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Updated COVID Shot Expected to Come This Fall, CDC Director Says
Americans should expect yet another update of the COVID-19 vaccine this fall at about the same time as flu shots are available, the top U.S. public health official said Monday.
Researchers are working on selecting a strain for the upcoming version, and will probably wait until May to pick one to target with vaccines, Centers for Disease Control and Prevention Director Mandy Cohen said in an interview at Bloomberg’s offices in Washington.
“Folks should anticipate that when they get their flu shot, they’ll get an updated COVID shot as well,” Cohen said in an interview.
CDC is unlikely to pull back on its COVID vaccine recommendations for children, Cohen said, even though the virus broadly impacts kids less than in the past.
Acute Pancreatitis Induced by COVID Vaccine: A Systematic Review
Acute pancreatitis, marked by a sudden inflammation of the pancreas, presents a complex spectrum of causative factors including gallstone obstruction, alcohol abuse, and viral infections. Recent studies have illuminated the emergence of vaccine-induced acute pancreatitis, notably associated with COVID-19 vaccinations, presenting diverse mechanisms ranging from direct viral-mediated injury to autoimmune reactions.
Understanding this link is pivotal for public health, yet challenges persist in identifying and managing cases post-vaccination. Comprehensive literature reviews employing the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement outline the potential pathways and mechanisms leading to vaccine-induced pancreatitis, emphasizing the need for deeper investigations into underlying health conditions and modifications to vaccine components.
Notably, the rare occurrences of vaccine-induced pancreatitis extend beyond COVID-19 vaccines, with reports also documenting associations with measles, mumps, and rubella (MMR), human papillomavirus (HPV), and other viral vaccinations. Mechanistically, hypotheses such as molecular mimicry and immunologic injury have been proposed, necessitating ongoing vigilance and exploration.
Regulatory agencies play a crucial role in monitoring and communicating vaccine safety concerns, emphasizing transparency to address potential risks and maintain public trust. Understanding and communicating these rare adverse events with transparency remain integral for informed vaccination policies and to allay concerns surrounding vaccine safety.
GlaxoSmithKline Boss’s Pay Package Jumps 50% to £12.7 Million
The annual pay package of the boss of GlaxoSmithKline, Emma Walmsley, has jumped by 50% to £12.7m, mainly because of a higher share bonus payout reflecting the British drugmaker’s improved performance.
Walmsley’s huge pay rise makes her one of the highest-paid executives in the FTSE 100 index of leading shares, a week after it emerged that her counterpart at Britain’s biggest pharmaceutical group AstraZeneca, Pascal Soriot, received a £16.9m pay package last year and is in line for an even higher package, £18.6m, this year.
Walmsley is thought to be the highest-paid among the 10 female FTSE 100 chief executives.
GSK’s Arexvy RSV jab, launched in the summer, has already become a blockbuster (defined as a drug with at least $1bn annual sales), racking up £1.2bn sales in four months.
‘It’s a Nightmare’: One of the Most Common Children’s Asthma Meds Is No Longer Available, Leaving Families Scrambling
Boston Globe via STAT News reported:
A commonly prescribed medication for children’s asthma is disappearing from pharmacists’ shelves, forcing parents and pediatricians to scramble for alternatives just as allergy season is about to start.
In a move unusual for such a widely used drug, GlaxoSmithKline discontinued Flovent HFA, the brand name of its corticosteroid treatment fluticasone propionate, at the end of December. Critics, including Massachusetts Senator Elizabeth Warren, say the decision helps the company avoid new Medicaid penalties going into effect this year for medications with price increases that outpace inflation.
“It was all very confusing, and we were left scrambling, trying to find out what we could do,” said Simone Fung, whose 5-year-old son, David, endured worse asthma symptoms over the past two months as the Cambridge family navigated confusing insurance policies and shortages of alternative medications to find a replacement for Flovent.
Another California Zantac Lawsuit Settlement Reached Before Trial
GlaxoSmithKline has announced that it has reached a Zantac lawsuit settlement agreement, resolving a complaint that the recalled heartburn drug caused cancer just a month before it was expected to go to trial in California state court.
The drug manufacturer issued a press release on February 29, indicating the company had agreed to a confidential settlement in a Zantac cancer lawsuit, which will result in the dismissal of the claims without evidence being presented in a public trial.
Zantac (ranitidine) was used by millions of Americans for the treatment of heartburn and acid reflux, before it was removed from the market in late 2019, following the discovery that the active pharmaceutical ingredient is inherently unstable and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a potent human carcinogen.
Despite the settlement, GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Sanofi and various other manufacturers, distributors, and retailers, continue to fight nearly 80,000 Zantac lawsuits in various state courts nationwide, with most filed in Delaware. The claims were brought by former users who indicate they have been diagnosed with bladder cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries after taking the brand name Zantac or one of its generic equivalents.
Ohio Foundation Begins Process to Distribute Millions in Opioid Settlement Money
Ohio is ready to begin doling out millions of dollars in opioid settlement money to community and government organizations, an influx eagerly anticipated since the first sums were secured in 2021.
The OneOhio Recovery Foundation, which has been tasked with distributing over $860 million of settlements reached with drugmakers and pharmaceutical companies for their roles in the national opioid crisis, plans to release its formal request for proposals on Monday.
Drugmakers, wholesalers, pharmacies and other companies have agreed to settlements over the toll of opioids that are to pay state, local and Native American tribal governments more than $50 billion. Under the agreements, most of the money is to be used to address the overdose epidemic.
The foundation will allocate up to $51 million in its 2024 grant cycle for Ohio-based non-profits, for-profits and government entities alike who are “on the frontlines of Ohio’s opioid battle.” The program is the first of its kind in the United States.
Statistical Models vs. Front-Line Workers: Who Knows Best How to Spend Opioid Settlement Cash?
In this Gulf Coast city, addiction medicine doctor Stephen Loyd announced at a January event what he called “a game-changer” for state and local governments spending billions of dollars in opioid settlement funds.
The money, which comes from companies accused of aggressively marketing and distributing prescription painkillers, is meant to tackle the addiction crisis.
But “how do you know that the money you’re spending is going to get you the result that you need?” asked Loyd, who was once hooked on prescription opioids himself and has become a nationally known figure since Michael Keaton played a character partially based on him in the Hulu series “Dopesick.”
Loyd provided an answer: Use statistical modeling and artificial intelligence to simulate the opioid crisis, predict which programs will save the most lives, and help local officials decide the best use of settlement dollars.
Bayer Pays $310 Million to Buy Into BridgeBio Heart Drug
The BridgeBio deal will bring Bayer into a coming commercial battle with billions of dollars at stake.
The disease acoramidis treats, TTR cardiomyopathy, has quickly become one of the more competitive areas of drug research. The condition is caused by the buildup of a misfolded protein that corrodes heart tissue, potentially causing heart failure and death. The only drug available, Pfizer’s Vyndamax, generated $3.3 billion in sales last year. BridgeBio is now leading a group of other developers, including Alnylam Pharmaceuticals, Ionis Pharmaceuticals and Intellia Therapeutics, that aims to come up with better options.
Some industry watchers believe acoramidis is a blockbuster-to-be. Consensus estimates have the drug pulling in about $2 billion in peak yearly sales, but that figure “could be larger,” Mizuho Securities analyst Salim Syed wrote last month. BridgeBio has already struck multiple deals ahead of its launch. In addition to the Bayer agreement, it secured $500 million in January by selling a small share of royalties. AstraZeneca also owns rights to acoramidis in Japan through a deal its Alexion Pharmaceuticals subsidiary forged five years ago.
Assuming the drug is approved, the partnership with Bayer should “accelerate the accessibility” of acoramidis in Europe, Sridhar wrote. BridgeBio is preparing to commercialize the drug in the U.S., where it holds full drug rights.
Weight-Loss Medications Are Not Effective Without ‘Nutrition Therapy,’ Experts Say
People who are on weight-loss journeys should not rely solely on anti-obesity medications, according to a statement from a national nutrition association. The Academy of Nutrition and Dietetics released the statement on March 4, which is World Obesity Day.
“The academy calls on the medical community, including pharmaceutical manufacturers of anti-obesity medications, obesity medicine providers and other healthcare practitioners specializing in obesity, to enhance the efficacy of these medications and maximize patient success rates by including a referral for medical nutrition therapy from a registered dietitian nutritionist alongside prescriptions for anti-obesity medications,” said Dr. Lauri Wright, Ph.D., president of the Chicago-based academy.
“We must reevaluate how we treat and prevent obesity by increasing access to nutritious food and for health insurance plans to cover nutrition services,” she said.
The number of people in the U.S. using GLP-1 agonists for either diabetes or obesity reached 40 million in 2022, research has shown.
White House Is Told the Big Three PBMs Are ‘Everything Wrong With This Industry’
As part of its battle to blunt the growing cost of medicines, the White House on Monday held a so-called listening session in hopes of finding ways to rein in big pharmacy benefit managers, which occupy an opaque but crucial role in pharmaceutical pricing in the U.S.
The gathering resembled something of a fact-finding mission as a small group of policymakers and business people briefly shared their experiences dealing with the largest industry middlemen, who negotiate with drugmakers on behalf of insurers and employers and, in the process, create formularies or lists of medicines that are covered by insurance.
But critics say the three biggest pharmacy benefit managers — CVS Health, OptumRx, and Express Scripts — run opaque businesses that drive up costs for patients and taxpayers by favoring their own pharmacies over independent drug stores and forcing drug companies to raise prices that cover the cost of rebates needed to win favorable formulary placement. These three companies control 80% of the U.S. market.
