- Drugmakers pledge speedier European market launches to avert stricter regulation (reuters.com)
Drugmakers...pledged to speed up the market launch of new drugs in underserved EU member states in a bid to avert stricter regulation by Brussels..European Federation of Pharmaceutical Industries and Associations said in a statement...its members pledge to file for reimbursement by national health systems no later than two years after EU regulatory approval, "provided that local systems allow it"...The pledge would reduce the time patients wait for new medicines by four to five months in several countries...The lobby group warned that any new rules forcing drugmakers to bring new products to all EU countries within a certain deadline could backfire and discourage companies from bringing some products to public health systems in the region altogether...READ MORE
- Walgreens goes to trial in Florida lawsuit on opioids (apnews.com)
Most of the defendants in Florida’s lawsuit over the opioid epidemic have settled for more than $870 million, according to the state attorney general. One remains: Walgreens Co. is not giving up...A jury has been seated in Pasco County, Florida, just north of Tampa, to hear the state’s case against Walgreens, a huge drug store chain with more than 9,000 outlets on streetcorners throughout the country. Opening statements are set for early next week...The Deerfield, Illinois-based company says it will not settle...“We are prepared for trial,” said Walgreens spokesman Fraser Engerman in an email...READ MORE
- West Virginia says J&J, drugmakers created ‘tsunami’ of opioid addiction (reuters.com)
West Virginia's attorney general on Monday urged a judge to hold Johnson & Johnson , Teva Pharmaceuticals Industries Ltd, and AbbVie Inc's, Allergan liable for causing a "tsunami" of opioid addiction in the state...The addiction crisis has affected the state's police forces, hospitals, foster care system and jails, with effects that will linger for more than a generation, Attorney General Patrick Morrisey said..."This epidemic has impacted virtually all of West Virginia," Morrisey said. "Our lawsuit speaks for all West Virginians who have suffered due to the defendants' unlawful, callous and destructive conduct."...READ MORE
- High from hemp: States wrestle with chemically made THC (apnews.com)
Over the past few years, Jonny Griffis has invested millions of dollars in his legal marijuana farm in northern Michigan, which produces extracts to be used in things like gummy bears and vape oils...But now that farm — like many other licensed grows in states that have legalized marijuana — faces an existential threat: high-inducing cannabis compounds derived not from the heavily regulated and taxed legal marijuana industry, but from a chemical process involving less strictly regulated, cheaply grown hemp...At the center of the issue is THC, marijuana’s main intoxicating component. While marijuana and hemp are the same plant — cannabis — the distinction between the two is a legal one, and comes down to the amount of THC in the plant, specifically the amount of a type of THC called delta-9...People exploiting what they see as a loophole in the law have taken that hemp, extracted a non-intoxicating compound called CBD, and chemically changed it — generally by the addition of solvents and heat — into various types of impairing THC...READ MORE
- Moderna recalls vaccine batch after foreign substance found in CDMO-made vial—again (fiercepharma.com)
The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either...Moderna...said it was recalling one Spikevax lot in Europe...The batch contains 764,900 doses made by CDMO Rovi that were deployed across Norway, Poland, Portugal, Spain and Sweden between Jan. 13 and Jan. 14. Moderna yanked the shots because of a “foreign body” found in one vial of the batch made at Rovi’s site in Spain...READ MORE
- Senate blesses bill to wrest US supply chains from China’s grasp, with pharma front and center (fiercepharma.com)
With several efforts to resurrect American drug manufacturing already underway, congressional members on both sides of the aisle are setting their sights on one of the nation’s chief economic rivals...The Senate has signed off on innovation and competition legislation designed to boost American competitiveness, restore the country’s manufacturing base and curb its reliance on China for critical supplies—especially drugs and medical devices...The bill encourages the U.S., the EU and other European countries to work together on “joint strategies to diversify reliance on supply chains away from the People’s Republic of China,” and “especially” so in the medical and pharmaceutical fields...READ MORE
- Florida reaches $878 million opioid settlements with CVS, Teva, others (reuters.com)
Florida has reached more than $878 million in settlements with CVS Health Corp and three drug companies to resolve claims and avert a trial next month over their roles in fueling an opioid epidemic in the third most populous U.S. state...CVS will pay $484 million, Teva Pharmaceutical Industries Ltd will pay $194.8 million, Abbvie Inc's, Allergan unit will pay $134.2 million and Endo International Plc will pay $65 million, Florida's attorney general Ashley Moody said in a statement...Most of the money will be spent on opioid abatement. Teva will also provide $84 million of its generic Narcan nasal spray...READ MORE
- Prepare for ‘mass-overdose’ events from fentanyl, DEA warns police nationwide (washingtonexaminer.com)Responding to Nationwide Increases in Fentanyl-Related Mass-Overdose Events (dea.gov)
The leading U.S. drug enforcement agency issued an unprecedented warning to law enforcement nationwide to brace for a spike in “fentanyl-related mass-overdose” deaths as Mexican cartels push the drug into the United States...The Drug Enforcement Administration sent a letter to federal, state, and local law enforcement departments nationwide...alerting officials they should prepare not only for deaths caused by fentanyl to rise but also for mass-casualty events in which a group of people dies as a result of knowingly or unknowingly overdosing...READ MORE
- Pfizer asks hourly staffers to return overpayments in aftermath of vendor’s cyberattack: reports (fiercepharma.com)
In December, a ransomware attack struck Ultimate Kronos Group, a vendor that Pfizer uses to track work time and pay out hourly staffers...Employees were under- and overpaid as a result...Now, the drug behemoth is repaying those who were shortchanged—but it’s also asking overpaid staffers to return their surplus cash...Pfizer isn’t the only corporation dealing with the fallout of last year’s cyberattack. Tesla and PepsiCo have filed a class-action lawsuit that contends Ultimate Kronos Group owes damages because it was negligent in guarding against an attack...READ MORE
- Walmart reportedly to stop selling cigarettes in select stores (drugstorenews.com)
Walmart is the latest retailer with plans to stop selling cigarettes. Cigarettes are being removed from Walmart in various markets, including some stores in California, Florida, Arkansas and New Mexico...In 2019, Walmart, which has around 5,000 stores in the United States, raised the minimum wage to buy tobacco to 21 years old and stopped selling e-cigarettes. Sam's Club, owned by Walmart, has also stopped selling cigarettes at most of its stores in recent years, according to the report...READ MORE