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J&J Must Pay Cancer Patient $18.8 Million in Baby Powder Lawsuit, Jury Says
Johnson & Johnson was ordered by a California jury on Tuesday to pay $18.8 million to a man who said in a lawsuit that he developed cancer due to exposure to its baby powder, per Reuters. J&J said it will appeal the decision.
Why it matters: J&J is seeking to settle lawsuits from cancer survivors and their families who allege the company’s talc-based powder caused their illness while denying that this is the case.
Driving the news: California cancer patient Emory Hernandez Valadez, 24, alleged in a lawsuit in state court in Oakland last year that he developed mesothelioma in the tissue around his heart because he was exposed to the J&J product as a child.
Yes, but: Hernandez cannot be awarded the damages as it stands due to bankruptcy proceedings that prevent such payments in cases involving J&J talc, which accusers say caused cancer due to contamination with the known carcinogen asbestos — a claim the company denies.
House Judiciary Committee Probes Big Pharma’s Potential Role in COVID Censorship
House Judiciary Committee Chair Jim Jordan (R-Ohio) has asked Pfizer, Johnson & Johnson and Merck, along with other pharmaceutical companies, to turn over documents related to an alleged “censorship regime” during the COVID-19 pandemic.
In a news release posted Tuesday, Jordan pointed to documents obtained by his committee, which claimed that the three drugmakers met with representatives from Stanford University, tech companies and agencies of the U.S. government’s executive branch in December 2020 to form a united front against misinformation related to COVID-19 vaccines.
Jordan also cited “other reporting” that allegedly revealed how the pharmaceutical industry pressured social media companies to strike posts about low-cost generic vaccines from their platforms.
The House Judiciary Committee has launched an investigation into the matter, for which Jordan has sent letters to Pfizer CEO Anthony Bourla, J&J CEO Joaquin Donato and Merck CEO Robert Davis.
Myocarditis and COVID Vaccination: Yale Researchers Reveal New Insights
Two years ago, as COVID-19 vaccines first started to be rolled out, there was a surge in myocarditis cases, a condition characterized by inflammation of the heart muscle. This was particularly noticeable in young males who received mRNA vaccines. It was unclear, however, what exactly was causing this reaction.
However, Yale researchers have now shed light on this issue through a recent study, where they identified the immune signature of these heart inflammation cases.
Myocarditis is a generally mild inflammation of heart tissue that can cause scarring but is usually resolved within days. The increased incidence of myocarditis during vaccination was seen primarily in males in their teens or early 20s, who had been vaccinated with mRNA vaccines, which are designed to elicit immune responses specifically to the SARS-CoV-2 virus.
For the new study, the Yale research team conducted a detailed analysis of immune system responses in those rare cases of myocarditis among vaccinated individuals. The team was led by Carrie Lucas, associate professor of immunobiology, Akiko Iwasaki, Sterling Professor of Immunobiology, and Inci Yildirim, associate professor of pediatrics and epidemiology. “The immune systems of these individuals get a little too revved up and over-produce cytokine and cellular responses,” Lucas said.
Pfizer, Flagship Pioneering to Invest $100 Million in Drug Discovery
U.S. drugmaker Pfizer (PFE.N) and venture firm Flagship Pioneering on Tuesday said they would invest $100 million together to develop up to 10 new potential drugs for areas including internal medicine, oncology, infectious diseases and immunology.
Flagship, which has incubated biotech companies, most famously Moderna Inc (MRNA.O), and Pfizer will each invest $50 million. Flagship’s drug discovery initiative Pioneering Medicines will lead the exploration process.
Under the terms of the agreement, Flagship-backed companies could receive up to $700 million in milestones and royalties upon the successful launch and sale of any of the experimental treatments discovered and developed under the partnership. That would be up to $7 billion if the partnership were to develop 10 medicines.
CDC Vaccine Committee Sets August Date to Weigh Use of Sanofi, AZ’s RSV Antibody Beyfortus
After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee’s calendar to determine its place in U.S. immunization guidelines.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will convene on Aug. 3 to evaluate and vote on Beyfortus’ potential addition to the children’s vaccine schedule in the U.S.
The committee will also vote on the drug’s place in the CDC’s Vaccines for Children program, which provides free vaccines to eligible kids whose families might not otherwise be able to pay for the recommended vaccines.
The antibody’s recent FDA approval covers infants who are born during or entering their first RSV season, plus children up to 24 months of age who remain at risk of severe RSV through their second virus season. Sanofi and AZ plan to make the vaccine available in the U.S. before the upcoming 2023-24 RSV season, the two companies said in a release.
Johnson & Johnson Sues Biden Administration Over Medicare Drug Price Negotiations
Johnson & Johnson on Tuesday sued the Biden administration over Medicare’s new powers to slash drug prices, making it the third pharmaceutical company to challenge the controversial provision of the Inflation Reduction Act. The lawsuit filed in a federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
Earlier suits brought separately by drugmakers Merck and Bristol Myers Squibb, as well as by the U.S. Chamber of Commerce and PhRMA, the pharmaceutical industry’s largest lobbying group, made similar arguments.
J&J’s complaint asks a judge to block the U.S. Health and Human Services Department from compelling the drugmaker to participate in the program.
President Joe Biden’s Inflation Reduction Act, which passed in 2022 by a narrow party-line vote, empowered Medicare to negotiate drug prices for the first time in the program’s six-decade history. The provision aims to make drugs more affordable for older Americans but will likely reduce pharmaceutical industry profits.
Mother Takes Drugs Message to Late Son’s School
A mother who lost her teenage son to drugs has taken her campaign against illegal substances to his old school. William Horley died in 2018, aged 17, after taking the prescription painkiller tramadol with a friend.
Since William’s death, Webster has spoken to more than 25,000 teenagers in partnership with the Kenward Trust charity. “Will was a typical teenager but he was naive, curious and uneducated in the dangers of drug use, just like all our children.”
She added: “It is a privilege to continue to help make a difference. It has become a passion of mine to educate our young people since losing Will.”
The Two-Horse Race to Make Blockbuster Obesity Drugs
The push to develop blockbuster weight-loss drugs has turned into a two-horse race between Novo Nordisk and Eli Lilly, and the stakes are rising.
Driving the news: Lilly’s planned $1.9 billion acquisition of privately held Versanis Bio, announced last week, marked the latest move to revamp obesity care, by potentially giving Lilly access to an experimental drug that acts directly on fat cells without leading to appetite loss.
Other pharma giants such as Pfizer, Merck and Amgen are trying to gain a foothold with their own drug candidates, as are smaller biotechs like Viking Therapeutics and Structure Therapeutics.
But “in terms of commercial impact, this year and next year, it’s Lilly and Novo,” Evan Seigerman, a senior research analyst for BMO Capital Markets told Axios.
FDA Approves Drug Remdesivir for COVID Treatment in People With Kidney Problems, Despite Data Showing Renal Failure
The U.S. Food and Drug Administration (FDA) on July 14 approved Veklury, also known as remdesivir, to treat COVID-19 in people with severe renal impairment, including dialysis, despite data showing the drug increases the risk of kidney failure.
Remdesivir is an antiviral medication that targets the RNA in viruses to prevent replication. The FDA first authorized remdesivir for emergency use in May 2020 to treat people with severe COVID-19. It has since been approved for adults and children as young as 28 days who weigh at least 6.6 pounds. Remdesivir is the first and only FDA-approved antiviral COVID-19 treatment for people with renal disease.
According to the company, the FDA based its approval of remdesivir for use in patients with severe renal impairment on the results of a phase 1 study and a phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study trial that assessed how the drug interacts with the body and its safety profile. Yet the phase 3 study terminated prematurely due to “feasibility issues” and because it was “underpowered to assess for efficacy because of lower-than-expected enrollment.”
The company said their data did not reveal any new safety signals “associated with increased metabolite levels in patients with severely reduced kidney function.” However, data from the phase 3 study show serious adverse events were significantly higher in those who received remdesivir than those who received the placebo. People who took remdesivir were more likely to experience acute kidney injury (AKI), sepsis, COVID-19 pneumonia, sudden death, and heart problems.
Polio Scare Hits Malawi With 17 Possible Cases, Just as Huge Vaccine Drive Ends
Malawi is investigating at least 17 suspected polio cases just as a vaccination campaign is completed with more than 90% of the country’s children inoculated against the virus.
Health authorities fear Cyclone Freddy — the world’s longest-lasting tropical cyclone — which made landfall in March in the southern African nation and led to hundreds of deaths and thousands of displacements — could be a contributing factor.
Arnold Mdalira, a spokesperson for the Zomba district health office in southern Malawi, said on Monday that the results of the investigation will come out in a fortnight. “Zomba is one of the districts affected by Cyclone Freddy, and it destroyed toilets and other sanitation facilities,” he said in a radio interview. The development could pose danger to children, especially newborns, he added.
Malawi has been vaccinating children since last year following a recorded first case of wild polio in 30 years, and the first in Africa since the region was certified free of indigenous wild polio in 2020.
