- Bristol-Myers is sued for $6.4 billion over delayed cancer drug (reuters.com)
Bristol Myers Squibb Co was sued for $6.4 billion...allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019...According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required "diligent efforts" to win U.S. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec. 31, 2020, deadline...By missing the deadline, Bristol Myers was excused from owing an additional $9 in cash to Celgene shareholders for each share they held, enabling it to acquire Celgene at an "enormous discount" and enjoy a "windfall," the complaint said...READ MORE
- ICER, vocal critic of drug company pricing, turns scrutiny to insurers (biopharmadive.com)
The Institute for Clinical and Economic Review, a nonprofit and frequent critic of drugmakers for excessively high drug prices, now plans to assess how health insurance policies harm patient access to care...This follows research by the group that argued cost-sharing should not be structured to shift healthcare costs to patients when they have no medically appropriate lower-cost option...ICER's review will not, however, look at whether cost-sharing should be reduced for drugs on which payers receive large rebates or whether payers should be asked to demonstrate how their policies on drug access save overall healthcare costs...READ MORE
- Eli Lilly hit with DOJ subpoena over New Jersey factory making COVID-19 drug (fiercepharma.com)
...Eli Lilly’s COVID-19 drug factory in New Jersey garnered unwanted headlines for quality control snafus and alleged document tampering. Now, the Department of Justice has stepped in to investigate...Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants...In early May, Reuters reported that employees at the site accused an executive of altering FDA-required documents in an effort to downplay serious quality control problems...READ MORE
- Industry-heavy Patient Protection Commission could get significant membership overhaul (thenevadaindependent.com)
When Gov. Steve Sisolak proposed establishing a Patient Protection Commission to conduct a top-to-bottom review of Nevada’s health care system, he told industry representatives that his goal was compromise — and that those not working toward that goal could lose their seats at the table...Under a bill Sisolak put forward and the Legislature approved in 2019, the commission was established as an industry-heavy body, with a few patient and general public representatives added in, that would come together to address pressing health care issues in the state — in the vein of an industry working group that had successfully compromised on surprise emergency room billing legislation earlier that year...READ MORE
- COVID-19 Update: New Naming System, Support for Investigation and More (biospace.com)
News continues to come out about COVID-19, including support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination. Here’s a look...READ MORE
- WHO Creates Naming System for COVID-19 Variants
- Scientists Support Full Investigation of Viral Leak Theory
- US Companies Can Legally Mandate Vaccinations
- New Variant from Vietnam is Highly Contagious
- Moderna Initiates Rolling Submission to FDA for Full Approval of COVID-19 Vaccine
- More US citizens arrested for moving drugs over Mexico border (reviewjournal.com)
An increasing number of American citizens have been apprehended as they have tried to smuggle illegal drugs into the U.S. since the start of the coronavirus pandemic, an uptick that’s come amid travel restrictions at the border with Mexico...the closure of the southern border to nonessential traffic has sharply limited the number of foreign citizens entering the U.S. by land...Law enforcement officials and drug trafficking experts say the border rules — put in place in April 2020 to curb the spread of the coronavirus — and their lopsided enforcement are driving the rise in U.S. citizens involved in borderland drug busts...U.S. citizens were apprehended nearly seven times more often than Mexican citizens between October 2020 and March 31 for trying to smuggle drugs in vehicles, U.S. Customs and Border Protection data shows...READ MORE
- Eli Lilly wants court to halt HRSA from issuing penalties over 340B contract pharmacy moves (fiercehealthcare.com)
Eli Lilly is asking a federal court to stop the federal government from imposing any penalties over its decision to restrict sales of 340B-discounted products to contract pharmacies...The request for a preliminary injunction and temporary restraining order...comes less than a week after the Health Resources and Services Administration wrote to Lilly and five other drug companies over the contract pharmacy restrictions...The injunction and order show that drug companies appear likely to fight HRSA’s order to immediately offer 340B-discounted drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of the 340B covered entities...READ MORE
- U.S. Supreme Court rebuffs J&J appeal over $2 billion baby powder judgment (reuters.com)
The U.S. Supreme Court...declined to hear Johnson & Johnson’s bid to overturn a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in the company’s baby powder and other talc products ...The justices turned away a J&J appeal and left in place a Missouri state court ruling in litigation brought by 22 women whose claims were heard together in one trial...READ MORE
- Bayer hits major Roundup setback—again—as judge rejects ‘unreasonable’ $2B settlement (fiercepharma.com)
Bayer’s efforts to put an end to the consuming Roundup litigation have hit a wall, raising uncertainties over the weedkiller’s future and its impact on the German conglomerate’s financial position...A U.S. federal judge in San Francisco...rejected Bayer’s already revised $2 billion proposal to settle potential future lawsuits alleging Roundup causes cancer. The deal would have put a halt to litigation over four years, during which time eligible plaintiffs could have received compensation of up to $200,000 each...READ MORE
- Lawmakers aim to move ‘very quickly’ to pass bill mandating electronic prior authorization for MA plans (fiercehealthcare.com)
Lawmakers behind the Improving Seniors’ Timely Access to Care Act...not only requires electronic prior authorization for MA plans, but also requires the Department of Health and Human Services to create a process for faster decisions on items and services that commonly get approved...While the bill only applies to MA plans, lawmakers hope to eventually tackle more types of insurance such as commercial plans...READ MORE