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 […]
Drug-Device Combinations
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 […]
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 […]
Insulet Q2 sales tops estimates
Shares in Insulet (NSDQ:PODD) rose today after the company met earnings expectations on Wall Street and beat sales estimates with its second quarter results. The Billerica, Mass.-based company posted a net loss of -$7.8 million, or -13¢ per share, on sales of $109.8 million for the 3 months ended June 30, for bottom-line loss of -85% on […]
National Cancer Institute to back research efforts for local delivery of chemo
The National Cancer Institute and the National Institutes of Health said last month that it plans to fund up to five projects involving novel methods to locally deliver chemopreventative drugs. The two organizations pointed out that new technologies have enabled healthcare practitioners to detect cancer earlier in humans, but the ability to treat these high-risk […]
Pacira misses on Q2 sales, earnings
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell slightly today after the pharmaceutical company missed expectations on Wall Street with its second quarter results. The Parsippany, N.J.-based company posted a net loss of -$19.7 million, or -49¢ per share, on sales of $70.9 million for the 3 months ended June 30, for bottom-line loss of -148% on sales growth […]
Aerie Pharmaceuticals misses Q2 EPS by a penny
Shares in Aerie Pharmaceuticals (NSDQ:AERI) held steady today after the pharmaceutical company missed EPS estimates on Wall Street with its second quarter results. The Irvine, Calif.-based company posted a net loss of -$28.4 million, or -82¢ per share, with its bottom line down -22.5% compared with the same period last year. Get the full story at our […]