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Judge weighs key evidence ahead of first Zantac cancer trial

Thu, 16th Feb 2023 23:17

Feb 16 (Reuters) - Lawyers for a man who alleges he developed bladder cancer after taking GSK Plc's heartburn drug Zantac urged a California judge on Thursday to allow expert testimony linking the drug to the illness at an upcoming trial.

The trial in the case, brought by California resident James Goetz, is scheduled to begin Feb. 27 before Alameda County Superior Court Judge Evelio Grillo. It will offer the first test of how Zantac cancer claims may fare in state courts, and its outcome could depend heavily on what expert testimony Grillo allows.

A federal judge in December threw out all of the Zantac cases in federal court, some 50,000, after finding the opinions of the experts put forth by plaintiffs to establish their cancer was caused by the drug were not backed by sound science.

Tens of thousands of cases still remain in state courts, many consolidated before Grillo in California.

Brent Wisner, a lawyer for Goetz and other Zantac plaintiffs, argued that jurors should hear expert testimony about studies that he called "pretty powerful evidence that there is a causal relationship" between consuming Zantac's active ingredient, ranitidine, and cancer.

GSK has denied that the drug can cause cancer.

"Obviously our position is, no it doesn't," GSK lawyer Kimberly Branscome said at the hearing, which Reuters viewed via Courtroom View Network.

Zantac, first approved by the U.S. Food & Drug Administration in 1983, became the world's best selling medicine in 1988 and one of the first drugs to top $1 billion in annual sales.

Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer Inc, Boehringer Ingelheim and finally Sanofi SA. All four drugmakers are facing Zantac lawsuits and have denied that the pill causes cancer.

In 2019, some manufacturers and pharmacies halted sales of the drug over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts.

The FDA in 2020 pulled all remaining brand name Zantac and generic versions off the market, citing research showing the amount of NDMA in the products increases the longer the drug is stored and could potentially become unsafe.

Lawsuits began piling up soon after the recalls began from people who said they developed cancer after taking Zantac. Plaintiffs said the companies knew, or should have known, that ranitidine posed a cancer risk and that they failed to warn consumers.

Cases have been filed linking Zantac to at least 10 types of cancer. The now-dismissed federal litigation was limited to bladder, stomach, esophageal, liver and pancreatic cancers, but cases over other cancers remain in state courts. (Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)

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1 Nov 2023 07:40

LONDON BRIEFING: GSK raises annual guidance following Arexvy launch

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IN BRIEF: GSK says Jemperli meets endpoint in endometrial cancer trial

GSK PLC - Brentford, west London-based pharmaceutical maker - Jemperli, whose generic name is dostarlimab, meets endpoint of overall survival in phase III Ruby trial on adult patients with primary advanced or recurrent endometrial cancer. Jemperli, combined with standard-of-care chemotherapy, followed by dostarlimab, demonstrated a "statistically significant and clinically meaningful benefit" to the patients in the trial.

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GSK's Jemperli sees success in endometrial cancer trial

(Sharecast News) - GSK reported encouraging outcomes from part one of the 'RUBY' phase three trial evaluating the efficacy of 'Jemperli', or dostarlimab, with standard chemotherapy for treating adult patients with advanced or recurrent endometrial cancer on Monday.

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TOP NEWS: GSK subsidiary ViiV receives HIV drug approval in China

(Alliance News) - GSK PLC on Thursday said its subsidiary ViiV Healthcare has received marketing authorisation in China for its cabotegravir treatment, marketed as Vocabria.

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GSK HIV injection regimen gets approval in China

(Sharecast News) - GSK announced on Thursday that its majority-owned HIV specialist subsidiary ViiV has received approval from the National Medical Products Administration (NMPA) of China for an injection regimen.

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(Alliance News) - GSK PLC on Wednesday said a trial found its respiratory syncytial virus vaccine Arexy delivered an immune response in adults aged 50 to 59.

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GSK hails success in US RSV vaccine trial

(Sharecast News) - Pharma giant GSK has announced positive preliminary results from a trial of its Arexvy vaccine to treatment respiratory syncytial virus (RSV) disease for a younger patient population in the US.

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TOP NEWS: GSK receives positive EU opinion on Jemperli for cancer

(Alliance News) - GSK PLC on Monday said its monoclonal antibody Jemperli is closer to becoming the first new frontline treatment option in the EU in decades for a certain form of endometrial cancer.

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LONDON BRIEFING: Hipgnosis pulls interim dividend on lower royalties

(Alliance News) - The FTSE 100 is likely to open higher on Monday, benefitting from higher oil and gas prices, while fears of escalating regional conflict in the Middle East damp risk sentiment elsewhere.

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GSK nears green light for Jemperli usage in Europe

(Sharecast News) - Pharma giant GSK has announced that European experts recommended the approval of its Jerperli drug for the treatment of a specific type of endometrial cancer - paving the way for marketing authorisation by the continent's regulatory body.

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11 Oct 2023 11:51

GSK settles California Zantac lawsuit

(Sharecast News) - GSK has agreed to settle another lawsuit concerning its discontinued heartburn treatment Zantac, the drugs giant confirmed on Wednesday.

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