Alkermes, Inc Receives FDA Warning Letter
Enforcement Report - Week of October 9, 2019
Enforcement Report - Week of September 4, 2019
This is not an industry that tends to learn much from its cautionary tales.
Elliot Ehrich, M.D., who capped an 18-year career at Alkermes in January, has joined Expansion Therapeutics as its chief medical officer. The company closed a $55.3 million series A round in January to advance a pipeline targeting disease-driving RNAs.
Alkermes plc has expanded its ongoing phase 1 study for ALKS 4230, the company's immuno-oncology drug candidate, to evaluate its safety and anti-tumour activity when administered in combination with the FDA-approved PD-1 inhibitor Keytruda (pembrolizumab) in patients with advanced solid tumours. ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumour-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumour response. Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells.
LOS ANGELES (Reuters) - A new front in the battle over the cost of expensive medicines in the United States is opening up in Oklahoma, the first state where the government’s Medicaid program is negotiating contracts for prescription drugs based on how well they work.
Alkermes has three key catalysts ahead for the company that could significantly alter the perceived value of the company.
A single shot of Vivitrol, given in the buttocks, lasts for four weeks and eliminates the need for the daily doses common with alternatives such as methadone. But each shot costs as much as $1,000, and because the drug has a limited track record, experts do not agree on how well it works.