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Novel Cancer Vaccine Offers New Hope for Dogs — and Those Who Love Them

YaleNews reported:

Two years since his initial diagnosis, Hunter has no signs of cancer. The dog’s life-saving treatment incorporated typical approaches, including amputation of the left leg and chemotherapy. But Hunter also received a novel therapy — a cancer vaccine developed by Yale’s Mark Mamula.

The treatment, a form of immunotherapy that is currently under review by the U.S. Department of Agriculture (USDA), which regulates animal treatments, has been subject to multiple clinical trials over the past eight years. And the results are promising; for hundreds of dogs, including Hunter, the vaccine has proved effective.

Mamula, a professor of medicine (rheumatology) at Yale School of Medicine, believes the vaccine offers a badly needed weapon in the fight against canine cancer.

Even as recently as a decade ago, Mamula didn’t anticipate that he would one day develop a cancer vaccine for dogs. A rheumatology researcher, he studies autoimmune diseases like lupus and Type 1 diabetes and how the body gives rise to them. But that work eventually led him to cancer research as well.

‘Let’s Get Serious’: Eli Lilly Slams Hollywood’s Ozempic Obsession Ahead of Oscars

USA TODAY reported:

Pharmaceutical giant Eli Lilly is finally weighing in on Hollywood’s obsession with Ozempic. In a commercial spot released Thursday, the company criticizes people who prescribe or take weight loss drugs without an obesity diagnosis. The ad hits the airwaves days before the 96th Academy Awards, an epic Hollywood gathering where people tend to be laser-focused on celebrities and their bodies.

James Zervios, vice president and chief of staff for the Obesity Action Coalition, applauded the drugmaker for speaking up about misuse of the drug, but he said the spot doesn’t address the glaring challenge average Americans with obesity face in accessing expensive drugs.

Eli Lilly also released a second ad, in black and white, on Thursday that touched on the stigma of weight as part of a campaign to connect with patients, company CEO Dave Ricks said.

“It feels sneaky to me. It feels insidious,” said Tigress Osborn, executive director of the National Association to Advance Fat Acceptance. “I need more than one commercial to make me start trusting that Eli Lilly is genuinely interested in what’s best for me.”

Weight-Loss Drugs Like Wegovy Are Meant for Long-Term Use. Some Patients Want to Stop

Associated Press reported:

Millions of Americans who have dropped pounds and boosted their health using popular obesity drugs like Wegovy are facing a new dilemma: What happens if they stop taking them? Many worry, rightly, that they’ll regain weight and revert to old habits. In clinical trials, patients who paused the drugs put back on most of the weight they lost.

But others are gambling on a do-it-yourself strategy to ease off the drugs and stay slim by stretching out doses, taking the medication intermittently or stopping and starting again only if needed.

More than 3 million prescriptions for the new medications are dispensed each month in the U.S., according to recent data from the health technology company IQVIA. They include semaglutide, the drug in Ozempic and Wegovy, and tirzepatide, the drug in Mounjaro and Zepbound.

Doctors who treat obesity stress that the disease is a chronic condition that must be managed indefinitely, like heart disease or high blood pressure. The new injection drugs work by mimicking hormones in the gut and the brain to regulate appetite and feelings of fullness. They were designed — and tested — to be taken continuously, experts said.

Lilly Finds Bacteria, Other Impurities in Mounjaro, Zepbound Knockoffs

Reuters reported:

Eli Lilly (LLY.N) said on Thursday it has found bacteria and high levels of impurities in products claiming to be compounded versions of tirzepatide, the active ingredient in its popular diabetes drug Mounjaro and weight loss treatment Zepbound.

The U.S. drugmaker has sued several medical spas, weight-loss clinics and compounding pharmacies to stop them from selling products purporting to contain tirzepatide.

The company said it does not sell or provide tirzepatide to any compounding pharmacies.

“Lilly rightly notes that compounded drugs are not FDA-approved. But that fact does not mean compounded drugs are unsafe — any more than it means that FDA-approved drugs are always safe,” said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians.

Gastroparesis Lawsuit Filed Over Side Effects of Ozempic and Trulicity

AboutLawsuits.com reported:

A Pennsylvania woman has filed a product liability lawsuit against the makers of Ozempic and Trulicity, indicating that gastroparesis side effects linked to the diabetes drugs caused her to suffer severe and painful injuries, including bowel obstruction and severe nausea.

Danielle Kindrew filed the complaint against Novo Nordisk and its subsidiaries on February 22 in the U.S. District Court for the Eastern District of Pennsylvania, indicating that the drug manufacturer failed in its duty to warn the medical community about the full risks of Ozempic and Trulicity, both of which belong to a class of diabetes and weight loss medications known as glucagon-like peptide-1 receptor agonists (GLP-1RAs), which also include drugs like Mounjaro, Zepbound, Victoza and Byetta.

Initially approved for the treatment of Type 2 diabetes, aggressive advertisements that promoted Ozempic’s weight loss benefits have led to GLP-1 drugs being increasingly prescribed for weight loss in recent years.

Although advertisements promote the drug as safe and effective, with few long-term side effects, Kindrew and other former users are now pursuing Ozempic lawsuits against Novo Nordisk, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to disclose the risk of gastroparesis, intestinal blockages, and other severe injury risks.

Eli Lilly Says Alzheimer’s Drug Approval Delayed as FDA Seeks Input From Advisers

CNN Health reported:

Drugmaker Eli Lilly says that approval of its experimental Alzheimer’s medication donanemab will be delayed beyond the end of March as the U.S. Food and Drug Administration plans to call a last-minute meeting of its outside advisers to review the drug’s safety and efficacy.

The medicine had been expected to be cleared by the end of the first quarter of this year, after being pushed back already from an expected approval last year. It would follow Eisai and Biogen’s Leqembi to market as the second drug shown to slow the course of the memory-robbing disease, which affects more than 6 million Americans. Both drugs work by targeting plaque buildups in the brain that are known as amyloid.

The FDA told Lilly that it plans to call the advisory meeting to discuss the safety of donanemab, as well as the design of a key clinical trial supporting its application, called Trailblazer-Alz 2, the company said in a news release Friday. The date for the meeting hasn’t been set, Lilly said.

Bayer Indicates Resolving Roundup Lawsuits in 2024 Is a Priority, Amid Continuing Trials and Verdicts

AboutLawsuits.com reported:

A top Bayer executive told investors this week that resolving Roundup lawsuits is one of the company’s priorities over the next two to three years, due to the high ongoing costs associated with litigation over the failure to warn about the risk of non-Hodgkins lymphoma. However, that does not mean the company is ready to settle, as it continues to attempt to defend the safety of the controversial weed killer.

Over the past eight years, more than 167,000 Roundup lawsuits have been filed throughout the U.S., Bayer officials told investors, each raising similar allegations that users were not adequately warned about the risk of developing non-Hodgkin’s lymphoma from the weed killer, either when using the product in an agricultural setting or around the home.