Author: Peter

Health care companies and insurers were among the biggest spenders of the 2020 campaign cycle, shelling out more than $1 million on legislative campaigns over the two year period...That marks a sharp increase over the 2018 cycle, which saw just $744,000 in combined legislative campaign contributions from the industry...The Nevada Independent categorized and analyzed more than 7,700 individual contributions of more than $200 made to sitting Nevada lawmakers in 2019 and 2020...These contributions capture nearly all campaign spending throughout the two-year cycle, and more broadly show to whom the largest contributions flowed and how much those contributions were worth in the aggregate...not included is roughly $272,000 contributed by pharmaceutical companies. That fundraising total is large enough to justify a separate category in The Nevada Independent’s Follow the Money series, and a full breakdown of pharmaceutical campaign spending will be included in a later installment...READ MORE

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

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 That's no longer in force according to the FDA Orange Book.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 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

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

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

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

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 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