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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

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

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

Texas federal judge Mark Pittman will conduct a hearing...to consider whether to allow Pfizer to participate in the redaction and release of information about the development of its COVID-19 vaccine, Comirnaty...Earlier this month, Pittman ruled that the FDA would have to turn over 55,000 pages of documentation on the vaccine per month, starting on March 1...Last Friday, Pfizer provided the court a memorandum outlining why it should participate in the process...“Pfizer supports the public disclosure of the vast majority of this information to promote transparency and the public’s confidence in the vaccine,” the company wrote in the filing. “Pfizer seeks to intervene for the limited purpose of ensuring that information that is exempt from disclosure under FOIA is not disclosed inappropriately.”...READ MORE

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

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

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

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

State officials and lawyers representing death row inmate Zane Floyd agreed that an execution of the convicted quadruple killer will not happen before a key drug in the state’s lethal injection protocol expires at the end of the month — putting the matter on hold for the foreseeable future...Their statements in federal court on Monday come after the Clark County district attorney’s office did not obtain an execution warrant by Feb. 13, the latest possible day to obtain a warrant and order for a Feb. 28 execution date...READ MORE

Native American tribes in the U.S. have reached settlements over the toll of opioids totaling $590 million with drugmaker Johnson & Johnson and the country’s three largest drug distribution companies, according to a court filing...The filing in U.S. District Court in Cleveland lays out the details of the settlements with Johnson & Johnson and distribution companies AmerisourceBergen, Cardinal Health and McKesson...All federally recognized tribes will be able to participate in the settlements, even if they did not sue over opioids...More than 400 tribes and intertribal organizations representing about 80% of tribal citizens have sued over opioids...READ MORE