Shares in Mallinckrodt Pharmaceuticals (NYSE:MNK) fell today after the company beat earnings estimates but missed on revenue with its second quarter results. The U.K.-based company posted profits of $62.8 million, or 72¢ per share, on sales of $824.5 million for the 3 months ended June 30, for bottom-line loss of -68% on sales loss of -5% […]
Pharmaceuticals
Rebiotix launches late-stage superbug trial for microbiome-based drug
Rebiotix isn’t a traditional drugmaker. Its products are alive. The 32-person company, based in Roseville, Minn., is developing a microbiome-based therapy to prevent recurrent Clostridium difficile infection. Its Microbiota Restoration Therapy, which is delivered via enema or a lyophilized, non-frozen oral capsule, is designed to supply a patient’s intestinal tract with an array of healthy, human-derived microbes. […]
Endo swings to Q2 loss on $775m pelvic mesh set-aside
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants. The generic drugmaker faced other setbacks this quarter, including the FDA asking that Endo pull its painkiller, Opana ER, from the […]
FDA approves 4-year intrauterine device
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 […]
Kaleo launches program to give Auvi-Q allergy devices to 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. Kaleo’s emergency allergy auto-injector features voice […]
FDA approves Jazz Pharmaceuticals’ 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. “Vyxeos is the first new chemotherapy […]
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. Unlike conventional metered-dose inhalers, the Qvar RediHaler does not […]
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. Adjusted […]
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 […]
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. “This is the first time that all-injectable […]