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Home » Topics » Regulatory » WHO

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International regulators call for voluntary disclosure of all trial data

May 10, 2021
By Mari Serebrov
Biopharma companies need to provide unredacted access to both positive and negative clinical data for all new drugs and vaccines, whether the drugs have been rejected, authorized for emergency use, or granted full or conditional approval, according to the World Health Organization (WHO) and international regulators. “The COVID-19 pandemic has brought into sharp focus the need for improved transparency of medical research,” said EMA Executive Director Emer Cooke, who also chairs the International Coalition of Medicines Regulatory Authorities (ICMRA).
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COVID-19 mRNA vaccine vials, syringe

With COVID-19 deaths on the rise, countries scramble for vaccines

April 20, 2021
By Mari Serebrov
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
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COVID-19 mRNA vaccine vials, syringe

With COVID-19 deaths on the rise, countries scramble for vaccines

April 19, 2021
By Mari Serebrov
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
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Regulatory front for March 8, 2021

March 8, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
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Global pandemic threat
Keeping up with the variants

Governments challenged with sequencing, tracking SARS-CoV-2 variants

Feb. 11, 2021
By Mark McCarty
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
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Regulatory front for Jan. 29, 2021

Jan. 29, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reissues policy for coagulation systems; FDA announces recall of Penumbra’s Jet 7; Stericycle to buy buses as part of settlement; Athena agrees to $18M fine; WHO refreshes essential diagnostics list; TGA pulls two pandemic-driven exemptions.
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Remdesivir vial and syringe

WHO recommends against use of Gilead's Veklury for COVID-19

Nov. 20, 2020
By Michael Fitzhugh
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
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Hospital patient wearing pulse oximeter

As WHO findings disappoint, COVID-19 developers stand in Solidarity

Oct. 20, 2020
By Randy Osborne
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
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Hospital patient wearing pulse oximeter

As WHO findings disappoint, COVID-19 developers stand in Solidarity

Oct. 16, 2020
By Randy Osborne
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
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Product image

Rapid TB test detects multidrug resistance

July 17, 2020
By Annette Boyle
The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of multidrug resistant tuberculosis (TB). The new test enables clinicians to return results in 90 minutes and see immediately whether the pathogen would respond to standard first- or second-line therapies.
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