Wacker Biotech said today that it won FDA approval to start producing reteplase, the active ingredient in Chiesi‘s thrombolysis drug, Retavase. The medication, which is designed to treat acute myocardial infarction in adults, will be marketed in the U.S. by Chiesi and made in Wacker’s Germany-based plant. Wacker reported that it landed approval to commercially […]
Pharmaceuticals
Novo Nordisk’s once-weekly diabetes injection cleared in Canada
Health Canada has approved Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide injection as an adjunct to diet and exercise that can help adults with Type II diabetes control their blood sugar levels. The drug, Ozempic, is a GLP-1 receptor agonist and won FDA approval in the U.S. in December. “Many of our patients with Type II diabetes […]
Ascensia inks global distro sale with Insulet for blood glucose monitor
Ascensia Diabetes Care has expanded its partnership with Insulet (NSDQ:PODD) to include a global commercial deal. The two companies inked a world-wide development agreement in June last year to connect Ascensia’s Contour Next One blood glucose monitor with Insulet’s next-gen Omnipod system, Omnipod Dash. According to the terms of the non-exclusive commercial deal, Insulet plans to distribute […]
Allergan talks taxes and competition in 2018 outlook
Allergan (NYSE:AGN) had a busy, and occasionally fraught, 2017. After the company inked a controversial deal with a Native American tribe to shield its Restasis patents from review, a federal judge in Texas invalidated the IP, helping to clear the way for generics. And just last week, Allergan announced that it would slash 1,400 jobs in […]
Novaliq enrolls first patient in Ph2 dry eye disease trial
Novaliq said today that it has begun randomizing patients in a Phase II trial of its product candidate for dry eye disease. Patients with evaporative dry eye disease caused by Meibomian gland dysfunction have impaired tear film lipid layers, according to the specialty pharma company, and treatment options for these patients are limited. Novaliq’s NOV03 […]
Intersect ENT reports Q4, full-year revenue prelims
Shares in Intersect ENT (NSDQ:XENT) held steady today after the company reported preliminary data for its fourth quarter and full-year revenues. The Menlo Park, Calif.-based company said it expects to reel in $96.1 – $96.3 million in revenue for the full year of 2017, up 22% from 2016. Intersect also pegged its fourth-quarter revenue between $29.3 […]
pSivida seeks FDA nod for 3-year treatment of posterior segment uveitis
pSivida (NSDQ:PSDV) has submitted a new drug application to the FDA for its Durasert implant that provides three years of treatment for people with posterior segment uveitis. The drug-delivery product’s NDA includes data from two Phase III trials, both of which met their primary efficacy endpoints after six months. pSivida’s Durasert product also boasts a safety […]
KemPharm launches pivotal efficacy trial for extended-release ADHD prodrug
KemPharm (NSDQ:KMPH) has launched a pivotal efficacy trial of its extended-release prodrug product for the treatment of attention deficit hyperactivity disorder in children. The company’s classroom-style study is designed to support a potential label for KP415 that would include both early-onset and long duration treatment effect for ADHD. The 140-patient trial is slated to wrap up […]
Insulet lands Medicare Part D coverage for Omnipod insulin delivery system
The Centers for Medicare and Medicaid Services issued guidance today noting that Insulet‘s (NSDQ:PODD) Omnipod tubeless insulin delivery device can be covered by the Medicare Part D prescription drug program. The Billerica, Mass.-based company estimated that its latest reimbursement win extends access to the Omnipod system to 450,000 people with Type I diabetes across the U.S. […]
Facing competition for Restasis, Allergan moves to cut costs by slashing 1,400 jobs
Allergan (NYSE:AGN) said this week that it plans to cut more than 5% of its workforce in an attempt to cut costs. The drug-maker is facing competition from up-coming generics to its dry-eye drug, Restasis. The company said it anticipates taking a $125 million hit from the job cuts, the majority of which will be noted […]