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July 1, 2024 Toxic Exposures

Big Pharma News Watch

Scientists Wary of Bird Flu Pandemic ‘Unfolding in Slow Motion’ + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Scientists Wary of Bird Flu Pandemic ‘Unfolding in Slow Motion’

Reuters reported:

Scientists tracking the spread of bird flu are increasingly concerned that gaps in surveillance may keep them several steps behind a new pandemic, according to Reuters interviews with more than a dozen leading disease experts.

Many of them have been monitoring the new subtype of H5N1 avian flu in migratory birds since 2020. But the spread of the virus to 129 dairy herds in 12 U.S. states signals a change that could bring it closer to becoming transmissible between humans. Infections also have been found in other mammals, from alpacas to house cats.

“It almost seems like a pandemic unfolding in slow motion,” said Scott Hensley, a professor of microbiology at the University of Pennsylvania. “Right now, the threat is pretty low … but that could change in a heartbeat.”

The earlier the warning of a jump to humans, the sooner global health officials can take steps to protect people by launching vaccine development, wide-scale testing and containment measures.

Cancer Victims Lose Bid to Block Proposed J&J Talc Bankruptcy

Reuters reported:

A federal judge on Friday rejected a bid by a group of cancer victims to block Johnson & Johnson (JNJ.N) from pursuing a proposed bankruptcy settlement of tens of thousands of lawsuits alleging the company’s baby powder and other talc products contain cancer-causing asbestos.

The cancer victims sought a preliminary order in New Jersey on June 11 to preventing J&J from filing for bankruptcy outside the state, which would have effectively foiled the $6.48 billion settlement plan. The motion was part of a class action lawsuit brought by plaintiffs’ lawyers opposed to the plan.

But U.S. District Judge Michael Shipp on Friday said he could not grant the motion because any harm to the victims was “strictly hypothetical.” He said he had no jurisdiction to resolve a dispute over “events that have not, and may never, occur.”

The healthcare conglomerate faces lawsuits from more than 61,000 plaintiffs alleging its talc caused ovarian cancer or mesothelioma, a deadly cancer linked to asbestos exposure.

Chevron Ruling Could Clog the Drug Pipeline

Politico reported:

A Friday Supreme Court ruling could mean it will take longer to develop new drugs and medical devices, former FDA attorneys say.

The Supreme Court overturned a Reagan-era precedent, called the Chevron deference, which required judges to defer to federal agencies’ interpretations of ambiguous federal laws.

The White House said the rule takes the country “backwards” and could “thwart efforts to respond to a global pandemic.”

Slowed response time: The former FDA attorneys worry that the FDA’s process to reach decisions could fall under greater scrutiny, they said, leading to more lawsuits and potentially longer lead times for agency decisions as government lawyers work to shore up their legal standing, POLITICO’s Lauren Gardner and David Lim reported.

A Lyme Vaccine Is in Late-Stage Trials. Could an Anti-Tick Vaccine Be Next?

Medical Xpress reported:

As a vaccine against Lyme disease enters late-stage clinical trials, scientists around the globe are already looking beyond Lyme and exploring the possibility of an anti-tick vaccine that could effectively protect against all kinds of tick-borne diseases.

The research centers around a weird — and some would say wonderful — phenomenon called acquired tick resistance (ATR). Basically, a human or animal with ATR has had so many tick infestations that they’ve developed an immune response that causes ticks attempting to feed on them to fall off and even die, says Constantin Takacs, an assistant professor of biology at Northeastern University.

A Lyme vaccine currently is on the horizon, with Pfizer and Valneva being in the late stages of a clinical trial for VLA15. The partners hope that if all goes well, they can apply for a license from the U.S. Food and Drug Administration in 2026.

While a Lyme vaccine could make a dent in the approximately 476,000 cases of Lyme disease diagnosed annually in the U.S. as a result of deer tick bites, an anti-tick vaccine could also, in theory, protect against a proliferating number of other tick-borne diseases such as malarial-like babesiosis and potentially deadly Powassan virus.

AstraZeneca’s COVID Prevention Drug Application Gets EU Fast-Track Assessment

Reuters reported:

AstraZeneca (AZN.L) said on Monday that the European Union drug regulator has accepted a market authorization application for its investigational COVID-19 prevention drug, sipavibart, for an accelerated assessment.

The submission was based on positive data from a late-stage trial that showed the drug reduced the risk of infection in patients with weaker immunity.

The drugmaker earlier this year withdrew its COVID-19 vaccine, one of the first and most widely used, due to “surplus of available updated vaccines” since the pandemic.

Antibiotic Overuse in Preemies’ Early Life Tied to Higher Risk of BPD, Death — Findings Suggest That Early-Onset Sepsis Concerns in Those at Low Risk Could Have Consequences

MedPage Today reported:

Overuse of antibiotics early in life may increase the risk for bronchopulmonary dysplasia (BPD) or mortality in very premature infants, a national cohort study from China found.

Among 6,510 such newborns considered to be at low risk for early-onset sepsis, prolonged exposure to antibiotics in the first week of life was associated with a 23% higher odds of moderate to severe BPD or death compared with no exposure (adjusted odds ratio [OR] 1.23, 95% CI 1.01-1.50) and a 40% higher odds compared with short-term antibiotic exposures (aOR 1.40, 95% CI 1.15-1.71).

Furthermore, any exposure to broad-spectrum antibiotics during this timeframe was associated with a 27% higher odds of moderate to severe BPD or mortality compared with no antibiotic exposure (aOR 1.27, 95% CI 1.04-1.55), reported Xiaolu Ma, MD, PhD, of Zhejiang University School of Medicine in Hangzhou, and coauthors in JAMA Network Open.

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