The World Health Organization has suspended a trial testing the malaria drug hydroxychloroquine as a treatment for COVID-19 due to safety concerns, according to WHO Director-General Tedros Adhanom Ghebreyesus. A study published in The Lancet found no benefit associated with hydroxychloroquine or chloroquine, while treatment was associated with higher mortality and risk of ventricular arrhythmia.
As states begin to reopen, the demand for blood products could rise with the resumption of elective procedures. "It is important that centers everywhere have implemented social distancing measures and taken steps to make sure donors remain safe," said Eduardo Nunes, vice president of science and practice at AABB.
Data from a trial assessing Kadmon's belumodsil showed that after six months the drug inhibited graft-versus-host disease in 73% of patients who took the drug once daily and 74% in those taking it twice a day. The company is preparing to file its new drug application for belumodsil in the fourth quarter.
UK's government has given more than $161 million to its Vaccines Manufacturing and Innovation Center to expedite its completion by a year. The funding will also be used to create a "virtual VMIC" to buy manufacturing equipment, build out staffing and set up space for manufacturing COVID-19 vaccines.
New Jersey contract development and manufacturing organization Catalent took four months to produce a clinical batch of drugs before the COVID-19 pandemic, but timelines have been collapsed to less than a month, said Kay Schmidt, senior vice president of technical operations. Other changes due to COVID-19 include social distancing measures at the plants, a transition to work at home for about 25% of staff members and an increase in ingredients and packing supplies purchases.
GlaxoSmithKline has agreed to a $231 million-plus deal with Samsung Biologics to increase commercial production of the drug Benlysta. More specialty-care products are expected to be added.
The COVID-19 pandemic is leading companies to reconsider their supply chains and how their companies are staffed. Partnerships with suppliers, logistics providers and distributors are needed to transition to an on-demand model, writes Sharad Tyagi, managing director of Boehringer-Ingelheim in India.
Globalization, complexity and now the COVID-19 pandemic have put pressure on pharmaceutical supply chains, underscoring the importance of data management and data security. A white paper from Overhaul and FreightWaves outlines risks and solutions for supply chain visibility, including artificial intelligence for detection of disruptions and notification of law enforcement and others when illegal activity is detected.
Operation Warp Speed is designed to expedite development of a COVID-19 vaccine, enabling a process that normally takes decades to be completed by year's end, and its success is dependent on unprecedented collaboration among researchers, manufacturers and the government. New technologies such as messenger RNA and proteomics could accelerate progress, but the timeline is "incredibly optimistic," according to Harvard Medical School epidemiologist John Brownstein and other experts.
The World Health Organization has halted a portion of a trial testing hydroxychloroquine for treatment of COVID-19 due to safety concerns, officials said. Other studies will be evaluated as well, after a study in The Lancet found that patients treated with the drug had a higher death rate than other COVID-19 patients.
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