The EMA’s human medicines committee (CHMP) Monday recommended expanding the compassionate use of Gilead Sciences Inc.’s remdesivir so more patients with severe COVID‑19 can be treated with the investigational drug. Based on preliminary results from a U.S. NIH trial, CHMP advised that, in addition to patients undergoing invasive mechanical ventilation, the EU’s compassionate use of the drug should cover the treatment of hospitalized patients requiring supplemental oxygen, noninvasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation.
Although the 21st Century Cures Act was enacted in December 2016, the U.S. Department of Health and Human Services (HHS) has yet to use the new authorities it received under the act to recruit and retain scientists, according to a Government Accountability Office (GAO) audit released Friday. Those authorities enable HHS agencies – such as the FDA, NIH and CDC – to offer higher salaries to 1,500 more scientists. Last month, HHS finally issued regulations to guide the implementation of those recruitment and retention authorities, and it’s now preparing guidance on allocating the additional scientist slots for each agency. NIH and FDA officials told the GAO that they would begin their recruitment and retention process after they receive their slots. It could take up to six months to fill those slots at the FDA. Since the Cures Act was passed, the FDA and NIH have continued to struggle to fill vacancies and retain staff, since the private sector pays doctors and other scientists much more. In fiscal 2017, for instance, the FDA had a 14% job vacancy rate at two of its centers while other government agencies experienced vacancy rates of 5% to 7%. That same year, the Milken Institute reported that the FDA had “substantial staffing shortfalls, with more scientists going to the private sector, where the salaries are higher, than to government positions,” the GAO said.
The U.S. Court of Appeals for the Federal Circuit last week ruled that, due to how Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., drafted patents for Belrapzo (bendamustine), it dedicated the use of ethanol to the public by disclosing, but not claiming, ethanol as an alternative solvent to propylene glycol in the claimed composition for the leukemia/lymphoma drug. The ruling affirms a lower court decision that found Slayback Pharma LLC’s application for a generic version of the drug didn’t infringe Eagle’s patents with its use of ethanol. Eagle had argued infringement based on the doctrine of equivalents, but the Federal Circuit agreed with the Princeton, N.J.-based Slayback that the “disclosure-dedication doctrine bars application of the doctrine of equivalents.” Eagle asserted that the specification didn’t disclose ethanol as an alternative when discussing the claimed antioxidant formulations; it only disclosed it in discussing unclaimed chloride salt formulations. That’s not how the appellate court reads the claim. “Nothing in the specification suggests that these repeated disclosures of ethanol are limited to certain formulations, or that they do not extend to the claimed formulation,” the court said in its precedential decision.
Resolving a felony charge of price-fixing, Apotex Corp., part of Toronto-based Apotex Inc., agreed last week to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug companies to artificially raise the price of pravastatin, a cholesterol drug. As part of the 2013-2015 price-fixing scheme, Apotex communicated with competitors about the price increase and refrained from submitting competitive bids to customers that had previously purchased pravastatin from another company, according to the U.S. Department of Justice (DoJ). Apotex is the fourth generic drug company to be charged in an ongoing DoJ investigation into price fixing, bid rigging and other anticompetitive conduct in the generic drug industry; four individuals also have been charged. In addition, more than 40 states have filed a lawsuit against several generic companies alleging price fixing.