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Delaware Judge Lets More Than 70,000 Zantac Lawsuits Go Forward
A Delaware judge has allowed more than 70,000 lawsuits over discontinued heartburn drug Zantac to go forward, ruling that expert witnesses can testify in court that the drug may cause cancer.
The ruling on Friday by Judge Vivian Medinilla of the Delaware Superior Court in Wilmington is a setback for former Zantac makers GSK (GSK.L), Pfizer (PFE.N), Sanofi (SASY.PA) and Boehringer Ingelheim, which had argued that the expert witnesses’ opinions lacked scientific support.
“This moves us one step closer to justice for our clients,” Brent Wisner, one of the plaintiffs’ lead lawyers, said in a statement on Saturday.
Lawsuits began piling up 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. In addition to the cases in Delaware, the drugmakers are facing about 4,000 claims in California state court and about 2,000 in various other state courts around the country.
Antibiotic Innovation Is Ailing. ‘Brain Drain’ May Kill It
Three years ago, I became CEO of the AMR Action Fund, which is investing approximately $1 billion in biotech companies developing treatments for antimicrobial-resistant infections, a growing global health crisis that now contributes to 4.9 million deaths every year. I have spent most of my career developing antibiotics and investing in biotechnology companies, so I was aware of the scientific and financial headwinds we’d be up against — including workforce challenges. The latter is worse than I expected, and I now worry the field is suffering irreparable harm from a prolonged period of “brain drain” that could affect everything from how new antibiotics are discovered to regulators’ ability to evaluate antibiotic candidates in the future.
Antibiotics are arguably the most important drug class ever discovered. They have dramatically extended the average human lifespan, saved many millions of lives, and transformed modern medicine. The quest for these miracle cures also inspired generations of microbiologists and chemists who devoted their careers to discovering and developing new antibiotics.
That’s no longer the case. In today’s life sciences market, antibiotics represent a perilous career path with diminishing opportunities, and researchers young and old are steering clear. A recent analysis from The AMR Industry Alliance estimated that there are only 3,000 active researchers in the world focused on antibiotic resistance, compared with some 46,000 cancer researchers.
The report also found that the number of individuals listed as authors on publications related to antibiotic resistance declined by 50% from a high of 3,599 in 1995 to just 1,827 in 2020.
The Top 10 Pharma Drug Ad Spenders for 2023
AbbVie has toppled Sanofi and Regeneron as the biggest drug ad spender across the pharmaceutical industry in 2023 with a major victory for its next-gen immunology blockbuster Skyrizi.
In 2022, the plaudits went to Dupixent, Sanofi and Regeneron’s megablockbuster immunology med (and major rival to AbbVie) when it took the title. However, a huge injection of cash from AbbVie into Skyrizi saw it claim the top spot in 2023, pushing Dupixent into second place.
That’s based on ad spending data for last year analyzed and shared with Fierce Pharma Marketing by Vivvix. While the top 10 pharmaceutical companies spend a considerable amount on TV ads, the data encompass all advertising platforms, including TV, print, social media and streaming channels, providing a more comprehensive view of companies’ marketing expenditure.
It was AbbVie that spent the most in 2023: Spending on all ads for Skyrizi was up 154% year over year, while spending on its second immunology blockbuster, Rinvoq — which came in third overall — saw an 18% bump on 2022. Meanwhile, its bipolar and major depressive disorder drug Vraylar saw the largest increase in spending, up a massive 337% from 2022 to 2023, with AbbVie the only pharma to have three drug brands in the top 10.
Why the New Human Case of Bird Flu Is so Alarming
The third human case of H5N1, reported on Thursday in a farmworker in Michigan who was experiencing respiratory symptoms, tells us that the current bird flu situation is at a dangerous inflection point.
The virus is adapting in predictable ways that increase its risk to humans, reflecting our failure to contain it early on. The solutions to this brewing crisis — such as comprehensive testing — have been there all along, and they’re becoming only more important. If we keep ignoring the warning signs we have only ourselves to blame.
H5N1 has long been more than a bird problem. The virus has found its way into dairy cattle across nine states, affecting 69 herds that we know about. Of the three human cases of H5N1 that have been identified, all involve farmworkers who were in direct contact with infected cows or milk. The first two cases were relatively mild, involving symptoms like eye irritation, or conjunctivitis. However, the most recent case has shown more concerning signs, including coughing.
The emergence of respiratory symptoms is disconcerting because it indicates a potential shift in how the virus affects humans. Coughing can spread viruses more easily than eye irritation can.
Some Drugmakers to Cap Cost of Asthma Inhalers at $35 a Month
Starting Saturday, the cost of inhalers will fall for many Americans, as new out-of-pocket price caps go into effect for the asthma medications from AstraZeneca and Boehringer Ingelheim.
Following years of public outcry about the high cost of inhalers, the two drugmakers — along with a third, GlaxoSmithKline — have committed to capping the out-of-pocket cost at $35 a month. GSK’s cap is expected to take effect by Jan. 1.
The moves mirror similar steps taken by insulin manufacturers last year following the passage of the Inflation Reduction Act.
Like insulin, the cost of inhalers in the U.S. is significantly higher than in other wealthy countries. An investigation by the Democratic-led Senate Committee on Health, Education, Labor and Pensions noted AstraZeneca charges $645 in the U.S. for the same inhaler it charges $49 for in the U.K. Teva Pharmaceuticals, another major inhaler manufacturer, charges $286 in the U.S. for an inhaler that costs $9 in Germany.
Moderna, Merck Say Vaccine Improved Survival in Patients With Deadly Skin Cancer
Moderna and Merck released more positive three-year data Monday on their experimental vaccine, given to patients with the most deadly form of skin cancer in combination with the therapy Keytruda.
The shot is a key part of Moderna’s pipeline that has helped shore up investor sentiment for the biotech company following a rocky last year, when demand plummeted for its COVID vaccine, for now its only commercially available product.
The vaccine, which uses the same mRNA technology as Moderna’s COVID vaccine, is custom-built based on an analysis of a patient’s tumors after surgical removal. The shot is designed to train the immune system to recognize and attack specific mutations in cancer cells.
Antibody Discovery Promises New Hope in Influenza B Battle, Paves Way for Universal Vaccine
Researchers at Vanderbilt University Medical Center have isolated human monoclonal antibodies against influenza B, a significant public health threat that disproportionately affects children, the elderly and other immunocompromised individuals.
Reporting in the journal Immunity, the VUMC researchers describe how, from the bone marrow of an individual previously vaccinated against influenza, they isolated two groups of monoclonal antibodies that bound to distinct parts of the neuraminidase glycoprotein on the surface of influenza B.
Intranasal antibody administration may be more effective and have fewer systemic side effects than more typical routes — intravenous infusion or intramuscular injection — in part because intranasal antibodies may “trap” the virus in the nasal mucus, thereby preventing infection of the underlying epithelial surface, the researchers suggested.
These findings support the development of FluB-400 for the prevention and treatment of influenza B and will help guide efforts to develop a universal influenza vaccine, they said.
Top 5 Highest Paid Biopharma R&D Executives in 2023
While 2022 offered quite a few R&D leadership shake-ups, 2023 proved much calmer. But one member of this year’s list of top-paid scientists got a whopping pay raise: Johnson & Johnson’s new head of pharma R&D got a $20 million payout.
John Reed, M.D., Ph.D., jumped to join J&J after nearly five years serving as Sanofi’s global head of R&D. His eye-popping compensation package includes a $5.7 million signing bonus and nearly $11.7 million in stock awards. When it comes to base pay, Reed earns around what each of our other highest-paid R&D leaders make in total.
J&J, safely securing the crown for 2023’s list, was the sole new entry since 2022’s highest-paid R&D executives list. While J&J booted Moderna from the list, Eli Lilly, Merck & Co., Pfizer and Gilead R&D leaders continue to rake in the highest sums.
