About Covid-19
BREAKING: FDA Panel Clears J&J COVID-19 Vaccine For Emergency Use: “A U.S. Food and Drug Administration panel approved Johnson & Johnson's request for emergency use authorization of its COVID-19 vaccine Friday, clearing the way for a third vaccine that J&J said is safe and offers strong protection against severe disease, hospitalization and death.
The committee voted to back emergency use unanimously 22 to 0 with no abstentions, the last step before the FDA decides whether to issue an emergency use authorization, or EUA, which is a quicker process than seeking full FDA approval. While the FDA doesn't have to follow the committee's advice, it often does and is expected to approve the EUA soon.”
Biden marks 50 million coronavirus vaccines but warns virus fight not over: “Biden said the vaccine count marked major progress toward reaching and surpassing his administration’s goal of getting 100 million shots in the arms of Americans in his first 100 days in office…
Some public health experts have criticized Biden’s goal of 100 million vaccinations in 100 days as too low.”
New COVID-19 deaths in U.S. rise to highest level in 2 weeks: “The data show an addition of almost 75,000 COVID-19 cases nationwide on Wednesday, a slight increase over the day before but still way down from the peak in the middle of January.”
FDA allows storage, transport of Pfizer vaccine at higher temperatures: “The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.”
COVID-19 vaccine websites violate disability laws, create inequity for the blind: “Many COVID vaccination registration and information websites at the federal, state and local levels violate disability rights laws, hindering the ability of blind people to sign up for a potentially lifesaving vaccine, a Kaiser Health News investigation has found.”
KFF COVID-19 Vaccine Monitor: February 2021: A great update with charts as recent as 3 days ago.
COVID-19 vaccine vial maker Stevanato preps IPO valuing it at up to $5 billion: sources: “Italy’s Stevanato Group, manufacturer of glass vials for COVID-19 vaccines and other healthcare products, is making plans for an initial public offering this year that could value the company at between $4 billion-$5 billion, three sources with knowledge of the situation told Reuters.”
Lilly scores $210M supply deal for newly authorized coronavirus antibody cocktail: “ Eli Lilly on Friday scored a government supply deal for its newly authorized antibody cocktail, which dramatically reduced deaths and hospitalizations in a late-stage trial.
Lilly agreed to sell the U.S. government 100,000 doses of the bamlanivimab-etesevimab combination for $210 million. The doses will be delivered before the end of March, and the government has the option to purchase 1.1 million more doses through Nov. 25 depending on demand.”
About pharma
Watch out, Novo Nordisk. Lilly's new dual action diabetes med could pressure Ozempic: analyst: “Novo Nordisk’s Ozempic is already duking it out with Eli Lilly’s Trulicity in the once-weekly diabetes treatment field. But looming competition from the Indianapolis pharma could pose a serious threat, especially at its lowest tested dose, one analyst said.
That’s the tentative conclusion Bernstein analyst Ronny Gal reached after delving into results from three phase 3 clinical trials of Eli Lilly’s investigational drug candidate tirzepatide, a dual GIP/GLP-1 agonist.
Data unveiled from the SURPASS-3 and -5 trials last week showed the drug was able to significantly drive down blood sugar levels as well as body weight at all three dosing levels tested.”
The CRO megamerger is back as Icon snaps up PRA Health for $12B: “Icon is getting out its checkbook in a massive $12 billion buyout of PRA Health.
The deal sees Icon stump up that sum in a cash and stock transaction, and it's around a 30% premium to PRA’s closing price as of Feb. 23. This comes after a tough year for Icon, which, in the spring last year, amid the height of the first pandemic wave, was forced to slash costs due to the COVID-19 disruptions to its business, while around a third of trial sites were hit.”
Orna Therapeutics Launches with over $100M Raised to Develop a New Class of Fully Engineered Circular RNA Therapies: “Orna's engineered circular RNAs have several key advantages, including superior protein expression, simpler and more cost-effective manufacturing, and improved delivery. Unlike other RNA therapies, oRNA does not require the addition of cap or tail structures and does not require the use of modified nucleotides to address innate immune responses. In addition, oRNAs are designed to drive unparalleled protein production while resisting degradation inside the body.”
AbbVie, Eli Lilly lead Big Pharma's 2020 market cap growth as Merck, Gilead lag: The headline speaks for itself. More details in the article.
Moderna expects $18.4bn from Covid vaccine deals this year: “The Boston-based biotech’s coronavirus vaccine revenue forecast is far higher than the $11.2bn analysts had predicted for 2021, as well as the $15bn that Pfizer said it expected when it reported earnings this month. Moderna said this number could rise because it was in discussions with governments about more vaccine orders for 2021 and 2022, as well as Covax, the vaccination programme for the developing world.”
Merck & Co. to buy Pandion for $1.85 billion, gaining autoimmune drug pipeline: ”Merck & Co. announced Thursday a definitive agreement to acquire Pandion Therapeutics for $60 per share in cash, representing an equity value of approximately $1.85 billion. The purchase will hand Merck a clutch of experimental drugs, including lead candidate PT101, that target a range of autoimmune diseases…
PT101 is an engineered IL-2 mutein fused to a protein backbone designed to activate and expand regulatory T-cells (Tregs) as a potential treatment for ulcerative colitis and other autoimmune diseases.”
Small Odds Humira Patents All Invalid 'Worries' 7th Circ: “Do Humira buyers need to prove every single patent in the ‘thicket’ surrounding AbbVie's blockbuster immunosuppressant was invalid to show the drug giant is illegally shielding the biologic from competition? A Seventh Circuit judge seemed to think so Thursday on a divided panel weighing whether to revive the lawsuit. Circuit Judge Frank H. Easterbrook hit the plaintiffs with their toughest questions during oral arguments, pressing Tom Sobol of Hagens Berman Sobol Shapiro LLP to explain how they can accuse AbbVie of protecting the world's best-selling drug with a thicket containing many allegedly ‘overlapping and non-inventive’ patents even though they were granted. . .”
This case has very important implications for drug patent protections. A common strategy is for pharma companies to get as many patents as possible on each of their products so that competitors will need to successfully challenge all of them.
About hospitals and health systems
Brookdale Selling Majority Stake in Home Health Business to HCA Healthcare: ”Brookdale has agreed to sell 80% of the equity in Brookdale Health Services to the Nashville, Tennessee-based HCA Healthcare for a purchase price of $400 million.”
UHS records $944M annual profit, notes cyberattack loss of $67M: “Despite COVID-19 expenses and taking a $67 million hit from a cyberattack last year, King of Prussia, Pa.-based Universal Health Services ended 2020 with a $944 million profit, according to financial documents released Feb. 25. This net income was a growth of 15.8 percent year over year.
In the 12 months ended Dec. 31, the for-profit hospital operator saw its revenue hit $11.6 billion in 2020, up slightly from $11.4 billion recorded in 2019. It also saw its expenses rise less than 1 percent to $10.2 billion.
After factoring in the expenses, UHS recorded an operating income of $1.4 billion for 2020, up from $1.2 billion recorded in 2019.
UHS also said the cyberattack experienced from Sept. 27, 2020 into October 2020, negatively affected its financial results. UHS said that it was forced to divert patients to competitor facilities, saw significant increases in labor expenses to restore its networks and saw administrative functions such as coding and billing delayed into December, "which had a negative impact on our operating cash flows during the fourth quarter of 2020."
About healthcare IT
Cigna's Evernorth to acquire telehealth company MDLive: “Cigna will acquire telehealth platform MDLive, the insurer announced Friday morning.
Cigna has been a longtime partner of and investor in MDLive and will fold it into its Evernorth subsidiary, which houses its health services business. The deal is expected to close in the second quarter of 2021, pending regulatory approvals.”
Allscripts Announces Fourth Quarter 2020 Results and Outlook For 2021:
“Fourth quarter GAAP EPS of $4.82; 71% year-over-year growth in non-GAAP diluted EPS to $0.29
Closed sales of EPSi and CarePort Health and recognized a combined pre-tax gain of $1.2 billion
Repurchased $280 million of stock in the quarter and ended the quarter in a net cash position”
Telehealth company sues HHS for allegedly excluding overseas physicians: “RemoteICU wants to compel Medicare to pay for telehealth services provided by overseas physicians amidst an intensivist shortage and the pandemic.
RemoteICU wants to compel Medicare to pay for telehealth services provided by overseas physicians amidst an intensivist shortage and the pandemic.”
About health insurance
Fort Worth Doctor Sentenced to 10 Years in Health Care Fraud Conspiracy: “A Fort Worth osteopath who attempted to incinerate clinic records has been sentenced to 10 years in federal prison for his role in a $10 million healthcare fraud…
Mark Kuper, the 43-year-old owner of the Texas Center for Orthopedic and Spinal Disorders (TCOSD), was indicted in June 2020. The defendant admitted he fraudulently billed insurers for services the clinic never actually rendered, including physical therapy and psychotherapy, and required patients to attend these bogus appointments in order to receive Schedule II controlled substance prescriptions.
He also admitted that he gave his wife access to the secure device and passcode he used to sign controlled substance prescriptions, allowing her to improperly dispense pain medications on her own initiative, without his input.”
Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million: “Priority Healthcare will pay Roche Diagnostics $43.3 million to settle a lawsuit alleging that it fraudulently submitted claims to insurers and pharmacy benefit managers for Roche’s Accu-Chek blood glucose test strips that put Roche on the hook for tens of millions of dollars.
Roche claimed in its 2018 complaint that it had to pay more than $37.5 million in “unwarranted” rebates to insurance companies and PBMs for blood-glucose testing strips that either were different, pricier versions of the test strips patients actually received or were not shipped to patients at all. Roche also contended that Priority Healthcare’s efforts to introduce new pharmacies caused it to pay millions of dollars per year in unwarranted rebates for the tests.”
About healthcare professionals
Traumatized and tired, nurses are quitting due to the pandemic: While the headline speaks for itself, the article provides insights via interviews with nurses on the front lines.
About the public’s health
Stopping Menthol, Saving Lives: “For more than 60 years and continuing today, the tobacco industry has targeted Black communities, especially children, with marketing for menthol cigarettes and other tobacco products like flavored cigars.
The industry’s predatory marketing has had a devastating impact on Black health and lives. Tobacco use is the number one cause of preventable death among Black Americans and menthol cigarettes are a major reason why. Black Americans die at higher rates than other groups from tobacco-related diseases such as cancer, heart disease and stroke. To make matters worse, Black Americans are now being disproportionately impacted by COVID-19 and the CDC has found that current and former cigarette smokers are at greater risk for severe illness from COVID-19.”