Although President Donald Trump’s nominee for FDA commissioner has won approval from lawmakers across the aisle, he is facing questions from consumer watchdog Public Citizen over his ties to the drug industry that will likely arise during his confirmation hearings. The Medical Device Manufacturer Association has voiced its approval for Scott Gottlieb, saying “Dr. Gottlieb is a […]
Wall Street Beat
Sanofi, Voluntis ink deal for digital insulin management system for T2D
Sanofi (NYSE:SNY) and Voluntis said today that the groups inked a non-exclusive agreement to bring digital insulin management systems for Type II diabetes to the U.S. and several European countries. The companies 1st established in alliance in 2011, developing a mobile phone application that was designed to improve decision-making and self-management of patients with Type II […]
Senate confirms Verma to head CMS as debate intensifies over Obamacare replacement
The U.S. Senate voted yesterday 55-43 to confirm Seema Verma to head the Centers for Medicare and Medicaid Services. Verma is the founder & CEO of SVC Inc, a healthcare consulting firm, and worked with now-Vice President Mike Pence when he was governor of Indiana to redesign the state’s Medicaid program. Get the full story […]
BioTime expands OpRegen dry-AMD trial with U.S. sites
BioTime Inc. (NYSE:BTX) said today that it expanded its OpRegen Phase I/IIa trial into the U.S. with 2 new trial sites. The company’s study is evaluating its OpRegen cell therapy in patients with advanced dry form age-related macular degeneration. The 2 U.S.-based trial sites will include ophthalmologists Dr. David Boyer from the Retina-Vitreous Associates Medical Group […]
Alimera, Brill Pharma ink exclusive distribution deal for Iluvien intravitreal implant
Alimera Sciences (NSDQ:ALIM) said today that it inked an exclusive distribution deal with Spain-based Brill Pharma for its Iluvien sustained-release intravitreal implant. According to the agreement, Brill Pharma will promote, market and commercialize the diabetic macular edema implant in Spain. It will also negotiate with the Spanish Ministry of Health on the implant’s public price and […]
Grassley questions Auvi-Q’s list price, while Trump shows support for Medicare drug-pricing reform
Although Mylan (NSDQ:MYL) has been under fire for its pricey EpiPen device since August last year, competitor Kaleo found itself garnering unwanted attention from politicians this week over the price of its epinephrine injection, Auvi-Q. Chairman of the Senate Judiciary Committee, Sen. Chuck Grassley (R-Iowa), wrote a letter to the Richmond, Virginia-based company asking CEO Spencer Williamson to explain […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
Tandem looks to raise $50m in public offering; shares fall despite Q4 earnings win
Shares in Tandem Diabetes Care (NSDQ:TNDM) fell today, although the medical device maker met expectations on Wall Street with its 4th quarter results. The San Diego-based company posted losses of -$15.7 million, or -48¢ per share, on sales of $24.8 million for the 3 months ended Dec. 31, for bottom-line loss of -40% on sales loss […]
PolyPid wins FDA designation for antibiotic drug reservoir
Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA. Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity. The D-Plex antibiotic drug reservoir is designed to prevent post-cardiac surgery sternal […]
Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide. The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm. “Respiratory is a core […]
