Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]
Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler
Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler. London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK […]
Enable Injections inks deal with Genentech
Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]
FDA wants more on new manufacturing process from Clearside Biomedical
Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year. Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. Clearside said […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]
Insulet touts full market launch of mobile apps for Omnipod Dash
Insulet (NSDQ:PODD) touted the full market launch of the Omnipod Display and Omnipod View apps for people using the company’s Omnipod Dash system. The Display app enables users to display data from their Personal Diabetes Manager device onto their smartphones. The View app gives caregivers and family members the option to remotely monitor Omnipod Dash […]
On mixed Q2 results, Glaukos announces Avedro buy
Glaukos (NYSE:GKOS) posted its second-quarter financial results this week and reported that it plans to acquire Avedro in an effort to build out its corneal health franchise. Avedro develops single-use drug formulations designed to strengthen corneal tissue and stop the progression of a degenerative corneal ectatic disease known as keratoconus. According to the Mass.-based company, the […]
Omnipod Dash sales drive Insulet Q2 results
Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or $0.02 per share, on sales of $177.1 million for the three months ended June 30, 2019, for a bottom-line […]
Pfizer to absorb Mylan in off-patent drug spinout
Pfizer (NYSE:PFE) plans to absorb Mylan (NSDQ:MYL) as part of the spinout of its Upjohn off-patent drugs business in an all-stock deal. The deal, structured to avoid taxes on any gains from the spinout, would see each Mylan share converted into a share of the as-yet-unnamed new company. Pfizer stockholders would then own 57% of […]
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