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Pfizer Says They’re ‘Deeply Sorry’ for Violating 5 Regulatory Codes and Illegally Promoting Their Vaccine
According to the Prescription Medicines Code of Practice Authority, Pfizer promoted unlicensed medicines and violated a total of five regulatory codes. The pharmaceutical giant has been accused of “bringing discredit” to the industry after employees promoted the COVID-19 vaccine across social media during the height of the pandemic.
Per Biopharma-reporter, medical director of Pfizer Dr. Berkley Phillips retweeted a post on Twitter, now known as X, stating: “Our vaccine candidate is 95% effective in preventing COVID and 94% effective in people over 65 years old.”
“The complainant alleged the tweet included relative efficacy rates without any information about absolute efficacy rates and that no safety data or safety information was provided, and therefore that Pfizer had misleadingly and illegally promoted its COVID-19 vaccine,” the case summary alleged.
See more on the full report regarding Complaint V. Pfizer here.
Genetics Played Role in Rare Blood Clots Linked to COVID Vaccines, Researchers Find
Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Plc’s COVID-19 shots were caused by an autoimmune reaction that some people are predisposed to, researchers found a discovery that they say will shape the development of future vaccines.
Adenovirus-based vaccines, like the J&J and AstraZeneca shots that were later pulled from the market, contain a component that, in genetically susceptible people, can trigger the production of unusually structured antibodies against a protein involved in blood clotting, scientists said Wednesday in a letter to the New England Journal of Medicine. Researchers plan to identify the culprit and then try to remove it using genetic engineering.
An extremely similar deleterious antibody response occurs in susceptible patients after infection with adenoviruses, which often infect the airways and lead to cold-like symptoms, the study found. It’s not known how many people may be susceptible to the complication, said Tom Gordon, head of immunology at Flinders University in South Australia, whose molecular sleuthing led to the finding.
The immune reaction linked to the shot is “a new disease,” he said in an interview. Hematologists and intensive care specialists are likely to spot more cases as they become familiar with it, he said.
A small number of clot-related deaths tied to the AstraZeneca vaccine led to its withdrawal or restriction in Denmark, Norway and other countries in 2021. The complication occurred in about 2-3 people per 100,000 vaccinated with the Astra shot under age 60 in Australia, where it hasn’t been available since March 2023. The European Commission withdrew the marketing authorization for the immunization in March 2024.
Pfizer Offers Up to $250 Million to Settle Zantac Cancer Lawsuits, FT Reports
Pfizer (PFE.N) will pay up to $250 million to settle more than 10,000 U.S. lawsuits over cancer risks associated with its discontinued heartburn drug Zantac, the Financial Times reported on Thursday.
The drugmaker was set to pay between $200 million and $250 million in the settlement, the newspaper reported, citing two people briefed on the deal. The settlement was disclosed in a court filing in Delaware last week, and is aimed at reducing Pfizer’s potential liability, the report added.
First approved in 1983, Zantac became the world’s best-selling medicine in 1988 and was one of the first drugs to top $1 billion in annual sales.
However, the U.S. Food and Drug Administration asked drugmakers to pull Zantac and its generic versions off the market in 2020, after a cancer-causing substance called NDMA was found in samples of the drug.
Wegovy Could Bankrupt U.S. Health System, Sanders Says in New Report
Blockbuster weight-loss drug Wegovy could bankrupt the U.S. healthcare system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.).
Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.
Novo Nordisk charges Americans with Type 2 diabetes $969 per month for Ozempic, compared to just $155 in Canada, $122 in Italy, $71 in France and $59 in Germany. The company lists Wegovy for $1,349 per month in the U.S. compared to $186 in Denmark, $137 in Germany and $92 in the U.K.
CDC to End Program to Vaccinate Uninsured Adults Early
Uninsured and underinsured adults could have a harder time getting the newest COVID-19 vaccine this fall, just as temperatures cool and cases are expected to rise.
The CDC’s Bridge Access Program, which provides free updated COVID vaccines to uninsured adults, will end in August, according to the agency. The program was slated to end in December.
The earlier termination results from Congressional cuts to COVID funds in the Further Consolidated Appropriations Act of 2024, which passed Congress in March, the CDC said.
Eisai Predicts Sharp Leqembi Sales Increase as Launch Efforts Begin to Bear Fruit
Reflecting on Eisai’s Alzheimer’s disease development journey — from Aricept’s U.S. launch in 1997 to Leqembi nearly a quarter century later — the company’s CEO Haruo Naito on Wednesday offered these words from Japanese poet Takamura Kotaro’s famous work Dōtei: “There is no way before us, but there will be a way after us.”
Naito waxed poetic as Eisai laid out an ambitious goal to hit 56.5 billion yen (roughly $364 million) in global Leqembi sales for the 2024 fiscal year, which will wrap up next March. That target represents a nearly 13-fold increase from the med’s sales of 4.26 billion yen (around $27.4 million) during the 2023 fiscal year.
Of that projected sales haul, Eisai expects to garner around 43.5 billion yen ($279 million) from the U.S., 10 billion yen ($64 million) from Japan and 3 billion yen ($19 million) from the rest of the world, mainly in China, Naito said, according to a translation of Eisai’s Japanese-language earnings call.
Leqembi — the amyloid-targeting antibody successor to Eisai and Biogen’s Aduhelm — won accelerated approval in the U.S. last January. The partners converted that nod into a full, traditional FDA approval in July, in turn unlocking broader Medicare coverage for the drug.
