Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the biopharmaceutical company missed earnings expectations, but beat sales estimates on Wall Street with its 4th quarter results. The Bedford, Mass.-based company posted losses of -$-12.8 million, or -52¢ per share, on sales of $0.5 million for the 3 months ended Dec. 31, for bottom-line loss of -20.5% on […]
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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 […]
Medtronic launches DCB clinical trial for below-the-knee peripheral artery disease
Medtronic (NYSE:MDT) said today that it launched a clinical trial to evaluate the use of its In.Pact paclitaxel-coated percutaneous transluminal angioplasty balloon catheter in patients with below-the-knee peripheral arterial disease. The company treated its 1st patient in the In.Pact BTK study, performing the procedure on a patient with critical limb ischemia. “The 1st patient enrollment in […]
PolyPid touts early data for BonyPid-1000 antibiotic-eluting bone substitute
PolyPid touted interim data today from the 1st group of patients to reach the 6-month follow-up period in the clinical trial of its BonyPid-1000 doxycycline-eluting synthetic bone substitute. The Israel-based company’s clinical trial enrolled 64 patients with open tibia fractures. In this type of fracture, the bone is severely damaged and exposed, leaving it vulnerable […]
Stem cell transplants could improve insulin independence in T1D
Researchers from the City of Hope demonstrated that some patients with Type I diabetes can be cured, at least temporarily, with a stem cell transplant. The team’s work was published in Frontiers in Immunology. The trial enrolled 21 patients and found that autologous hematopoietic stem cell transplantation increased C-peptide levels and induced insulin independence in patients with […]
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 […]
Novo Nordisk approaches Global Blood Therapeutics for possible takeover
Insulin giant Novo Nordisk (NYSE:NVO) has reportedly approached Global Blood Therapeutics (NSDQ:GBT) to discuss a possible takeover. The U.S. biotech is reviewing its options with an investment bank, according to Reuters, and there is no guarantee that it will enter formal negotiations with Novo Nordisk. Global Blood Therapeutics is developing GBT440, a once-daily, oral therapy to treat […]