GSK now has dozens more Zantac lawsuits to contend with.
Plaintiffs on Wednesday filed 88 suits against GSK in Delaware court on behalf of more than 7,000 claimants who allege the popular ranitidine heartburn products caused a range of cancers. Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, were also named in the suit, in addition to Thermo Fisher’s Patheon Manufacturing Services.
GSK has been named in about 3,000 personal injury cases as well as class action suits. Plaintiffs in multidistrict litigation in Florida initially named 10 types of cancer in the suit, but later withdrew breast, kidney, colorectal, prostate and lung. Those cancers are still being pursued in state courts, GSK said last month. And on Friday, a Sanofi spokesperson attributed the recent surge in state court filings to plaintiffs who exited federal MDL, or whose alleged injuries have been dropped.
“The recent increase in state court filings predominantly involve plaintiffs who have opted to exit the federal multi-district litigation and whose alleged injuries lead plaintiffs’ lawyers in the MDL have abandoned,” the spokesperson said. “As plaintiffs search for new venues, Sanofi will continue to vigorously defend itself against these claims, which the medical, scientific, and regulatory communities have extensively evaluated and have found to be without merit.”
The new cases allege nine types of cancer, including bladder, breast, colorectal and intestinal, esophageal, gastric, liver, lung, pancreatic and prostate.
Zantac was first approved as a prescription medicine for heartburn in 1983, and after a decade of record sales, GSK began working on an over-the-counter formulation. Several OTC forms were OK’d in 1995, and those sales rights later passed through the hands of Pfizer, Boehringer Ingelheim and Sanofi.
However, the blockbuster drug was recalled in 2019 over unacceptably high levels of a potential carcinogen known as NDMA. Plaintiffs say studies have shown that ranitidine can transform into NDMA in the body or on the shelf in high temperatures. Previous lawsuits have claimed that a single ranitidine pill can contain NDMA levels that are “hundreds of times higher” than the FDA’s acceptable limit. In 2020, the FDA requested the recall of all ranitidine products.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” former acting commissioner Janet Woodcock said around the time of the recall. “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
GSK said in a statement last month that regulatory agencies, including the FDA, have since concluded there is no evidence of a link between ranitidine and cancer. In November 2019, the FDA determined that NDMA levels in ranitidine are similar to levels in some foods such as grilled and smoked meats.
“There have been no material developments to what has been previously disclosed,” the GSK statement read. The company was not immediately available for comment.
“The overwhelming scientific evidence establishes that the use of Zantac is not associated with an increased risk of cancer,” a Boehringer Ingelheim spokesperson said on Friday. “We will defend any allegations otherwise and do not comment on specifics of pending litigation.”
Pfizer and Patheon did not respond to requests for comment as of press time.
Last month, GSK’s first scheduled Zantac cancer trial was voluntarily dismissed by the plaintiff. The company said it didn’t settle the claim or pay anything in exchange for dropping the case.
“The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine,” GSK said at the time.
If you work in cancer biomarker and target research, chances are you use data from The Cancer Genome Atlas (TCGA) to help you make discoveries. This comprehensive and coordinated effort helps accelerate our understanding of the molecular causes of cancer through genomic analyses, including large-scale genome sequencing. TCGA covers 33 types of cancer with multi-omics data, such as RNA-seq, DNA-seq, copy number, microRNA-seq, and others. Detailed analyses of individual TCGA datasets, as well as pan-cancer meta-analysis, have revealed new cancer subtypes with important therapeutic implications. A key value here is the TCGA metadata. TCGA samples include extensive clinical metadata for diverse cancers. However, inconsistent terminology and formatting limit the utility of these data for pan-cancer analyses.
The first slice of data has arrived from a dose escalating study of Intellia’s in vivo CRISPR treatment for hereditary angioedema, and it’s a promising first step toward a potential once-and-done therapy.
The CRISPR crew at Intellia $NTLA reported Friday morning that six HAE patients treated with either the low 25 mg dose or the high 75 mg dose of NTLA-2002 experienced a 65% and 92% mean reduction in plasma kallikrein. The low-dose group experienced a 91% reduction in HAE attacks after the drug was used to knock out the KLKB1 gene in liver cells.
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Although “pay-for-delay” agreements and other egregious generic-blocking tactics may be in the rearview mirror, a new report from the nonprofit I-Mak explains how companies are still looking to protect the next generation of blockbusters with piles of new patents.
While some industry insiders point to a broken system that incentivizes these dozens and dozens of new patents — on average there are 74 granted patents on each of America’s 10 top-selling drugs — drugmakers have filed more than 140 patent applications on average per drug, and about two-thirds of those filings came after the approval.
While Moderna has been focused on building out its manufacturing apparatus in North America, Europe and Africa, the company appears to be turning toward Japan for its next act.
According to a report from Nikkei Asia, Moderna CEO Stéphane Bancel said the company would like to build a facility in Japan as well as centralize all processes, including manufacturing, into a single facility.
While no other details on the manufacturing site were offered, such as location and timing, Bancel said the site would ideally manufacture vaccines for Covid-19, flu and other diseases. Endpoints News reached out to Moderna to get more details on the matter but they did not respond by press time.
The Department of Health and Human Services is taking the next step in its campaign to encourage Covid-19 vaccinations. The new fall “We Can Do This” ads move past the initial message to get a vaccine and asks Americans — especially people aged 50 and older — to get an “updated vaccine.”
Updated or bivalent boosters are the newer Pfizer-BioNTech and Moderna vaccines that add Omicron BA.4 and BA.5 components to the original vaccine — the CDC and HHS both recommended the shots earlier this month.
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Novo Nordisk never hesitated in its pursuit of Forma’s sickle cell drug etavopivat. Dating back to the early part of 2021, Novo execs were reaching out to Forma to see if they could work out a collaboration. And from the start, Forma wasn’t much interested in that sort of an alliance.
But things got serious after Forma laid out its update on the program at ASH in early December.
The data were from a small Phase I trial, and Forma concluded:
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In August, Alnylam touted a Phase III success for transthyretin amyloidosis, or ATTR for short, with cardiomyopathy — a disease that causes protein buildup in the heart, so it can’t pump at full capacity. However, Intellia and Regeneron are here to compete, with a therapy that only needs to be dosed once.
In today’s update on part 1 of the study, Intellia said that its therapy, known as NTLA-2001, reduced mean serum transthyretin (the protein that builds up in the heart) by 93% and 92% in patients who got either a 0.7 mg/kg or 1.0 mg/kg dose of the therapy, respectively.
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Illinois-based pharma company Akorn, which filed for bankruptcy back in 2020, has now agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims related to generic drugs that had already transitioned to OTC products.
As part of the settlement, the DOJ said Akorn admitted to delaying its conversion of certain generics — the NSAID pain drug diclofenac, and the antihistamines olopatadine and azelastine — from prescription-only to OTC status.
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While CMS drug price negotiations won’t actually kick off until 2026, a group of more than two dozen Republican senators is already raising questions about how this new law will be implemented.
The partisan law (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations but mandatory inflation-related rebates that will begin next year, as well as million-dollar fines for noncompliance.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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