Bird Flu Concern Prompts U.S. to Award Moderna $176 Million for Vaccine Development + More

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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.

Bird Flu Concern Prompts U.S. to Award Moderna $176 Million for Vaccine Development

Reuters reported:

The U.S. government has awarded $176 million to Moderna (MRNA.O) to advance the development of its bird flu vaccine, the company said on Tuesday, as concerns rise over a multi-state outbreak of H5N1 virus in dairy cows and infections of three dairy workers since March.

Shares of the Cambridge, Massachusetts-based company rose more than 2% to $118.32 in early trade.

The funds from the U.S. Biomedical Advanced Research and Development Authority will be used to complete late-stage development and testing of a pre-pandemic mRNA-based vaccine against H5N1 avian influenza, the company said in a statement.

Last year, Moderna started a safety and immunogenicity study of its bird flu vaccine called mRNA-1018 in healthy adults aged 18 and older. That study included both the H5 subtype of bird flu that is currently circulating in dairy cattle, as well as the H7 bird flu subtype. Results of that study are expected this year and will be used to map out late-stage development plans, the company said. Moderna's vaccine uses mRNA or messenger RNA, the technology in its COVID-19 shot.

Scientist Defeats J&J Lawsuit Over Cancer Research

Reuters reported:

A New Jersey federal judge has dismissed a lawsuit brought by a Johnson & Johnson subsidiary against a scientist who published a paper linking talc-based consumer products to cancer, finding that the research was not fraudulent or libelous.

U.S. District Judge Georgette Castner on Friday found that Dr. Jacqueline Moline, the chair of occupational medicine at Northwell Health, did not engage in fraud, libel or false advertising when she published an influential 2020 paper concluding that exposure to asbestos-contaminated talcum powder products can cause mesothelioma.

Moline's conclusions were protected by her free speech rights under the U.S. Constitution's First Amendment, and J&J's lawsuit did not show that the underlying research was "verifiably false," Caster wrote.

J&J's subsidiary LTL Management, which was created to shield the healthcare conglomerate from talc lawsuits, sued four researchers last year, attacking scientific studies that the company alleges are fraudulent. J&J's lawsuit against three other researchers is still working its way through courts.

Pfizer Bops to the Top With New Ashley Tisdale Collab Around Alopecia Areata

Fierce Pharma reported:

The Big Pharma has teamed up with Ashley Tisdale to discuss the actor-singer-entrepreneur's experience with alopecia areata, an autoimmune disease that typically causes sudden bouts of hair loss in patches on the head and face.

In a video that Tisdale shared on her social media pages last week and Pfizer reposted Monday, the "High School Musical" star told her "alopecia areata story." While looking through old photos of herself in the clip, Tisdale said she first began noticing "significant hair loss" in her early twenties. On her hair colorist's suggestion, Tisdale sought help from a dermatologist, who diagnosed her with alopecia areata at age 24.

The partnership is framed around improving awareness and education and sharing a real patient's story, rather than being tied to any specific product -- though Pfizer did just last year earn FDA approval for Litfulo, a daily oral treatment for severe alopecia areata, indicated for patients aged 12 and older.

Pfizer v Moderna COVID Vaccine Patents Battle Set to Continue After UK Ruling

Reuters reported:

Pfizer and Moderna's legal battle over their rival COVID-19 vaccines looks set to continue after London's High Court gave a mixed ruling on two of Moderna's patents, likely prompting a flurry of appeals in the London leg of the litigation. Pfizer (PFE.N) and its German partner BioNTech (22UAy.DE)  sued Moderna (MRNA.O) in London in September 2022, seeking to revoke two patents held by Moderna, which hit back days later alleging its patents had been infringed.

Moderna had argued Pfizer and BioNTech copied mRNA advances it had pioneered and patented well before the COVID-19 pandemic began in late 2019. U.S.-based Moderna was seeking damages for alleged infringement of its patents by Pfizer and BioNTech's Comirnaty shot on sales since March 2022.

Pfizer made $11.2 billion in sales from Comirnaty last year, while Moderna earned $6.7 billion from its vaccine Spikevax, illustrating the potentially huge sums at stake.

The High Court ruled on Tuesday that one of Moderna's two patents relating to mRNA technology was invalid, but that another similar patent was valid and that Pfizer and BioNTech's Comirnaty vaccine had infringed it.

Potassium Chloride Medications Recalled Due to Failure That Could Cause Heart Attacks: FDA

Fox News reported:

Two brands of potassium chloride capsules are being recalled because they may not dissolve as they should, which could cause a person to have a heart attack, according to the Food and Drug Administration (FDA).

In a press release published on June 25, the FDA explained that Glenmark Pharmaceuticals Inc. is recalling 114 batches of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. The reason is because of "failed dissolution" in the pills.

The product is intended for patients who suffer from low potassium levels, or hypokalemia.

According to the FDA, the failed dissolution could elevate consumers' potassium to the point where a heart attack is possible.

Drugmakers' Appeal to End Zantac Cancer Lawsuits Rebuffed by Judge

Reuters reported:

A Delaware judge rebuffed a request by GSK (GSK.L) and other drugmakers to appeal a ruling allowing more than 70,000 lawsuits claiming that the heartburn drug Zantac caused cancer to go forward.

The ruling by Judge Vivian Medinilla of the Delaware Superior Court means that the drugmakers, which also include Pfizer (PFE.N)Sanofi (SASY.PA) and Boehringer Ingelheim, will have to ask the Delaware Supreme Court directly for permission to appeal. GSK said it already submitted its appeal to that court.

If the state high court declines to take the appeal, it will clear the way for the Zantac lawsuits to go to trial.

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