Drug Discovery and Development Archives - Page 156 of 158

Want to reopen your pharma lab amid COVID-19? Consider these strategies first

Here are a few real estate and facility management strategies to help you get your pharma R&D lab up and running amid the COVID-19 pandemic, courtesy of commercial real estate outfit JLL.

Roger Humphrey, JLL

[Photo by Fusion Medical Animation on Unsplash]

COVID-19 has unleashed a logistical conundrum for pharmaceutical leaders: How do you keep momentum in therapeutics development, when, like all workplaces, most labs have had to either restrict use or close altogether? The answer lies, at least in part, in what companies do now to prepare for a safe, effective reopening.

It won’t be easy, given the pandemic’s colossal impact. Every company will have its own best path to reopening, based on variances in local regulations and capital flow. But there are four key real estate and facility management strategies that can support leaders through this crisis:

1. Harness the power of data to supp…

BD launches COVID-19 antigen test that can produce results in 15 minutes

Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week.

BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run on BD’s highly portable Veritor instruments; the company already has about 25,000 Veritor instruments installed at healthcare providers and pharmacies across the U.S.

The assay can produce results in 15 minutes, with 84% sensitivity (ability to exclude false positives) and 100% specificity (ability to exclude false negatives).

“This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices,” sai…

Novartis, Alexion charged with FPCA violations

Novartis (NYSE:NVS) and Alexion Pharmaceuticals (NSDQ:ALXN) were charged with violations of the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).

The Securities & Exchange Commission (SEC) announced that the pharmaceutical companies both committed violations and both agreed to pay millions of dollars to settle the charges. Novartis settled to pay over $112 million and Alexion agreed to pay more than $21 million.

Basel, Switzerland-based Novartis, with its local subsidiaries or affiliates, or former subsidiary Alcon, was found to have engaged in schemes to make improper payments or to provide benefits to public and private healthcare providers in South Korea, Vietnam and Greece in exchange for prescribing or using Novartis or Alcon products.

The SEC says the schemes took place between 2012 and 2016 and were known among certain managers of the subsidiaries or affiliates. According t…

COVID-19 vaccines need to work at least half of the time, FDA says

[Image courtesy of World Health Organization]

FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today.

The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called “Development and Licensure of Vaccines to Prevent COVID-19″ that provides a host of guidelines for vaccine developers.

The goal of the guidance is to ensure that the rush to produce a COVID-19 vaccine results in a vaccine that is both safe and effective.

“While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we k…

Partnership will study use of existing drugs for COVID-19 and and more

A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19.

The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory (CDRC). The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is also supporting the public-private partnership, which aims to create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world.

CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID web platform and mobile app. CURE ID is designed to serve as a centralized source of reliable, curated, clinician-submitted information.

“The CURE ID platform enabl…

Wyss Institute lands $16m to repurpose drugs for COVID-19

Lindsay Brownell, Wyss Institute

The U.S. Defense Advanced Research Projects Agency (DARPA) has awarded Harvard university’s Wyss Institute for Biologically Inspired Engineering $16 million to identify and test FDA-approved drugs that could be repurposed to prevent or treat COVID-19.

Using its computational drug discovery pipelines and human Organ Chip technologies, the institute has already found multiple approved compounds that show promise against the SARS-CoV-2 virus that causes COVID-19. The team, led by Wyss founding director Dr. Donald Ingber, is evaluating many more drugs. Lead compounds are being tested in high-throughput cell-based assays with CoV-2 virus in the lab of Matthew Frieman, associate professor of Microbiology and Immunology at the University of Maryland School of Medicine.

The most promising drugs are being transferred to the lab of Benjamin tenOever at the Icahn School of Medicine at Mount Sinai for testing in COVID-19 animal model…

Merck acquires Themis to speed COVID-19 vaccine development

Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount.

In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, making Themis now a wholly-owned subsidiary of Merck.

Merck and Themis are set to accelerate and develop a measles vector-based SARS-CoV-2 vaccine as an early focus of the acquisition. The candidate is currently in pre-clinical development with clinical studies planned to begin later this year, according to a news release.

Last month, Merck announced today that they are collaborating with IAVI to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19.

Just days after that announcement, Merck announced that i…

Beckman Coulter wins CE Mark for COVID-19 antibody test

Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe.

Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the globe. It already has more than 16,000 immunoassay analyzers worldwide and ramped up its manufacturing to deliver more than 30 tests per month.

The Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG) and targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein when testing for the virus causing COVID-19. The company will be seeking CE Mark approval for its Access SARS-CoV-2 IgM assay in the near future as well.

“Our assay has the potential to identify individuals who have already mounted an immune response to the novel coronavirus and could donate convalescent plasma for use i…

Researchers identify potent antibody cocktail to treat COVID-19

Researchers at the University of Maryland School of Medicine (UMSOM) said they identified a promising anti-viral cocktail therapy against COVID-19.

According to a news release, the researchers evaluated several human antibodies to determine the most potent combination to be mixed and used against SARS-CoV-2, the virus causing COVID-19. In collaboration with Regeneron Pharmaceuticals (NSDQ:REGN), UMSOM published results of a study in Science.

Just last week, Regeneron announced that it had initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19, having already used the same “rapid response” approach to develop its REGN-EB3 antibody treatment for Ebola that is under review by the FDA.

The research was conducted using Regeneron’s proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19. Researchers selected the most potent antibo…

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…