Author: Peter

The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 vaccine warrants limiting its use to adults who either can’t or won’t get another available shot...The agency is taking stricter measures following a new analysis...has uncovered 60 known cases of the side effect, nine of which were fatal. The overall rates remain very low — about 3.23 cases per million vaccinations with J&J’s shot and 0.48 deaths per million. Regulators still aren’t sure exactly which factors put people at risk for the disorder, which initially appeared most common in younger women. It isn’t associated with either Pfizer’s or Moderna’s vaccines...READ MORE

The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies - Hutchmed Ltd - needs to test its drug for the U.S. population in a diverse multi-regional trial...This is the second time the U.S. regulator has declined to approve a drug that was tested mainly in China. In March, it declined to approve Eli Lilly and partner Innovent Biologics Inc's lung cancer drug that had been studied only in China...Coherus BioSciences Inc and Chinese partner Shanghai Junshi Biosciences Co Ltd said the FDA indicated their China-only trial may be sufficient for its cancer drug, toripalimab, but declined to approve it over quality processes...READ MORE

The Equitable Community Access to Pharmacist Services Act (H.R. 7213) is legislation to help ensure that patients can receive point-of-service testing, treatment, and vaccine services provided by pharmacists for COVID-19, influenza, respiratory syncytial virus, and strep throat. ASHP, as an executive committee member of the Future of Pharmacy Care Coalition, is working aggressively to secure congressional support for H.R. 7213. You can help by sending an email to your representative asking them to co-sponsor the bill. Personalize the email provided in ASHP’s online advocacy center with examples from your practice that demonstrate your critical role on the healthcare team...READ MORE

It was a good year to be a pharmaceutical company, especially one that came up with a product to combat COVID-19. Of the world’s top 20 pharmas ranked by 2021 revenues, 12 had at least 10% growth, including five that saw their sales boom at least 40%...No company pulled in more revenue from COVID products than Pfizer. Fueled by Comirnaty, Pfizer nearly doubled its top line.Johnson & Johnson needed a healthy 14% increase in revenue to stay comfortably in front of Pfizer and remain in the top spot, where it has resided since 2012. But that reign is in jeopardy this year, as Pfizer is projecting combined sales of $54 billion from Comirnaty and its oral COVID-19 treatment, Paxlovid...READ MORE

A federal judge in Las Vegas said Monday he’ll decide in three weeks whether to dismiss a condemned Nevada killer’s lawsuit challenging the state’s plan for his lethal injection, because the state doesn’t have one of the drugs it would use...U.S. District Judge Richard Boulware II acknowledged during a brief hearing with attorneys for the state and the inmate, Zane Michael Floyd, that key questions about the execution method remain unanswered following weeks of testimony late last year...But the Nevada Department of Corrections supply of the sedative ketamine expired on Feb. 28, and Randall Gilmer, chief deputy state attorney general, said prison officials have been unable to get more...READ MORE

List prices of branded drugs in the U.S. rose by an average of nearly 5% last year, according to a report released...by Iqvia, a consultancy and research services provider. After accounting for the rebates and discounts pharmaceutical companies often pay insurers, however, the average increase was 1%, the fifth year in a row that net price growth has tracked below general inflation...Rebates and discounts on drugs don't necessarily translate to lower out-of-pocket costs for patients, and some, such as people covered by Medicare Part D or on high-deductible insurance plans, are more vulnerable to rising list prices, often referred to as a drug's wholesale acquisition cost...READ MORE

The petition, going to Senator Catherine Cortez Masto and Jacky Rosen, pleads Congress to take action...Both Senators have cosponsored legislation to cap out-of-pocket insulin costs at $35...Senators Cortez Masto and Rosen also support giving Medicare more power to negotiate drug prices, and they are pushing for penalties that would keep drug companies from increasing prices faster than the rate of inflation..."I've seen it in my own family with my grandmother who had to make the decision whether she could put food on the table or pay for her drugs," said Senator Cortez Masto. "She was living off of Social Security after she retired. No senior, nobody should have to go through that."...READ MORE

Law firm Kessler Topaz Meltzer & Check LLP on Sunday said it had filed a securities class action lawsuit against pharmaceutical company Natera Inc on behalf of shareholders...The law firm said the main justification for the lawsuit filed in the U.S. district court of the Western district of Texas was that Natera, which specializes in genetic testing and diagnostics, provided information about the efficacy of its tests that have not proved accurate..."Natera said that its tests are much more reliable than it appears they really are," Kessler Topaz said in the statement...READ MORE

Self-Administered Hormonal Contraceptives Dispensed Without a Prescription

Senate Bill (SB) 190 was passed during the 2021 legislative session. The language to the bill can be located here. SB 190 permits a pharmacist to dispense a self-administered hormonal contraceptive to a patient under a protocol established by regulation by the Nevada State Board of Pharmacy without a prescription from a practitioner.

Nevada Medicaid Fee-for-Service Transition of Pharmacy Benefits Management to Magellan Medicaid Administration, Inc

On July 1, 2022, Magellan Medicaid Administration, Inc, (MMA) will assume the administrative operation of pharmacy benefits management on behalf of the state of Nevada Department of Health and Human Services, Division of Health Care Financing and Policy for the Nevada Medicaid fee-for-service...READ MORE

Cannabis is illegal federally – classified as a Schedule I controlled substance – but even state law, despite cannabis being legal to use in Nevada, maintains cannabis as a Schedule I drug alongside methamphetamine, heroin and cocaine...The Nevada State Board of Pharmacy continues to list cannabis as a Schedule I substance, and that listing prompted a lawsuit this week by the ACLU of Nevada seeking to get cannabis removed from the list...“For cannabis to be classified as a Schedule I substance, the Board of Pharmacy must find that it has no accepted medical use in treatment or it cannot be safely distributed to the public,” ACLU representatives said. “However, the Nevada Constitution explicitly allows for the ‘use by a patient, upon the advice of his physician, of a plant of the genus Cannabis for the treatment or alleviation of cancer, glaucoma, acquired immunodeficiency syndrome… or other chronic or debilitating medical conditions.’”...The ACLU alleges the pharmacy board’s classification continues to waste taxpayer dollars by continuing criminal convictions against those using and possessing cannabis...READ MORE