Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.
The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
Paxlovid, when administered within five days of symptoms appearing, has been proven to bring about a 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.
COVID-19 vaccinations are at a critical juncture as companies test whether new approaches like combination shots or nasal drops can keep up with a mutating coronavirus—even though it’s not clear if changes are needed.
The imaging agent is the six-year-old company’s first commercial launch, following millions of dollars’ worth of research and clinical tests. It was approved by the U.S. Food and Drug Administration in December.
The expansion comes on top of more than 1,000 positions the drugmaker has added since Jan. 1, 2021, bringing its current Bloomington workforce total to more than 4,000, which includes employees and workers provided by staffing agencies.
Moderna hopes to offer updated COVID-19 boosters in the fall that combine its original vaccine with protection against the omicron variant.
Acacia Pharma Group employees are waiting to see what will happen to their jobs and whether the company will remain in Indianapolis in any form, now that it is being acquired by New Jersey-based specialty drugmaker Eagle Pharmaceuticals Inc. for $103.9 million.
The push by Eli Lilly and Co. will come despite an unfavorable ruling last week from Medicare that sharply restricts reimbursements for a drug in the same class.
Thursday’s coverage decision illustrates the impact that a single medication can have on the budgets of individuals and taxpayers.
The state’s capital city, the suburbs of Noblesville and Fishers and other cities, including Muncie and Franklin, decided to join the statewide settlement after it was made more attractive by a new state law that gives local governments more direct funding and flexibility.
The Affordable Insulin Now Act will serve as a political vehicle to rally Democrats and force Republicans who oppose it into uncomfortable votes ahead of the midterms.
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.”
