The Federal Trade Commission approved Baxter‘s (NYSE:BAX) $625 million acquisition of Claris Lifesciences‘ (BOM:533288) injectable drug biz, but mandated that the companies divest two drugs products – an antifungal agent, fluconazole, and intravenous milrinone. The FTC filed a complaint saying that the original deal would likely reduce competition in the U.S. for fluconazole since Baxter and […]
Drug-Device Combinations
Insulet, Ypsomed go their separate ways
Ypsomed has been the exclusive distributor of Insulet‘s (NSDQ:PODD) Omnipod insulin management system in Europe since 2010. But today, the companies announced that the arrangement is slated to end on June 30, 2018, after the pair could not agree on extending the contract based on the price set by Insulet, according to Ypsomed. Insulet said it will […]
Kala Pharmaceuticals prices $90m IPO
Kala Pharmaceuticals (NSDQ:KALA) today priced its initial public offering of 6 million shares of common stock at $15.00 apiece. The IPO is slated to bring in nearly $90 million for the Waltham, Mass.-based company. The offering, which is expected to close on July 25, includes a 30-day option for underwriters to buy up to 900,000 additional shares of […]
Study: Microneedle patch, protein combo could boost efficacy of flu vaccine
Researchers at Georgia State University and Georgia Institute of Technology have devised a method to boost the efficacy of a traditional influenza vaccine. The team combined a fusion protein into a microneedle patch made from a biocompatible polymer. The patch’s needles are biodegradable, releasing vaccine into the skin as they dissolve. Get the full story at our sister site, […]
Lawsuit stalls approval of Merck’s insulin injection
Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection. The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval. Get the full story at […]
Mylan, Theravance’s inhaled COPD therapy proves safe in late-stage trial
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic obstructive pulmonary disease. If approved, revefenacin would be the first nebulized long-acting muscarinic antagonist on the market for COPD patients in the U.S. Get the full story at our sister site, Drug Delivery Business […]
Inovio prices $75m public offering
Inovio Pharmaceuticals (NSDQ:INO) said today that it priced its underwritten public offering of 12.5 million shares of common stock at $6.00 apiece. The offering is expected to bring in nearly $75 million for the Plymouth Meeting, Penn.-based company. The offering, which is expected to close on July 25, includes a 30-day option for underwriters to buy up […]
Antibiotic-eluting polymer could help treat prosthetic joint infections
Researchers from Massachusetts General Hospital have developed an antibiotic-eluting polymer that could be used to treat infections in orthopedic implants, according to a report published in Nature Biomedical Engineering. Traditionally, treating a prosthetic joint infection involves removing an implant and replacing it with a temporary spacer made from antibiotic-releasing bone cement for at least six […]
Inovio looks to raise $75m in public offering
Inovio Pharmaceuticals (NSDQ:INO) said yesterday that it is launching an underwritten public offering to sell $75 million shares of common stock. The Plymouth Meeting, Penn.-based company said it plans to grant underwriters an option to buy up to $11.3 million additional shares of common stock. Get the full story at our sister site, Drug Delivery Business News.
Corium touts clinical data for transdermal delivery of Alzheimer’s drug
Corium (NSDQ:CORI) touted data today from a pilot bioequivalence study, comparing its Corplex Donepezil transdermal patch to oral Aricept as delivery method for the most commonly prescribed treatment for Alzheimer’s disease. Data from the pilot study demonstrated that Corium’s transdermal patch met the criteria for bioequivalence to oral Aricept, as measured by primary pharmacokinetic endpoints previously […]
Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The company’s software already works with Lantus and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app gives real-time […]