Following is a summary of current health news briefs.
Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer’s drug
The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.
The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing.
China COVID deaths accelerate to 9,000 a day – UK research firm Airfinity
Around 9,000 people in China are probably dying each day from COVID-19, UK-based health data firm Airfinity said on Thursday, nearly doubling its estimate from a week ago, as infections ripped across the world’s most populous nation. COVID infections started to sweep across China in November, picking up pace this month after Beijing dismantled its zero-COVID policies including regular PCR testing on its population and publication of data on asymptomatic cases.
Analysis-China’s COVID policymaking under scrutiny as infections soar
After China scrapped three years of zero-COVID curbs in 30 days, setting off a massive wave of infections, Beijing’s policymakers face an immense challenge to treat the sick and minimize deaths while winning back public trust dented by previous policies. Scenes of overwhelmed hospitals, people on intravenous drips by the roadside and lines of hearses outside crematoria have fuelled public concern. An extraordinarily small number of reported fatalities – 10 deaths since the old policy regime was overturned on Dec. 7 – and a decision by authorities to stop publishing data on cases have also stoked distrust.
South Korea to require COVID tests for travellers from China
South Korea said on Friday it will impose mandatory COVID-19 tests on travellers from China, joining the United States, Japan and other countries in taking new border measures after Beijing’s decision to lift stringent zero-COVID policies. South Korea would also restrict issuing short-term visas for Chinese nationals until the end of next month and temporarily halt increasing flights from China while using Incheon International Airport as the only gateway for any flights from the neighbouring country, Prime Minister Han Duck-soo said.
COVID travel curbs against Chinese visitors ‘discriminatory’ -state media
Chinese state media said COVID-19 testing requirements imposed by several places around the world in response to a surging wave of infections were “discriminatory”, in the clearest pushback yet against restrictions that are slowing down its re-opening. Having kept its borders all but shut for three years, imposing a strict regime of lockdowns and relentless testing, China abruptly reversed course toward living with the virus on Dec. 7, and a wave of infections erupted across the country.
U.S. sues AmerisourceBergen, says distributor helped ignite opioid epidemic
The U.S. government on Thursday filed a lawsuit accusing AmerisourceBergen Corp, one of the nation’s largest drug distributors, of helping ignite the nation’s deadly opioid epidemic by failing to report hundreds of thousands of suspicious orders of prescription painkillers. In a complaint filed in Philadelphia federal court, the Department of Justice said AmerisourceBergen and two units had repeatedly violated their legal obligation to address suspicious customer orders, or alert the federal Drug Enforcement Administration (DEA) to red flags of suspicious behavior.
Italy urges EU peers to test China arrivals for COVID, but many say ‘no’
Italy on Thursday urged the rest of the European Union to follow its lead and test travellers from China for COVID, but others said they saw no need to do so for now or were waiting for a common stance across the largely border-less bloc. The EU’s health officials could not agree on one course of action when they held talks in the morning and said they would continue their talks later.
Exclusive-U.S. considers airline wastewater testing as COVID surges in China
As COVID-19 infections surge in China, the U.S. Centers for Disease Control and Prevention is considering sampling wastewater taken from international aircraft to track any emerging new variants, the agency told Reuters. Such a policy would offer a better solution to tracking the virus and slowing its entry into the United States than new travel restrictions announced this week by the U.S. and other countries, which require mandatory negative COVID tests for travelers from China, three infectious disease experts told Reuters.
Factbox-South Korea joins places restricting Chinese travellers
Places around the world are imposing or considering curbs on travellers from China amid a COVID-19 surge thereafter authorities relaxed “zero-COVID” rules. They cite a lack of information from China on variants and are concerned about a wave of infections. China has rejected criticism of its COVID data and said it expects future mutations to be potentially more transmissible but less severe.
Pfizer’s hemophilia B gene therapy succeeds in late-stage study
U.S. drugmaker Pfizer Inc said on Thursday its experimental gene therapy for the treatment of hemophilia B, a rare inherited blood disorder, met its main goal in a late-stage study. Data from the study showed that a single dose of the therapy was superior to the current standard of care in helping reduce the bleeding rate in patients with moderately severe to severe forms of hemophilia B.
(With inputs from agencies.)
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