OptiNose said today that the FDA approved its Xhance nasal spray for the treatment of nasal polyps in patients 18 years and older. The fluticasone propionate nasal spray is designed to deliver medication using OptiNose’s exhalation delivery system. The patient actuates the pump spray into one nostril while simultaneously blowing into the mouthpiece of the […]
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ALR Technologies’ insulin dose adjustment feature wins FDA approval
ALR Technologies said today that the FDA approved the insulin dose adjustment feature of its ALRT diabetes management system. The ALRT system uses insulin dosing guidelines from the American Association of Clinical Endocrinologists and American Diabetes Association as reference doses. The reference doses are compared with a patient’s current insulin dose to decide if a patient’s […]
Catalent dishes out $950m for biologics manufacturer
Catalent said today that it plans to purchase Cook Pharmica for $950 million in cash. Cook Pharmica, a unit of privately-held medical device maker Cook Group, is a contract manufacturer that develops biologics-based drug compounds. The deal readies Catalent for an expansion of its biologics biz. Catalent will have access to Cook Pharmica’s Indiana-based facility […]
Study: Women with esophageal cancer fare better than men
The survival rate for esophageal cancer is, according to Dr. K. Robert Shen, bleak. Last year, there were 17,000 Americans diagnosed with the disease and nearly 16,000 of them died, the Mayo Clinic cardiothoracic surgeon told Drug Delivery Business News. “It’s almost reached an epidemic,” Shen said. “It doesn’t get a lot of airplay and […]
Micell raises $62m for MiStent SES
Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
CIRSE 2017 Round-up: Delcath touts second-gen hemofiltration system in percutaneous hepatic perfusion
Delcath Systems (NSDQ:DCTH) touted data today from a study of its second-generation hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan hydrochloride. The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark. The investigational product, an injectable melphalan hydrochloride for use with […]
Dexcom launches program to connect CGM data with 3rd-party apps
Dexcom (NSDQ:DXCM) today launched a public API that allows 3rd-party developers to connect patient-authorized continuous glucose monitoring data into software apps. The data-sharing platform is designed to make use of the blood glucose data produced by Dexcom’s CGM systems. Companies, including One Drop, have begun accessing the API and others in the U.S. can register online, […]
FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler
The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today. The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules […]
FDA’s medical gas guidance offers clarity to manufacturers
FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]
FDA approves Ipsen’s lanreotide depot injection for carcinoid syndrome
Ipsen (EPA:IPN) said today that the FDA approved a supplemental indication for its Somatuline depot (lanreotide) injection for the treatment of carcinoid syndrome. “The new indication for Somatuline depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors.,” Ipsen’s VP of R&D and chief scientific officer, Dr. Alexandre Lebeaut, […]