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A federal judge found drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies...But a separate ruling found that manufacturers don’t have to provide discounts...The opinions...are the latest in a legal fight between six drugmakers and the Biden administration over whether they must offer discounted products to contract pharmacies. Federal judges issued separate rulings in lawsuits filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics...READ MORE

...Johnson & Johnson has made sweeping moves to resolve a mountain of litigation involving the safety and marketing of its opioid and talc products...J&J revealed it has settled liability claims surrounding its antipsychotic drug Risperdal...The agreement resolves approximately 9,000 cases the company faced from those who claimed Risperdal caused breast tissue development in males, a condition called gynecomastia...READ MORE

When posed with the decades-old question of how drug price reform would affect their operations in the U.S., pharma execs have a ready-made response: Reducing drug prices would hinder innovation...While Eli Lilly CEO David Ricks falls in line with the mantra, he bolsters his case with a cautionary example, pointing to Europe and the effect government pricing regulations have had there...“In the 80s and 90s, this was a European industry,” Ricks said in an interview. “Eighty percent of global R&D was happening on the European continent and today it’s less than 20. Where’s that going? It’s gone to America.”...READ MORE

The Centers for Disease Control and Prevention has given its go-ahead for the use of Moderna's and Janssen's COVID-19 vaccines as booster shots...after their initial series as well as the approval of mixing and matching vaccines...READ MORE

A state attorney asked a federal judge Friday for a quick hearing and ruling about the constitutionality of Nevada’s execution procedure, saying a drug that officials want to use for condemned killer Zane Floyd’s lethal injection will expire in late February...“We need to continue to expedite this case,” Chief Deputy Nevada Attorney General Randall Gilmer told the judge, who plans at least three days of hearings this month and possibly more next month amid challenges by Floyd’s attorneys of the method, the personnel and the drugs that would be used to kill him...Floyd, a convicted mass killer, is fighting on several fronts to avoid becoming the first Nevada inmate put to death in 15 years...READ MORE

Officials with the FDA have authorized the COVID-19 vaccine from Pfizer and BioNTech for use in children 5 through 11 years of age, based on submitted data and an advisory committee recommendation...the vaccine’s safety was evaluated in approximately 3100 children who received the vaccine. No serious adverse effects were detected in the ongoing study, according to the press release...approximately 8300 cases in children 5 through 11 years of age resulted in hospitalization, and as of October 17, 2021, 146 deaths from COVID-19 have been reported in the United States in this age group...READ MORE

Testimony revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo despite Pfizer’s decline to partner with the startup blood-testing company...The ongoing criminal trial of Holmes revealed the misrepresentation of Pfizer’s logo...Holmes, along with former Theranos President Ramesh “Sunny” Balwani, were charged with multiple counts of fraud in 2018. According to the charges that the government brought against the duo, from 2013 to 2015, Holmes and Balwani raised more than $700 million from investors for falsely claiming their single-drop blood-testing technology would revolutionize the medical industry...READ MORE

The pharmaceutical industry scored a muted win in its long-running feud with the Department of Health and Human Services over 340B program discounts...when a federal court judge granted Eli Lilly’s bid to vacate two administrative actions aimed at drugmakers...U.S. District Court...ruled that a...advisory opinion from HHS’ Office of the General Counsel and a May enforcement letter from the Health Resources and Services Administration were “arbitrary and capricious” and in violation of the Administrative Procedures Act...the judge determined that Lilly and other drug manufacturers are not permitted under the current 340B statute “to impose unilateral extra-statutory restrictions on its offer to sell 340B drugs to covered entities utilizing multiple contract pharmacy arrangements.”...READ MORE

UnitedHealthcare will adjust claims for COVID-19 vaccines in response to providers who said they were paid sub-Medicare rates to administer the shots...the nation's largest insurer said it has been reimbursing for COVID-19 vaccines at the $40 per administration Medicare rate since July 1 but that it will adjust claims that were underpaid between March 15 and June 30 to that same rate...A number of physicians, particularly pediatricians, have called out UHC for underpaying them to administer COVID-19 vaccines...George Rogu, M.D., a pediatrician and CEO of Commack, New York-based RBK Pediatricians, said physicians of all kinds faced significant costs in setting up vaccine programs...READ MORE

Sharing real-time patient benefit and eligibility information with providers at the point of prescribing improves medication access and, ultimately, patient outcomes...To help patients access their prescribed medications during office closures due to the pandemic, many health plans relaxed or waived medication regulations, such as prior authorization and refill-too-soon orders...Despite this temporary relief, many patients still experienced delays getting their prescriptions filled...Solutions such as real-time prescription benefit, electronic prior authorization and intelligent pharmacy workflows can help reduce administrative and benefit barriers contributing to these delays – and improve medication adherence along the way...READ MORE