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 […]
Pharmaceuticals
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 […]
Kala Pharma reveals mixed Ph3 data for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) shares dropped -28% today after the company revealed mixed results from two Phase III trials of its dry eye disease drug, KPI-121. In its Stride 1 trial, the company’s drug met statistical significance for the primary endpoint of conjuctival hyperemia change from baseline to day 15, as well as the primary endpoint of […]
Denali inks collab with Takeda to help Alzheimer’s drugs get into the brain
Denali Therapeutics (NSDQ:DNLI) has landed a strategic partnership with Takeda Pharmaceutical (TYO:4502) to develop and commercialize three of its product candidates for neurodegenerative diseases. The deal includes Denali’s preclinical Alzheimer’s projects, among other undisclosed candidates, which make use of the company’s antibody transport vehicles, or ATVs, to penetrate the blood-brain barrier. According to the terms of […]
Ohr Pharmaceutical shares plummet after eye drug fails in wet-AMD trial
Shares in Ohr Pharmaceutical (NSDQ:OHRP) dropped -83% to trade at 35¢ apiece this morning after the company revealed that its topical therapy did not meet the primary endpoint of a trial evaluating its efficacy as a treatment for wet age-related macular degeneration. The company’s Mako study randomized patients 1:1 to receive either Ohr’s topical, twice-daily […]
Swiss biotech Oculis raises $21m for nanoparticle eye-drops
Swiss biotech Oculis has raised $21 million in a Series B round backed by investors including Novartis (NYSE:NVS) and Bay City Capital. The company is developing topical drugs for back-of-the-eye diseases, which are normally treated with painful injections directly into the eye. Oculis reported that its newly-acquired funds will be used to support the clinical development of […]
Drug-delivery tech developer AMW lands $30m from EU bank
Drug-delivery tech developer AMW has landed $30 million from the European Union’s lending institution to help fund the company’s development activities and expand production capacity. The German pharmaceutical company’s newly-acquired funds will specifically support a new R&D facility located in Bavaria. The transaction was supported by the European Fund for Strategic Investments. “Supporting research, development […]
The ‘smart pill’ market could be worth $3B by 2025 – meet the key players
The “smart pill” market is expected to nearly quadruple in value to $3 billion by 2025, according to Grand View Research. Driving this growth is an increasing demand for minimally-invasive procedures, as well as better patient monitoring capabilities. There are a number of players in the pharmaceutical and medtech arenas looking to stake a claim […]