Category:

Hospital groups are imploring either the Centers for Medicare & Medicaid Services or Congress to step in and help providers facing loan repayments happening as soon as Aug. 1...The...deadline has sparked concerns from some experts and hospital groups that worry providers couldn’t afford to lose out on Medicare revenue as they combat revenue losses caused by the pandemic. While the program was intended to be a short-term solution, COVID-19 surges are proving that is not the case for some hospitals...At the onset of the pandemic in March, the Centers for Medicare & Medicaid Services extended the advance payment program, which has been used previously to help providers beset by disasters...CMS had given out $100 billion of loans before suspending the program...The goal behind the program is to help providers stay afloat and was meant to be a short-term solution, as repayment starts 120 days after a provider gets the first payment...READ MORE

The country’s leading pharmacy groups said that any action on a prescription drug rebate rule must address skyrocketing fees extracted by pharmacy benefit managers on behalf of plan sponsors in Medicare Part D...“We remind the Administration of the continuous and heightened impact of pharmacy DIR fees imposed by Medicare Part D plan sponsors and their pharmacy benefit managers (PBMs) on our members. Pharmacy DIR fees are growing beyond CMS’ projection of 10% year-over-year...“If pharmacy DIR fees are not addressed in a forthcoming rebate rule, the impact on our members and their ability to care for patients in such a system will prove detrimental...READ MORE

Drug companies refused to attend a White House meeting on drug prices...President Donald Trump seems to have hit a nerve with his Friday executive orders on drug pricing. As drug companies work to battle the pandemic, executives declined to attend a White House meeting today on drug prices...When he touted the executive orders Friday, the president said Tuesday's meeting would facilitate talks with pharmaceutical executives on an issue important to many Americans. But the major industry trade groups declined to send representatives...Industry representatives weren't sure it would have been a "productive meeting,"...READ MORE

...Moderna will begin the first clinical trial of its kind, a massive placebo-controlled study to definitively determine whether an experimental vaccine can thwart the disease caused by the novel coronavirus...four other like-sized trials from other coronavirus vaccine developers are also expected to begin in the U.S. Combined, they are looking for a specific group of about 150,000 total volunteers, and aiming to amass enough information from them within months to back potential approvals for emergency use...Other, similarly large trials have been run before to test vaccines. But never have so many been done, simultaneously, for the same disease during a pandemic. Those factors make for one of the most logistically challenging research initiatives in history...READ MORE

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19...The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits...Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far...READ MORE
A familiar family
An acute, not chronic infection
Cutting-edge approaches
Money, money, money
Regulatory nimbleness
The challenges ahead

AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements...With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations...“This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters...READ MORE

The Southern Nevada Health District released data Monday showing an alarming uptick in deaths in Clark County involving fentanyl — despite opioid deaths falling in the last five years...According to the data, in just half a year, the county nearly tied the number of fentanyl deaths for all of 2019...Between January and July, amid the statewide shutdown triggered by the COVID-19 pandemic, fentanyl killed 63 people in Clark County, a 125 percent increase from the 28 deaths seen last year during the same time, according to the health district...Fentanyl is cheap, easy to find, and, the Drug Enforcement Administration has said, is often added to other drugs to increase potency...“Many users believe that they are purchasing heroin and actually don’t know that they are purchasing fentanyl – which often results in overdose deaths,” according to the DEA...READ MORE

The Eastman Kodak Co. (traditionally associated with cameras, film, printers and other imaging technology) announced the launch of its new Kodak Pharmaceuticals arm, which will produce various pharmaceutical ingredients. The $765m funding is the first action occurring under the president’s executive order, which authors the International Development Finance Corp. (DFC) and Department of Defense (DoD) to collaborate on COVID-19 response...”Kodak is stepping up to help onshore pharmaceutical production and this DPA action will allow the modernized Strategic National Stockpile to have domestic resiliency. Once Kodak ramps up we will have the ability to tap into that capacity for domestic use​."...READ MORE

Chinese government-linked hackers targeted biotech company Moderna Inc... earlier this year in a bid to steal valuable data...the U.S. Justice Department made public an indictment of two Chinese nationals accused of spying on the United States, including three unnamed U.S.-based targets involved in medical research to fight the COVID-19 pandemic. The indictment states the Chinese hackers “conducted reconnaissance” against the computer network of a Massachusetts biotech firm known to be working on a coronavirus vaccine in January...READ MORE

The National Institutes of Health is preparing to launch a “flurry” of large clinical trials to test new approaches to treating Covid-19, according to the agency’s director, hoping to expand what for now remains a limited arsenal of therapies to help people with the disease...Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines...READ MORE