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A third member of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has resigned in protest over the agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease...As was reported yesterday, two members, David S. Knopman...and Joel S. Perlmutter...resigned in protest earlier this week...Now, Aaron Kesselheim...has stepped down...“My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees … because I didn’t think that the firm recommendations from the committee in this case … were appropriately integrated into the decision-making process,” Kesselheim told Reuters...READ MORE

The Bureau of Labor Statistics has recently released its employment and salary data for 2020. That means it’s time to update Drug Channels Institute’s annual analysis of pharmacist salaries and employment...We have found that the share of pharmacists who work at hospitals reached a new high. What’s more, average base salaries for retail pharmacists have dropped, while salaries have risen for pharmacists employed by hospitals, physician offices, and other non-retail settings...READ MORE

Bristol Myers Squibb Co was sued for $6.4 billion...allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019...According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required "diligent efforts" to win U.S. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec. 31, 2020, deadline...By missing the deadline, Bristol Myers was excused from owing an additional $9 in cash to Celgene shareholders for each share they held, enabling it to acquire Celgene at an "enormous discount" and enjoy a "windfall," the complaint said...READ MORE

The Institute for Clinical and Economic Review, a nonprofit and frequent critic of drugmakers for excessively high drug prices, now plans to assess how health insurance policies harm patient access to care...This follows research by the group that argued cost-sharing should not be structured to shift healthcare costs to patients when they have no medically appropriate lower-cost option...ICER's review will not, however, look at whether cost-sharing should be reduced for drugs on which payers receive large rebates or whether payers should be asked to demonstrate how their policies on drug access save overall healthcare costs...READ MORE

State lawmakers in Oregon have tried to lower high drug prices from nearly every angle: They’ve sought to cap how much people can pay for insulin, install a panel that could determine how much state agencies should pay for medicines, and even import drugs in bulk from Canada. Nearly every proposal has failed...One reason, at least according to the effort’s supporters: Two-thirds of the state legislature accepted at least one campaign check from the drug industry during the 2020 election cycle...READ MORE

A former pharmacist in Wisconsin who intentionally tampered with more than 500 doses of a COVID-19 vaccine was sentenced to three years in prison on Tuesday. Steven Brandenburg, 46, pleaded guilty in February to two felony counts of attempting to tamper with a consumer product...He had admitted to intentionally removing the doses manufactured by Moderna from a refrigerator for hours at Aurora Medical Center in Grafton, located just north of Milwaukee...READ MORE

News continues to come out about COVID-19, including support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination. Here’s a look...READ MORE

• WHO Creates Naming System for COVID-19 Variants
• Scientists Support Full Investigation of Viral Leak Theory
• US Companies Can Legally Mandate Vaccinations
• New Variant from Vietnam is Highly Contagious
• Moderna Initiates Rolling Submission to FDA for Full Approval of COVID-19 Vaccine

Other recommendations include boosting local production, promoting research and development, and creating robust quality management maturity...The White House and several federal agencies...released a series of policy recommendations for addressing the vulnerabilities in U.S. pharmaceutical supply chains...The review came in response to an executive order signed by President Joe Biden...that directed the government to identify risks, address vulnerabilities and develop a strategy to promote supply chain resilience throughout sectors...READ MORE

Moderna is hard at work ramping up production of its mRNA COVID-19 vaccine, which is projected to reap over $19 billion for the company by year’s end. But given that the pandemic is easing in parts of the world, what’s less certain is how 2022 will play out…After a breakout year, Moderna sees strong reason to believe 2021 won't be a one-off boom year. That's thanks to the predicted need for booster shots and additional supply deals coupled with stronger pricing power…READ MORE

The U.S. Supreme Court...declined to hear Johnson & Johnson’s bid to overturn a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in the company’s baby powder and other talc products ...The justices turned away a J&J appeal and left in place a Missouri state court ruling in litigation brought by 22 women whose claims were heard together in one trial...READ MORE