Category:

The COVID-19 pandemic is reshaping the global supply chain, and the Trump administration has a message for established generics drugmakers: Bring your manufacturing on shore, or we will find new companies that do...two recent contracts the U.S. government signed to bring drug manufacturing to American soil. But will companies follow?...The HHS’ Biomedical Advanced Research and Development Authority just inked a $354 million four-year deal with a company called Phlow to make generic medicine and active pharmaceutical ingredients in Virginia. The Department of Defense awarded a $138 million grant to ApiJect to expand U.S. production capability for prefilled syringes, following a $450 million deal the company won from the HHS...Both deals fall in the injectables category and involve significant investments to upgrade facilities and purchase future products. They both tap relatively new companies, which appear to be using innovative manufacturing technologies...Where does that leave traditional generic players such as Teva, Novartis’ Sandoz and Mylan? They may choose to join in...READ MORE

Johnson & Johnson says it's pulling its talc-based powders from the U.S. and Canadian markets. But the move comes as the drugmaker faces thousands of personal injury lawsuits over the product's safety—and as demand has fallen due to years of publicity about the legal fight...In response to the COVID-19 pandemic, J&J stopped shipping certain products—including its iconic baby powder—back in March to allow its factories to make high-demand medicines and to allow workers to spread out for social distancing reasons, the company said in a statement...Now, it's permanently discontinuing about 100 products, including its talc-based powders...READ MORE

U.S. President Donald Trump’s administration awarded a contract worth up to $812 million for a new U.S. company to manufacture drugs and drug ingredients to fight COVID-19 on American soil, aiming to end dependence on other countries...The administration has been looking to build up the ability to produce drugs and their raw materials in the United States after the global pandemic exposed the industry’s dependence on China and India for its supply chain...The U.S Department of Health and Human Services said it had awarded a four-year, $354 million contract to privately-held Phlow Corp to make COVID-19 drugs, other essential drugs and their ingredients. The contract - which is for generic drugs, not more complicated products like vaccines - can be extended to a total of $812 million over 10 years...READ MORE

Federal prosecutors turned up the heat in recent months on a generic price-fixing probe that targeted some of the industry's biggest players before COVID-19 slowed the hunt. Teva, the biggest target in that investigation, has reportedly bailed on settlement talks in a decision meant to test the government's resolve...Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it's part of the COVID-19 pandemic response...Teva is betting that its role in aiding the U.S. coronavirus response, including donating millions of doses of antimalarial hydroxychloroquine sulfate to hospitals, will put the Justice Department in a bind on its decision to file charges...READ MORE

The U.S. Centers for Disease Control and Prevention has issued a 60-page document that provides detailed suggestions for different phases of reopening workplaces, schools and restaurants, after an earlier draft was rejected by the White House for being too prescriptive...The document, which expands on several tools the agency released last week to guide specific types of organizations, was posted on the CDC website over the weekend without fanfare. The guidelines are similar to ones included in the draft, though they pertain to fewer types of businesses and are less restrictive...READ MORE

When retired Navy Chief Petty Officer Richard Gray and his wife, Sheila, were able to go to the Nellis Air Force Base pharmacy, they picked up their prescriptions with full coverage and no copayment...But now their only option is off base, and the 16 medications they take between them cost upward of $2,000 a month out of pocket at Walgreens...Under the base’s public health emergency called on April 3 and renewed May 4 in response to the coronavirus outbreak, only uniformed members and their dependents and essential civilian contract employees are allowed on base, including the pharmacy...The Nellis pharmacy was placed off limits for retirees on April 10, leaving thousands of local military widows and retirees, many of them living on fixed incomes, locked out of the no-cost medication to which they are entitled. Now they are subject to copays that can quickly add up to hundreds of dollars...READ MORE

Moderna announced new interim clinical data results for its coronavirus disease 2019 (COVID-19) vaccine candidate from a phase 1 study...The investigational vaccine, called mRNA-1273, was launched...on March 16, making it the first trial to be started in humans for a vaccine for this virus...Tal Zaks, MD, PhD, chief medical officer at Moderna, said in a statement. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”...Moderna expects to begin its phase 3 study in July 2020...READ MORE

Gilead Sciences’ initial donation of remdesivir will be exhausted by early summer. The biotech will start charging for the drug in COVID-19 after that, and it might not be just a year or two of revenue flow...The company will pivot to a commercial plan after the donated supply of 1.5 million doses runs out around June or early July...The Institute for Clinical and Economic Review recently found remdesivir would be cost-effective at $28,670...But the U.S. drug cost watchdog argued that $50,000/QALY should be applied to remdesivir during a public health emergency. After that calculation, ICER pegged a reasonable price at $4,460...READ MORE

The chief scientist brought on to lead the Trump administration’s vaccine efforts has spent the last several days trying to disentangle pieces of his stock portfolio and his intricate ties to big pharmaceutical interests, as critics point to the potential for significant conflicts of interest...Moncef Slaoui, is a venture capitalist and a former longtime executive at GlaxoSmithKline. Most recently, he sat on the board of Moderna...He resigned when President Trump named him last Thursday to the new post as chief adviser for Operation Warp Speed, the federal drive for coronavirus vaccines and treatments...In agreeing to accept the position, Dr. Slaoui did not come on board as a government employee. Instead, he is on a contract, receiving $1 for his service. That leaves him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. And the contract position is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow...READ MORE

Rapid coronavirus disease 2 (COVID-19) testing, contract tracing, and preparing for vaccines and treatments are the 3 key priorities as the United States reopens, NACDS said in a new report...Pharmacies: A Vital Partner in Reopening America...The organization also urged that additional steps should be taken to ensure that pharmacists and pharmacies are fully utilized to support this national effort...READ MORE