Big Pharma News Watch
Moderna Stock Is Lone Omen of Bird Flu Pandemic + More
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.
Moderna Stock Is Lone Omen of Bird Flu Pandemic
The recent rise of Moderna’s (MRNA.O) stock tells a grim tale. The $56 billion company that pioneered a COVID vaccine has seen its market value rise 40% since the discovery of bird flu in American cows in March. The benefit to Moderna of a new outbreak is probably far less.
The H5N1 flu that’s common in various animals might mutate to spread between humans. Influenzas have a history of making such jumps. About half of the hundreds of people diagnosed since 2003 have died. This virulence can’t be assumed, however, as mild cases have been missed and the virus will change. Likewise, the odds of a strain spreading easily, and when, are impossible to predict.
More certain is the value of Moderna’s mRNA technology, which uses a virus’ genetic code to instruct the body to make antibodies. The company and its German rival BioNTech developed effective COVID vaccines faster than traditional methods. MRNA vaccines may have another edge. Traditional inoculations use inactivated virus, grown in fertilized eggs. The U.S. government even keeps a secret hoard of hens to ensure millions of eggs are available. The problem is that avian flu might kill fertilized eggs, hampering production.
The value to society could be vast. The International Monetary Fund estimated in 2022 that the economic damage from COVID would exceed $12.5 trillion. The tab for a more deadly bird flu could be higher, and a vaccine might slash trillions off this tab.
A pandemic opportunity would be larger. Moderna and Pfizer (PFE.N) sold about $130 billion of COVID vaccines during the pandemic. Assume similar total revenue, that Pfizer takes half, and Moderna’s net margin is 66%, the same as in 2021. The company’s profit would be $43 billion.
Merck Gets Shot in the Arm With FDA Approval for First Pneumococcal Vaccine Designed for Adults
The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.
While the nod applies to people at least 18 years of age, Capvaxive is specifically adapted for patients age 50 and older as the 21 serotypes it covers account for 84% of the pneumococcal disease of people in the age group, according to epidemiologic data from the CDC.
This compares to a 52% figure in the same population for the 20 serotypes covered by the world’s dominant pneumococcal disease vaccine, Pfizer’s Prevnar 20, which is allowed both in children and adults. There have not been any studies conducted to compare the efficacy of Capvaxive and Prevnar 20.
The accelerated nod for Capvaxive remains contingent upon verification of clinical benefit in a confirmatory study. On June 27, the CDC will assemble the Advisory Committee on Immunization Practices (ACIP) to discuss recommendations for the use of Capvaxive.
Novavax Applies for FDA Nod for Its Updated COVID Vaccine
Novavax announced last week that it has submitted an amendment to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its updated COVID vaccine targeting the JN.1 variant.
The vaccine is the only protein-based option and contains the Matrix M adjuvant. It is indicated for use in people ages 12 and older. Novavax said its submission aligns with guidance from the FDA, the European Medicines Agency, and the World Health Organization.
The company said it will have vaccine doses ready to distribute in the middle of July and is preparing to promptly deliver it as prefilled syringes as soon as the FDA authorizes it and the Centers for Disease Control and Prevention recommends it.
J&J Talc Users Want Cancer Checks Even if It Cost Billions
Johnson & Johnson should be on the hook for potentially billions of dollars in medical fees for women who used its talc-based baby powders and want to monitor their future health over cancer fears, according to a lawsuit.
Lawyers representing ex-talc users asked a New Jersey federal judge Monday to set up a so-called “medical-monitoring class” to cover the expenses of doctor’s visits and tests for women worried about gynecological and ovarian cancers.
The suit is the latest salvo in the ongoing legal battle between J&J and former talc users, who allege the world’s largest maker of healthcare products hid the cancer risks of its iconic baby powder for almost half a century. J&J is seeking backing from thousands of people who have sued it over the product for an $11 billion settlement of the claims.
J&J officials Monday dismissed the proposed class action as a “meritless complaint.” Erik Haas, J&J’s lead in-house lawyer on the talc cases, said the suit was another attempt by the plaintiffs to “disseminate false messaging in an effort to thwart their clients from voting on” the company’s proposed settlement.
Such medical surveillance programs have been approved in other mass-tort cases, including claims that Dutch manufacturer Koninklijke Philips NA hid flaws in its line of machines designed to treat sleep apnea. The company agreed as part of a $1.1 billion settlement earlier this year to set up a health-monitoring program for users.
New Drug’s Potentially Fatal Side Effects Obscured by ‘Soothing Acronym,’ Doctors Say
Seventy-nine-year-old Genevieve Lane volunteered to take the Alzheimer’s drug Leqembi in a clinical trial because she was forgetting words and misplacing her keys.
Infusions of the drug gave her headaches so severe they sent her to bed. A week after the third dose, she was at a restaurant with her best friend when her speech slurred and she had a seizure. Five days later she was dead.
An autopsy found that Lane died of a mysterious side effect that has a name that sounds like it might be part of an Italian opera, but has doctors on edge.
The complication called ARIA has nothing to do with music. It is a term adopted by an influential group of pharmaceutical executives and academic scientists to describe potentially fatal bleeding and swelling in the brain caused by drugs like Leqembi.
EU Drugs Watchdog Probes Painkiller Linked to Deaths
An investigation has been launched by the European drugs regulator into a popular painkiller linked to a series of illnesses and deaths.
The European Medicines Agency (EMA), one of the biggest EU regulators, confirmed on Friday it was reviewing the painkiller metamizole, which can lead to agranulocytosis, a potentially fatal condition in which a patient’s white blood cells are severely depleted.
It was revealed by the Observer last November that a patient group in Spain had launched a legal action against their government over claims it had failed to safeguard people against the drug’s side effects.
The drug, marketed in Spain under the Nolotil brand, is already banned in several countries, including the U.K. The EMA said there were “concerns that the measures in place to minimize the known risk of agranulocytosis may not be effective enough.”
Novo Nordisk CEO to Testify in U.S. Senate Hearing on High Cost of Ozempic, Wegovy
The Senate Committee on Health, Education, Labor, and Pensions said on Friday that Novo Nordisk (NOVOb.CO) CEO Lars Jorgensen has agreed to testify voluntarily in a hearing focusing on U.S. prices for weight loss drugs Ozempic and Wegovy.CEO Lars Jorgensen has agreed to testify voluntarily in a hearing focusing on U.S. prices for weight loss drugs Ozempic and Wegovy.
A U.S. Senate health panel vote that was scheduled for its June 18 meeting, to decide whether to subpoena Novo to answer questions about U.S. prices for the blockbuster drugs, is no longer necessary and will be canceled, Senator Bernie Sanders, who chairs the committee, said.
Jorgensen will testify before the committee, and the hearing will be held in early September.
Novo charges Americans $1,349 a month for Wegovy, while it can be purchased for $140 in Germany and $92 in the U.K., Sanders said.
Ambitious Federal Study Failed to Curb Opioid Deaths, NIH Announces
In 2019, amid an ever-worsening drug crisis, the federal government launched a research study with an ambitious goal: to lower opioid overdoses in participating communities by 40% using evidence-based interventions like distributing naloxone and providing access to addiction medications.
But communities that implemented the public health strategies did not see a statistically significant reduction in opioid overdose deaths, according to data published Sunday in the New England Journal of Medicine.
Over $1 Billion to Be Pledged for Africa Vaccine Sovereignty: France
More than one billion dollars will be pledged towards ramping up vaccine production in Africa at a summit held in Paris later this week, France said on Monday.
A “new mechanism to accelerate the financing of vaccine production on the African continent” will be launched during the summit on Thursday, which will be attended by several African leaders, together with the heads of the World Health Organization and the Gavi vaccine alliance, the French president’s office said.
The goal is to boost the ability of manufacturers in Africa to produce their own vaccines, giving the continent more sovereignty to address the many health crises it faces.
The money will also go towards setting up an African medicines agency similar to the European Medicines Agency, the French presidency said.
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