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Talc in Johnson’s Baby Powder Determined to Be ‘Probably Carcinogenic’ by World Health Organization
Even without being contaminated by asbestos, exposure to talc in Johnson’s Baby Powder probably increases the risk of cancer, particularly ovarian cancer, according to a new assessment by the World Health Organization (WHO).
Following years of concerns about the link between talcum powder and ovarian cancer, researchers with WHO’s International Agency for Research on Cancer (IARC) have now determined that there is enough evidence between studies on humans and animals, as well as how talc interacts with the body, to conclude that the substance is probably a cancer-causing agent.
The findings were published in The Lancet Oncology on July 5, following a string of scientific studies and evaluations that have suggested the risk of cancer from talc has been underestimated for decades.
As a result of the manufacturers’ failure to previously warn about this risk, tens of thousands of women are now pursuing Johnson’s Baby Powder lawsuits and Shower-to-Shower lawsuits against Johnson & Johnson, indicating that false and misleading information has been provided for decades about the safety of applying talc around the genitals.
Generic-Viagra Safety Called Into Doubt After False Data Found by FDA
Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the U.S. market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found.
The U.S. Food and Drug Administration alerted brand-name and generic companies on June 18 about a research company in India that had falsified the data used in key studies to gain approval of their medications. Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans’ medicine cabinets.
European regulators last year flagged Synapse to the FDA, which later told U.S. companies that relied on Synapse for key studies to gain approval of their medications that they would have to redo the work somewhere else.
The FDA isn’t telling patients, doctors or pharmacists which drugs among thousands might be impacted because the agency said whether a drugmaker used a particular research company for hire is “confidential information,” according to the FDA alert. “This is kind of shocking to me,” Michael Santoro, a professor at Santa Clara University who specializes in business ethics and co-wrote a book called “Ethics and the Pharmaceutical Industry,” said about the FDA keeping the drugs secret. “There’s no question in my mind that this data needs to be in front of the public.”
Purdue Pharma Secures Litigation Ceasefire After U.S. Supreme Court Ruling
Purdue Pharma on Tuesday received U.S. court approval for a 60-day freeze on lawsuits against its owners, members of the wealthy Sackler family, in its first court appearance since a landmark Supreme Court ruling upended its bankruptcy settlement.
U.S. Bankruptcy Judge Sean Lane granted an injunction at a court hearing in White Plains, New York, saying that a litigation ceasefire will give Purdue a chance to renegotiate a comprehensive settlement of lawsuits alleging that its painkiller OxyContin spurred an opioid addiction crisis in the U.S.
The U.S. Supreme Court ruled on June 27 that Purdue Pharma’s bankruptcy settlement cannot shield the Sacklers, who did not file for bankruptcy themselves, over their role in the nation’s deadly opioid epidemic.
Purdue’s attorney, Marshall Huebner, said the company will engage in “a high-speed, high-stakes mediation” with the Sacklers, state and local governments, and other stakeholders. Protecting the Sacklers during a “modest” 60-day negotiating period will give Purdue a real chance to negotiate a new bankruptcy settlement and put money toward stopping opioid overdoses and treating addiction, Huebner said.
Johnson & Johnson Pays $50 Million to Resolve Its Ugly Divorce With Emergent BioSolutions
Johnson & Johnson will pay Emergent BioSolutions $50 million to settle a two-year contract squabble and bring closure to an ill-fated, government-arranged partnership between the biopharma giant and the contract manufacturer to produce COVID-19 vaccines.
According to a filing with the Securities and Exchange Commission (SEC), J&J has agreed to pay Emergent $50 million by the end of this month to resolve the CDMO’s claims of breach of contract.
In 2022, J&J terminated a five-year deal that called for Emergent to produce drug substance for J&J’s COVID-19 vaccine. The Maryland manufacturer responded in an SEC filing that J&J was on the hook for $420 million for bailing on the agreement. Two months later, J&J filed its own breach of contract complaint against Emergent and asked for an arbitration.
The contract battle began after Emergent made high-profile errors at its sprawling Bayside plant in Baltimore where it was producing COVID vaccines for AstraZeneca and J&J. The mistakes caused millions of contaminated vaccine doses to be discarded and led the FDA to hand control of the plant over to J&J in April 2021.
FTC Report Slams Pharmacy ‘Middlemen’ for Seemingly Driving Up Prices, Limiting Access
Pharmacy benefit managers (PBMs) wield enormous power on the accessibility and affordability of prescription drugs, and a scathing new report from the Federal Trade Commission (FTC) found “these powerful middlemen may be profiting by inflating drug costs and squeezing Main Street pharmacies.”
The report signals a significant intensification of scrutiny into the business practice of PBMs, the opaque intermediaries in the center of the pharmaceutical distribution system.
The interim staff report, which is part of an ongoing inquiry launched in 2022 by the FTC, details how increasing vertical integration and concentration has enabled the three largest PBMs — CVS Caremark Rx, Express Scripts, and OptumRx — to manage nearly 80% of the approximately 6.6 billion prescriptions filled in the United States.
Six of the largest PBMs control nearly 95% of all prescriptions, according to the report.
SEC Blasts Pfizer’s Bid for $75 Million From Insider Trading Victims’ Fund
One of the most notorious insider trading schemes in U.S. history has led to a $75 million fight between drugmaker Pfizer and the U.S. Securities and Exchange Commission.
That sum is what remains of a fund to compensate victims of insider trading by the now-shuttered hedge fund SAC Capital, which reaped more than $275 million in profits in 2008 from trading on unlawfully obtained clinical data about a prospective Alzheimer’s drug. SAC Capital and related entities paid more than $600 million in 2013 to resolve the SEC’s case in the largest insider trading settlement in U.S. history.
Bharat Biotech Readying Tuberculosis, Cholera Vaccines
Bharat Biotech International (BBIL), which developed India’s first indigenous COVID-19 vaccine Covaxin and the world’s first nasal vaccine iNCOVACC against the same virus, is close to launching vaccines against tuberculosis and cholera. The company is also developing vaccines against diseases like chikungunya, malaria and zika, Suchitra Ella, Managing Director and Co-Founder of BBIL tells Fortune India.
”Our cholera vaccine is ready and is going through the regulatory approval and licensing process. Similarly, we have exclusive technology transfer for a malaria vaccine and we’ll be making it again for the first time,” she says.
Bharat Biotech is developing a cholera vaccine, licensed from Hilleman Laboratories, a joint venture between MSD and U.K.-based Wellcome Trust, in 2019. It completed the Phase 3 trial at various locations in India in early 2023. In collaboration with Spanish biopharmaceutical company Biofabri, it is currently undertaking clinical trials in India of MTBVAC, a tuberculosis vaccine.
Bharat Biotech, which makes about 20 vaccines and 4-5 biotherapeutics, is also preparing to manufacture the world’s first malaria vaccine approved by the World Health Organization (WHO), developed by GlaxoSmithKline (GSK) after 30 years of research and development. In June 2021, GSK, PATH, and Bharat Biotech signed a product transfer agreement for the malaria vaccine.
