"No decision has been taken on Sandoz, we continue to evaluate the options," Vas Narasimhan said at the J.P. Morgan Healthcare conference. He also said the Swiss drugmaker continued to look for value-creating bolt-on acquisitions.
California would be the first state to provide health coverage to all immigrants in the country illegally under the budget Gov. Gavin Newsom proposed Monday.
It's part of his effort to address what he termed five of the most populous state's biggest challenges in a $286.4 billion budget that builds on a surplus projected by the Legislative Analyst to be at least $31 billion. Newsom's budget proposal uses a much bigger surplus estimate because his administration uses a different definition of what counts as a surplus.
What his administration termed "existential threats" include the surging coronavirus pandemic; wildfires and drought worsened by global warming; homelessness; income inequality including the lack of health insurance for some immigrants; and public safety, including combatting a recent flurry of coordinated smash-and-grab robberies.
The most populous state has made great strides in reducing its uninsured population in recent years, but the largest single group left behind under the state's Medicaid program are low-income residents in the country illegally.
The state began covering immigrants 26 and under in 2019, and those 55 and older last year. Now Newsom wants state lawmakers to cover the remainder, starting no sooner than Jan. 1, 2024.
It wasn't immediately clear if he would phase in the additional health coverage or how he planned to pay for it.
One legislative analysis put the price tag for covering the remaining donut hole of uninsured immigrants at $2.4 billion per year. Covering those age 50 and up, the most recent expansion, will eventually cost taxpayers about $1.3 billion per year.
His budget address kicks off months of haggling with his fellow Democrats, who control the state Legislature, talks that will intensify when Newsom presents an updated spending proposal in May.
Some progressive legislative Democrats last week proposed creating in California the nation's first universal health care system, backed by steep tax hikes that would have to be approved by voters.
Newsom also has pledged to spend $300 million on boosting law enforcement efforts to combat retail theft and another $2.7 billion to spend on things like coronavirus testing and hospital staffing.
He additionally on Monday proposed spending $648 million to back wildland firefighters and buy more helicopters and bulldozers, plus another $1.2 billion on top of the current budget year's $1.5 billion for forest management.
Another $750 million would go to drought relief, on top of the current budget year's $5.2 billion water package.
Also on the environmental front, he pledged to keep reducing California's reliance on fossil fuels.
To confront the state's seemingly intractable homelessness problem, he proposed spending $2 billion for mental health services, housing, and clearing homeless encampments. That's on top of last year's $12 billion package. The combination would create a projected 55,000 new housing units and treatment slots.
To help with the ever-growing cost of living in California, Newsom proposed "doubling down" on the state's existing plan to provide free universal pre-kindergarten; adding thousands of child care slots and boosting to before, after and summer school programs.
He also proposed continued aid to small businesses hit hard by the pandemic by waiving fees and providing hundreds of millions in grants and tax breaks.
Newsom's massive projected budget and surplus brings the state a long way from the gloom of 2020, when Newsom and state lawmakers cut spending, raised taxes and pulled money from the state's savings accounts to cover what they feared would be a pandemic-fueled $54 billion deficit.
That deficit never happened. Instead, state revenues soared like never before. In September, collections from the state's three largest taxes — personal income, sales and corporation — were 40% higher than September 2020 and nearly 60% higher than September 2019, before the pandemic hit, according to the Legislative Analyst's Office.
Newsom has also promised to substantially increase spending on infrastructure, including things like roads and bridges. These types of projects are good ways to spend surplus money — which is only available for one year — because they don't have recurring costs that must be funded every year. Another advantage is infrastructure spending does not count toward the state's constitutionally-set spending limit, meaning it can offset other spending to help lawmakers stay under that cap.
Nationally, people will be watching closely to see how Newsom wants to spend money to increase access to abortion. The U.S. Supreme Court is considering whether to overturn or significantly weaken Roe v. Wade, the landmark decision that forbids states from outlawing abortion. If that happens, as many as two dozen other states could pass laws outlawing or restricting access to abortion.
Last year, Newsom convened a group of more than 40 abortion providers and advocacy groups to ask for their ideas on what to do should that happen. In December, the group released 45 recommendations. They include spending money to help clinics hire more workers and funding to reimburse abortion providers for patients who can't afford to pay — including those who travel to California from other states.
In an interview with The Associated Press last month, Newsom indicated some of the report's recommendations will be included in his budget proposal.
The US Food and Drug Administration (FDA) has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug's manufacturer, Idorsia, has announced.
The FDA's decision was based partly on a phase 3 trial of adults with moderate-to-severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.
Whereas the overall results are very positive, the improvements in daytime functioning are especially "exciting," Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, Michigan, told Medscape Medical News.
"That's sort of a big deal. For me, that's the biggest deal there is," said Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.
The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the US Drug Enforcement Administration, daridorexant is expected to be made available in May.
Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.
As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.
The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.
Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.
Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.
"They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea," said Roth, who presented the phase 3 findings at SLEEP 2020.
In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Roth has also served as a consultant for other companies that develop sleep agents.
The U.S. Food and Drug administration is recommending that health care providers consider race and or ethnicity in addition to underlying health conditions when determining if a patient should be given a COVID-19 antibody treatment.
The recommendation was made in given out by the agency on the emergency use authorization of the drug sotrovimab in order to treat mild to moderate cases of COVID-19.
“The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death,” the fact sheet states.
FDA officials also list a number of medical qualifications that would deem a patient as "high risk for progression to severe COVID-19" including being overweight, pregnant, 65 years of age or older, suffering from kidney disease, diabetes or cardiovascular disease.
Below that list, FDA officials wrote, in parentheses, that health care providers can use “other medical conditions” to place patients at high-risk for progression to severe COVID-19.
“Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above,” the document reads.
The factsheet was first released in September of last year and was last updated in December.
There are some caveats to the drug’s emergency use authorization, mainly that it is not recommended for patients who already have severe COVID-19 and who have been hospitalized due to the virus, require oxygen therapy due to COVID-19 or require an increase in baseline oxygen flow rate due to COVID-19.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced nomination of the first targeted alpha therapy (TAT) candidate under the Company's collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion's Fast-Clear™ linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225.
"Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles," said John Valliant, Ph.D. "One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology. We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase 1 study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing."
Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing.
https://finance.yahoo.com/news/fusion-pharmaceuticals-announces-nomination-first-213000178.html
The FDA's emergency use authorizations of monoclonal antibodies and more recently molnupiravir and nirmatrelvir/ritonavir (Paxlovid) for treating COVID-19 in people at high risk for severe disease brings great hope to the world and the global community of people impacted by intellectual disability. But access barriers pose a challenge. It is critically important that healthcare providers make these life-saving treatments available immediately to people with intellectual disabilities who test positive for COVID-19 -- and advocate for those high-risk individuals.
We struggled to get this right during the initial rollout of COVID-19 vaccines. In March 2021, our research group released a study in the New England Journal of Medicine-Catalyst where we described the devastating impact of COVID-19 on individuals with intellectual disabilities. Indeed, our analysis of 64 million medical records across the U.S. demonstrated that having an intellectual disability is the highest risk factor for getting COVID-19 and, second only to age, for dying from it. Tragically, when admitted to the hospital with COVID-19, those with an intellectual disability were 32% more likely to die as inpatients. The CDC has now recognized the robust evidence that having an intellectual disability is a significant risk factor for death from COVID-19.
Our study, and others like it, led to the expansion of vaccine prioritization to people with intellectual disabilities in more than a dozen states as well as in Japan and other countries around the world. Civil rights lawsuits against Connecticut and Maryland allege they failed to prioritize intellectually disabled persons for vaccination. Ultimately, most states and countries failed to follow the clear evidence regarding this high-risk group with their early vaccine deployments.
We are at risk of repeating this mistake with these new life-saving treatments because few realize the risk of COVID-19 in individuals with intellectual disabilities. Tragically, information about the risk of COVID-19 in this population is more difficult to find than information about other risk factors such as age and pre-existing medical conditions. Therefore, providers may be less likely to provide these life-saving treatments to this vulnerable population. The CDC webpage that describes high risk categories merely references "disabilities" -- much deeper research is required to understand the specific risk to the intellectually disabled population. This lack of clarity may have grievous consequences because the body of evidence for COVID-19 treatment is rapidly evolving, making it very difficult for providers to remain up to date.
Undoubtedly, healthcare providers would make this treatment available to patients with intellectual disabilities if they were aware of intellectual disabilities as a major risk factor for severe COVID-19 and mortality. It's critical that healthcare providers understand this and discuss these treatment options with intellectually disabled patients.
With the rapid spread of Omicron and future COVID-19 variants, the CDC and leading medical organizations should clearly communicate the risk of severe COVID-19 for people with intellectual disabilities, and advocate for access to these newer oral antivirals and monoclonal antibodies that remain active against Omicron for these populations.
These medications offer the opportunity for us to save countless vulnerable lives -- or to risk perpetrating a health disparity. We must get this right.
Wendy Ross, MD, is director of the Jefferson Center for Neurodiversity and Autism. Jonathan Gleason, MD, is chief clinical officer of Prisma Health.
Initial Purchase Order for $13 Million, Reflecting $7 Million Gross Margin, to be Delivered in Q1
FDA EUA-approved PCR collection kit tests provide
24-hour certified lab results and retail for $9.99
In response to a national shortage of COVID-19 test options, Pittsburgh-based McDade Products, LLC has partnered with G Medical Tests and Services, a division of G Medical Innovations Holdings Ltd. (NASDAQ: GMVD), to manufacture several million U.S. FDA Emergency Use Authorization (EUA) approved COVID-19 PCR collection test kits available for retailers for sale by the end of January, 2022. McDade Products is a division of McDade Group, a specialty sales, marketing, and distribution company serving the U.S. retail industry.
McDade Products is now accepting orders for the co-branded LiveNow PCR Collection Kit, which will retail for $9.99. The diagnostic PCR (polymerase chain reaction) test detects the presence or absence of SARS-CoV2, the virus that causes COVID-19. Users register with the lab online, collect a nasal swab sample at home, and send the sample to G Medical’s CLIA-certified lab with the pre-paid return pack. On average, tests results are expected to be available online within 24 hours from the time the sample is received.
G Medical’s labs are approved by the FDA under the EUA. Currently, G Medical has two CLIA-certified labs; one in Southern California, and the other in North Carolina. In addition, G Medical has launched six testing centers in California, with many more planned. G Medical’s labs are capable of being run 24 hours per day 7 days a week, and can each process up to 24,000 COVID tests per hour to meet the current demand.
The first test kit order is for 4 million units. G Medical will be selling these units wholesale for $3.25 each, reflecting gross profit of $7 million. Additionally, G Medical expects to be paid an average of $85.00 per test through each patient’s insurance.
https://finance.yahoo.com/news/mcdade-products-llc-joins-forces-120000869.html
