Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
On January 2, 2024, AstraZeneca and Sanofi announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab/nisevizumab) has been officially approved for marketing by the State Drug Administration of China (SDA) for the prevention of Lower Respiratory Tract Infections (LRTIs) caused by Respiratory Syncytial Virus (RSV) in newborns and infants. The drug is indicated for newborns and infants who are entering or born during the first season of RSV infection. Nisevizumab is expected to be available in China during the 2024-2025 RSV infection season. Nisevizumab is the first and only* approved prophylaxis in China to protect the broader infant population against RSV infection, covering healthy term infants, preterm infants, and infants vulnerable to serious RSV infection due to specific health conditions. Nisevizumab was approved in China based on the results of three pivotal clinical trials and the Chinese clinical development program. For all clinical trial endpoints, a single injection of nisevizumab demonstrated ...
In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states. By FRANK VINLUAN An old drug with a wide range of uses now has a new FDA alert that could spare patients from some severe reactions. The FDA communication covers promethazine hydrochloride, a medicine approved for managing allergic reactions, motion sickness, and post-operative nausea and vomiting. It’s also used as a sedative or as an adjunct to analgesics. While promethazine is available in oral formulations, the FDA alert issued Wednesday covers versions administered either as a deep intramuscular injection or as a slow intravenous injection. The agency now says it recommends administration by deep intramuscular injection to reduce the risk of severe chemical irritation and damage to tissues. If promethazine must be dosed intravenously, the FDA ...
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