The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans—and the question is whether everyone who’s eligible should rush out and get it.
On Wednesday, a panel of FDA advisers will take a non-binding vote on whether the drug warrants approval. The meeting is being closely watched as an indicator of the FDA’s approach to experimental drugs with imperfect data and its ability to withstand outside pressure.
Moderna is working to reassure investors about its longer-term growth prospects as the new cases decline following the winter spread of highly transmissible omicron.
Experts who study FDA decision-making see a troubling pattern in which the beleaguered agency is continually pressured to accept weaker evidence, damaging its scientific credibility and opening the door to ineffective treatments.
For the third year in a row, an investor is proposing that the pharmaceutical company scrap the tradition of combining the role of chief executive officer and board chair.
The goal is to get patients started on either Pfizer’s Paxlovid tablets or Merck’s molnupiravir capsules within five days of symptoms appearing. But the tight deadline has highlighted several challenges.
The company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the vaccine.
Additionally, the pharmaceutical giant said in a statement that it had “suspended all investments, promotional activities, and new clinical trials in Russia.”
Nearly 30 million Americans have diabetes, and more than 6 million use insulin to keep their blood sugars under control. It’s an old drug, refined over the years, that has seen relentless price increases.
In all, the plan could be worth more than $10 billion over time. It calls for members of the Sackler family to give up control of the Stamford, Connecticut-based company so it can be turned into a new entity with profits used to fight the crisis.
Pfizer’s new COVID-19 treatment came with a catch when it debuted late last year: Supplies were limited, and it would take months to make the tablets.
Indiana stands to collect up to $507 million from the deal if communities opt into the state’s settlement under pending legislation in the Indiana General Assembly, according to the state attorney general’s office.
The Indianapolis-based pharmaceutical company said the facility is part of its strategy to advance RNA-based therapeutics and builds on its acquisition of Prevail Therapeutics, a gene therapy company based in New York.
The Indianapolis-based drugmaker said the antibody is effective against the omicron variant and it has already manufactured several hundred thousand doses. The deal calls for the federal government to pay Lilly more than $720 million.
U.S. regulators on Friday put the brakes on their push to speed Pfizer’s COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.
The FDA has agreed to speed up review of donanemab, but the Centers for Medicare and Medicaid Services is moving to limit reimbursement for drugs in this class to only patients in clinical trials.
The deal calls for the federal government to pay Eli Lilly and Co. more than $720 million for the antibody, which the company said is effective against all COVID-19 variants.
Efforts to lower prescription drug costs have long been popular with voters, but bipartisan consensus has proved elusive. It’s unclear if there’s a political path forward for Biden’s plans in Congress.
In December, the U.S. government paused distribution of Lilly’s two previous antibodies, saying they did not appear effective against the omicron variant.
If regulators agree to the long-awaited move, Pfizer shots containing just one-tenth of the dose given to adults could be dispensed to children as young as 6 months.
