October 2021 - December 2021
Israel to Share Data with Pfizer in Exchange for COVID-19 Vaccine Doses
Merck Says Antiviral Pill Is Effective Against COVID-19, Lifting Hopes for First Oral Drug
An antiviral pill being developed by Merck & Co. and Ridgeback Biotherapeutics dramatically reduced the number of hospitalizations from COVID-19 in a clinical trial, a major finding that could mark a turning point in the coronavirus pandemic. Merck now plans to seek emergency authorization of molnupiravir in the U.S. “as soon as possible” and seek approvals in other countries as well.
Texas Abortions Pick Up After Federal Judge Allows Them
The law, known as the Texas Heartbeat Act, or SB 8, has been in effect for a month, barring physicians from knowingly performing an abortion if there is detectable embryonic cardiac activity. However, some Texas clinics again began performing abortions later than six weeks Thursday after a federal judge blocked a state law imposing a near ban on the procedure, while others are moving more slowly as legal challenges play out.
WHO Will Announce New Team to Study Coronavirus Origins
Despite those considerable obstacles, more than 700 people have applied for spots, which will be unpaid positions, on a new committee charged with breathing life into the World Health Organization’s stalled inquiry into the origins of the coronavirus pandemic. Its new advisory team will include specialists in fields like laboratory safety and biosecurity, a step that analysts say may help placate Western governments pressing for consideration of whether the virus emerged from a lab.
FDA Spells Out Lower Sodium Goals for Food Industry
Food companies are coming under renewed pressure to use less salt after US regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries, and potato chips. To get people used to eating less salt, the Food and Drug Administration said reductions have to be gradual and across the entire food supply so people don’t keep reaching for higher sodium options.
As Opioid Crisis Worsens, Ed Markey Pitches 2 Bills to Help Inmates Get Treatment
US Sen. Ed Markey is proposing two pieces of legislation that he says would help inmates who are suffering from drug abuse while they are behind bars and when they are released back into society. Citing a record high number of drug overdose deaths in 2020, Markey on Thursday said he’s reintroducing a bill to ensure people in the justice system have access to opioid-use disorder treatment. Another bill would let people in custody awaiting trial to keep their federal health benefits.
Walgreens Doubles Stake in Provider Network VillageMD with $5.2B Investment
Walgreens is doubling its ownership stake in value-based medical network VillageMD with an additional investment of $5.2 billion, the pharmacy chain said Thursday. The major investment should accelerate the opening of 600 “Village Medical at Walgreens” primary care practices in more than 30 U.S. markets by 2025, and 1,000 by 2027. More than half of the clinics will be in medically underserved communities.
Biogen Alzheimer’s Drug Is Struggling, and A Turnaround Might Not Be Coming Soon
Despite high expectations, Aduhelm, the first drug developed by Biogen and ever approved in the U.S. to slow Alzheimer’s disease, has sought to get roughly 900 Alzheimer’s centers to use Aduhelm, but so far, only around 120 are doing so. The FDA’s approval of Aduhelm was also highly controversial. The debate over the drug’s merits has hung over its launch and, seemingly, physician’s willingness to prescribe it.
Biogen Alzheimer’s Drug Is Struggling, and A Turnaround Might Not Be Coming Soon
Despite high expectations, Aduhelm, the first drug developed by Biogen and ever approved in the U.S. to slow Alzheimer’s disease, has sought to get roughly 900 Alzheimer’s centers to use Aduhelm, but so far, only around 120 are doing so. The FDA’s approval of Aduhelm was also highly controversial. The debate over the drug’s merits has hung over its launch and, seemingly, physician’s willingness to prescribe it.
HHS Announces Nearly $800M in American Rescue Plan Funds to Support Domestic Violence and Sexual Assault Survivors and Their Children
The U.S. Department of Health and Human Services (HHS), through the Family and Youth Services Bureau (FYSB) at the Administration for Children and Families (ACF), is awarding a total of $797.5 million in American Rescue Plan (ARP) funding to support survivors of domestic violence and sexual assault and their children. The funds will cover COVD-19 testing, vaccines, mobile health units, and other support for domestic violence services programs, as well as increase support for sexual assault service providers and culturally specific services.
FDA, NIH, and 15 Private Organizations Join Forces to Increase Effective Gene Therapies for Rare Diseases
The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases.
Merck Sees Up to $7B in Coming Sales of Coronavirus Pill
Merck & Co. executives forecast between $5 billion and $7 billion in sales of the company’s COVID-19 pill through the end of 2022, assuming an expected emergency use authorization from the Food and Drug Administration in December. The sales of molnupiravir, as the experimental, antiviral pill is known, could go higher if additional research shows it can prevent disease in people who have become exposed but not sick, Merck executives said on an earnings call Thursday.
Democrats Reach Deal on Lowering Prescription Drug Prices
Democrats reached an agreement on provisions designed to lower the price of some prescription drugs, appearing to resolve one of the final issues in the party’s negotiations over their $1.85 trillion healthcare, education and climate-change bill. The agreement, which is backed by the White House, would empower Medicare to negotiate the price of some drugs, penalize drug companies for raising prices faster than the rate of inflation and cap out-of-pocket costs for seniors at $2,000 annually
Once Sidelined, Eli Lilly’s COVID-19 Antibody Treatment Is on the Comeback Trail with New $1.3B Supply Agreement
On Tuesday, the company revealed that it has struck a deal with one of its loyal customers, the United States government, which has agreed to purchase 614,000 doses of the therapy for $1.29 billion. The combination of etesevimab and bamlanivimab is a treatment for mild to moderate COVID-19 or for post-exposure prophylaxis in high-risk individuals. Lilly will provide at least 400,000 doses by the end of the year, with the rest guaranteed by the end of January 2022.
Biden Administration to Invest $650M in Rapid Diagnostic Testing in Latest Action to Increase Access to Tests
As part of the Biden-Harris Administration’s ongoing commitment to increasing access to COVID-19 testing for Americans and to further strengthen domestic manufacturing of needed tests, the U.S. Department of Health and Human Services (HHS) will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and increase Americans’ access to them.
J&J, World’s Largest Drugmaker, Plans to Split in Two
On Friday, J&J said it will separate its consumer health division, which sells well-known brands like Tylenol, Listerine, and Band-Aids, into a new publicly traded company. Expecting to complete the separation, which is meant to boost the value of the company’s main businesses, in the next 18 to 24 months, J&J will retain its prescription drug and medical device units and keep in place its current leadership plan.
The FDA Authorizes COVID Booster Shots for All U.S. Adults
The Food and Drug Administration has given its OK for fully vaccinated Americans who are age 18 and older to receive a COVID-19 booster shot. The FDA on Friday granted emergency use authorization for a third dose of the Pfizer-BioNTech and Moderna vaccines, which had already been available to people 65 and older and to anyone 18 years and older who is at elevated risk of contracting COVID-19. People who got the Pfizer or Moderna immunizations to start would be eligible for a booster six months after their second shot, the FDA said. People who got the Johnson & Johnson vaccine would be eligible for a booster two months after their first shot.
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