Without calling out any drug companies by name, the U.S. Dept. of Health and Human Services’ Office of Inspector General revealed this week that 10 potentially misclassified drugs may have resulted in $1.3 billion in lost rebates to Medicaid between 2012 and 2016. The issue of ducking rebates came to the public’s attention earlier this […]
Pharmaceuticals
United Therapeutics dishes out $210m to settle charity-kickback claims
United Therapeutics (NSDQ:UTHR) has agreed to pay $210 million to squash claims that it used a charity to illegally cover Medicare patients’ out-of-pocket costs in an attempt to boost sales. Drug companies are not allowed to subsidize co-pays for people enrolled in Medicare, but they can donate to independent non-profits that provide co-pay assistance. The settlement […]
FDA rejects Santen’s intravitreal uveitis therapy
Shares in Santen Pharmaceutical (OTC:SNPHY) fell -3% today after the company’s U.S. subsidiary said that the FDA rejected the application for its intravitreal sirolimus therapy The company is developing its DE-109 product to treat people with noninfectious uveitis of the posterior segment, which can cause blindness in adults. Santen reported that the FDA’s complete response […]
Aura Biosciences raises $30m for nanoparticle cancer treatment
Aura Biosciences has closed a $30 million Series C round with funding from new investors like Arix Bioscience and Lundbeckfonden Ventures, as well as existing investors, including the estate of former-Genzyme CEO Henri Termeer, who died earlier this year. The privately-held biotech is developing a light-activated nanoparticle therapy for patients with ocular melanoma. Aura said […]
BioCorp’s smart cap wins CE Mark for insulin pen
Biocorp (PAR:ALCOR) said today that its smart cap, Easylog, won CE Mark clearance for use with insulin delivery devices. The company’s device turns traditional pen injectors into connected devices, capturing treatment information like dose, date and time of injection. Easylog transfers that data to a mobile app for patients to monitor. “CE marking for Easylog is […]
TherapeuticsMD shares tumble after FDA pushes NDA decision to mid ’18
TherapeuticsMD (NSDQ:TXMD) shares fell 7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia. The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response […]
Eyenovia looks to $35m IPO for ocular drug-delivery tech
Eyenovia is looking to raise up to $35 million in an initial public offering, according to recent filings. The company plans to use the funds to support trials of its device, which is designed to deliver small doses of drugs to the eye. The New York-based company uses a piezo-electric dispensation technology to deliver microdoses […]
Mass Innovation Labs expands to give startups a better way to do research
At the 124,000-square foot Cambridge headquarters of Mass Innovation Labs, co-founder & CEO Amrit Chaudhuri points to a cluster of tables and identifies them one by one: This startup went public and did a massive deal with Merck (NYSE:MRK), he says, and sits shoulder-to-shoulder with a different company working on a Phase II clinical asset. More than a […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
Bristol-Myers Squibb taps Taris’ drug-release tech for bladder cancer trial
Bristol-Myers Squibb (NYSE:BMY) and Taris Biomedical have inked a deal to combine Taris’ investigational GemRIS drug-releasing tech with the pharma company’s PD-1 immune checkpoint inhibitor, Opdivo, in a Phase Ib muscle invasive bladder cancer trial. As part of the collaboration, Bristol-Myers has also made an equity investment in Lexington, Mass.-based Taris. Taris’ GemRIS system is designed […]