Author: Peter

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

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

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

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

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

...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

Two new pharmacy benefit management startups are aiming to inject greater price transparency into the market...The Purchaser Business Group on Health has announced...EmsanaRx... As PBGH is a coalition of 40 large employers, the company says its PBM solution is "built by employers, for employers."...Emsana Health aims to serve as an "innovation studio" that will develop new products and solutions designed with input from PBGH's employer members...In addition...the Mark Cuban Cost Plus Drug Company PBC  also launched its own PBM this week...Cuban's company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof...READ MORE

A charity that funds programs to expand access to emergency medical care for people in remote areas announced...it will make grants to upgrade technology at several rural Nevada hospitals...The Leona M. and Harry B. Helmsley Charitable Trust said it will provide grants totaling $11.3 million to hospitals in towns including Caliente, Ely, Incline Village, Lovelock and Yerington to buy diagnostic and radiology equipment like CT scanners and X-ray devices...Walter Panzirer, a Helmsley Charitable Trust representative...said the aim is to provide access to the same equipment found in urban centers to patients at rural hospitals...READ MORE

At 7:30 p.m. local time Sept. 23, 1,000 drones ascended into the vast clear night sky above the Baimiao Village in the Chinese city of Xichang. They had a special delivery to make—health tips from Pfizer...Pfizer recently put on a drone light show in the remote mountain area of southwestern China, where people of the Yi ethnic group...the light-bearing vehicles formed different shapes in the sky to relay six basic medical messages. Paired with broadcast commentaries in both Mandarin and Nuosu, the images tried to educate local residents about the importance of maternity testing, childhood vaccination, washing hands, restraint in alcohol use, wearing a mask and a balanced diet...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