About Covid-19
Eli Lilly to make COVID-19 antibody drug commercially available from August “Eli Lilly and Co said on Wednesday it plans to make its COVID-19 antibody drug commercially available to U.S. states as well as hospitals and other healthcare providers from August….
The U.S. government will exhaust their supply of bebtelovimab as early as the week of August 22 and, without congressional appropriations, does not have the funds to purchase more, Lilly told Reuters.
Lilly would make bebtelovimab commercially available through a sole distributor beginning the week of Aug. 15, the company said.”
About health insurance
CVS plans to make a major primary care play by the end of 2022 “CVS, which operates 9,900 locations across the country, is looking to enhance its health services in primary care, provider enablement and home health, CVS CEO Karen Lynch said during the company's second-quarter earnings call Wednesday morning.
M&A will be a key part of that strategy, she said.”
Cigna boosts guidance as it posts $1.6B in profit for Q2 “Cigna posted $1.6 billion in profit and $45.5 billion in revenue for the second quarter, according to its earnings report released Thursday.
Both results beat Wall Street analysts' forecasts… They also represent growth year over year, as in the second quarter of 2021 Cigna brought in $43.1 billion in revenue and $1.5 billion in profit.
Through the first half of this year, Cigna has earned $2.7 billion in profit and $89.5 billion in revenue. By comparison, the insurer earned $2.6 billion in profit and $84.1 billion in revenue in the first six months of 2021.”
About hospitals and healthcare systems
Studies show that hospitals that serve black patients receive less financial assistance “According to a recent study by medical researchers at UCLA and Princeton, Johns Hopkins and Harvard Universities, hospitals that serve a large proportion of black patients receive less financial support for care compared to hospitals that serve a smaller proportion.
The peer-reviewed study collected data from Medicare and the American Hospital Association on 5,740 hospitals from 2016 to 2018. Of these hospitals, 574 were identified as “serving blacks” or in the top 10% for the largest proportion of black patients. among Medicare inpatients. Most of the hospitals serving blacks were concentrated in the southern and/or urban areas.
The researchers found that total reimbursement, which includes payments from patients and insurers for patient care per day, was on average 21.6% lower at hospitals serving blacks. Hospitals serving more black patients lost $17 per patient per day on average, compared with an average profit of $126 per patient per day among other study hospitals.
Median profits at black hospitals were $111 lower per patient per day, adjusted for a variety of cases and conditions.”
About pharma
Amgen chief Bradway nabs a rare disease player in $4B buyout as the M&A tempo accelerates “Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.
Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.”
FDA approves Cimerli as interchangeable biosimilar to Lucentis “The FDA approved Cimerli as a biosimilar to and interchangeable with Lucentis, according to a press release from Coherus BioSciences.
The approval confirms that Cimerli (ranibizumab-eqrn), an anti-VEGF therapy that helps patients with retinal diseases maintain or gain vision, meets all FDA safety, efficacy and quality standards. It is indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.”
Lucentis is very expensive and some ophthalmologists use generic Avastin (off label) instead.
Cimeril will have a list price of $1,130 per single-use vial, a 40% discount to Lucentis.
Compare the price to generic Avastin, which costs $50 per dose.
Court Says AstraZeneca, Merck and Takeda Should Face Litigation Over Nexium and Prevacid “A federal judge in New Jersey has recommended that AstraZeneca, Merck and Takeda Pharmaceuticals should face litigation for failure to add warnings on two proton pump inhibitors about the risk of kidney injury.
The case concerns two antacids, AstraZeneca and Merck’s Nexium (esomeprazole magnesium) and Takeda’s Prevacid (lansoprazole).”
Gilead to acquire biotech company for $405M “Biopharmaceutical company Gilead Sciences has agreed to acquire MiroBio, a biotechnology company focused on the research of cellular immunity.
Once the transaction is complete, Gilead will have the rights to MiroBio's entire catalog of immune inhibitory receptors and MiroBio's platform used to develop antibodies targeting immune inhibitory receptors. Gilead will acquire MiroBio for $405 million, according to the Aug. 4 press release.”
About the public’s health
U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year “The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.
By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.
The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. It does not expect the next delivery, of half a million doses, until October.”
And in a related story: U.S. declares monkeypox outbreak a public health emergency
Biden issues second executive order to protect abortion access “The executive order directs the Department of Health and Human Services to ‘consider action to advance access’ to reproductive health services, including through Medicaid for patients who travel out of state.”
Association Between Prostate-Specific Antigen Screening and Prostate Cancer Mortality Among Non-Hispanic Black and Non-Hispanic White US Veterans ”In this cohort study of 45 834 US veterans, PSA screening was associated with decreased risk of prostate cancer–specific mortality (PCSM) among Black men and White men. Compared with less frequent screening, annual screening was associated with decreased risk of PCSM among Black men but not among White men.”
About healthcare IT
Digital therapeutics for mental health: Is attrition the Achilles heel? “To date, only a few clinically tested software devices have been authorized by the U.S. Food and Drug Administration for treating specific mental health disorders (excluding devices marketed under pandemic-related emergency use authorization). These include reSET for substance abuse disorder, reSET-O for opioid use disorder, Somryst for chronic insomnia and EndeavorRx for pediatric attention deficit hyperactivity disorder. SaMDs and MMAs for treating mild cognitive impairment, Alzheimer's disease, schizophrenia, autism, depression, social anxiety disorder, phobias and PTSD are in clinical trials and may also come to market soon.”
However: “Our scrutiny of published data also reveals several scientific gaps. First is the lack of standardized definitions of attrition and engagement in the field of digital therapeutics. Second is the lack of standardized reporting requirements by journals. A single digital therapeutic session can generate a dozen or more different metrics of how a user may interact with the app. Even widely used clinical trials reporting checklists, such as CONSORT, have not yet required the reporting of all such engagement metrics in digital trials. This makes it hard to extract such data from published reports and compare metrics across trials and products. Third, is the lack of a standardized definition of compliance. Fourth is the lack of standardized statistical methods, such as mixed models or last observation carried forward, to account for attrition and engagement biases in digital trials.”
The article offers some potential ways to address these obstacles.
About health technology
A physical wiring diagram for the human immune system “A first of its kind comprehensive map of the network of connections that make up the human immune system has been created, which could lead to new immunotherapies to treat cancer, infectious diseases, and other conditions where immune responses play a role.”
New patent-pending method mass-produces antitumor cells to treat blood diseases and cancer “Xiaoping Bao, a Purdue University assistant professor from the Davidson School of Chemical Engineering, said CAR-neutrophils, or chimeric antigen receptor neutrophils, and engraftable HSCs, or hematopoietic stem cells, are effective types of therapies for blood diseases and cancer. Neutrophils are the most abundant white cell blood type and effectively cross physiological barriers to infiltrate solid tumors. HSCs are specific progenitor cells that will replenish all blood lineages, including neutrophils, throughout life…
Bao has developed a patent-pending method to mass-produce CAR-neutrophils from human pluripotent stem cells (hPSCs), that is, cells that self-renew and are able to become any type of human cell. The chimeric antigen receptor constructs were engineered to express on the surface of the hPSCs, which were directed into functional CAR-neutrophils through a novel, chemically defined protocol.”