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Pfizer Recalls Millions of Migraine Prescription Drug Packs Due to a Risk of Child Poisoning
Pfizer is recalling more than four million packages of the Nurtec ODT prescription migraine medication over a risk of poisoning children due to a failure to meet child-resistant packaging safety requirements.
The company is recalling around 4.2 million units of Nurtec ODT (rimegepant) 75mg orally disintegrating tablets, which are sold in packs of eight doses on a blister card, on Thursday, the U.S. Consumer Product Safety Commission said. Anyone affected will be able to obtain a free child-resistant pouch to store the product, the commission said.
The prescription drugs are required to be in child-resistant packaging, as mandated in the Poison Prevention Packaging Act, the safety commission said.
Consumers were told to “immediately secure the recalled product out of the sight and reach of children and contact Pfizer for a free child-resistant pouch to store the product.”
After a Wave of Teen Fentanyl Overdoses, a Texas Community Grapples With Shock and Anger at the Epidemic’s Toll
Jose Alberto Perez, who died in January, is among the nearly one dozen students spread across three schools in the Carrollton-Farmers Branch Independent School District in Texas who have overdosed on fentanyl from September to March. He is one of three who have died.
The rash of overdoses has brought shock and anger to families in the Carrollton community, about 20 miles north of Dallas. It is also a sobering reminder of how rampantly fentanyl has made its way to young people in recent years.
Fentanyl, a highly potent and addictive synthetic opiate that can be deadly with a dose as small as the tip of a pencil, has ravaged adult populations for nearly a decade. But mass proliferation of the drug in recent years, coupled with a COVID pandemic that eroded teen mental health, has given it a wider path to young people.
Teen fentanyl overdoses have been reported in communities across the country, from Arlington, Virginia, to Portland, Oregon. In the Los Angeles School district alone, at least seven teens overdosed in a one-month span last year after taking pills possibly laced with the drug.
Moderna, Riding COVID Success and Busy Growing Its Pipeline, Hikes Pay of CEO Bancel to $19.4 Million
After another year of transformational revenue from Moderna‘s COVID-19 vaccine, the company has rewarded CEO Stéphane Bancel with a pay package of $19.4 million, according to a proxy statement. It is a raise of $1.2 million from the $18.2 million he earned in 2021.
In 2022, Moderna scored authorization for two Omicron-adjusted bivalent vaccines, helping the company reach $18.4 billion in global vaccine sales. That figure fell short of the company’s estimate at the start of the year of $22 billion, but it did exceed Moderna’s $17.7 billion figure from 2021.
Moderna also used its windfall to advance its pipeline of programs built around its mRNA technology. The company now has three programs in phase 3 testing.
Bancel, 50, collected $12.9 million in total pay in 2020, when Moderna was developing its vaccine with the help of approximately $2.5 billion in grants and vaccine purchase agreements from the United States government. Bancel earned $8.9 million in 2019 before the company became a household name.
‘Silent Pandemic’ Warning From WHO: Bacteria Killing Too Many People Due to Antimicrobial Resistance
The World Health Organization (WHO) is warning of a “silent pandemic” of antimicrobial resistance from infections caused by deadly pathogens that doctors are not able to cure because of a lack of novel agents.
That’s according to an early release of special presentations by Dr. Valeria Gigante and Professor Venkatasubramanian Ramasubramanian of an online “pre-meeting” of the European Congress of Clinical Microbiology & Infectious Diseases on April 15 to 18 in Copenhagen, Denmark.
“Antibiotic resistance is one of the major concerns in modern medicine today,” Dr. Aaron Glatt, chief of infectious diseases at Mount Sinai South Nassau Hospital on Long Island, New York, told Fox News Digital. “There is a dearth of safe, effective and inexpensive agents to use to treat many of these significant infections,” added Glatt. “It is critical that new and innovative products be investigated.”
Overuse and improper use of antimicrobials breed resistance. The CDC estimates that some 47 million antibiotic prescriptions in doctors’ clinics and emergency departments — an estimated 28% of all prescribed in these settings — are annually prescribed in the U.S. for infections that don’t require antibiotics, such as colds and the flu.
Polio Cases Derived From New Oral Vaccine Reported for First Time
Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one.
The Global Polio Eradication Initiative announced Thursday that six children in the Democratic Republic of the Congo and one in Burundi have been paralyzed by viruses from the new vaccine, which is referred to as the novel oral polio vaccine, or nOPV2. (The “2” signals the vaccine targets type 2 polioviruses.) In addition, five environmental samples collected from Burundi contained the so-called type 2 circulating vaccine-derived polioviruses, or cVDPV2s.
The Gates Foundation is one of a half-dozen partners in the Global Polio Eradication Initiative. The others include the World Health Organization; UNICEF, the United Nations Children’s Fund; the Centers for Disease Control and Prevention; Gavi, the vaccine alliance; and the service club Rotary International.
Bandyopadhyay and the polio eradication initiative itself were quick to point out that this turn of events was not unexpected. The live polioviruses used in oral vaccines are manipulated to eliminate their ability to paralyze. Children who receive these vaccines shed live viruses in their stools. In settings where sanitation and hygiene are poor, the viruses can move from child to child, effectively indirectly vaccinating children whom vaccination teams haven’t reached — a feature that has made the Sabin vaccines the workhorse of polio eradication.
Pfizer the Biggest TV Drug Ad Spender at the Oscars, as HHS Also Spends Big on COVID Messaging
While Novo Nordisk’s diabetes drug Ozempic was the talk of the town, it was Pfizer that spent the most on TV drug ads at this year’s Oscars. That’s according to new data from real-time trackers at iSpot.TV, which estimates that the Big Pharma spent $5.7 million on its new COVID-19 drug ad: “If it’s COVID, it’s Paxlovid” during a single Oscars airing on Sunday, March 12.
This put Pfizer, which was also a sponsor of the event, at the top of the list of five major companies and one government agency that spent big on TV ads during the biggest event in Hollywood.
Pfizer was also joint second with its second COVID ad of the night: “A Whole Different Ball Game,” featuring, fittingly, a load of celebrities, including P!nk, Questlove, Michael Phelps and Jean Smart. Pfizer spent $3.8 million on that spot, the exact same figure ViiV Healthcare spent on its HIV PreP drug Apretude’s TV Spot, “Prep Without Pills.”
In fourth was an unusual entrant: Not a pharma company, but the U.S. Department of Health and Human Services and its TV Spot, “Updated COVID Protection.” The agency spent $1.9 million on the 30-second COVID awareness ad that aims, with no pharma branding, to get people to think about signing up for the latest COVID boosters amid “fading protection.”
Sanofi Announces Insulin Price Cap After Actions by Eli Lilly and Novo Nordisk
Sanofi will cap the out-of-pocket cost of its most popular insulin, Lantus, at $35 per month for people with private insurance, the French drugmaker said Thursday. The change will take effect on Jan. 1, 2024.
Sanofi is the last of three major insulin makers in the United States to cut or cap the price of the drug.
Both Eli Lilly and Novo Nordisk announced changes to how they price their insulin this month. Together, the three drugmakers make up roughly 90% of the insulin market in the U.S.
“This is a big deal,” said Larry Levitt, the executive vice president for health policy at KFF, formerly known as the Kaiser Family Foundation. “This is a combination of market forces, government Medicaid rebate policies and public pressure.”
Questions Still Swirl Over Paxlovid as FDA Full Approval Nears
Pfizer‘s antiviral Paxlovid is one step closer to gaining full approval from the Food and Drug Administration, but whether that convinces more doctors to prescribe it is an open question.
Driving the news: Vaccine advisers to the FDA voted 16-1 on Thursday to endorse Paxlovid for high-risk COVID-19 patients, but experts later said there’s not enough data to determine precisely who would benefit most from the drug.
That poses a dilemma for physicians who — in addition to considering drug interactions and how the virus has evolved — also have to weigh factors like Paxlovid’s effect on pregnant and immunosuppressed people and other vulnerable populations.
Catch up quick: Many doctors are already hesitant to prescribe the drug, either because of possible side effects like muscle pain or altered taste or out of a belief that a patient is not sick enough. And there are longstanding questions about how well the drug, once hailed as a pandemic “game-changer,” works on vaccinated patients or younger people.
Drug Used to Treat Advanced Prostate Cancer in Short Supply, Novartis Says
Pluvicto, a drug used to treat advanced prostate cancer, is in short supply, the Food and Drug Administration reported last week.
Novartis, the pharmaceutical company that manufactures Pluvicto, outlined the causes behind the supply issues in a letter posted by the FDA last month.
In the letter, the company said that it currently only manufactures Pluvicto in Italy in “small batches,” and is awaiting FDA approval on a new manufacturing site. That approval was expected to come in four to six months, Novartis said.
Company spokesperson Julie Masow told The Wall Street Journal Thursday that Novartis is seeking FDA approval for manufacturing commercial Pluvicto at its site in Millburn, New Jersey.