Drug Discovery and Development Archives - Page 157 of 158

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 …

FDA clears Propeller Health sensor to work with Symbocort inhaler

Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform.

The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents.

Propeller’s digital health platform helps users with asthma or COPD manage their condition in tandem with their clinician by attaching sensors to existing inhalers to deliver insights on medication use to the Propeller app on their smartphone. Then, users can share insights with their clinician to help inform their treatment plan.

Clinical studies have revealed that the Propeller platform can increase asthma control by up to 63 percent, increase medication adherence by up to 58 percent, reduce asthma-related emergency department visits and hospitalizations b…

FDA clears Propeller Health sensor to work with Symbocort inhaler

Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform.

The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents.

Propeller sensors are designed to attach to existing inhalers and deliver insights on medication to the Propeller app on the user’s smartphone. The information delivered to the app can then be shared with clinicians to help inform treatment plans, according to a news release.

The company said its platform has shown in previous clinical studies to increase asthma control by up to 63% and increase medication adherence by up to 58%. It’s also shown to reduce asthma-related emergency department visits and hospitalizations by as much as 57% and reduce…

Insitro raises $143m Series B

Machine-learning-driven drug discovery and development company Insitro announced today that it raised $143 million in an oversubscribed Series B financing round.

San Francisco-based Insitro said in a news release that it plans to use the funds to build its foundations of technology and automation, enabling data generation at a larger scale, expanding its capabilities for creating predictive models of human disease.

The company also plans to use the money for helping to identify patient segmentation biomarkers and advancing therapeutics in genetically-defined patient populations. Other uses of the funds include building partnerships along the R&D chain to accelerate drug discovery and development.

Insitro is working on applying bioengineering technologies to creating data sets that allow for machine learning methods to assist in pharmaceutical R&D.

“Since our founding, insitro has been focused on building a data-driven drug discovery and de…