WASHINGTON - President Joe Biden's administration on Monday said it will end COVID-19 emergency declarations on May 11, nearly three years after the United States imposed sweeping pandemic measures to curb the spread of the illness.
The COVID-19 national emergency and public health emergency (PHE) were put in place in 2020 by the administration of then-President Donald Trump. Biden has repeatedly extended the measures, which were set to expire in the coming months.
The White House's Office of Management and Budget (OMB) in a statement said the declarations would be extended again until May 11, and then terminated.
"This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE," OMB said in an administration policy statement.
OMB said in a separate statement that Biden would veto a proposed bill in the U.S. Congress that would eliminate COVID-19...
- The U.S. government on Monday proposed a new rule to expand coverage of the Obamacare health insurance plans for all women who need or want birth control.
Regulations in 2018 expanded exemptions for religious beliefs and moral convictions allowing private health plans and insurers to exclude coverage of contraceptive services.
The new rules proposed by the U.S. Department of Health & Human Services (HHS) and the Departments of Labor and the Treasury would remove the moral exemption and retain the existing religious exemption.
The rules would ensure that "tens of millions of women across the country" who have access to birth control coverage under the Affordable Care Act would get access to contraception, the HHS said.
(Reporting by Manas Mishra in Bengaluru; Editing by Anil D'Silva)...
By Brendan Pierson
- Drug manufacturers can limit healthcare providers' use of outside pharmacies for dispensing drugs under a federal drug discount program, a federal appeals court ruled Monday.
The ruling from a three-judge panel of the 3rd U.S. Circuit Court of Appeals based in Philadelphia is a victory for Sanofi SA, Novo Nordisk AS and AstraZeneca PLc. The companies had sued the U.S. Department of Health and Human Services (HHS) after it ordered them to stop restricting sales of discounted drugs to so-called contract pharmacies.
Spokespersons for Sanofi and AstraZeneca said the companies were pleased with the decision. HHS and Novo Nordisk did not immediately respond to requests for comment.
The case centers on the federal 340B program, in which drugmakers provide discounts to eligible healthcare providers that serve low-income populations. Drugmakers are required to participate in the 340B program in order to receive f...
By Leroy Leo
- French drugmaker Sanofi SA is reviewing operations at two of its vaccine making facilities in India and plans to let go of all employees at the plants, the company told , after it failed to win a UNICEF contract.
The drugmaker is offering voluntary retirement scheme (VRS) to all its employees at two sites near Hyderabad, a spokesperson for Sanofi's India unit told in an email.
About 800 employees could be affected by the decision, two sources familiar with the matter said. The sources did not want to be named as the matter is confidential.
Sanofi India declined to comment on the number of employees who would be offered VRS. The French company has over 5,000 employees in India, according to its website.
The two plants manufacture vaccines against hepatitis B, diphtheria and tetanus, and also have packaging facilities for insulin, but demand for their products has been hit by the pandemic as othe...
By Manas Mishra and Michael Erman
- Clarity from Pfizer Inc this week on whether China's relaxation of its Zero-COVID policy and the surge in infections there will lead to a spike in demand for its antiviral Paxlovid could spur analysts to alter their 2023 sales forecasts for the treatment.
China was an insignificant market for Paxlovid before the strict infection-control policy was lifted, but Pfizer Chief Executive Albert Bourla said the company has since distributed millions of Paxlovid treatment courses there through a deal with China's Meheco.
Still, the status of deliveries later this year remains unclear. Talks between Pfizer and China's government health insurer bogged down over price, and the drug is only covered by China's broad healthcare insurance plan until late March.
Analysts say they have based their 2023 Paxlovid sales estimates primarily on public details of announced deals, with a token amount of es...
GENEVA - The world is "dangerously unprepared" for future pandemics, the International Federation of the Red Cross and Red Crescent Societies (IFRC) say in a report published on Monday, calling on countries to update their preparedness plans by year-end.
In its World Disasters Report 2022, the IFRC said "all countries remain dangerously unprepared for future outbreaks" despite COVID-19 killing more people than any earthquake, drought or hurricane in history.
"The next pandemic could be just around the corner. If the experience of COVID-19 won't quicken our steps toward preparedness, what will?" said Jagan Chapagain, secretary general of the IFRC, the world's largest disaster response network.
"There will be no excuse for a continued lack of preparedness after having gone through three terrible years."
The report said that countries should review their legislation to ensure it is in line with their pandemic preparedness plan...
BEIJING - China said on Monday that the COVID-19 situation in the country was at a "low level", and that fever clinic visits due to the coronavirus during the Lunar New Year dropped about 40% from before the week-long holiday
"The overall epidemic situation in the country has entered a low level, and the epidemic situation in various places has maintained a steady downward trend," National Health Commission spokesperson Mi Feng told a media briefing on Monday .
Travel domestically as well as in and out of China during the holiday period rose sharply as millions boarded planes, trains, buses and highways after Beijing abruptly dismantled an almost three-year zero-COVID policy in early December.
Passenger trips during the annual travel rush period reached 892 million between Jan. 7 and Jan. 29, up 56% from 2022, a transport ministry official told reporters, but down 46.9% from the same period in 2019.
China's sudden relaxatio...
- The World Health Organization (WHO) said on Monday that COVID-19 continues to constitute a public health emergency of international concern, its highest form of alert.
The pandemic was likely in a "transition point" that continues to need careful management to "mitigate the potential negative consequences", the agency added in a statement.
It is three years since the WHO first declared that COVID represented a global health emergency. More than 6.8 million people have died during the outbreak, which has touched every country on Earth, ravaging communities and economies.
However, the advent of vaccines and treatments has changed the pandemic situation considerably since 2020, and WHO Director-General Tedros Adhanom Ghebreyesus has said he hopes to see an end to the emergency this year, particularly if access to the counter-measures can be improved globally.
Advisers to the WHO expert committee on the pandemic's status...
JAKARTA - Indonesian police said on Monday a local trader of industrial-grade chemicals sold them as pharmaceutical-grade, leading to their use in medicated syrups that authorities suspect may have caused deaths of more than 200 children across the country.
Authorities have said two ingredients, ethylene glycol (EG) and diethyelene glycol (DEG), found in some syrup-based paracetamol medications are linked to acute kidney injury, which many of the children suffered.
The two ingredients are used in antifreeze, brake fluids and other industrial applications, but also as a cheaper alternative in some pharmaceutical products to glycerine, which is a solvent or thickening agent in many cough syrups. They can be toxic and can lead to acute kidney injury.
Pipit Rismanto, a senior police official, told reporters authorities have found that CV Samudera Chemical sold "industrial-grade" EG and DEG as pharmaceutical-grade propylene glycol manufactured...
PARIS - Healthcare companies Sanofi and Regeneron said on Monday that their Dupixent product had won approval from the European Commission to treat eosinophilic esophagitis (EoE), which is a condition that damages the esophagus.
"This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union," said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron.
(Reporting by Sudip Kar-Gupta; Editing by Himani Sarkar)...
- Japanese drugmaker Eisai Co Ltd and Biogen Inc said on Sunday the Japanese Ministry of Health, Labour and Welfare has given priority review for their Alzheimer's disease drug.
The drug, lecanemab, which was recently granted accelerated approval in the United States, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of patients in the early stages of the mind-wasting disease.
(Reporting by Baranjot Kaur in Bengaluru; Editing by Stephen Coates)...
BEIJING - China has approved two domestically developed oral medicines for COVID-19 patients with mild symptoms, the National Medical Products Administration said on Sunday.
The drugs, used for treating adult patients with mild to moderate COVID-19 infections, have been developed by Simcere Pharmaceutical Group <2096. HK> and a unit of Shanghai Junshi Biosciences Co Ltd, the administration said in a statement on its website.
China abandoned its stringent "zero COVID" policy in early December after protests against it, allowing people to travel and the virus to spread rapidly throughout the country, boosting demand for COVID treatments.
(Reporting by Kevin Yao; Editing by Muralikumar Anantharaman)...
PARIS - France has extended mandatory COVID tests for travellers from China until Feb. 15, a government decree published on Saturday showed.
While Chinese officials have said infections have peaked, some global experts have warned about the possibility of a rise in cases in rural areas less equipped to deal with them as millions of Chinese travel for family reunions during the Lunar New Year holiday.
On Dec. 30, France announced it would require travellers from China to provide a negative COVID-19 test result less than 48 hours before departure as China eased lockdown rules.
The measure, which had been set to last until Jan. 31, imposed tests on all flights from China - including flights with stopovers - and required travellers on airplanes arriving from China to wear masks.
China abandoned its strict "zero COVID" policy in early December after protests against the restrictions, allowing people to travel and the virus to...
By Leonardo Benassatto and Amanda Perobelli
BOA VISTA, Brazil - Dozens of indigenous children suffering from malnutrition and acute diseases have been hospitalized in northern Brazil, with relatives in hammocks holding their emaciated frames in scenes that underscore the gravity of a public health crisis.
The health secretary of Boa Vista, the capital of Roraima state, said on Friday that 59 indigenous children were currently at the only pediatric hospital in the state, 45 of them from the Yanomami people. Eight were under intensive care.
That compares to a total 703 hospitalizations in all of last year, the secretary said, noting that most children have been taken to hospital for acute diarrhea, gastroenterocolitis, malnutrition, pneumonia and malaria.
Brazil's government last week declared a medical emergency in the Yanomami territory, the country's largest indigenous reservation, after reports of children dying of malnutr...
-Eli Lilly and Co said on Friday the U.S. health regulator approved its drug for the treatment of a rare form of blood cancer.
The Food and Drug Administration gave accelerated approval to Jaypirca for the treatment of adults mantle cell lymphoma after at least two lines of therapy.
The approval is based on data from a subset of patients from early- to mid-stage trial. The confirmatory late-stage trial is currently enrolling patients, the U.S. drugmaker added.
The drug is expected to be available in the United States in the coming weeks, the company said.
(Reporting by Leroy Leo and Sriparna Roy in Bengaluru; Editing by Maju Samuel)...
- The U.S. Food and Drug Administration on Friday classified the recall of LivaNova's device that controls a blood-pumping system at its most serious type, citing that their use could cause serious injuries or death.
The medical device company recalled 589 units of the LifeSPARC system's controller, through the period of Dec. 19, 2019 to Nov. 17, 2022, for a software update to address a previously known malfunction.
The controller's software malfunction may trigger the device to enter critical failure mode causing the pump to stop for an extended time period, the FDA said, which may lead to serious injury or death of the patient.
LivaNova's recall is in addition to a previous withdrawal of 484 units due to the same issue. The company has reported 66 complaints and the FDA has received reports of two injuries due to this issue.
On Dec. 5, LivaNova started notifying customers about the software update's availability to resolv...
- The U.S. health regulator on Friday proposed new blood donation guidelines for men who have sex with men that are based on individual risk rather than across-the-board requirements, a move it said is in line with other countries and will help ensure the U.S. blood supply.
The U.S. Food and Drug Administration said the rules aim to reduce the risk of transfusion-transmitted HIV and are similar to those in the UK and Canada.
The proposed rule comes several years after the FDA reversed a 1980s guideline, which banned men who have sex with men from donating blood, but said they had to abstain from sex for at least a year before donating.
In 2020, the agency shortened the abstinence period to three months amid a pandemic-driven shortage of blood supply.
The removal of time-based deferrals also applies to women who have sex with the men who have sex with other men, the FDA said.
Under the new proposal, any pr...
- Walmart Inc said on Friday it would adjust working hours for its U.S. pharmacy team and implement it nationwide in 4,600 locations, with drugstore operator CVS Health Corp doing the same for about two-thirds of its retail pharmacies, amid a tight labor market.
The United States has been experiencing a nationwide labor shortage since the COVID-19 pandemic which has forced retailers to offer attractive incentives and pay increases.
Walgreens Boots Alliance and CVS each raised their minimum wage to $15 per hour in 2021 while Walmart said last year it would increase the average pay of pharmacy workers to more than $20 per hour.
Earlier on Friday, the Wall Street Journal first reported CVS Health Corp and Walmart were cutting pharmacy hours.
Walmart's pharmacies will be open from 9 AM to 7 PM, Monday through Friday from March, while the weekend hours would not change, a spokesperson for the company said. Currently, they are o...
- The Omicron subvariant XBB.1.5 has likely become the dominant variant in the United States, accounting for 61.3% of COVID cases in the week ended Jan. 28, data from the U.S. Centers for Disease Control and Prevention showed on Friday.
The subvariant accounted for 49.5% of cases in the week ended Jan. 21, estimates from CDC showed.
XBB.1.5, which is currently the most transmissible variant, is an offshoot of XBB, first detected in October.
The now-dominant XBB-related subvariants are derived from the BA.2 version of Omicron.
An analysis from CDC showed on Wednesday that updated COVID-19 boosters from Pfizer Inc/BioNTech SE and Moderna helped prevent symptomatic infections against the new XBB-related subvariants.
(Reporting by Khushi Mandowara and Raghav Mahobe in Bengaluru; Editing by Krishna Chandra Eluri and Shailesh Kuber)...
- Johnson & Johnson said on Friday its cancer drug, Carvykti, met the main goal of a late-stage study for treating patients with a type of myeloma, according to an interim analysis.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Vinay Dwivedi)...