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GSK Soothes Investors by Settling First Zantac Cancer Lawsuit Due for U.S. Trial
GSK (GSK.L) agreed to settle a U.S. lawsuit alleging its discontinued heartburn drug Zantac caused cancer, the British drugmaker said on Friday, preventing the first such case from going to trial next month. The company said it had reached a confidential deal with Californian resident James Goetz who says he developed bladder cancer from taking the drug.
The deal clears a near-term threat from the lawsuit and could set a precedent for thousands of cases set to go to trial next year. The drugmaker’s (GSK.L) shares rose nearly 5%, making it the best performer on London’s blue-chip FTSE 100 (.FTSE).
GSK on Friday said the settlement reflected its desire to avoid distraction related to protracted litigation in this case. It did not admit any liability and said it would vigorously defend itself in any other Zantac cases.
The trial was due to start on July 24, the first test of how Zantac cancer claims would fare before a jury. Apart from a small number of cases pending in California, most of the remaining Zantac U.S. litigation involves more than 75,000 cases in the state court in Delaware, with hearings likely in January.
Moderna Files for FDA Approval of Updated COVID Vaccine for Fall
Moderna on Thursday applied for U.S. Food and Drug Administration approval of the biotech company’s updated COVID vaccine for the fall.
The shot targets Omicron subvariant XBB.1.5, the dominant strain of the virus nationwide.
Moderna said the submission is based on the FDA’s recommendation last week that vaccine makers update their jabs to target XBB.1.5, which is one of the most immune-evasive COVID strains to date.
Moderna and rivals Pfizer and Novavax already began to develop versions of their vaccines targeting XBB.1.5 months before the FDA’s recommendation. All three companies are expected to make vaccines available to Americans in time for the fall, pending the FDA’s approval.
The Greed of Big Pharma Cannot Continue
The American healthcare system is broken. Despite spending twice as much per capita on healthcare as the people of any other nation, nearly $13,000 per person, we have 85 million Americans who are uninsured or underinsured and more than 500,000 households who go bankrupt each year because of medically related bills.
Further, while insurance companies make tens of billions a year in profits, we have a major shortage of doctors, nurses, dentists and mental health practitioners. Even with decent insurance, it is increasingly difficult for many patients to arrange timely visits with their doctors.
One of the reasons that our healthcare system is so broken and expensive is the outrageously high cost of prescription drugs. In the United States, we pay, by far, the highest prices in the world for prescription drugs.
Novo Nordisk is charging Americans with diabetes $12,000 for Ozempic while the exact same drug can be purchased for just $2,000 in Canada. Eli Lilly is charging the American people nearly $200,000 for Cyramza to treat stomach cancer — a drug that can be purchased in Germany for just $54,000.
At a time, when 10 of the top pharmaceutical companies made over $112 billion in profits last year, why do we continue paying the highest prices in the world for prescription drugs?
FDA Fast-Tracks Experimental Drug for Preventing Flu
Cidara Therapeutics, of San Diego, announced today that the US Food and Drug Administration (FDA) has granted fast-track designation for CD388, the company’s novel drug for preventing influenza A and B in adults at high risk for severe influenza, including those for whom vaccines are either ineffective or not indicated.
Fast-track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. The purpose is to get key new drugs to patients earlier. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review.
Cidara is developing CD388, a drug-Fc conjugate candidate, in collaboration with Janssen Pharmaceuticals.
How Big Pharma Is Using AI to Untangle the Language of DNA
ChatGPT and other large language models have seen a surge in popularity in recent months, transforming firms like OpenAI into multi-billion dollar businesses and amassing hundreds of millions of users worldwide, employing the tool to summarise reports, answer queries or write people’s homework.
But in a small office block wedged in between St Pancras Station and Google’s giant new London headquarters, a team of researchers is exploring another purpose for large language models: to understand the language of DNA.
Their work in building up a picture of the structure of human DNA and how it influences medical outcomes, combined with a range of other AI-powered tools being built, is set to rapidly transform the world of pharma, including improved diagnoses, better treatment and faster drug development.
How a Six-in-One Vaccine Could Soon Help the World Get Rid of Polio for Good
Polio eradication is a delicate dance. And one of the biggest challenges facing the people trying to choreograph its final steps is how to phase out the use of oral polio vaccines.
A decision that will be made next week may make it easier to take the final steps of the eradication endgame. The governing board of Gavi, the Vaccine Alliance is expected to approve a new vaccine that would increase the number of children around the world who are protected against the worst of what polioviruses can do, in the process making the eventual withdrawal of oral polio vaccines less dangerous.
The Gavi board will vote on a proposal to offer the countries it helps a combination product that includes inactivated polio vaccine. IPV, as it is known, does not contain live viruses and cannot create the problem seen with oral vaccines.
The United States has used IPV exclusively since 2000, and Gavi has been helping qualifying countries to buy IPV since 2013. But this would be the first time it would offer assistance in purchasing polio vaccine in a combination format that would protect children against hepatitis B, Haemophilus influenza, diphtheria, tetanus, pertussis and all three types of polioviruses. It will be a six-in-one vaccine, a hexavalent in the vernacular of vaccines.
