FDA panel backs first-of-a-kind COVID-19 pill from Merck
The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.
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FDA panel set to review Merck’s COVID-19 pill
If authorized, Merck’s pill would be the first that U.S. patients could take at home to ease symptoms and speed recovery, but new information released last week paints a less compelling picture of the drug than when the Merck first publicized its early results in October.
Cap on drug price hikes for privately insured sparks battle
The main drug industry lobbying group, the Pharmaceutical Research and Manufacturers of America, says inflation rebates would undermine innovation that continues after medicines are approved.
Pfizer, U.S. ink $5.29B deal for possible COVID-19 treatment
Pfizer asked the Food and Drug Administration on Tuesday to authorize emergency use of the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections.
U.S. offering investment to boost COVID-19 vaccine capacity
The Biden administration is making billions of dollars available to drugmakers to expand domestic production of COVID-19 vaccines in the hopes of building capacity to produce an additional 1 billion shots per year to share with the world.
Boosters for all adults in U.S. could be OK’d by this weekend
Pfizer asked U.S. regulators last week to allow boosters of its COVID-19 vaccine for anyone 18 or older. The Food and Drug Administration is expected to sign off on Pfizer’s application.
Pfizer asks U.S. officials to approve promising COVID-19 pill
Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19.
Pfizer asks FDA to approve COVID-19 booster shots for all adults
Pfizer asked U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings.
Pfizer says COVID-19 pill cut hospital, death risk by nearly 90%
Shares of Indianapolis-based Eli Lilly and Co., which makes an antibody treatment for COVID-19 that requires infusions, were down 2.7% in late-morning trading Friday, to $263.76 each.
U.S. gives final clearance to COVID-19 shots for children 5-11
The decision marks the first opportunity for Americans under 12 to get the protection of any COVID-19 vaccine.
Feds buy another $1.29B worth of Lilly antibody treatment for COVID-19
The purchase will amount to 614,000 doses of two drugs, bamlanivimab and etesevimab, that make up the drug-cocktail infusion, Lilly said.
Democrats scramble to get a drug-price compromise
The compromise would allow Medicare to negotiate some prescription drug prices but significantly scale back Democrats’ earlier ambitions.
COVID vaccine for children 5-11 already being packed, shipped
Anticipating a green light from vaccine advisers, the Biden administration is assembling and shipping millions of COVID-19 shots for children ages 5-11, the White House said Monday. The first could go into arms by midweek.
Federal court blocks drug pricing enforcement action against Lilly
The ruling from Senior Judge Sarah Evans Barker also hinted that Congress needs to address the problems with the 340B Drug Pricing Program.
Indiana expects 200,000 COVID vaccines for children next week
Indiana officials said Wednesday that the state should be able to immediately inoculate a third of children ages 5 to 11 if the federal government gives approval to vaccines for that age group.
Cheap antidepressant shows promise treating early COVID-19
Researchers tested the pill used for depression and obsessive-compulsive disorder because it was known to reduce inflammation and looked promising in smaller studies.
FDA panel backs Pfizer’s low-dose COVID-19 vaccine for children
The U.S. moved a step closer to expanding COVID-19 vaccinations for millions more children as government advisers on Tuesday endorsed youth-size doses of Pfizer’s shots for 5- to 11-year-olds.
Lilly misses earnings estimates but raises full-year outlook
Indianapolis-based Eli Lilly and Co. saw revenue in the third quarter increase 18 percent over the same period of 2020, to $6.77 billion.
FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters
The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month.
Vaccine booster mix-and-match approach poised for FDA clearance
Preliminary results of a U.S. government-sponsored trial found that mixing coronavirus vaccines produces as much or more antibodies as using the same shot as a booster.