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Merck, Moderna Unveil Phase 3 Trial Details for Closely Watched mRNA Cancer Vaccine
After a major phase 2 win that stirred up much excitement within the oncology community, Merck & Co. has officially formulated a pivotal trial plan for its Moderna-partnered personalized cancer vaccine, mRNA-4157.
A phase 3 trial coded V940-001 will test the combination of the mRNA vaccine, also known as V940, and Merck’s PD-1 inhibitor Keytruda for post-surgery treatment of patients with resected melanoma that’s at high risk of recurrence. The trial was posted on ClinicalTrials.gov Thursday and is expected to kick off on Aug. 1.
The vaccine is made by profiling each patient’s tumor mutational signature and is designed to induce an immune response against the corresponding antigens. If eventually successful, Merck and Moderna could open up an entirely new area of cancer treatment.
While the midstage trial data included patients with stage 3b to 4 melanoma, the new phase 3 stretches to disease as early as stage 2b.
RSV Vaccine for Older Adults Approved by U.K. Medicines Regulator
The U.K.’s medicines regulator has approved the first vaccine against respiratory syncytial virus (RSV) in older adults.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized the vaccine, Arexvy, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years and older — the first time an RSV vaccine for older adults has been authorized for use in the U.K.
The vaccine, produced by GlaxoSmithKline, has already been approved for use in the U.S. and Europe. Further adult RSV vaccines from Moderna and Pfizer are expected to be considered in the coming months.
EU Investigates Ozempic Maker After Reports of Suicidal Thoughts
Novo Nordisk A/S, the company responsible for popular weight-loss and diabetes drugs such as Ozempic, Saxenda, and Wegovy, is being investigated by the European Medicines Agency after Iceland’s health regulators flagged several cases of patients reporting thoughts of self-harm while using the company’s drugs.
The EMA’s investigation is a result of the Icelandic Medicines Agency noting three cases of patients on the diabetes drug Ozempic and weight loss drug Saxenda experiencing thoughts of self-harm or suicide, according to multiple reports.
The three cases include two instances of suicidal thoughts potentially linked to Ozempic and Saxenda, and one instance of thoughts of self-harm linked to Saxenda, according to the regulator.
Novo Nordisk cashed in $22.4B in revenue and $7.6B in profits for 2022, according to Forbes.
Jurors Urged to Impose Heavy Punitive Damages in J&J Talc Trial
Lawyers for a California man who says he developed a rare cancer from exposure to asbestos in Johnson & Johnson‘s (JNJ.N) talc-based baby powder on Monday urged a jury to order the company to pay heavy punitive damages, calling its conduct negligent and “despicable.”
“A reasonably careful corporation would not sell a product that allowed carcinogens to be applied to babies,” Joseph Satterley, a lawyer for Emory Hernandez Valadez, said in a closing argument at the end of a six-week trial in Alameda County Superior Court in California.
J&J has consistently denied that its now-discontinued talc baby powder contains asbestos or causes cancer.
Satterley asked jurors to award Hernandez punitive damages about nine times greater than so-called compensatory damages, which include $3.8 million for his medical costs as well as damages for pain and suffering. Satterley said the pain and suffering damages should be much larger than the medical costs.
Tens of thousands of plaintiffs have sued, alleging that J&J’s baby powder and other talc products sometimes contained asbestos and caused ovarian cancer and mesothelioma. J&J has said its talc products are safe and do not contain asbestos, which has been linked to mesothelioma.
EMS Crews May Not Always Follow Guidelines When Dosing Kids: Study
U.S. News & World Report reported:
Less than half of all children treated by emergency medical services receive the right amount of medication during out-of-hospital emergencies, a new study found. In some cases, these incorrect doses can have serious consequences.
“If you don’t give the appropriate dose of the anti-seizure medication for a patient with an ongoing seizure, the seizure will not stop,” said study co-author Dr. Sriram Ramgopal, an attending physician in emergency medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Specifically, the study — published July 10 in the journal Pediatrics — found that in the nearly 1 million pediatric encounters examined, just 42.6% of administrations of 10 commonly used medications followed national guidelines.
For children, most medications are dosed out based on weight. While there are techniques for doing so, guessing someone’s weight with relative accuracy can be difficult. Plus, when EMS workers face the stress of treating a child in crisis all while riding in the back of a truck, doing the math to determine how much medication is needed can prove quite challenging.
Newly Approved Alzheimer’s Drug May Not Work as Well on Women
Some experts are questioning whether a newly approved Alzheimer’s drug was shown in clinical trials to be less effective on women — even though the FDA didn’t flag any such concerns when it was authorized last week.
Why it matters: Nearly two-thirds of Americans living with Alzheimer’s disease are female, according to the Alzheimer’s Association. The $26,500 drug, Leqembi, also can cause significant side effects, and some experts question whether the benefits outweigh the risks even without accounting for any gender disparities.
Details: The results from Leqembi’s clinical trial were published in the New England Journal of Medicine last year and concluded that the drug slowed clinical decline by 27%.
But in a supplementary appendix also published in the NEJM, analyses of subgroups found that the rate the disease was slowed was lower for women than for men in the study. The drug slowed cognitive decline in women by 12% compared to 43% in men.
Novavax Stock Spikes 29% After Company Snags $350 Million From Canada for Unused COVID Shots
Novavax’s stock price jumped nearly 30% on Monday after the embattled biotech company said Canada has agreed to pay $350 million for forfeiting COVID vaccine doses that were previously scheduled for delivery.
The settlement is part of an amended COVID shot purchase agreement between Maryland-based Novavax and the Canadian government that the parties first established in January 2021, the company said Friday in a filing with the Securities and Exchange Commission.
It’s unclear how many doses of Novavax’s jab — its only commercially available product after 35 years — went unused. Under the amended agreement, Novavax will also provide Canada with fewer doses of its vaccine on a revised delivery schedule.
However, Canada can terminate the contract if Novavax fails to receive regulatory approval for vaccine production at the Canadian government’s biomanufacturing facility by Dec. 31, 2024, according to the agreement.
Upgraded Lyme Disease Vaccine Promising in Phase I Results — the Vaccine Neutralizes Lyme-Causing Bacteria in the Tick Before It Can Get to the Human
A novel multivalent outer surface protein A (OspA)-based vaccine candidate (VLA15) against Lyme borreliosis (Lyme disease) appeared safe and generated immunogenicity in young adults, according to phase I trial results.
Safety and tolerability were similar between adjuvanted and non-adjuvanted formulations, with adverse events reported in 94-97% of participants getting the intermediate (48 μg) and highest doses (90 μg) when compared with the lowest dose (89% with 12 μg, 95% CI 69.4-94.5). Injection site tenderness or pain were the most common adverse events; common systemic reactions were headache in 45%, excessive fatigue in 25%, and myalgia in 25%.
VLA15 also is different in that it doesn’t contain the epitope present in the LYMErix vaccine thought to be associated with the development of autoimmune arthritis through a cross-reaction with human leukocyte function-associated antigen (hLFA1), Hajdusek and Perner wrote.
VLA15 phase III trials are currently underway, and the vaccine has been given fast-track designation by the FDA, with the potential to be evaluated for approval in 2026.
Samsung Biologics, After Expanding Pfizer Collab, Inks Novartis Production Deal Worth $391 Million
Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile — this time courtesy of an expanded pact with Novartis.
Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022.
Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation.
Samsung’s Novartis deal comes in below the Pfizer deal from June. Still, the Novartis tie-up now represents Samsung’s second-biggest production pact ever, taking silver over a $360 million deal with AstraZeneca.
Germany on Track to Bin 200 Million COVID Vaccine Doses
Germany has thrown out 83 million doses of coronavirus vaccines at a rough cost of €1.6 billion and has 120 million more doses sitting unused in stock, even as it is set to receive more jabs at a time when vaccination has flatlined.
According to data provided by the country’s health ministry, Germany scrapped 54 million COVID-19 vaccine doses by the end of 2022 and another 29 million in the first quarter of 2023.
Meanwhile, another 120 million doses are still in stock as the number of people getting vaccines has plummeted. The EU’s disease control agency’s most recent data shows that a total of 268 doses were administered in Germany in the week of June 5. And 1,462 people were jabbed in the three weeks before that.
EU countries, including Germany, are still on the hook for even more doses after a recent deal negotiated between the Commission and U.S. pharmaceutical Pfizer. The exact number of deliveries that the bloc is set to receive isn’t public, but one participant in a confidential meeting where details of the revised contract were shared with a select group of MEPs told POLITICO that the figure is 260 million doses spread out over the course of the next four years — or 65 million doses per year.
