- New Hampshire Passes Bill Allowing Pharmacist-Provided COVID-19 Vaccinations (drugtopics.com)
The state joins New York and Minnesota in providing COVID-19 vaccination access through pharmacy...New Hampshire has passed into law authorization for pharmacists to administer vaccinations for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)...once it becomes available...READ MORE
- Trump wants broader role for telehealth services in Medicare (apnews.com)
The Trump administration is taking steps to give telehealth a broader role under Medicare, with an executive order that serves as a call for Congress to make doctor visits via personal technology a permanent fixture of the program...The order President Donald Trump signed...applies to one segment of Medicare recipients — people living in rural communities. But administration officials said it’s intended as a signal to Congress that Trump is ready to back significant legislation that would permanently open up telehealth as an option for all people with Medicare...READ MORE
- Seqirus begins shipping 2020/21 influenza vaccines to U.S. market (chaindrugreview.com)Vaccine sales driven down by pandemic's effects on doctor visits Vaccine sales driven down by pandemic's effects on doctor visits (biopharmadive.com)
Seqirus announced Thursday it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world’s largest influenza vaccine companies and is well-positioned to supply up to 60 million doses* for the U.S. market this year, depending on demand...“Influenza vaccination is critical every year, and it is more important than ever this season as it can help reduce the risk of co-infection from seasonal influenza and COVID-19 and minimize the burden of flu on the healthcare system to preserve capacity for patients with COVID-19 and other serious disorders,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “Our cell-based and adjuvant vaccine technologies are designed to address influenza prevention challenges...against seasonal influenza.”...READ MORE
- Pharmacy groups tell HHS that any action on rebate rule must involve fixing pharmacy DIR fees (chaindrugreview.com)
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
- Next big COVID-19 treatment may be manufactured antibodies (reuters.com)
As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders - antibodies designed specifically to attack this new virus...Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease...READ MORE
- Appeals court upholds nearly 30% payment cut to 340B hospitals (fiercehealthcare.com)
A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program...The ruling...is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services announced back in 2017...340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs...HHS sought to address a payment gap between 340B and Medicare Part B, which reimburses providers for drugs administered in a physician's office such as chemotherapy. There was a 25% and 55% gap between the price for a 340B drug and on Medicare Part B...So HHS administered a 28.5% cut in the 2018 hospital payment rule. The agency also included the cuts in the 2019 payment rule...Three hospital groups sued to stop the cut, arguing that HHS exceeded its federal authority to adjust the rates to the program...READ MORE
- A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast (statnews.com)The coronavirus vaccine frontrunners are advancing quickly. Here's where they stand (biopharmadive.com)
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
- Special Report: COVID opens new doors for China’s gene giant (reuters.com)
As countries scramble to test for the novel coronavirus, a Chinese company has become a go-to name around the world...BGI Group, described in one 2015 study as “Goliath” in the fast-growing field of genomics research, is using an opening created by the pandemic to expand its footprint globally. In the past six months, it says it has sold 35 million rapid COVID-19 testing kits to 180 countries and built 58 labs in 18 countries. Some of the equipment has been donated by BGI’s philanthropic arm, promoted by China’s embassies in an extension of China’s virus diplomacy...But as well as test kits, the company is distributing gene-sequencing technology that U.S. security officials say could threaten national security. This is a sensitive area globally. Sequencers are used to analyse genetic material, and can unlock powerful personal information...READ MORE
- Some providers face daunting repayment deadline for Medicare advance loans (fiercehealthcare.com)
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
- Kodak Pharmaceuticals lands $765m US loan (outsourcing-pharma.com)
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