Orthocell (ASX:OCC) touted interim data today from an ongoing clinical study of its CelGro collagen soft tissue repair device for peripheral nerve regeneration. Researchers are evaluating the safety, tolerability and effectiveness of CelGro in surgery with patients who have suffered injury to 1 or more peripheral nerves in the hand and upper limb. The company said that […]
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Alimera, Knight seek Canadian regulatory nod for Iluvien intravitreal implant
Alimera Sciences (NSDQ:ALIM) and Knight Therapeutics (TSE:GUD) said today that Health Canada accepted the companies’ New Drug Application for its intravitreal implant, Iluvien. The FDA approved Atlanta-based Alimera’s sustained release intravitreal implant in 2014 to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise […]
FDA accepts Ocular’s NDA resubmission for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Lantheus inks deal with GE Healthcare for PET imaging agent
Lantheus Medical Imaging (NSDQ:LNTH) said today that it signed the term sheet for a deal with GE Healthcare (NYSE:GE) for the development and commercialization of a positron emission tomography myocardial perfusion imaging agent used to improve the diagnosis of coronary artery disease. According to the deal, GE Healthcare will fund a 2nd phase III trial evaluating the imaging […]
Fresenius guides for double-digit growth
(Reuters) — Fresenius (NYSE:FMS) set out new targets for 2020 today, aiming for double-digit annual gains in sales and net income. Sales will grow to between €43 billion and €47 billion ($45.3 billion to $49.5 billion) by 2020, from €29.1 billion in 2016, which is an average annual growth rate of 11.2% at the midpoint of the […]
Actamax seeks FDA nod for sprayable adhesion barrier trial
Actamax Surgical Materials, a DSM-DuPont joint venture, said today that it submitted an Investigational Device Exemption application to the FDA for its adhesion barrier device in gynecological laparoscopic surgery. Adhesions, excessive scar tissue that can form between adjacent internal tissues, are a result of normal wound healing. Adhesions occur post-surgical operations at rates of 50-90%. […]
Study: Industry funding biases drug trials in favor of sponsors
Researchers from the University of Sydney published a review this week, concluding that industry-funded drug trials are often biased in favor of the sponsors’ products. According to Lisa Bero of the university’s Charles Perkins Centre, the study provides “definitive evidence that pharmaceutical industry funding of drug studies biases the results and conclusions to look favourable […]
Ex-banker Stewart draws 3 years for insider trading on healthcare deals
A former Wall Street investment banker was sentenced to 3 years in prison last week after he was convicted on insider trading charges related to a quintet of medical device and life science acquisitions. Sean Stewart, who worked at Perella Weinberg Partners and JPMorgan Chase, was found guilty in New York City on all of the 9 counts he faced, including […]
Common Sensing, Welkin Health collaborate on digital diabetes management system
Common Sensing and Welkin Health said last month that the companies are partnering to develop a digital diabetes management program designed to improve insulin adherence. The companies plan to craft a program that combines insulin dosing data collected from Common Sensing’s Gocap smart insulin pen with Welkin Health’s digital coaches to support patients with diabetes. […]
Supreme Court declines Boston Scientific’s appeal in $309m CRM patent loss
The U.S. Supreme Court today declined to take up an appeal by Boston Scientific (NYSE:BSX) of a $309 million loss in a lawsuit over cardiac rhythm management device patents. Marlborough, Mass.-based Boston Scientific lost the judgment in September 2014, part of a long-running patent war with the family of the late physician who helped invent the implantable cardioverter defibrillator, Dr. Michel […]
Adapt Pharma seeks regulatory nod for naloxone nasal spray in Europe
Adapt Pharma said today that it filed a European Marketing Application for its naloxone hydrochloride nasal spray for the treatment of opioid overdose. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in an 0.1 mL nasal spray and does not require assembly prior to use, according to […]