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DOJ Challenges Johnson & Johnson’s Talc Bankruptcy Attempt in Texas
With Johnson & Johnson (J&J) sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
But the U.S. Department of Justice (DOJ) has called a foul.
In federal bankruptcy court in Houston, Texas, the U.S. Trustee program — the DOJ’s unit that oversees bankruptcy cases — has filed a motion to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.
Calling J&J’s strategy “a textbook example of bad faith,” the U.S. Trustee claims that the company’s subsidiary Red River Talc LLC — which was established by J&J with the intent to declare it bankrupt and forge a settlement — “has no need for bankruptcy relief.”
B.C. Breaks Vaccination Records, With 82,000 COVID-19 and Flu Shots in One Day
Record numbers of people in British Columbia (B.C.) are being vaccinated against COVID-19 and flu, as the province ramps up its immunization campaign for respiratory illness season.
The health ministry says in a news release invitations for priority populations started going out on Oct. 8, and on the first day of delivery on Oct. 15, B.C. pharmacies administered almost 82,000 vaccinations. It says that was a record for any single day, with about 50,000 shots for the flu, and about 32,000 for COVID-19.
The ministry says there are updated vaccines for both influenza and COVID-19 on offer, including new mRNA vaccines for the so-called KP.2 COVID variant. The first week of the campaign also set a record, with almost 370,000 vaccines administered.
RNA Editing: Emerging From Crispr’s Shadow
Thorsten Stafforst remembers being told to stop wasting his time.
It was early last decade and scientists across the world were buzzing over a new tool, called CRISPR, that could precisely alter human DNA. Working in the German college town of Tubingen, Stafforst and fellow researchers at the local university were instead engrossed by the prospect of rewriting RNA, DNA’s chemical cousin.
“Everybody told me, ‘Why do you want to edit RNA?’” Stafforst said. “You can edit DNA now; that doesn’t make sense.”
Yet in 2012 they and, shortly afterwards, a group at the University of Puerto Rico figured out how to use a naturally occurring enzyme to swap out single “letters” in RNA sequences. Their discovery drew from research into the biology of octopuses and squids, which are adept at rewriting their own RNA. And as with CRISPR, the findings pointed to a novel way of treating disease. In a world newly enchanted by gene editing, however, their papers were met with far less acclaim.
More than a decade later, RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli Lilly, Roche and Novo Nordisk, have taken an interest.
Weight Loss Jabs for Jobless Not Dystopian — Streeting
Health Secretary Wes Streeting has dismissed suggestions that plans to provide weight loss jabs to unemployed people with obesity are “dystopian.”
The U.K. government is partnering with pharmaceutical giant Lilly who are running a five-year trial in Greater Manchester to test if the weight-loss drug Mounjaro can help get more people back to work and prevent obesity-related diseases to ease the strain on the National Health Service, or NHS in England.
The announcement prompted a backlash, with accusations that the government was stigmatizing unemployed individuals and reducing people to their economic value.
Speaking on Sunday with Laura Kuenssberg, Streeting said the jabs were part of a broader healthcare plan, adding that he was “not interested in some dystopian future where I involuntarily jab unemployed people who are overweight.”
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Vaccine Against the MERS Coronavirus Tested as Safe and Effective in Phase Ib Clinical Trial
The MERS coronavirus — MERS stands for “Middle East respiratory syndrome” — causes severe respiratory diseases with a high mortality rate. To date, there is neither a vaccine nor a specific treatment.
The safety, immunogenicity and optimal dosing regimen of the MVA-MERS-S vaccine candidate developed at the DZIF have now been investigated in a phase Ib study in healthy individuals who were previously infected with the related coronavirus SARS-CoV-2.
The study, led by Prof Marylyn Addo at the University Medical Center Hamburg-Eppendorf and published in The Lancet Infectious Diseases, has shown that the vaccine is safe and effective. Further studies on the safety and efficacy of the vaccine in risk groups for severe MERS-CoV disease, including the elderly and people with relevant comorbidities, will follow.
Starboard Wants to Hold Pfizer Leadership ‘Accountable’ for Overpaid M&A Deals, Poor Return on R&D Investment
Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job.
Starboard has called on Pfizer’s board to “hold management accountable” for what the hedge fund described as poor revenue returns on investments in R&D and M&A, according to a new presentation for the 13D Monitor Active-Passive Investor Summit in New York.
“We measure success in producing blockbuster drugs and we all get measured by our track records. The track record here is not great,” Starboard CEO Jeffrey Smith said at the conference Tuesday, as quoted by Reuters.
“We have to amp up the accountability” at Pfizer, Smith said, according to Bloomberg.
By Starboard’s count, Pfizer has lost more than $20 billion in market value since 2019 despite receiving a $40 billion boost from the COVID-19 franchise during the pandemic. A low valuation and leveraged balance sheet could hamper Pfizer’s ability to do more acquisitions, further limiting future growth, Starboard argued.
Covid Vaccine Tech Is Being Used to Fight a Nasty, Diarrhea-Causing Bacteria
We might soon have a way to prevent one of the world’s most debilitating and hard-to-treat infections in the world.
Scientists are developing a cutting-edge vaccine that could stop Clostridioides difficile — a bacteria known for causing severe gut infections — in its tracks. Scientists detailed their development of an experimental vaccine candidate for C. difficile bacteria, better known as C. diff, in new research this week.
The vaccine is based on the same mRNA technology used to create some of the first widely available COVID-19 vaccines. Researchers at the University of Pennsylvania and Children’s Hospital of Philadelphia developed the vaccine candidate, which leverages mRNA technology to target C. diff at different key points.
Success of Long-Lasting HIV Drug Hinges on Pricing
Affordability and mass distribution will be critical to the success of a long-lasting injectable human immunodeficiency virus (HIV) prevention drug that has proven highly effective in human trials, say global health specialists.
U.S. pharma company Gilead Sciences is seeking regulatory approval for the drug lenacapavir in a number of African countries — a key step towards making it available across the region, where almost 1 in 25 people live with HIV.
Lenacapavir is a long-acting pre-exposure prophylaxis (PrEP) product, a treatment that works by stopping HIV from getting into the body and making copies of itself.
Unlike oral PrEP treatments, which are taken daily, the drug is administered at six-month intervals and is the longest acting injectable produced to date.
Does Microdosing Ozempic Work? What Experts Are Saying About the Diabetes Drug Also Used for Weight Loss
The high price and side effects of Ozempic, the blockbuster diabetes drug also used off label for weight loss, has led people to stretch out their supply by taking the medication in smaller, micro doses.
But the efficacy of microdosing Ozempic has yet to be determined by clinical trials, says Northeastern professor Mansoor Amiji. A micro dose could amount to one-tenth the amount of the standard prescription, says Amiji, university distinguished professor of pharmaceutical sciences and chemical engineering.
“Nobody has done any clinical studies with one-tenth of the dose to show whether it is working or not working,” he says.
