About pharma
GAO Shines Spotlight on Dearth of Antibacterial and Antifungal Treatments: “There aren't enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such candidates, the Government Accountability Office (GAO) reported.
Thus far, economics have been an issue. Since the population who needs these drugs is very limited, drug companies can’t recoup their high drug development costs through sales, which has resulted in few drugmakers willing to fund development of such candidates, GAO found.”
Jury holds pharmacies responsible for role in opioid crisis: “Three retail pharmacy chains recklessly distributed massive amounts of pain pills in two Ohio counties, a federal jury said Tuesday in a verdict that could set the tone for U.S. city and county governments that want to hold pharmacies accountable for their roles in the opioid crisis.
The counties blamed pharmacies operated by CVS, Walgreens and Walmart for not stopping the flood of pills that caused hundreds of overdose deaths and cost each of the two counties about $1 billion, their attorney said.”
Prevalence of Medications That May Raise Blood Pressure Among Adults With Hypertension in the United States: “In total, 14.9% (95% CI, 14.1%-15.6%) of US adults reported using medications that may cause elevated BP, including 18.5% (95% CI, 17.5%-19.5%) of adults with hypertension. The most commonly reported classes were antidepressants (8.7%; 95% CI, 8.0%-9.5%), prescription nonsteroidal anti-inflammatory drugs (NSAIDs) (6.5%; 95% CI, 5.8%-7.2%), steroids (1.9%; 95% CI, 1.6%-2.1%), and estrogens (1.7%; 95% CI, 1.4%-2.0%).”
STATEMENT ON UCB RESTRICTING 340B DISCOUNTS THROUGH COMMUNITY-BASED PHARMACIES: “The global drug company UCB has announced that it will stop providing 340B discounts to hospitals on drugs dispensed at community-based pharmacies starting Dec. 13. This development makes UCB the ninth drug company to impose restrictions on 340B pricing through community pharmacies.”
Novartis may have a buyer for $21B generics unit Sandoz: report: “Swedish-based investment group EQT and the Struengmann family of Germany are considering a joint move to purchase the generics outfit for $21.6 billion, according to German newspaper Handelsblatt.
The price would make it the largest pharma deal of the year. EQT and the Struengmanns, who provided the investment power behind BioNTech, have attracted interest from other private equity investors to join the group, the outlet reported.”
EMA listing shows Biogen previously pulled Aduhelm from PRIME scheme: “According to a listing on the European Medicines Agency's (EMA) website, the PRIME designation for Biogen's Alzheimer's disease drug Aduhelm (aducanumab) was withdrawn at the company's request. The treatment, which is currently under review in the EU, was initially accepted for the PRIME programme in 2016…
Last week, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a "negative trend vote" on the Aduhelm filing, suggesting the drug is unlikely to secure European approval…”
In a related article: Amyloid-Related Imaging Abnormalities [ARIA] in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease: “In an integrated safety data set of 2 phase 3 clinical trials (EMERGE and ENGAGE) including 3285 participants, 425 patients (41.3%) in the combined 10 mg/kg aducanumab group (n = 1029) experienced ARIA; ARIA-edema occurred in 362 patients (35.2%), and 94 of these patients (26.0%) experienced associated symptoms (eg, headache, confusion, dizziness, and nausea). ARIA-microhemorrhage and ARIA–superficial siderosis occurred in 197 patients (19.1%) and 151 patients (14.7%), respectively.
Meaning Amyloid-related imaging abnormalities occurred in approximately 40% of participants in the phase 3 studies of aducanumab, and approximately one-quarter of these patients experienced symptoms.”
About the public’s health
Smoking Cessation in Stroke Survivors in the United States: A Nationwide Analysis: “Among 4 434 604 Americans with a history of stroke and smoking, the median age was 68 years (interquartile range, 59–76), and 45.4% were women. The overall quit ratio was 60.8% (95% CI, 60.1%–61.6%). Quit ratios varied by age group, sex, race and ethnicity, and several geographic factors. There was marked geographic variation in quit ratios, ranging from 48.3% in Kentucky to 71.5% in California. Furthermore, compared with cancer survivors, stroke survivors were less likely to have quit smoking (odds ratio, 0.72 [95% CI, 0.67–0.79]) after accounting for differences in demographics and smoking-related comorbidities.”
About health insurance
BMA: Plans offering extra Medicare Advantage supplemental benefits grow by 43%: “The number of Medicare Advantage plans offering at least one of five recently expanded supplemental benefits increased by 43% from 2021 to the 2022 coverage year, a new analysis finds.
The findings, released Thursday by the Better Medicare Alliance (BMA), come as supplemental benefits not offered by traditional Medicare have become a popular tool by insurers to market MA plans, an increasingly lucrative space for the industry.
Overall, MA plans that offered at least one of the five expanded benefits increased from 575 in 2021 to 824 for 2022, according to the analysis conducted by consulting firm Milliman.”
CVS Health to Invest $7.7 Million in Affordable Housing in Tampa: “CVS Health announced it will invest $7.7 million with Raymond James Tax Credits Funds to build a 61-unit multifamily apartment home development called Uptown Sky for families in Tampa. This investment is part of the company's commitment to address racial inequity and social determinants of health in underserved communities.”
About Covid-19
Judge declines Florida request to block federal mandate for healthcare workers: “A federal judge has denied Florida's request to block a CMS rule requiring vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs, according to court documents.
In an 11-page order issued Nov. 20, U.S. District Judge M. Casey Rodgers wrote that the court found ‘no showing of irreparable injury’ to support a preliminary injunction or temporary restraining order against the federal rule.”
Biden administration lays out some agency vaccination rates: “More than 90 percent of 3.5 million federal employees covered by the Biden administration’s vaccine mandate have received at least one dose, and a ‘vast majority’ of those have been fully vaccinated, White House coronavirus response coordinator Jeff Zients said at a news conference Monday.
The figure is high compared with the approximately 59 percent of the general population that is fully vaccinated…”
About hospitals and health systems
Ascension's net income dips by more than $1B in Q1: “St. Louis-based Ascension posted net income of $80.4 million in the three months ended Sept. 30, a more than $1 billion decrease from the same period last year, according to its quarterly financial report. The large decrease was largely driven by a drop in nonoperating gains, which totaled $79.7 million in the first quarter of fiscal year 2022 and $1.2 billion in the same quarter one year prior…
Ascension's operating expenses rose to $6.9 billion in the first quarter of fiscal 2022, a 6.4 percent increase from the same period in fiscal 2021. Expenses rose in all categories except interest.”
About healthcare personnel
Harris announces $1.5B investment in health care workforce: “Vice President Kamala Harris announced Monday that the Biden administration is investing $1.5 billion from the coronavirus aid package to address the health care worker shortage in underserved communities.
The funding will go to the National Health Service Corps, Nurse Corps and Substance Use Disorder Treatment and Recovery programs, all federal programs that offer scholarship and loan repayments for health care students and workers if they pledge to work in underserved and high-risk communities.”