The monkeypox outbreak was declared a public health emergency by the Biden administration, as Health and Human Services Secretary Xavier Becerra called on all Americans to “take responsibility to help us tackle this virus” and left the door open for a second declaration that would accelerate possible treatments and vaccines without being subjected to the standard, full-fledged federal reviews. Food and Drug Administration Commissioner Robert Califf said officials are mulling a “dose-sparing” plan to squeeze five doses per vial out of the Danish-produced Jynneos monkeypox vaccine. (The Washington Post)
Senate Majority Leader Chuck Schumer (D-N.Y.) is teeing up a Saturday afternoon vote on a motion to proceed with the party’s reconciliation bill after Sen. Kyrsten Sinema (D-Ariz.) said she’d back the bill following an agreement with colleagues to eliminate the carried-interest provision for fund managers and add a 1% excise tax on stock buybacks, clearing Democrats’ last intraparty hurdle. The Senate parliamentarian today will review the package’s updated language on measures to lower prescription drug prices, a Democratic aide said, while an additional provision from Sen. Raphael Warnock (D-Ga.) to lower the cost of insulin is expected to face GOP challenges. (Politico)
PhRMA and its 31 board members sent a letter to every member of Congress yesterday imploring them to vote against Democrats’ reconciliation package, while Steve Ubl, head of the powerful trade group representing drugmakers, said in an interview that lawmakers “who vote for this bill will not get a free pass.” The letter mostly sticks to arguments PhRMA has made in a multimillion-dollar advocacy campaign railing against the drug pricing provisions in the bill, saying that the measures would “put the U.S. system on a course toward broad government control, setting the stage for our country to fall behind.” (Politico)
Amgen Inc. struck a $3.7 billion deal to buy ChemoCentryx Inc., giving the biotech access to Tavneos, a drug used to treat patients with a rare type of blood vessel inflammation that generated $5.4 million in sales in the first full quarter after its regulatory approval. Amgen reported second-quarter revenue of $6.59 billion, a 1% jump from the year-ago period fueled by a 13% rise in sales of its osteoporosis drug Prolia. (Reuters)
One in eight people recovering from Covid-19 had lingering symptoms due to the illness at least three months later in a study that provides greater clarity on the ailments triggered by the pandemic disease.
By the time a cell senses that it’s been infected by a virus, it generally knows it is doomed. Soon, it will be busted up by the body’s immunological patrol or detonated by the invader itself. So the moribund cell plays its trump card: It bleats out microscopic shrieks that danger is nigh.
Jane Henney, a former commissioner of the FDA, has been tapped by the Reagan-Udall Foundation to lead a FDA-requested external review of key agency offices on human food safety and tobacco regulation, two sources with knowledge of the matter told POLITICO.
Democratic lawmakers introduced legislation on Thursday to assist Americans with disabilities seeking reproductive health services, hoping to reduce the barriers they may face after the U.S. Supreme Court overturned Roe v. Wade and the constitutional right to abortion.
A former supervisor in a baby formula plant linked to infant deaths earlier this year — now at the center of an ongoing formula shortage — has stepped forward to describe a facility with constant roof leaks, lax food safety and recordkeeping, and a culture of fear, raising new questions about why such problems were allowed to continue and the FDA did not discover them earlier.
The man, Thomas Patrick Connally Jr., 56, had pleaded guilty in May to making threats against a federal official and also admitted to sending threatening messages to other health officials, including Francis Collins, the former director of the National Institutes of Health, according to the U.S. Attorney’s Office in Maryland.
Democrats seeking to retain control of Congress are doubling down on the need for abortion rights after Kansas voters resoundingly defeated a ballot measure that would have made it easier for state lawmakers to restrict the procedure.
Fenit Nirappil and Amrita Jayakumar, The Washington Post
As the Centers for Disease Control and Prevention weighs whether to recommend limiting sexual partners, health officials in San Francisco, Chicago, New York and other U.S. cities battling surges disproportionately sickening gay men are avoiding calls for sexual restraint, wary of further stigmatizing same-sex intimacy.
The insurer said this week that will offer Medicare coverage in more than 150 new counties in five states: Illinois, Montana, New Mexico, Oklahoma and Texas. The expanded footprint will boost coverage options for as many as 1.1 million Medicare-eligibles, according to the announcement.
Hospitals that weren’t affected by cuts to the 340B drug discount program shouldn’t be required to repay any of those funds now that the Supreme Court ruled such cuts were unlawful, a key industry group said.
For the first half of the year, the chain reported a $327 million net loss and $6.04 billion in revenue, compared to a $58 million net loss and $6.02 billion in revenue during the first half of last year.
The state of Tennessee sued Walgreens on Wednesday, accusing the retail pharmacy giant of fueling the state’s opioid epidemic by willfully flooding the market with an oversupply of prescription narcotics in violation of consumer protection and public nuisance laws.
Biomedical scientists using embryonic stem cells or fetal tissue could find their studies at risk in conservative states aiming to redefine personhood after the US Supreme Court’s rollback of abortion rights.
When coronary arteries are blocked, starving the heart of blood, there are good medications and treatments to deploy, from statins to stents. Not so for heart failure, the leading factor involved in heart disease, the top cause of death worldwide.
The U.S. Food and Drug Administration declined to approve expanded use of Acadia Pharmaceuticals Inc’s (ACAD.O) antipsychotic drug for treating psychosis related to Alzheimer’s disease, the company said on Thursday.
Drug price controls in the U.S. Senate are being met with dire warnings that such an approach will stifle innovation, shut off the pipeline of new medicines, and cost lives down the road. Is innovation so fragile that a modest reduction in profits of global giants could seriously impact the supply of new drugs?
Social, economic, and location-based drivers of health (DOH) have an outsize impact on health — especially for Medicare and Medicaid beneficiaries, who are more likely to be elderly, have low income, or have complex medical needs. The Center for Medicare and Medicaid Innovation (CMMI) addresses DOH in many of their health care payment and care delivery models, but lessons from them have not been synthesized.