Takeda Pharmaceutical (TYO:4502) touted top-line data today from its pivotal Phase III Visible 1 trial evaluating an investigational subcutaneous formulation vedolizumab as a maintenance therapy for adults with moderate to severe ulcerative colitis. The trial specifically focused on patients who experienced a clinical response at six weeks following two doses of open-label vedolizumab IV induction therapy. […]
Pharmaceuticals
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set […]
FDA issues warning for Claris manufacturing site bought by Baxter
The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month. Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter. The […]
Novartis posts Q2 beat, promises to hold off on drug price hikes
Shares in Novartis (NYSE:NVS) were up today after the company beat expectations on Wall Street with its second-quarter financial results. The Switzerland-based company posted profits of $7.77 billion, or $3.34 per share, on sales of $13.16 billion for the three months ended June 30. Novartis saw its quarterly sales climb 7% compared with the same period […]
Pulmatrix touts data from first-in-human trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that all dosing and follow-up visits have finished for its first-in-human study of an inhaled formulation of itraconazole as a treatment of allergic bronchopulmonary aspergillosis in people with asthma. The inhaled iSperse formulation, called Pulmazole, was well-tolerated, according to the Lexington, Mass.-based company. Pulmatrix plans to launch a Phase II trial of […]
Takeda, leon-nanodrugs ink feasibility testing deal for reformulated drug
leon-nanodrugs said today that Takeda (TYO:4502) tapped its MicroJet Reactor technology as part of a feasibility study that could result in the reformulation of one of Takeda’s pipeline products. Using leon’s nanotechnology platform, the companies plan to boost the solubility, bioavailability and stability of one of Takeda’s pipeline products. Positive results from the feasibility study could […]
Reva lands new partner in Italy for bioresorbable scaffold
Reva Medical (ASX:RVA) said today that it inked a deal with Bio Vascular Group to distribute Reva’s Fantom bioresorbable scaffold in Italy. The partnership expands Reva’s commercial activities to Italy, adding to its ongoing efforts in Germany, Switzerland, Austria and Turkey. The San Diego, Calif.-based company also touted today that the first commercial implant of its […]
Johnson & Johnson sees global pharma sales climb 20% in Q2
Healthcare giant Johnson & Johnson (NYSE:JNJ) today topped sales and earnings estimates with its second-quarter financial results, posting sales growth of 19.9% for its pharmaceutical segment compared to the same period last year. The New Brunswick, N.J.-based company reported overall profit growth of 3.1% to $3.95 billion, or $1.45 per share, on sales of $20.83 billion […]
CeQur acquires wearable insulin delivery device
CeQur said today that it acquired a wearable, on-demand insulin delivery system from Johnson & Johnson‘s (NYSE:JNJ) Calibra Medical for an undisclosed amount. The Calibra device is designed to dose rapid-acting, mealtime insulin for people with Type II diabetes. In a 278-person study, use of the Calibra device resulted in higher ease-of-use and patient satisfaction […]
FDA recalls heart failure, blood pressure drugs due to cancerous contaminant
The FDA announced last week a voluntary recall of several high blood pressure and heart failure medications containing valsartan due to a cancerous impurity. Some valsartan drugs were found to contain N-nitrosodimethylamine (NDMA), a compound that is classified as a probable human carcinogen. Not all drugs containing valsartan were recalled, the FDA noted. Teva Pharmaceuticals (NYSE:TEVA), […]