a 75-year old male patient, who has a life-threatening cancerous mass in his chest. Surgeons removed the portion of his esophagus affected by the cancer and Biostage’s implant was used […]
MiMedx files IND for Achilles tendonitis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial. The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. Get the full story at our sister site, Drug […]
VC shops back CeloNova BioSciences
CeloNova BioSciences said today that it inked a 4-year financing deal with Congruent Investment Partners and SWK Holdings Corp. The funds are slated to support CeloNova’s ongoing clinical trials and product initiatives, including the launch of its Cobra PzF NanoCoated coronary stent. Get the full story at our sister site, Drug Delivery Business News.
Pulmatrix beats Q2 EPS by a penny
Shares in Pulmatrix (NSDQ:PULM) fell last week even though the biopharmaceutical company beat expectations on Wall Street with its second quarter results. The Lexington, Mass.-based company posted a net loss of -$5.6 million with no revenue for the 3 months ended June 30, for bottom-line growth of 39% compared with the same period last year. Get the […]
MannKind combines inhaled insulin with One Drop’s digital diabetes tech
MannKind Corp. (NSDQ:MNKD) and One Drop said today that the group launched its A-One trial evaluating MannKind’s inhaled insulin, Afrezza, for use with One Drop’s digital diabetes management platform. The companies reported that they are enrolling people with Type II diabetes and randomizing them in two treatment arms. One group of patients will use Afrezza with One Drop […]
Study: Injectable antiretroviral therapy proves as effective as oral treatment
Injectable antiretroviral therapy may be as effective as standard oral treatment in patients with HIV, according to the results of a Phase II clinical trial. The 286-patient study, published in The Lancet, compared a nanoparticle therapy that was injected intramuscularly every four or eight weeks with standard maintenance therapy. Get the full story at our sister […]