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RSS FeedPosted by Michael Wonder on 19 May 2020
Trump admin taps startup to build nation's first stockpile of key drug ingredients
19 May 2020 - The $354 million project is designed to shore up the drug supply chain and reduce the country's ...
Posted by Michael Wonder on 19 May 2020
FDA appears to soften stance on hydroxychloroquine after Trump says he takes malaria drug
19 May 2020 - The U.S. FDA said Tuesday that taking hydroxychloroquine is “ultimately” a choice between patients and their ...
Posted by Michael Wonder on 19 May 2020
Top pharma official rejects idea of free COVID-19 vaccine for all
18 May 2020 - A leading representative of the pharmaceutical industry has downplayed the idea of a vaccine against the ...
Posted by Michael Wonder on 19 May 2020
AveXis receives EC approval and activates “Day One” access program for Zolgensma, the only gene therapy for spinal muscular atrophy
19 May 2020 - Zolgensma (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy ...
Posted by Michael Wonder on 19 May 2020
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): an unprecedented partnership for unprecedented times
18 May 2020 - It has been more than a century since the world has encountered a pandemic like coronavirus disease ...
Posted by Michael Wonder on 18 May 2020
The coronavirus exposed the US' reliance on India for generic drugs. But that supply chain is ultimately controlled by China
17 May 2020 - Sarah Thebarge, a 41-year-old physician assistant living in San Francisco, takes a pill every day to ...
Posted by Michael Wonder on 18 May 2020
FDA approves Genentech’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
18 May 2020 - Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall. ...
Posted by Michael Wonder on 18 May 2020
EMA may conditionally authorise remdesivir in the ‘coming days’
18 May 2020 - The EMA's Executive Director Guido Rasi on Monday told a European Parliament committee that the agency ...
Posted by Michael Wonder on 18 May 2020
Beware of underpriced drugs for COVID-19 treatments
18 May 2020 - It has become painfully obvious that the only path back to normalcy involves either an effective ...
Posted by Michael Wonder on 18 May 2020
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA
18 May 2020 - Adamis Pharmaceuticals Corporation today announced the resubmission of the Company’s new drug application to the U.S. ...
Posted by Michael Wonder on 18 May 2020
Australia must work to avoid 'vaccine nationalism', former top bureaucrat warns
18 May 2020 - A former top bureaucrat has warned the international race to develop a vaccine against the novel ...
Posted by Michael Wonder on 18 May 2020
Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug
18 May 2020 - The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gastro-intestinal stromal tumour ...
Posted by Michael Wonder on 18 May 2020
COVID-19 vaccine frontrunners emerge as rollout debate rages
18 May 2020 - Governments and drug makers are weighing how to roll out coronavirus vaccines, including reserving the first ...
Posted by Michael Wonder on 18 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
18 May 2020 - The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around ...
Posted by Michael Wonder on 18 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 mutant metastatic non-small cell lung cancer
18 May 2020 - Designation based on phase 2 DESTINY-Lung01. ...