Drug Discovery and Development Archives - Page 158 of 159

Oxford researchers find widely available steroid reduces COVID-19 deaths

[Image courtesy of CDC]

Oxford researchers announced today that, following testing with thousands of patients, dexamethasone may improve patient survival in cases of COVID-19.

Dexamethasone is a corticosteroid commonly used for treating arthritis and other cases of inflammation. In total, 2,104 patients were randomized in Oxford’s trial to receive dexamethasone in doses of 6 mg, once per day, either by mouth or intravenous injection, over the course of 10 days.

The patients receiving the steroid were compared with 4,321 patients randomized to receive usual care alone. Among the usual care patients, 28-day mortality was highest in those who required ventilation (41%), intermediate in patients only requiring oxygen (25%) and lowest among those who did not require respiratory intervention (13%).

According to a news release, dexamethasone reduced deaths by one-third in ventilated patients and …

FDA revokes EUA for malaria drugs against COVID-19

FDA today announced that it has revoked its emergency use authorization allowing doctors to use the malaria drugs hydroxychloroquine and chloroquine to treat COVID-19, citing concerns about the drugs’ safety and efficacy against the virus.

A large, randomized clinical trial in hospitalized patients found the malaria medicines showed no benefit for decreasing the likelihood of death or speeding recovery, according to FDA. Said FDA: “This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19.”

President Donald Trump had previously touted the potential for the malaria drugs to treat the coronavirus, even disclosing that he himself was taking hydroxychloroquine preemptively after coming in contact with people who tested positive for the virus.

There has never been high-quality…

Q2 Solutions partners with Thermo Fisher Scientific to speed up clinical trial lab results

Thermo Ion Torrent Genexus Sequencer instrument

Q2 Solutions recently announced a partnership with Thermo Fisher Scientific to use the Ion Torrent Genexus System — touted as the first fully integrated, next-generation sequencing (NGS) platform — to quickly and economically deliver clinical trial lab results.

“Clinical trial oncology patients require lab testing before they can receive potential life-saving treatments, which makes lab testing turnaround time critical,” said Q2 Solutions CEO Brian O’Dwyer. “Our efforts in developing assays and tests to identify and target different aspects of diseases are critical to drug discovery for pharma clients. Adding the capabilities of the Ion Torrent Genexus System has the potential to drastically reduce our time to deliver clinical reports to trial sites, thereby enabling patients’ access to investigational drugs faster.”

Q2 Solutions (Morrisville, N.C.) is a…

New web resource keeps vaccine researchers up-to-date on COVID-19 protein structures

[Image courtesy of Marcin Minor, for University of Virginia]

Wladek Minor of the University of Virginia and other top structural biologists have created a Web resource so that scientists can track the progress of investigations into COVID-19 protein structures.

The website also includes the research team’s assessment of the quality of the individual models. It includes enhanced versions of the protein structures when possible.

“We have carefully analyzed the available models of SARS-CoV-2 proteins and present the results with the aim of helping the broad biomedical community. Structural models are ultimately the interpretation of the original researchers and sometimes are suboptimal. This is why a second set of eyes to validate important structures is so crucial,” Minor said in a news release.

Read the full story on our sister site R&D World.

Grifols starts production of COVID-19 prevention drug

Grifols (NSDQ:GRFS) announced today that it began production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies for combating COVID-19.

Barcelona-based Grifols touts the prevention drug, developed from the plasma of people who have overcome the disease, as the first specific drug developed to fight COVID-19, according to a news release.

The company is producing the potential anti-COVID-19 therapy in a collaboration agreement with the FDA, the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA) and other U.S. healthcare agencies. It is also moving forward to establish collaborations in Europe.

Grifols is producing the hyperimmune immunoglobulins at its Clayton, N.C., facility and anticipates the first doses to be available next month as part of a clinical trial.

Regeneron launches clinical trial of COVID-19 antibody ‘cocktail’

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that it initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19.

The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people with close exposure to a COVID-19 patient (such as a housemate). The placebo-controlled trials will be conducted at multiple sites, according to a news release.

Using its proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19, Regeneron scientists evaluated thousands of fully human antibodies. They then selected the two most potent, non-competing and virus-neutralizing antibodies and scaled them up for clinical use. The antibodies bind non-competiti…

Moderna to begin Phase 3 of COVID-19 vaccine study in July

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it expects to begin dosing in Phase 3 of the clinical trial for its COVID-19 vaccine candidate in July.

The Cambridge, Mass.-based biotech company said in a news release that it finalized the Phase 3 study protocol for the mRNA-1273 COVID-19 vaccine candidate based on feedback from the FDA. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 enrolled U.S. participants in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Get the full story at our sister site, MassDevice.

The rush to develop a COVID-19 vaccine: Is there reason to worry?

[Image courtesy of World Health Organization]

Some alarm appears to be growing amid the rush to develop COVID-19 vaccines, with two prominent critics warning that politics could harm the process.

In a New. York Times op-ed this week, Dr. Ezekiel J. Emanuel and Dr. Paul A. Offit of the University of Pennsylvania worried that potential pressure to produce good news for the Trump administration by October — before the November presidential election — could have negative consequences.

“Giving people a false sense of being protected will most likely lead to serious outbreaks of the disease as people reduce their compliance with physical distancing and other public health measures,” Emanuel and Offit said. “If only 20,000 participants receive the vaccine, serious but rare side effects might be missed. If such harms eventually arise, it could further erode a fragile vaccine confidence and th…

J&J accelerates development of its COVID-19 vaccine candidate

Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September.

“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” said Dr. Paul Stoffels, J&J’s chief scientific officer.

“Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” Stoffels said.

The randomized, double-blind, placebo-controlled Phase 1/2a study will take place in the U.S. and Belgium …

Respira Technologies seeks drug candidates for its nebulizer

(image from Respira Technologies)

Respira Technologies (West Hollywood, Calif.) announced the launch of a pharmaceutical-focused commercial development program for its RespiRx drug-delivery device platform.

RespiRx is a portable, handheld vibrating mesh nebulizer designed for local and systemic treatment and can operate in any position held by the patient. Current-generation nebulizers are gravity-fed, which limits usage and can lead to improper use and/or lower rates of drug-delivery efficacy, according to the company.

RespiRx also has a pre-filled cartridge that includes a disposable piezo element and the drug compound suspended in an aqueous solution. This format is designed to improve convenience and eliminate patient error and misuse due to the lack of proper cleaning. The cartridge is programmable for precise dose delivery and is Bluetooth-enabled for dose delivery tracking, measurement, and ele…

New research suggests neutralizing antibodies could help against COVID-19

This transmission electron microscope image shows SARS-CoV-2 – the virus that causes COVID-19 – isolated from a patient in the U.S. The protrusions visible on the outside are the spike proteins that the virus particles use to fuse with and gain entry to host cells. [Image courtesy of NIAID]

New findings from an international research team suggest that neutralizing antibodies could have a use as a preventative treatment or as a post-exposure therapy against COVID-19.

Their latest findings, which drew on data gathered from Berkeley National Laboratory’s (Berkeley Lab’s) Advanced Light Source (ALS) — suggest that antibodies derived from SARS survivors could potently block entry of SARS-CoV-2 and other closely related coronaviruses into host cells. The scientists, who recently published their work in Nature, noted that the most promising candidate antibody is already on an accelerated development path toward clin…

Thermo Fisher Scientific touts new mass spectrometers

Thermo Fisher Scientific has added two mass spectrometers — the Thermo Scientific Orbitrap Exploris 240 and Thermo Scientific Orbitrap Exploris 120 — to its Thermo Scientific Orbitrap Exploris portfolio.

The Thermo Scientific Orbitrap Exploris 240 mass spectrometer boasts the latest generation of system architecture and instrument control software to boost data acquisition and analysis capabilities for small- and large-molecule applications. The system includes positive/negative mode switching for comprehensive sample coverage, fast scan speeds and functionalities including Thermo Scientific AcquireX intelligent data acquisition workflow for greater automation.

“Scientists are seeking technologies that can streamline and speed proteomics studies to clinical applications, reduce time to market for candidate biotherapeutics and address the growing challenge of characterizing novel chemical entities in small-molecule studies,” said Iain Mylchreest, VP …