FDA asks Pfizer, Moderna to test vaccines in more children to help rule out safety issues
A federal official predicted that authorization of a coronavirus vaccine for children 5 through 11 might come by late October or early November.
A federal official predicted that authorization of a coronavirus vaccine for children 5 through 11 might come by late October or early November.
Local governments currently litigating, such as Indianapolis, were provided the ability to opt out of the state’s opioid plan. Those local governments have the opportunity to opt back in within 60 days of opting out, according to the attorney general’s office.
The national settlement is expected to be the biggest single settlement in the complicated universe of litigation over the opioid epidemic in the United States. It won’t end the cases, but it would change them.
Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
A new report submitted to the Indiana Legislative Council calls for the regulation of “white bagging,” a practice that requires hospitals to buy drugs from an outside pharmacy, which delivers them premixed ahead of time of the patient’s visit. It is a growing practice, aimed at lowering the cost of care, but many providers say it can compromise care.
The company said it was scheduled to have the meeting with the Food and Drug Administration and other officials Monday, days after Pfizer asserted that booster shots would be needed within 12 months.
The narrower label means the drug might be offered to 1 million or 2 million Alzheimer’s patients, rather than the more than 6 million people with Alzheimer’s in the United States.
The collaboration could be worth as much as $694 million and potential royalties to Verge Genomics if the two companies hit development milestones.
The agreement from multiple state attorneys general, including those who had most aggressively opposed Purdue’s original settlement proposal, was disclosed late Wednesday.
The radiopharmaceutical developer and manufacturer is the latest in a string of life sciences firms that have announced plans to grow operations in Fishers.
The role of the sticky substance in the brain has long divided researchers and is at the forefront again amid the FDA’s recent clearance of the first drug to treat the disease in almost two decades.
Drugmaker Biogen has until 2030 to complete a study confirming whether its new drug Aduhelm truly slows the brain-destroying disease. That’s under the terms of the Food and Drug Administration’s conditional approval of the drug.
Eli Lilly and Co. shares jumped more than 9% Thursday morning after it received “breakthrough therapy” designation for donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
Critics have blasted the approval of Aduhelm, saying the drug—with a list price of $56,000 a year per patient—offers false hope while threatening Medicare’s financial health and patients’ pocketbooks.
Stevanato Group, a producer of syringes, vials and glass containers, announced Wednesday it will spend $145 million to build and equip a 370,000-square-foot facility in Fishers.
The use of COVID antibodies has fallen across the United States lately and, along with it, Lilly’s sales in that category.
Separately, Dr. Aaron Kesselheim of Harvard University became the third member of an FDA advisory panel that opposed the drug to step down over the decision to approve it.
Shares of Biogen competitors soared after aducanumab became the first drug cleared by the U.S. Food and Drug Administration to slow the course of the mind-wasting disease that afflicts 6 million Americans.
Few such drugs are approved now, but the approach is predicted to become a new way to treat patients with other hard-to-reach or inoperable cancers.
Eli Lilly on Thursday said in a government filing that it has received a subpoena from the U.S. Justice Department for documents related to the factory and is cooperating with the investigation.