About Covid-19
California to mandate COVID-19 vaccines for health workers: “California will require all of its roughly 2.2 million health care workers and long term care workers to be fully vaccinated by Sept. 30 as the nation’s most populous state is losing ground in the battle against new infections of a more dangerous coronavirus variant.
The order, issued Thursday by the California Department of Public Health, is different than what Democratic Gov. Gavin Newsom said last month when he announced health care workers would have the choice of either getting vaccinated or submitting to weekly testing.”
Many healthcare facility managers are concerned that if they require employee vaccination, they will lose employees in a tight job market. If the state requires all such businesses to vaccinated employees, it substantively removes that threat.
South African study shows high COVID protection from J&J shot: “…the single-shot J&J vaccine offered 91% to 96.2% protection against death, while offering 67% protection against hospitalisation when the Beta coronavirus variant dominates and about 71% protection against hospitalisation when the Delta variant dominates.”
Vaccine Mandates Are Lawful, Effective and Based on Rock-Solid Science: This is an excellent summary and a “must read.”
“The DOJ and EEOC specifically stated that employer mandates may occur even under an EUA…
States have long had the constitutional authority to mandate vaccinations, which the Supreme Court has upheld twice, first in 1905 and then in 1922. The federal government, however, has limited power to mandate vaccines. It can only require them to prevent transmission of a dangerous infectious disease across state lines or international borders. The federal government has never sought to require nationwide vaccinations, and the courts probably would not allow it. To date, all state government mandates have been for fully approved vaccines. Thus, it is likely cities and states would wait to mandate COVID-19 vaccines until they are fully licensed.”
A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on: “After months in the doldrums, one of the world’s largest trials of COVID-19 treatments is finally restarting. Solidarity, a global study led by the World Health Organization (WHO), will test three new drugs in hospitalized COVID-19 patients: the cancer drug imatinib, an antibody named infliximab that is used to treat autoimmune diseases, and artesunate, an antimalarial.
The medicines have been shipped to Finland, the first country to have all approvals in place, says John-Arne Røttingen of the Norwegian Institute of Public Health, who chairs the study’s executive group. ‘I expect that the first patients will probably be recruited there any day,’ he says. Other countries could soon join SolidarityPlus, as the new phase has been dubbed; more than 40 are in the process of getting ethical and regulatory approvals.”
FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks: “The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
The Biden administration is pushing for the swift release of a booster strategy because some populations—people age 65 or older and people who are immunocompromised, as well as those who got the shots in December or January shortly after they were rolled out—could need boosters as soon as this month, two of the people said.”
Moderna's COVID-19 vaccine sales surge to $4.2 billion during Q2: “Moderna said Thursday that it generated sales of $4.2 billion for its COVID-19 vaccine mRNA-1273 during the second quarter, delivering 199 million doses in the period, for a total of 302 million doses so far this year. The vaccine comprised the bulk of Moderna's quarterly sales, which totalled $4.4 billion in all when grant revenues were taken into account, coming in slightly ahead of analyst expectations and towering over the $67 million it made in the prior-year period.
Company profit surged to $2.8 billion in the second quarter, beating estimates of $2.5 billion, whereas it had recorded a loss of $117 million the same time last year.”
Novavax's latest COVID-19 vaccine delay sends shares tumbling nearly 20%: “The latest roadblock—which will advance the timeline by just a couple weeks—spurred a 17.25% drop in Novavax's shares to about $195 apiece as of 10:41 a.m. ET Friday morning. It seems investors are fed up with delay after delay.”
About pharma
Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbochar”ge work: “In data dropped rather quietly during second-quarter earnings this week and to little fanfare, Pfizer said a challenge study, where vaccines were given to 62 adults under 50 who were then intentionally infected with RSV to see if the shot worked, showed ‘100% observed efficacy against mild to moderate symptomatic infection resulting from RSV.’
This is only a peek from the phase 2a test, which is set up to assess the immunogenicity and efficacy of the bivalent protein-based vaccine candidate, RSVpreF.”
Express Scripts Awarded 7-Year TRICARE Pharmacy Program Contract: “The U.S. Department of Defense today awarded Express Scripts, an Evernorth company, a contract for the administration of the TRICARE Pharmacy Program, Fifth Generation. Under the new contract, Express Scripts will serve 9.6 million active-duty service members, their family members, and retirees through 2029.”
Class-action lawsuit alleges 4 drugmakers colluded to restrict insulin sales to 340B contract pharmacies: “The class-action lawsuit alleges that Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca colluded in the summer of 2020 to restrict offering discounted products to 340B contract pharmacies.”
Gilead cracks down on fake versions of popular HIV drugs Biktarvy, Descovy being sold at US pharmacies: “Counterfeit versions of two of Gilead Sciences’ most popular HIV drugs are circulating in the U.S., threatening the health of people taking them.
Gilead’s original Biktarvy and Descovy have been replaced by fake versions at some pharmacies, Gilead warned Thursday. Unauthorized distributors were able to sell fake drugs to retailers; and then, ‘genuine Gilead bottles’ were filled with fake tablets, the company said.”
GSK again scores $235M in 'skinny label' case, but court admits it's 'unclear what Teva even did wrong': Read the whole story. It is a crazy, confusing exposition of the application of drug patent regulations.
About health insurance
Innovative Approaches to Addressing Social Determinants of Health for Medicare Advantage Beneficiaries: “On behalf of the Better Medicare Alliance's Center for Innovation in Medicare Advantage, NORC at the University of Chicago (NORC) assessed the current landscape of SDOH services within Medicare Advantage…
The new supplemental benefit authorities have been well received by health plans, with an explosion of participation in SSBCI’s [Special Supplemental Benefits for the Chronically Ill]-primarily health-related benefits to 845 separate plans in 2021, up from 245 in 2020 (the first year of SSBCI benefit availability).xxiv The top benefits offered in 2021 included Meals, Food and Produce, Social Needs Benefit, Pest Control, and Non- Medical Transportation. All health plans interviewed for this report described participating in SSBCI, with many enthusiastic about the results.”
Ascension Michigan to Pay $2.8 Million to Resolve False Claims Act Allegations: “Ascension Michigan and related hospitals… have agreed to pay $2.8 million to resolve claims that they violated the False Claims Act by submitting or causing the submission of false claims for payment to federal health care programs related to alleged medically unnecessary procedures performed by a gynecologic oncologist (‘the Doctor’)…
Ascension Michigan knowingly submitted false claims for payment to federal health care programs and improperly retained payment for professional and facility fees related to medically unnecessary radical hysterectomies that the Doctor performed, chemotherapy services that the Doctor administered or ordered that were not medically necessary, and evaluation and management services by the Doctor that were not performed or not rendered as represented.”
About the public’s health
Tennessee can enforce abortion waiting-period law, 6th Circuit rules: “The full 6th U.S. Circuit Court of Appeals, split largely along partisan lines, on Thursday revived a 2015 Tennessee law requiring a 48-hour waiting period for abortions, reversing a lower court decision blocking the law.
Circuit Judge Amul Thapar wrote in the 9-7 majority opinion that the law was constitutional because it did not place a ‘substantial obstacle’ in the way of a ‘large fraction’ of women seeking abortions before fetal viability.”
About healthcare IT
Allscripts Announces Second Quarter 2021 Results: “On a GAAP basis in the second quarter of 2021, income from operations was $10 million compared with a GAAP loss from operations in the second quarter of 2020 of $25 million. Non-GAAP income from operations in the second quarter of 2021 was $33 million compared with $25 million in the second quarter of 2020.”
About medical devices
llumina posts 78% revenue growth as cancer, DNA testing ramp back up: “Illumina’s sales (PDF) of consumables alone were up 82% year-over-year, totaling $704 million, with oncology testing showing three consecutive quarters of growth and the National Institute of Health’s All of Us program moving forward at full scale toward its goal of sequencing the genomes of at least one million people in the U.S.
About $189 million in Instrument sales set a new record, up 7% compared to the first quarter of this year, including about $20 million from COVID-19 tracking initiatives.”
Medtronic boosts ear, nose and throat portfolio with $1.1B bid for sinus implant maker Intersect ENT: “The medtech giant has set its sights on Intersect ENT, which has developed two types of steroid-eluting implants to treat cases of chronic rhinosinusitis, where symptoms like facial pain, pressure and nasal drainage or obstruction last for more than 12 weeks at a time, often requiring years of costly surgeries and other treatments.
Both companies’ boards of directors have approved the buyout, which will see Medtronic putting up $28.25 in cash for each of Intersect’s outstanding shares, pricing the transaction at about $1.1 billion.”