- Abbott announces its Pandemic Defense Coalition (worldpharmanews.com)
Abbott announced the formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind global scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. By connecting global centers of excellence in laboratory testing, genetic sequencing and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing and assess public health impact in real time...READ MORE
- Effective March 15: Joint Commission Returning to Unannounced Onsite Surveys (pharmacypracticenews.com)
As the COVID-19 caseload continues to dip across the country, at least one regulatory body—the Joint Commission (TJC)—has taken notice by stepping up its enforcement activities. The group is returning to unannounced, on-site surveys beginning March 15...“Over the last nine months, traditional onsite survey activity has been delayed or interrupted due to the restrictions and strain on the health care system caused by COVID-19,”...READ MORE
- Countering payers, drugmakers say net prices declined in 2020 (biopharmadive.com)
About half of gross drug sales earned by three large drugmakers in the U.S. are returned to insurers as rebates or discounts, the companies said in annual pricing reports that showed the net prices of their products declined last year when averaged across their businesses...In a report...Sanofi said its net price, or what it keeps after rebates and discounts have been factored, declined 7.8% in 2020, following earlier reports from Merck & Co. and Novartis, which reported drops of 0.9% and 0.5%, respectively...The disclosures from the companies contrast with reports from insurers and pharmacy benefit managers, which often focus on list, or wholesale, prices...READ MORE
- CVS to invest $12.4M in affordable housing in Phoenix (fiercehealthcare.com)
CVS Health is investing $12.4 million to build 60 units of affordable housing in south Phoenix...The development will be built in a neighborhood where 79% of residents identify as Black or Latino...The funding is part of CVS' commitment to invest $600 million over five years to address racial inequality and the social determinants of health in Black communities..."When people have access to high-quality, affordable housing and services like preventive screenings, it puts them in a better position to take care of their health and manage chronic disease," said David Casey, senior vice president and chief diversity officer at CVS Health...READ MORE
- Pfizer’s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report (fiercepharma.com)
About a month before Pfizer and BioNTech won an emergency nod for their COVID-19 vaccine in Europe, regulators raised flags about lower-than-expected levels of intact mRNA in commercial batches, the BMJ reports...The European Medicines Agency outlined “a significant difference" in the RNA in clinical batches and the proposed commercial batches, according to information leaked from an EMA cyberattack in December, which the BMJ subsequently reviewed...While the production issue has since been resolved—and Pfizer's vaccine has since won approval in Europe—the leaks show the “complexities of quality assurance” for mRNA vaccines, especially with regards to RNA instability, the BMJ said. It’s an issue that affects all mRNA developers, including Moderna and CureVac. That instability is the reason for the shots’ frigid cold chain requirements and the need to encapsulate mRNA in lipid nanoparticles, BMJ said...READ MORE
- AstraZeneca’s COVID-19 vaccine faces distrust in Europe, even as it gets rave reviews in neighboring UK, survey finds (fiercepharma.com)
AstraZeneca’s COVID-19 vaccine is facing a wave of mistrust in Europe—but that's a striking difference from its stellar reputation in the U.K...A recent survey from YouGov found that 81% of Britons believe the AZ vaccine is safe, on par with a similar 79% of U.K. citizens who trust the Pfizer vaccine. However, in Germany only 43% think the AZ vaccine is safe, and in France, just 33% consider it safe...READ MORE
- Washington State pharmacists retain “diagnosing” authority (pharmacist.com)
A December 2020 opinion issued by Washington Attorney General...affirmed pharmacists’ standard of practice under collaborative drug therapy agreements (CDTAs)...“[The opinion] clearly states that pharmacists working under CDTAs can identify and treat illness. This is reassuring news to practitioners who have developed practices that care for patients with these agreements,”...The opinion was a response to questions from the Washington State Medical Commission about whether pharmacists can diagnose patients pursuant to CDTAs—and if that constitutes unauthorized practice of medicine—and whether prescribers can enter CDTAs permitting pharmacists to diagnose patients...READ MORE
- Major European nations suspend use of AstraZeneca vaccine (apnews.com)EXPLAINER: Why countries are halting the AstraZeneca shot (apnews.com)
A cascading number of European countries — including Germany, France, Italy and Spain — suspended use of AstraZeneca’s COVID-19 vaccine Monday over reports of dangerous blood clots in some recipients, though the company and international regulators say there is no evidence the shot is to blame...The EU’s drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca shot and decide whether action needs to be taken...Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated...READ MORE
- Novartis’ Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first (fiercepharma.com)
Here's a hypothetical: What happens when the FDA grants exclusivity to a new drug ingredient that isn't exactly new?...Novartis' generics unit claims the agency did just that with Sanofi's multiple sclerosis med Aubagio—but the dispute isn't necessarily just about the New Chemical Entity exclusivity itself. That's no longer in force according to the FDA Orange Book. It's also about the 180-day exclusivity drugmakers win when they're first to file for copycat approval—and right now, 20 generics are poised to hit the scene simultaneously in 2023...READ MORE
- GlaxoSmithKline’s doctor payments double as relaxed policy plays out (fiercepharma.com)
GlaxoSmithKline payments to doctors are on the rise again, as its relaxed payment policy continues. It notched a 40% increase from $11 million in 2017 to more than $15 million in 2019 in the U.S., likely reflecting its loosening of a formerly strict physician payment policy...The company's 2016 policy...banned direct payments to doctors speaking on behalf of the pharma and contributed to a hefty drop in payouts from $30.6 million in 2016 to $11 million the following year, according to data from the U.S. Open Payments database. GSK’s tally dropped even further in 2018 to $8.9 million before increasing in 2019...READ MORE