- After raking in billions with its COVID shot, Moderna faces patent infringement suit related to vaccine delivery tech (fiercepharma.com)
Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the messenger RNA vaccine giant for infringement, but when. Now...Arbutus and Roivant’s Genevant Sciences on Monday filed a lawsuit against Moderna in the U.S. District Court for the District of Delaware. In their suit, the companies seek damages for infringement on six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine...The patents relate to nucleic acid-lipid particles and lipid vesicles, plus compositions and methods for their use...READ MORE
- Johnson & Johnson defends talc bankruptcy strategy called ‘rotten’ by cancer plaintiffs (reuters.com)
A Johnson & Johnson subsidiary came under attack in court...for attempting to use the bankruptcy process to resolve tens of thousands of claims that its baby powder and other talc-based products caused cancer...The subsidiary, LTL Management, is fighting to remain in bankruptcy, arguing that is the best way to reach an "equitable, efficient, and consensual resolution" of more than 38,000 claims alleging that J&J's talc-based products caused cancers including mesothelioma. J&J maintains that its consumer talc products are safe...J&J used a legal maneuver known as the "Texas two-step," which allows companies to split valuable assets from liabilities through a so-called divisive merger...Lawyers representing cancer patients say that the bankruptcy case is meant to delay and frustrate lawsuits that would otherwise go to a jury trial against J&J directly...READ MORE
- Senate narrowly confirms Robert Califf to lead the FDA (statnews.com)
The Senate voted...50-46 to officially confirm Robert Califf as the commissioner of the Food and Drug Administration...The vote puts an end to one of the most protracted and controversial confirmation processes in the FDA’s 115-year history. No candidate for the agency’s top job has so narrowly squeaked through the confirmation process. The only candidate that came close was Scott Gottlieb, who led the agency during the Trump administration and was confirmed 57-42...Few Biden nominees have received such opposition from the president’s own party. Many haven’t received any Democratic opposition at all.READ MORE
- GOP bills aimed at unproven treatments for COVID-19 (apnews.com)
Doctors and hospital leaders are pushing back against a package of Republican bills that seek to bar health care providers from withholding unproven treatments for COVID-19...The three bills released this week would prevent health systems and medical credentialing boards from disciplining doctors for ordering or advocating for therapies or medicine for patients that go against medical opinions held by their employers or regulators...
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- Michigan signs PBM reform law with new transparency requirement (fiercehealthcare.com)FTC deadlocked on whether to study PBM contracting practices such as DIR fees (fiercehealthcare.com)
Michigan Gov. Gretchen Whitmer signed a series of pharmacy benefit management reforms into law...including bills that don’t discriminate against pharmacies they don’t have a relationship with...The signing of the three bills...comes less than a week after the Federal Trade Commission was deadlocked on whether to investigate PBM contracting practices...“For too long, unlicensed pharmacy benefit managers have been able to engage in practices that drive up costs for Michiganders whose lives and health depend on critical prescription drugs like insulin,” said Whitmer in a statement Wednesday. “This bill brings much-needed transparency to our healthcare system.”...READ MORE
- Payers, Medicaid officials ask Congress for 90-day glide path to end of COVID-19 emergency (fiercehealthcare.com)
Several major payer groups and Medicaid advocates are pressing Congress for a 90-day heads up when the COVID-19 public health emergency ends, arguing they need as much time as possible to make Medicaid enrollees aware they could lose coverage...A collection of payer and Medicaid state advocacy groups wrote to congressional leadership on Thursday asking for the greater lead time. The letter comes as providers and other stakeholders are preparing for an end to key flexibilities granted back in January 2020...States and payers are facing the daunting task of redetermining the eligibility of Medicaid enrollees. The PHE prevented states from dropping any enrollees off Medicaid rolls for the duration of the emergency. States will have a year after the PHE ends to fully redetermine eligibility...READ MORE
- Pfizer expects $54 billion in 2022 sales on Covid vaccine and treatment pill (cnbc.com)
Pfizer projects it will generate record-high revenue in 2022, saying...it expects to sell $32 billion of its Covid-19 shots and $22 billion of its antiviral coronavirus treatment pill Paxlovid this year...Pfizer CEO Albert Bourla said sales of Paxlovid could be higher than the company’s guidance, but the expectations are based on deals signed or close to being signed...However, Pfizer’s fourth-quarter revenue more than doubled overall to $23.84 billion year-over-year, driven by $12.5 billion in sales of its Covid vaccine. The company’s antiviral pill that fights Covid, Paxlovid, contributed $76 million in U.S. sales during the fourth quarter...READ MORE
- Saudi Arabia pharmacy chain Nahdi to join spate of IPOs (reuters.com)
Nahdi Medical Co, Saudi Arabia's market leader in retail pharmacy...announced its intention to list on the local bourse by selling 30% of its shares, joining a spate of new initial public offerings in the kingdom...Nahdi has 1,151 pharmacies, catering to the needs of more than 100 million customers, as well polyclinics and express clinics, it said...It posted a revenue at 8.6 billion riyals ($2.3 billion) in 2020, reflecting a three-year compound annual growth rate of 8.4%, higher than the industry retailers' average of 7.9%...Nahdi expanded its presence in the United Arab Emirates last year to five stores and also started deploying its online and omni-channel capabilities in the UAE...READ MORE
- GSK launches trade secrets case against former employee, ordering data and property to be returned ‘in one piece’ (fiercepharma.com)
Following Pfizer and AbbVie, GlaxoSmithKline is the latest drug major to launch a trade secrets case against an ex-staffer. For GSK, the case comes after several other high-profile trade secrets suits that ended in settlements...GSK accused former employee Denise Brooks of trade secrets theft. The company says that on Jan. 13, the defendant “abruptly” resigned from her job as a GSK quality systems lead, a position that gave her “wide-ranging access” to proprietary company data, confidential methods and highly-sensitive trade secrets...READ MORE
- With single-payer flop, California’s progressives lose again (dailynews.com)
Once again, government-run healthcare crashed and burned in California...Yes, it died with a whimper, failing to be voted on before a deadline, which for any other policy wouldn’t have been that big of a deal. But for single-payer — the Holy Grail of bad progressive ideas — it was epic...The buildup was extraordinary. After Speaker Anthony Rendon, D-Lakewood, killed single-payer unceremoniously without a vote in 2017, calling that measure “woefully incomplete,” which it was, expectations were high this time around...READ MORE