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Cancer Vaccines Are Already a Reality — but Your Doctor Might Not Tell You About Them Unless You Ask
Cancer vaccines — it’s a concept seemingly torn from the plot of a futuristic sci-fi movie, or from the pages of some decades-old utopian novel far ahead of its time.
“If you took a poll and asked people, ‘Do we have a vaccine against cancer?’ people would say no,” Karen Knudsen, CEO of the American Cancer Society, tells Fortune. “They really don’t know that we do.”
Pharma giants BioNTech and Moderna recently made headlines for exploring the potential of mRNA vaccines, first employed with COVID, to treat cancer. Such vaccines use lab-created messengers, of sorts, that teach the body how to mount an immune response.
But clinical trials have long been underway using more traditional vaccine technologies — and participants are already receiving cancer vaccines, many personalized. A handful of vaccines have already received approval from the U.S. Food and Drug Administration. And cancer-preventing vaccines have been around since the 1980s.
Women Suing J&J Await Their Day in Court After the Company Failed to Get Talc Cases Moved to Bankruptcy Court
In the long legal fight over allegations that talc in Johnson & Johnson baby powder is linked to ovarian cancer, plaintiffs got an incremental victory on Monday: A federal appeals court rejected J&J’s effort to move more than 38,000 lawsuits to bankruptcy court.
J&J has faced mounting lawsuits for roughly a decade, with plaintiffs alleging that their ovarian cancer or mesothelioma — a rare cancer affecting the thin layer of tissue that lines the chest and abdomen — was caused by asbestos found in the company’s talc-based baby powder. J&J has consistently denied that its talc-based products contained asbestos.
However, a 2018 Reuters investigation suggested that J&J knew some of its baby powder was contaminated with small amounts of asbestos as early as the 1970s. Reuters reported that it obtained J&J company memos, internal reports, confidential documents and deposition and trial testimonies.
According to that investigation, the earliest known lawsuit linking ovarian cancer and J&J baby powder was filed in 1997. J&J denied to Reuters that it knew of or hid any talc-related safety issues and said independent tests had shown its talc did not contain asbestos.
Health Experts Want FDA Safety Review of Fast-Tracked Alzheimer’s Drug
Doctors and scientists are urging the Food and Drug Administration to convene an expert panel to review safety concerns around an Alzheimer’s drug that won fast-track approval in January.
The big picture: It’s the latest concern over whether the FDA is cutting corners evaluating Alzheimer’s drugs, prompted by its controversial 2021 approval of Biogen’s Aduhelm, which came over the objections of an advisory panel and without evidence the drug actually slowed the decline of memory and brain function.
Some health experts now say that the agency isn’t doing enough to address questions about Eisai’s lecanemab — including three patient deaths during clinical trials that scientists connected to the drug.
The FDA didn’t follow its customary process and convene an advisory panel before green-lighting the accelerated approval last month. What’s happening: Some health experts believe the agency should next convene a public discussion on Eisai’s drug, which would cost $26,500 per year for the average patient, before deciding whether it should get full approval based on its actual clinical benefit.
Teen Overdose Deaths Lead California Schools to Stock Reversal Drug
When a student at a Sacramento high school collapsed in an apparent overdose last fall, staff were able to render immediate first aid, administering a newly stocked dose of the opioid reversal drug naloxone.
“The results were pretty immediate,” said Victoria Flores, a health administrator with the Sacramento Unified School District. “The individual’s life was saved.”
Such incidents, though relatively rare, are behind a new push in California to not just stock school campuses with naloxone, sold under the brand name Narcan, but also allow students to carry and administer the drug.
With overdoses near record highs because of the prevalence of fentanyl, Gov. Gavin Newsom called in his recent budget proposal for $3.5 million to supply middle and high schools with naloxone — even as a potential deficit looms and some programs face cuts.
A Technicality Could Keep RSV Shots From Kids in Need
After more than five decades of trying, the drug industry is on the verge of providing effective immunizations against the respiratory syncytial virus, which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.
But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well-insured.
The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written. But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and FDA approval is expected this summer), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.
Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.
New Diabetes Drugs Do Not Tackle Root Causes of Obesity, Experts Warn
The promise of breakthrough drugs to help people lose weight must not be used as an excuse to avoid tackling the root causes of obesity, experts have warned, as concerns grow over a scramble for the slimming jabs.
With many finding keeping weight off through diet and exercise challenging, excitement is growing around drugs that have been found to help people lose large amounts of weight by mimicking hormones that help people feel full after consuming food.
Experts say that while the dramatic impact of such drugs is welcome, there are concerns it could detract from taking action to prevent obesity in the first place. Experts say more work is needed around safety and side effects, and the drugs have drawbacks, including that they are expensive and can be administered only by injection.
People Are Zapping Their Brains at Home to Improve Focus and Clear Brain Fog. But Is It Safe?
In 2021, Craig Gibbons was diagnosed with Lyme disease. His doctor prescribed him antibiotics, but the medication failed to eliminate one of his most debilitating symptoms: a lasting brain fog that made it difficult for him to focus or recall information. So he went with a different approach: at-home brain stimulation.
Over the past few years, Gibbons had been experimenting with transcranial direct current stimulation, or tDCS, which delivers weak electrical currents to the brain through electrodes attached to the head.
The at-home devices are available online and typically range in cost from as little as $40 to around $500. They are usually no bigger than a television remote or a smartphone; batteries, head caps and straps, saline and other accessories needed to send the weak pulses of electricity to the brain are sometimes sold separately.
Despite their growing popularity, many scientists oppose the use of the devices at home because not much is known about their safety in the long term, said Robert Reinhart, a neuroscientist at Boston University.
J&J’s Pharma Group Quietly Works Through Global Overhaul, With Layoffs Expected to Reach Multiple Countries
Three Johnson & Johnson pharmaceutical executives stood before a group of staff in the R&D unit Wednesday, joking about expensive Uber rides and one “phenomenal dinner” at a Japanese steakhouse while attending the J.P. Morgan Healthcare Conference in San Francisco in early January.
But just minutes earlier, the mood was anything but jovial, as the leaders explained to a nervous group of employees in the Janssen pharmaceutical unit an overhaul of operations for the infectious diseases and vaccine groups, with sweeping layoffs expected to claim staffers’ jobs in countries around the world. Some staff members have yet to be told that their positions will be cut.
For example, the company is ending work on its hepatitis B and D therapies and continuing only “legacy studies,” according to an internal presentation slide reviewed by Fierce Pharma. J&J is also discontinuing all antibacterial therapeutic efforts, as well as work on acute respiratory distress syndrome.
The company is also winding down work on its COVID-19 and HIV vaccines, the latter of which just failed a phase 3 trial. The COVID shot was authorized during the pandemic but failed to gain a foothold in the market due to concerns about blood clots. Moving forward, J&J plans to focus on pre-exposure prophylaxis to flu, COVID-19, RSV and HRV.
The EU Butts Heads With Big Pharma to Make Medicines Cheaper
The EU wants to give European consumers access to more medicines, faster and for less money — and it’s picking a fight with the pharmaceutical industry in the process.
A draft plan to overhaul the EU’s pharmaceutical laws — a copy of which has been obtained by POLITICO — would see the European Commission rip up the perks that drugmakers currently enjoy in order to let unbranded rivals enter the market earlier, driving down prices for consumers.
It proposes slashing the amount of time that pharmaceutical companies have to sell their medicines without competition. At the moment, companies that develop branded medicines have 10 years to sell a new drug unchallenged, after which rivals can launch unbranded “copycat” drugs that quickly drive down prices — and profits.
The EU wants to reduce that period by two years. That means cheaper drugs would be able to enter the market sooner, helping medicines reach more people. There’s an added twist, however. Under the draft plans, companies that make their medicines available in all EU markets get some (but not all) of that time back.
