- Pharmacy chains should pay $878 mln for opioid epidemic role, Ohio counties say (reuters.com)
A lawyer for two Ohio counties said...that CVS Health Corp, Walgreens Boots Alliance Inc and Walmart Inc should fund an $878 million plan to address the opioid crisis there, as a first-of-its-kind trial got underway to determine the pharmacy chains' contribution...the counties want the companies to fund a $878 million five-year plan that Mark Lanier, a lawyer representing the counties, said on Monday was aimed at solving the opioid crisis rather than allocating blame...READ MORE
- FDA places stricter limits on J&J’s COVID-19 vaccine after review of rare side effect (biopharmadive.com)
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
- Drug price hikes moderate as rebates rise, report finds (biopharmadive.com)The Use of Medicines in the U.S. 2022 Usage and spending trends and outlook to 2026 (iqvia.com)
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
- Walgreens theft convictions announced by San Francisco D.A. Boudin (ktvu.com)
San Francisco's district attorney's office...announced the conviction and sentencing in a high-profile Walgreens theft from last May...Jean Lugo Romero, who pled guilty to felony grand theft and misdemeanor petty theft, was sentenced to 16 months in prison and one-year probation, according to District Attorney Chesa Boudin's office...The brazen incident was caught on video and became an early flash point in examples of viral videos touting crime running rampant in the city. Lugo Romero is seen grabbing items off the shelf from a now-permanently-closed Hayes Valley Walgreens store, placing them into a garbage bag and then riding a bicycle through the store, past an employee and a security guard, to make an escape through the front door...These types of videos have been used as ammunition against Boudin, who critics say is too lenient on crime. Boudin faces a recall election this summer. A recent poll suggests that recall effort has strong support...READ MORE
- With spotlight on FDA, Congress weighs reforms to accelerated drug approvals (biopharmadive.com)
Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases...These so-called accelerated approvals have ushered in many new therapies, particularly for cancer. But they have also ginned up substantial controversy in several cases...because they brought to market high-priced therapies that weren’t proven to help people...Drugmakers have also faced criticism for dragging their feet on the follow-up studies meant to definitively show their medicines work...Soon, the FDA could receive new authority to compel pharmaceutical companies to follow through with these confirmatory studies and to order withdrawal of drugs that fall short of their initial promise...READ MORE
- Law firm files class action against pharma company Natera (reuters.com)
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
- The top 20 pharma companies by 2021 revenue (fiercepharma.com)
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
- Moderna mounts defense in COVID-19 vaccine patent feud with Arbutus, Genevant (fiercepharma.com)
In its COVID-19 vaccine patent kerfuffle with Arbutus Biopharma and Roivant’s Genevant Sciences, mRNA hot shot Moderna aims to shield itself with its government contract...Plaintiffs Arbutus and Genevant sued Moderna back in February, seeking damages tied to six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine Spikevax...the plaintiffs should have sued the U.S. government instead, Moderna said in a filing at the U.S. District Court for Delaware. To back up its argument, Moderna cited a federal law once used to “’prevent patent infringement suits from interfering with the supply of war materials during World War 1.'”...Moderna explained that it supplied its COVID-19 vaccine to the feds as part of the nation’s emergency response to the pandemic. It's "difficult to conceive of a situation more within the heart" of the wartime law than the pandemic, the company argued...READ MORE
- U.S. FDA declines to approve two more China-tested drugs (reuters.com)
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
- Who Will Pay for Prescription Drugs in 2030? (Hint: It’s Us) (drugchannels.net)
The econowonks at the Centers for Medicare & Medicaid Services recently released the latest projections for U.S. spending on healthcare. These data provide our first official look at post-pandemic U.S. healthcare spending...As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending. What’s more, taxpayers—via Medicare and Medicaid—will continue to crowd out the private insurance market. One bright spot: consumers will account for an ever-smaller share of drug spending...READ MORE