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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

The lion’s share of California cities and counties have signed off on a national settlement with four major pharmaceutical players to resolve allegations that they fueled the opioid crisis, Attorney General Rob Bonta announced...and that deal will award roughly $2.34 billion to state and local governments...The multistate lawsuit alleged that Cardinal, McKesson and AmerisourceBergen -- all major drug distributors -- had not met their legal duty to refuse to ship opioids to pharmacies that submitted suspicious drug orders. Johnson & Johnson misled patients and doctors about the addictive nature of opioids, the state’s alleged...READ MORE

Drug development is expensive, can take years to complete and doesn't guarantee a novel therapy for treating disease...But consumer genetic testing company 23andMe is forging ahead to leverage its massive database of genetic data for research and to make and sell its own therapies...Using genetic data based on the company's 12 million genotype customers and billions of phenotypic data points gives 23andMe a distinct competitive advantage for its therapeutics business, Kenneth Hillan, 23andMe’s head of therapeutics, said..."We talk about it as our secret power. It really is that statistical power, the size and scale of our databases, and using genetics to see things in terms of drug targets within diseases that others just can't see," he said...READ MORE

Pfizer and Moderna are now two of the leading pharma companies in the U.S. when it comes to public image, thanks to their COVID vaccines. On the flip side, vaccine rivals J&J and AstraZeneca have seen their reputations plummet...This is according to a new survey by market research firm Leger, which looked into how the pharma industry’s reputation has changed during COVID and the creation of new vaccines against the disease...READ MORE

A top federal watchdog believes the Department of Health and Human Services needs to totally transform how it handles public health emergencies...The Government Accountability Office issued a scathing report...placing HHS on its “high risk” list reserved for government agencies that need transformation or are vulnerable to fraud or mismanagement. The watchdog flagged HHS for several deficiencies that include failing to establish clear roles and responsibilities across its vast purview and providing clear communications to the public...READ MORE

A new 'linkage center' aimed at connecting homeless street addicts with drug rehab facilities opened in San Francisco last week - but distressing images show an open air illicit drug consumption site that is now littered with needles and crowded with addicts shooting up in broad daylight...READ MORE

Nearly 4,000 people may have received a slightly less than recommended dose of the Pfizer COVID-19 vaccine at a Kaiser Permanente location in California last year. The health system is offering repeat vaccinations to anyone affected...The vaccinations were given at the Kaiser Permanente Walnut Creek Medical Center...Individuals may have received between 0.01 and 0.04 milliliters less than the correct 0.3-ml dose. The health system reportedly said the incident was a misunderstanding among staff, which it has retrained, and is contacting patients about the error...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

Florida has been forced to shut down sites administering monoclonal antibodies, which have been widely used as supplemental treatment for Covid-19, after the FDA revoked authorization for distribution...“This evening, without any advanced notice, the U.S. Food and Drug Administration revised the Emergency Use Authorization for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States,” a press release from the Florida Department of Health read...“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” it continued...READ MORE

The National Community Pharmacists Association and the American Pharmacists Association... issued the following statement in response to a decision by the U.S. District Court for the District of Columbia to grant a stay the case, NCPA v. Becerra, which challenges the legality of retroactive pharmacy price concessions, also known as pharmacy direct and indirect remuneration fees:...“We are pleased by the court’s decision to grant our request for a stay, or a pause in the litigation, until the recently proposed rule potentially addressing retroactive pharmacy DIR fees is finalized. We are currently analyzing the proposed rule to determine whether it addresses our longstanding concerns with retroactive pharmacy DIR fees, and we plan to submit comments reflecting our analysis. Since our litigation also seeks to end retroactive pharmacy DIR fees, we believe, and the court agreed, that a pause in the case is appropriate pending the outcome of the rulemaking process.”