About Covid-19
U.S. renews COVID-19 public health emergency “The public health emergency was initially declared in January 2020, when the coronavirus pandemic began. It has been renewed each quarter since and was due to expire on April 16.”
NY health officials say two new subvariants ‘likely’ fueling rise in cases “New York health officials on Wednesday said that two newly identified subvariants of omicron could be helping fuel an increase in COVID-19 cases in the state.
The New York State Department of Health said the two subvariants are known as BA.2.12 and BA.2.12.1 and are thought to be even more transmissible than the original BA.2 subvariant of omicron, which already spread more easily than earlier variants.”
Covid booster shot bolsters protection in 5-to-11-year-olds, Pfizer and BioNTech say “Pfizer and BioNTech say they intend in coming days to request authorization from the Food and Drug Administration for a booster for 5-to-11-year-olds. The additional shot was given six months after children were fully vaccinated.”
About health insurance
UnitedHealth Group posts $5B in profit for Q1 “Revenues at UnitedHealthcare were $62.6 billion, growth of 13.6% year over year from the $55.1 billion haul in the first quarter of 2021. The insurer added 1.5 million members over the quarter, including notable growth in Medicare Advantage, dual special needs plans and Medicaid.
UnitedHealth said it has added 350,000 members across its new product offerings, such as virtual-first plans, over the past year.
Optum's revenue grew 18.9% year over year, reaching $43.3 billion. At OptumRx, the company's pharmacy benefit management arm, revenues were up 11% as it grew its base with large health plan clients and further expanded offerings in behavioral health, specialty pharmacy and e-commerce.”
About pharma
FDA Issues Manual on Complex APIs “The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER.”
McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators “A review by The New York Times of thousands of internal McKinsey documents found that the firm repeatedly allowed employees who served pharmaceutical companies, including opioid makers, to also consult for the F.D.A., the drug industry’s primary government regulator.
And, the documents show, McKinsey touted that inside access in pitches to private clients. In an email in 2014 to Purdue’s chief executive, a McKinsey consultant highlighted the firm’s work for the F.D.A. and stressed “who we know and what we know.”
About the public’s health
Merck's next-gen pneumococcal vaccine receives FDA breakthrough status ahead of phase 3 trial “V116—one of three pneumococcal vaccines in Merck’s clinical pipeline—targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by any licensed vaccines. The company expects to begin phase 3 trials later this year.”