Starting Sept. 1, eligible UnitedHealthcare members will be able to access thousands of live and on-demand classes via the Peloton App for up to 12 months, or receive a four-month waiver toward their All-Access Membership, at no additional cost
The UnitedHealthcare offer is the first of its kind between Peloton and a health plan, helping both organizations achieve their joint goal of making fitness and overall wellness more attainable and accessible
The three biggest U.S. drug distribution companies and the drugmaker Johnson & Johnson are on the verge of a $26 billion settlement covering thousands of lawsuits over the toll of opioids across the U.S., two people with knowledge of the plans told The Associated Press.
As a precursor to the bigger deal, New York reached an agreement Tuesday with the distribution companies AmerisourceBergen, Cardinal Health and McKesson to settle an ongoing trial in the state. That deal alone would generate more than $1 billion to abate the damage done by opioids there. The trial is expected to continue, but the settlement leaves only three drug manufacturers as defendants.
“Today, we’re holding them accountable delivering more than $1 billion more into New York communities ravaged by opioids for treatment, recovery, and prevention efforts,” New York Attorney General Letitia James said in a statement Tuesday.
The people who gave the AP details of the national settlement did so on the condition of anonymity because they were not authorized to speak as details are finalized.
The national settlement with the four companies is expected to be the biggest single settlement in the complicated universe of litigation over the opioid epidemic in the U.S. It won’t end the cases, but it will change them. With Johnson & Johnson settling in addition to deals being pursued by OxyContin maker Purdue Pharma and generic drugmaker Mallinckrodt, three key manufacturers will no longer be part of the cases, nor will the national drug distributors.
Other manufacturers, regional distribution companies and pharmacies will remain in the cases for now.
Cardinal Health declined to comment early Tuesday, and the other distribution companies did not respond to requests for comment. But Johnson & Johnson reiterated in a statement that it’s prepared to contribute up to $5 billion to the national settlement. The company settled with New York last month just before the trial there started.
“There continues to be progress toward finalizing this agreement and we remain committed to providing certainty for involved parties and critical assistance for families and communities in need,” the company said. “The settlement is not an admission of liability or wrongdoing, and the Company will continue to defend against any litigation that the final agreement does not resolve.”
The distribution companies face thousands of similar legal claims from state and local governments across the country and have long been trying to settle them all. The New York deal would become a part of a national agreement if one can be struck this year.
The state and local governments say distribution companies did not have proper controls to flag or halt shipments to pharmacies that received outsized shares of powerful and addictive prescription painkillers. The companies have maintained that they were filling orders of legal drugs placed by doctors — so they shouldn’t shoulder blame for the nation’s addiction and overdose crisis.
An Associated Press analysis of federal distribution data found that enough prescription opioids were shipped in 2012 for every person in the U.S. to have a 20-day supply.
And opioids — including both prescription drugs and illegal ones like heroin and illicitly produced fentanyl — have been linked to more than 500,000 deaths in the U.S. since 2000.
Under the New York settlement, the three companies would provide more than $1 billion to be used to abate the epidemic in the state. The money would be delivered in 18 annual payments, with the first one arriving this year.
The companies would also establish a national clearinghouse of data on opioid distribution, and the data would be monitored by an independent body. Johnson & Johnson would also agree not to produce any opioids for the next 10 years.
Including the New York case, there are currently three trials across the U.S. of government entities’ claims that companies should be held liable for the opioid crisis. One in California focuses solely on drugmakers, and one scheduled to wrap up this month in West Virginia aims only at distributors. That could be ended if a deal is reached.
Other cases are queued up to start. The only one of its kind to reach a verdict so far was two years ago in Oklahoma. There, a judge ordered Johnson & Johnson, the only company not to settle before that trial, to pay $465 million. The company is appealing the judgment.
The New York case is the broadest one to go to trial so far — and the first with a jury deciding the case rather than only a judge.
Johnson & Johnson settled for $230 million just before the case started. The remaining defendants are Teva Pharmaceutical Industries, Endo International and AbbVie, Inc.
With so many cases approaching trial, there’s been a flurry of proposed or realized settlements over opioids. OxyContin maker Purdue Pharma declared bankruptcy as part of its effort to settle cases. It is proposing a reorganization that would use all future profits to fight the epidemic as part of a deal the company values at about $10 billion over time. That plan will face some opposition at a confirmation hearing in U.S. Bankruptcy Court next month.
Key second quarter metrics (all percentage changes compare 2Q 2021 to 2Q 2020 unless otherwise noted):
Revenues totaled $14.435 billion
Net income attributable to HCA Healthcare, Inc. totaled $1.450 billion, or $4.36 per diluted share
Adjusted EBITDA totaled $3.219 billion
Cash flows from operating activities totaled $2.251 billion
Same facility admissions increased 17.5 percent and same facility equivalent admissions increased 26.8 percent
2021 Revised Guidance
The 2021 guidance ranges for the year have been revised from our first quarter release and are as follows:
2021 Guidance Range | ||
Revenues | $57.0 to $58.0 billion | |
Adjusted EBITDA | $12.10 to $12.50 billion | |
EPS (diluted) | $16.30 to $17.10 per diluted share | |
Capital Expenditures | Approximately $3.7 billion |
The Company’s 2021 guidance contains a number of assumptions, including, among others, the Company’s current expectations regarding the impact of the COVID-19 pandemic and related government legislation, and excludes the impact of items such as, but not limited to, gains or losses on sales of facilities, losses on retirement of debt, legal claims costs and impairment of long-lived assets.
https://finance.yahoo.com/news/hca-healthcare-reports-second-quarter-113000398.html
Scientists are working on a benchmark for COVID-19 vaccine efficacy that would allow drugmakers to conduct smaller, speedier human trials to get them to market and address a huge global vaccine shortage.
Researchers are trying to determine just what level of COVID-19 antibodies a vaccine must produce to provide protection against the illness. Regulators already use such benchmarks - known as correlates of protection - to evaluate flu vaccines without requiring large, lengthy clinical trials.
"You could use it to predict efficacy from a vaccine, which will be more important as we are less able to conduct placebo-controlled trials," said Stanley Plotkin, inventor of the Rubella vaccine and an expert on correlates of protection.
"The information is flowing in," he said. "By the end of this year, I think there will be enough data to convince everyone." An established benchmark for COVID-19 would allow drugmakers to conduct vaccine trials in just a few thousand people, about one-tenth the size of the studies conducted to gain authorization for currently widely-used coronavirus shots, researchers and drugmakers told Reuters.
Those studies, involving tens of thousands of volunteers, compared the rate of COVID-19 infections in people who received the shot with the rate in participants who got a placebo.
Such randomized, controlled trials may no longer be considered ethical in some countries, as researchers cannot give a dummy shot to people where an effective vaccine is widely available. In addition, many of the new shots are being developed by small companies that may not be able to conduct very large trials without government funding or a partner with deep pockets.
With an established correlate, drugmakers could test blood samples from a smaller number of trial participants who receive an experimental vaccine to see whether they produced that benchmark level of protective antibodies.
Such a benchmark is “urgently needed” to help overcome challenges faced by vaccine developers and boost availability of shots, Dr. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York wrote this month in the journal Nature.
Researchers at Oxford University late last month proposed a potential correlate of protection based on antibodies found in people who had received the AstraZeneca vaccine. The work awaits peer reviewed by other scientists.
Results from a U.S.-backed study of Moderna’s vaccine are expected to be published in a medical journal later this summer. "We're writing the paper right now," said Dr. Peter Gilbert, a biostatistician from the Fred Hutchinson Cancer Research Center.
Some vaccine experts question whether antibody levels will be a strong enough indicator of protection. Other components of the immune system, such as T-cells and B-cells, are thought to provide important defenses against COVID-19, but are more difficult to measure.
That has been the contention of some top vaccine experts at Pfizer, maker along with BioNTech of one of the most effective COVID-19 vaccines, produced in the largest quantities globally.
It is also possible that each different type of coronavirus vaccine will require its own correlate, some experts said. Drugmakers working on a new type of vaccine likely would not be able to rely on the correlates based on Moderna’s messenger RNA shot, they say.
BRIDGING THE GAP
Meanwhile, vaccine developers are trying to devise acceptable substitutes to huge, placebo-controlled trials. Some aim to show their shot provokes antibody responses at least as good as those seen with currently authorized shots.
European and UK health regulators are working with companies to set standards for these so-called “immunobridging” studies. The U.S. Food and Drug Administration declined to say whether it would accept such trials for next-generation vaccines.
“It doesn't have to be an established correlate of protection, but we have to ... arrive at the right pre-specified criteria, because we cannot risk that a second-generation vaccine ... is of low or modest vaccine efficacy," FDA vaccine official Dr. Marion Gruber told fellow regulators at a World Health Organization Meeting in May. "That would undermine confidence in the vaccine enterprise."
Italy's ReiThera Srl is developing a vaccine using technology similar to AstraZeneca's and will try to demonstrate that its shot is at least as effective.
The company has an agreement in principle on trial design with European and British regulators, ReiThera's senior director Stefano Colloca told Reuters. Massive clinical trials are "no longer ethical and feasible in most countries worldwide," he said.
French biotech Valneva and Taiwan's Medigen Vaccine Biologics Corp plan to test their vaccines against the AstraZeneca shot, even though both use a different technology. Valneva's trial design was approved by UK regulators. Medigen has a green light from Taiwan.
Sanofi, with partner GlaxoSmithKline, and Canada’s Medicago are still opting for placebo-controlled trials involving thousands of participants, including in countries with high infection rates and fewer authorized vaccines available. NEED FOR BOOSTERS? The hunt for a correlate is underway from the UK to the United States and Australia. Scientists are comparing antibody levels in vaccinated people who became infected with COVID-19 to those who did not, to find a threshold of protection that made the difference.
Oxford University researchers said work is needed to address correlates for emerging virus variants, such as the highly transmissible Delta that has quickly become dominant globally. Their proposed antibody model is based on trial volunteers who had mainly contracted the earlier Alpha variant, first identified in the UK.
U.S. government-backed scientists are studying infections in people who received the Moderna vaccine. Moderna spokesman Ray Jordan said the company is also working on the analysis and will publish updates when available.
The correlate benchmark might also indicate when and whether people need vaccine boosters.
Pfizer has sought authorization for a third booster dose of its vaccine, citing evidence of waning neutralizing antibody levels. But the company has pushed back against the idea that those same antibodies could be used to predict vaccine efficacy.
"No formal timeline is in place to have correlates of protection established," a Pfizer spokesperson said. "We will continue to work with the scientific community to better understand what immune responses, whether neutralizing antibodies or otherwise, might contribute to protection.”
https://finance.yahoo.com/news/focus-global-quest-underway-speed-100000164.html
Shares of Amneal Pharmaceuticals Inc. are trading higher in Monday's after-hours market, following news the company received an abbreviated new drug application approval from the U.S. Food and Drug Administration for the generic version of TobraDex.
TobraDex is used to treat infections and inflammation of the eye.
At 4:40 p.m. ET, shares of Amneal Pharmaceuticals were trading 7.41% higher at $4.64. Volume at the time topped 16,000 shares.
"After a record-speed discovery and development program, we are pleased that our COVID-19 antibody cocktail continues to reach even more people around the globe," said
In
Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2a clinical trial evaluating the safety, tolerability and pharmacokinetics (PK) of six monthly oral doses, over 24 weeks, of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of HIV-1 infection in adults at low-risk of contracting HIV-1. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose. These data were shared as a late-breaking oral presentation during the virtual 11th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).
“The 24-week analysis of investigational, once-monthly oral islatravir not only builds upon the PK data we have already seen, but also provides encouraging support for the safety and tolerability profile of this HIV-1 PrEP regimen,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”
Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. An overview of the islatravir treatment and prevention development program is available here, which includes our two Phase 3 IMPOWER trials evaluating islatravir as once-monthly oral PrEP across diverse populations of people who may benefit from additional HIV-1 prevention options.
