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Infant RSV Shot Wins Backing of CDC Advisors, Paving Way for Fall Availability
The first shot that protects all infants against respiratory syncytial virus, or RSV, won the unanimous backing of an advisory panel to the Centers for Disease Control and Prevention on Thursday.
CDC Director Dr. Mandy Cohen is not obligated to endorse the vote of the advisors, though the head of the agency usually follows the panel’s advice.
AstraZeneca and Sanofi are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand, a Sanofi spokesperson said. Though Dr. Sarah Long, a panel member, described the shot as a breakthrough, she said the CDC panel is “extremely disappointed” by the price set by Sanofi and AstraZeneca.
The CDC advisors also voted unanimously to include the shot in the federal Vaccines for Children Program, which provides shots to kids whose families are struggling financially.
Infants younger than 8 months entering their first RSV season would receive one dose. Kids 8 to 19 months who face an increased risk from the virus would receive another dose in their second RSV season.
Ozempic, Mounjaro Manufacturers Sued Over Claims of ‘Stomach Paralysis’ Side Effects
A personal injury law firm has filed a lawsuit against Novo Nordisk and Eli Lilly and Co., the manufacturers of Ozempic and Mounjaro, over claims that the diabetes drugs, which are popular for aiding weight loss, can cause gastroparesis, a paralysis of the stomach.
Paul Pennock and Jonathan Sedgh, the attorneys heading up the lawsuit from the firm Morgan & Morgan, announced the filing at a news conference Wednesday, saying the basis of the suit is “a failure to warn.”
“It is our opinion that these drugs are causing these problems. We think that the evidence is sufficient for us to be able to prove it or we would not have filed the case, and we intend to file many more in the coming days and weeks,” Pennock said during the Zoom conference, noting the first case filed involves a 44-year-old woman from Louisiana who has taken both drugs, Ozempic first and then Mounjaro, at the discretion of her doctor.
Pennock says his firm is investigating 400 other inquiries from clients across 45 states.
J&J Talc Cancer Plaintiffs Want 6-Month Ban on Further Bankruptcy Filings
Lawyers for thousands of people who claim Johnson & Johnson‘s talc-based powders caused them to develop cancer on Wednesday urged a U.S. judge to temporarily block the company from seeking bankruptcy protection for a third time for its talc subsidiary.
J&J’s attempt at resolving thousands of cancer lawsuits in bankruptcy court stumbled for a second time last week when a judge ruled that the talc subsidiary, LTL Management, was not in the kind of immediate financial distress necessary to trigger bankruptcy protection.
While J&J intends to appeal that ruling, cancer claimants and the U.S. Department of Justice’s bankruptcy watchdog asked U.S. Bankruptcy Judge Michael Kaplan in Trenton, New Jersey, to block the company from filing for bankruptcy a third time for at least 180 days.
LTL’s bankruptcy proceedings have largely paused the 38,000 lawsuits against J&J, although one case was allowed to proceed to a $18.8 million verdict in July. J&J has said its talc products are safe and do not contain asbestos.
Big Pharma’s Big Tax Dodge
Americans pay the highest prices in the world for lifesaving medicines — roughly triple what people in the world’s other big economies pay for the same name-brand, on-patent drugs. The cost of producing a medicine generally doesn’t vary much — so it stands to reason that the U.S.’s big pharmaceutical companies should therefore earn far more in the U.S. than they earn elsewhere. Simple math.
But take a look at the corporate disclosures of America’s largest pharmaceutical companies, and a puzzling hole opens. The six major U.S. pharmaceutical firms that provide fairly detailed data reported making $215 billion worth of sales in the U.S. for 2022.
Given America’s systematically higher prices, their sales abroad were logically more modest — totaling $170 billion. Despite this discrepancy, the companies reported earning very, very little in profits — in some cases, absolutely nothing — in the U.S. Of their $100 billion combined profit, the companies said $90 billion was made abroad, while a paltry $10 billion came from their U.S. operations. That comes out to a profit margin of 5% in the U.S. and a margin of over 50% abroad. What’s going on?
Tax avoidance, of course. When questioned, pharmaceutical companies inevitably respond that they pay all the tax that they legally owe. A Merck representative, for example, said that Merck “complies with all tax rules on a worldwide basis.” But these explanations are a smoke screen. Most of America’s major pharmaceutical companies have simply perfected the art of legally shifting the profit of their U.S. sales out of the country to low-tax jurisdictions.
The Real Costs of the New Alzheimer’s Drug, Most of Which Will Fall to Taxpayers
The first drug purporting to slow the advance of Alzheimer’s disease is likely to cost the U.S. healthcare system billions annually even as it remains out of reach for many of the lower-income seniors most likely to suffer from dementia.
Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi.
In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval on July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it.
Patients with early Alzheimer’s disease who took lecanemab in a major clinical trial declined an average of five months slower than other subjects over an 18-month period, but many suffered brain swelling and bleeding. Although those side effects usually resolved without obvious harm, they apparently caused three deaths. The great expense of the drug and its treatment raises questions about how it will be paid for, and who will benefit.
Regeneron Expects FDA Decision on Higher-Dose Eylea This Year
Regeneron Pharmaceuticals (REGN.O) expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday.
The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent (CTLT.N).
Regeneron said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August.
U.S. sales of Eylea fell 7% to $1.50 billion in the second quarter but came in slightly above estimates of $1.48 billion.
