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Opioids Were the Most Common Cause of Fatal Poisoning of Young Children, a Study Finds

NBC News reported:

Opioids were the most common substance contributing to the poisoning deaths of children ages 5 and younger, according to a new study.

The research, published Wednesday in the journal Pediatrics, found that opioids accounted for more than 47% of the poisoning deaths among children in that age group between 2005 and 2018 — 346 of 731 total deaths reported to the National Center for Fatality Review and Prevention.

The sobering findings underscore the extent of the opioid epidemic’s impact on children, according to Dr. Christopher Gaw, the study’s lead author.

Pfizer Ready to Launch RSV Vaccines for Older Adults, Pregnant Women in U.S., Europe

Reuters reported:

U.S. drugmaker Pfizer (PFE.N) is ready to launch its respiratory syncytial virus (RSV) vaccine for both older adults and pregnant women in the United States and Europe later this year, executives said on Thursday.

Both Pfizer and British drugmaker GSK (GSK.L) have RSV vaccines they hope to launch in the United States and Europe this year, pending regulators’ approval. “We are anticipating approval in both the U.S. and Europe in time for rollout in the fall,” Kena Swanson, Pfizer head of viral vaccines research & development, told a media briefing at the company’s biggest manufacturing and packaging site globally.

A GSK executive on Wednesday told Reuters that it was also ready to launch its RSV vaccine for older adults in the United States this year without supply constraints.

The U.S. Food and Drug Administration (FDA) is expected to approve both vaccines for people aged 60 and above by May, while an FDA decision on the use of Pfizer’s vaccine for pregnant women is due in August. The EU’s decision, which could pave the way for the vaccines to be introduced in the U.K. as well, is due in the second half of the year.

FDA Questioned About Plans to Investigate GSK for Hiding Cancer Risk From Zantac

AboutLawsuits.com reported:

Following news reports last month suggesting GlaxoSmithKline knew for decades about the cancer risk from Zantac, a recalled heartburn drug, a lawmaker is asking federal drug regulators what their plans are to investigate the pharmaceutical company’s actions.

According to a report by Bloomberg News, U.S. Representative Rose DeLauro, ranking member of the House Appropriations Committee, wrote a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Tuesday, asking for information about how the agency plans to investigate GlaxoSmithKline’s failure to report known Zantac cancer risks and how it will hold the company responsible for its actions.

The letter, which has not yet been publicly released, came in the wake of a prior Bloomberg News report last month, which indicated scientists working with the drug maker suspected ranitidine, the active ingredient in Zantac, posed a potential cancer risk since the drug was first developed in the late 1970s and released onto the market in the early 1980s.

While the risk concerned investigators at the FDA at the time, Bloomberg indicates the manufacturer failed to share critical study data, which may have raised even more health concerns about the potential Zantac side effects.

Chasing Moderna, Merck Pays $50 Million to Join Race to Develop Cancer-Preventing Vaccine

Fierce Biotech reported:

Merck & Co. has joined the emerging race to develop an Epstein-Barr virus (EBV) vaccine, paying ModeX Therapeutics $50 million upfront and dangling $872.5 million in bio bucks for global rights to a preclinical challenger to shots in clinical development at Moderna and the National Institutes of Health (NIH).

Merck, which pioneered the idea of vaccinating to prevent cancer with HPV shot Gardasil, sees the evidence as an opportunity — and has identified ModeX as the company to help it realize that opportunity. The deal with ModeX gives Merck an exclusive worldwide license to the preclinical vaccine candidate MDX-2201.

ModeX developed MDX-2201 using a modular nanoparticle vaccine platform. The approach has resulted in a vaccine that presents antigens from four viral proteins — gH, gL, gp42 and gp350 — involved in viral entry into host cells. By targeting four proteins, the vaccine could inhibit the infection of both B cells and epithelial cells.

The vaccine is differentiated from other candidates. Moderna’s mRNA-1189 uses lipid nanoparticles to get mRNA encoding for four viral proteins — gp42, gp220, gH and gL — into human cells. Other candidates, including the NIH’s clinical-phase prospect, target gp350, the most abundant glycoprotein on the EBV envelope, although this approach has so far failed to yield an effective vaccine.

FDA: Two More Eyedrop Brands Recalled Due to Risks

Associated Press reported:

U.S. health officials are alerting consumers about two more recalls of eyedrops due to contamination risks that could lead to vision problems and serious injury.

The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. One person died and at least five others had permanent vision loss. There’s no indication the latest recalls are related to those products.

The Food and Drug Administration posted separate recall notices for certain eyedrops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market. Both companies said the recalls were conducted in consultation with the FDA.

Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems “that could result in blindness.” The over-the-counter drops are designed to treat eye irritation. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased.

Are Drugs Promoted on TV Ads Better Than Others? No, Study Finds. Sometimes They’re Worse.

USA TODAY reported:

They often start with someone in late middle age, gray-haired but active, taking a brisk hike, biking or looking out to sea.

There’s a passing reference to some dreaded disease the person would be suffering but for the great drug they’re taking. Tucked in the advertisement is a long list of potential, often horrible, side effects, delivered so rapid-fire, they sound almost comical.

Pharmaceutical companies spend more than $6 billion a year on these direct-to-consumer ads meant to encourage people to ask their doctor about a particular medication.

A recent study finds the drugs promoted in these ads are not any better — and are sometimes worse — than others on the market. They often aren’t intended as first-line therapies, deliver little value to patients or have more side effects than other equally effective treatments.

Pfizer CEO Albert Bourla Maxed Out Campaign Contributions to Dr. Oz Ahead of Midterm Elections

STAT News reported:

Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records.

Bourla, who leads Pfizer and is the treasurer of the brand-drug lobby PhRMA’s board of directors, gave Oz $2,900 on Aug. 12; the maximum allowed for an individual. The contribution occurred on the same day that the Democratic-led House of Representatives passed the Inflation Reduction Act. The vote ensured drug pricing policies vehemently opposed by the pharmaceutical industry would become law.

The contribution illustrates the fervor with which drugmakers hoped to regain some Republican control of Congress in the midterm elections. Democrats in 2022 pursued aggressive reforms to the country’s pharmaceutical pricing landscape, and the traditionally formidable drug lobby was unable to stop the policies from passing.

Controversial Drug for Preterm Birth to Be Withdrawn, Maker Says

BioPharma Dive reported:

The maker of a controversial drug for preterm birth has decided to withdraw the hormonal treatment, bringing to a close a lengthy battle with the Food and Drug Administration over its continued use. In a letter to FDA officials dated March 6, the company, Covis Pharma, said it would voluntarily remove the drug from the market, and requested time from the agency to “wind down” its commercial operations.

Covis’ decision follows years of debate over the drug, called Makena, and approved in 2011 for the prevention of early labor. Its continued clearance was in substantial doubt after a meeting last October of FDA advisers, who recommended for the second time that it be withdrawn.

In moving to withdraw Makena, Covis is acting ahead of a final decision, expected soon, from FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus. The agency did not confirm to BioPharma Dive whether any order had yet been made.

A memo filed Wednesday by the FDA’s Center for Drug Evaluation and Research, which oversees Makena’s approval status, recommended an immediate removal from the market.

How Does the World’s First Vaccine for Honeybees Work? ‘It’s Like Magic’

CBS News reported:

Bee colonies are collapsing all over the world, threatening large parts of our food supply. But there’s good news in the fight to slow their decline: the U.S. government has approved the use of the world’s first vaccine for honeybees. “It’s like magic,” said Annette Kleiser, CEO of Dalan Animal Health, which partnered with the University of Georgia to develop the vaccine. “You vaccinate the queen and she passes it on to the millions of offspring that make the colony.”

Bees pollinate one-third of the food grown in the United States — essential to producing an estimated $15 billion worth of crops annually. But bee colonies are collapsing due to disease, parasites, pesticides and even climate change-fueled droughts, which dry up the water and flowers they need to survive.

Unlike humans and animals, insects don’t create antibodies, so scientists have long thought vaccines won’t work. But they discovered in the lab that bees have a primitive immune system and that exposing a queen bee to some of the dead bacteria through her food created immunity in the hive.

So far, scientists have not seen any side effects or impacts on food products such as honey. The hope is the breakthrough will pave the way for other vaccines to control all sorts of harmful viruses and pests.

Lilly’s Perfect Timing for Insulin Cost Cuts

Politico reported:

Eli Lilly’s decision to lower the list price of its most popular insulin product by 70% in the final months of 2023 will save the company millions of dollars it would have paid in rebates to state Medicaid programs starting in 2024, health policy experts say.

State Medicaid programs would have generated about $150 in revenue for every vial of Humalog they purchased had Lilly not capped its prices — about $140 million in revenue nationally — based on calculations by Sean Dickson, a drug-pricing expert at the nonprofit West Health Policy Center.

That number is a fraction of Eli Lilly’s $28.5 billion in revenue last year and does not amount to a large proportion of Medicaid funding. But the announcement garnered Lilly positive headlines and the appearance of being a good corporate citizen.

The timing of the price cuts suggests Lilly is trying to avoid paying the Medicaid rebates, said Edwin Park, a Medicaid expert and Georgetown University professor.