About Covid-19
Nearly every state expected to see increase in COVID-19 hospitalizations, forecast shows “As the nation's COVID-19 resurgence reaches its highest point since mid-February, daily hospital admission levels and new COVID-19 related deaths in the U.S. are projected to continue increasing over the next four weeks, according to newly updated forecast models used by the Centers for Disease Control and Prevention (CDC).
The forecast now predicts that nearly every U.S. state and territory is projected to see increases in new hospitalizations over the next two weeks.”
Patients charged hundreds of dollars to get Covid drugs already paid for by taxpayers “Doctors and hospitals are charging fees to give Evusheld, the only drug that works to prevent Covid-19 for many immune-compromised people, even though the government is distributing the drug for free.
Evusheld, a monoclonal antibody, is the only Covid prevention option for many people with weak immune systems, as vaccines failed to give them antibodies…
But have offered no plan, at least not publicly, to fix the situation, leaving some immune-compromised people hit with sticker shock when they go to the doctor to get Evusheld.”
NIH announces antiviral drug development awards | National Institutes of Health (NIH) “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
The AViDD centers will conduct innovative, multidisciplinary research to develop candidate COVID-19 antivirals, especially those that can be taken in an outpatient setting, as well as antivirals targeting specific viral families with high potential to cause a pandemic in the future. These include paramyxoviruses, bunyaviruses, togaviruses, filoviruses (including Ebola viruses and Marburg virus), picornaviruses (including enteroviruses and other cold-causing viruses), and flaviviruses (including the viruses that cause yellow fever, dengue and Zika).”
See the article for details about the awardees.
Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986–2020 “To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action… Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another (“device hops”). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.”
About health insurance
CMS rolls out changes to Medicare website aimed at usability “One of the key new features is to redesign the Medicare.gov home page to add more detailed information on Medigap policies and plan costs. Other new information on the homepage aims to improve how to compare and select drug coverage.
The changes also include new messages on the homepage that highlight the information most requested by people on Medicare, people nearing eligibility or family members.”
The Children’s Health Insurance Program at 25 A good review of the program’s history and current status.
About pharma
Merck to pay up to $1.4B in cancer deal with Kelun, but details are scarce “Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by.
The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.” However, what exactly is being exchanged remains unknown; Kelun has more than a dozen oncology assets, with 11 in clinical trials and three in preclinical testing.”
Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020 “This cohort study of 49 drugs approved by the FDA in 2020 found that they were supported by 75 pivotal trials, of which nearly two-thirds were double-masked, more than three-fourths had a randomization component, nearly half used a surrogate measure as a primary end point, and more than one-fourth used a historical, external, or other control. Surrogate measures and historical controls were much more common among oncology drug approvals than among nononcology drug approvals.
Meaning In this study, the cohort of 2020 novel drug approvals continued a trend of new drugs being supported by smaller numbers of preapproval pivotal trials and fewer features traditionally associated with rigor.
About the public’s health
Derivation and Validation of the UCAP-Q Case-finding Questionnaire to Detect Undiagnosed Asthma and COPD “Many people with asthma and COPD remain undiagnosed. We developed and validated a new case-finding questionnaire to identify symptomatic adults with undiagnosed obstructive lung disease.”
Biden invokes Defense Production Act for formula shortage “President Joe Biden on Wednesday invoked the Defense Production Act to speed production of infant formula and authorized flights to import supply from overseas, as he faces mounting political pressure over a domestic shortage caused by the safety-related closure of the country’s largest formula manufacturing plant.
The Defense Production Act order requires suppliers of formula manufacturers to fulfill orders from those companies before other customers, in an effort to eliminate production bottlenecks. Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S…”