Merck paying $780M to acquire Indianapolis drug manufacturer
Germany-based pharmaceutical giant Merck on Thursday announced it has signed a definitive agreement to buy Indianapolis-based drug contract manufacturer Exelead Inc.
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Doctors bemoan limited supply of game-changing antiviral pills amid winter surge
Easy-to-take antiviral pills, authorized just before Christmas, were hailed as a potential turning point in the fight against the coronavirus because of the medicines’ ability to keep high-risk people out of the hospital.
FDA expands Pfizer boosters for more teens as omicron surges
Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.
Lilly’s osteoporosis drug faces generic challenge from Indian drugmaker
Eli Lilly’s blockbuster drug for osteoporosis, Forteo, could face generic competition from Indian drugmaker Sun Pharmaceuticals if the company can get a federal judge to declare that a Lilly patent won’t be infringed.
New easy-to-use COVID-19 pills require early use
The challenge for possible users is getting tested, getting a prescription and starting the pills in a short window.
FDA authorizes Merck’s anti-coronavirus pill, a second treatment option
Molnupiravir cut the risk of hospitalization and death in high-risk patients by 30%. In contrast, Pfizer’s antiviral drug, authorized on Wednesday, reduced hospitalizations and death by nearly 90%.
Pfizer pill becomes first U.S.-authorized home COVID treatment
The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections and head off the worst effects of the virus. But initial supplies will be extremely limited.
French biotech firm expanding to Brownsburg, planning $15M facility
Orano Med LLC says the facility will be used to manufacture and distribute radiopharmaceuticals to treat cancer at hospitals throughout the country.
Omicron may sideline Lilly, Regeneron antibody drugs against COVID-19
The companies say they can quickly develop new omicron-targeting antibodies, but those aren’t expected to launch for at least several months.
Judge overturns deal giving Purdue Pharma’s Sackler family immunity from opioid claims
The chairman of the company’s board, Steve Miller, said in a statement that the ruling would “delay and perhaps end the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis.”
CDC recommends Pfizer, Moderna COVID-19 shots over J&J’s
The strange clotting problem has caused nine confirmed deaths after J&J vaccinations—while the Pfizer and Moderna vaccines don’t come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention.
FDA expands Pfizer COVID booster, opens extra dose to ages 16-17
On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech—if it’s been six months since their last shot.
New COVID-19 antibody drug OK’d to protect most vulnerable
People who could benefit from the antibody drug include cancer patients, organ transplant recipients and people taking immune-suppressing drugs for conditions like rheumatoid arthritis.
Biden pledges savings on insulin, other drugs for Americans
The biggest policy change—a system for Medicare to negotiate prices for prescription drugs—won’t begin to deliver lower costs until 2025, and then only for a selected set of 10 medicines, as well as insulin products.
New coronavirus vaccine may eventually be needed for omicron, says BioNTech CEO
CEO Ugur Sahin told Reuters on Friday that he could foresee a scenario where coronavirus vaccine shots became annual, like flu shots.
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.
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.