Meril Life Sciences has developed a drug-eluting, bioresorbable vascular scaffold that the body can slowly degrade and wash away. The company’s MeRes100 is made of biodegradable polymers, PLLA and PDLLA. Sirolimus, a commonly-used immunosuppressant found in drug eluting stents, is embedded in the scaffold’s coating. The company designed the struts of the device to be just […]
Wall Street Beat
Merit Medical sees 52-week high on Q4, 2016 beats
Merit Medical (NSDQ:MMSI) posted 4th-quarter results today that beat the consensus forecast on Wall Street, sending share prices to a new 52-week high. The South Jordan, Utah-based medical device company said profits were up 17.1% to $7.5 million, or 17¢ per share, on sales of $157.7 million for the 3 months ended Dec. 31, for top-line growth of 14.0% […]
BrainStorm seeks early Health Canada nod for NurOwn treatment
Brainstorm Cell Therapeutics (NSDQ:BCLI) is reportedly seeking early regulatory approval in Canada for its NurOwn stem cell treatment for patients with ALS. The company told Reuters this week that it has inked an agreement with a Canadian non-profit organization, CCRM, that helps to support the development of regenerative medicine. The organization plans to help BrainStorm meet Canadian regulatory requirements […]
Orthocell touts CelGro nerve regeneration study
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 […]
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 […]