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…

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…

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…

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…

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,…

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…

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…

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…

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’ 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…

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…

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.…

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…

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…

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…

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…

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…

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…

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 potentially block…

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…

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…

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…

Merck (NYSE:MRK) and IAVI announced today that they are collaborating to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19. The vaccine candidate is slated to use the recombinant vesicular stomatitis virus (rVSV) technology used as the basis for Merck’s Ervebo Ebola Zaire virus vaccine, which was the first such vaccine to be approved for use…

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.…

CRISPR startup Mammoth Biosciences will partner with GlaxoSmithKline’s (NYSE:GSK) consumer healthcare division to develop a home-based diagnostic capable of detecting active SARS-CoV-2, the novel coronavirus that causes COVID-19. The collaboration will use Mammoth Biosciences’ CRISPR-based Detectr  platform to design “guide-RNA” that can identify and signal the presence of viral strands obtained through a simple nasal swab, according to Mammoth…

Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients. Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release. The…