- Nevada’s revised COVID dashboard has better county-level details (reviewjournal.com)
Nevada launched an updated COVID-19 data dashboard...providing the public with more local data about the impact of the coronavirus...The dashboard contains county-level data about testing, cases, hospitalizations and deaths. For the first time, the data on the page can be downloaded...The Nevada Department of Health and Human Services compiles and updates the data daily. It can be accessed at nvhealthresponse.nv.gov...READ MORE
- Not so fast: FDA warns of ‘premature’ changes to COVID-19 vaccine dosing in clash with Slaoui (fiercepharma.com)
The FDA warns against changing the dosing levels and schedules of COVID-19 vaccines by Moderna and Pfizer-BioNTech...Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D...Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement...READ MORE
- Wisconsin hospital worker arrested for spoiled vaccine doses (apnews.com)
Authorities arrested a suburban Milwaukee pharmacist Thursday suspected of deliberately ruining hundreds of doses of coronavirus vaccine by removing them from refrigeration for two nights...Police...said the Advocate Aurora Health pharmacist was arrested on suspicion of reckless endangerment, adulterating a prescription drug and criminal damage to property, all felonies. The pharmacist has been fired and police said in a news release that he was in jail. Police did not identify the pharmacist, saying he has not yet been formally charged...His motive remains unclear. Police said that detectives believe he knew the spoiled doses would be useless and people who received them would mistakenly think they’d been vaccinated when they hadn’t...READ MORE
- U.S. government responsible for 68% of biopharma’s nonprofit and grant funding in 2020 (bioworld.com)
The amount of money flowing into the biopharma industry via grants and collaborations with nonprofit and government entities is a 272% increase over last year, with efforts to fight the COVID-19 pandemic accounting for 84% of the total for 2020...BioWorld has tracked 855 bio/nonprofit deals worth $14.66 billion and 630 grants awarded to the industry and valued at $12.72 billion for a combined total this year of 1,485 and $27.4 billion. Companies developing therapeutics and vaccines for the SARS-CoV-2 virus are the recipients of about $23 billion of those funds through 628 deals (42%)...READ MORE
- Las Vegas becomes third U.S. city with federally supported clinic offering COVID-19 antibody treatment (thenevadaindependent.com)
A new temporary clinic in Southern Nevada began administering COVID-19 antibody treatment on Friday, bringing new hope to lessen the severity of the virus and reduce the strain on local hospitals...Sunrise Hospital and Medical Center opened a Monoclonal Antibody Clinic with the support of the National Disaster Medical System and the U.S. Department of Health and Human Services. The clinic is expected to operate for four to six weeks but can be extended to match the community’s need...This is the third antibody infusion clinic in the country, with others opened in El Centro, California and Tucson, Arizona within the past two weeks...READ MORE
- Feds tell pharma companies to pony up 340B discounts, but it’s unclear whether they will (fiercepharma.com)
Several drug companies last year rolled out new rules on 340B-discounted medicines delivered through contract pharmacies, but the HHS Office of the General Counsel last week issued an advisory opinion stating the discounts must be offered regardless of where patients actually collect their meds...The opinion follows a months-long dispute between drug companies and 340B groups over the new restrictions. Drug companies have argued the 340B program has grown beyond its original intent and that contract pharmacies don't always pass discounts to patients. Some companies have started collecting de-identified claims data to ensure the program is working as intended, and others have prohibited discounts through contract pharmacies...READ MORE
- First antimicrobial drugs purchased via new ‘subscription’ payment model (pharmaceutical-journal.com)
The new model will pay pharmaceutical companies upfront for access to medicines based on their usefulness to the NHS...The...model aims to stimulate investment in the development of new antimicrobials...led by the National Institute for Health and Care Excellence, NHS England and NHS Improvement, will pay pharmaceutical companies upfront for access to medicines based on their usefulness to the NHS...two treatments, cefiderocol (Fetcroja) manufactured by Shionogi, and ceftazidime with avibactam (Zavicefta) manufactured by Pfizer, have become the first two drugs to be selected to move to an innovative health technology evaluation process as part of the payment system...READ MORE
- Look out, pharma. A ‘tidal wave’ of side effect reports is coming amid COVID-19 vaccine rollouts (fiercepharma.com)
With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow...With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said...All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview...READ MORE
- Fierce Pharma Politics—Judge blocks Trump’s ‘most favored nation’ drug pricing rule (fiercepharma.com)
On the drug pricing front, a major effort by the Trump administration to cut Medicare prices has been temporarily blocked by a federal judge...The president's "most favored nation" clause, which aims to tie drug prices in Medicare to lower prices abroad, has hit an early setback as a federal judge in Maryland ruled the administration didn't give the public a chance to weigh in...Judge Catherine Blake ruled the executive order was rushed unlawfully...After Trump moved to implement the measure in November, industry trade groups PhRMA and BIO sued to stop it. Blake's ruling is temporary and the Trump administration could still win the lawsuit...READ MORE
- UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger (biopharmadive.com)
The U.K.'s drug regulator has authorized a coronavirus vaccine from AstraZeneca and the University of Oxford, the first clearance for a shot viewed as critical to global immunization efforts but whose exact effectiveness is uncertain...The Medicines and Healthcare Products Regulatory Agency based its decision on positive data from studies in the U.K., Brazil and South Africa, which showed the shot was able to prevent symptomatic COVID-19 in a majority of vaccinated participants and protect against severe disease. The authorization comes less than a year after a team of Oxford researchers adapted pre-existing work on different coronaviruses to develop a shot for SARS-CoV-2...READ MORE