Sean Whooley

  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…

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…

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…

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…

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…

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response…

Shortly after touting positive results from its COVID-19 vaccine candidate, Moderna announced the pricing of an offering of 17.6 million shares of its common stock. The Cambridge, Mass.-based clinical-stage biotechnology company announced yesterday that it received positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). Get the full story at our sister site,…

Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two…

The National Institutes of Health and its foundation announced that, in collaboration with multiple biopharmaceutical companies and government agencies, they will develop an international strategy for coordinating research responses to the COVID-19 pandemic. The collaboration includes the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control…

Johnson & Johnson (NYSE:JNJ) shares dipped today despite first-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $5.8 billion, or $2.17 per share, on sales of $20.7 billion for the three months ended March 29, 2020, for a 54.6% bottom-line gain on sales growth of 3.3%. Get the full story…

BioSig Technologies (NSDQ:BSGM) announced today that it is beginning a Phase II clinical trial at Mayo Clinic for Vicromax as a treatment for COVID-19. ViralClear Pharmaceuticals, a subsidiary of BioSig, updated its clinical development program for the Vicromax treatment which is slated to be used in a trial under Dr. Andrew Badley, the professor and chair…

Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other…

General Electric (NYSE:GE) announced that it completed the sale of its BioPharma business to Danaher (NYSE:DHR) for net proceeds totaling approximately $20 billion. Boston-based GE said in a news release that, under the agreeement, it received a total consideration worth $21.4 billion, with $21 billion in cash along with Danaher’s assumption of certain pension liabilities. After accounting…

Synthetic biology company SGI-DNA is touting its efforts to accelerate research in the creation of vaccines for SARS-CoV-2, the virus causing the COVID-19 pandemic. The San Diego-based company said in a news release last month that it built the genes thought to be critical to developing successful vaccines against the virus and made those tools…

Researchers at the University of Bristol (United Kingdom) are touting their use of virtual reality (VR) as a means to design and develop the next generation of drug treatments. In a published work in the journal PLOS ONE, the researchers explained the use of VR in discovering new drugs by finding molecules that bind to…

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is offering advanced development support to Hologic (NSDQ:HOLX) for a molecular diagnostic test for coronavirus (COVID-19). Marlborough, Mass.-based Hologic’s test is the first coronavirus product selected for development through ASPR’s biomedical advanced R&D authority streamlined selection process (BARDA), which…

Evonetix announced today that it closed a $30 million Series B funding round as it develops technology for enabling gene synthesis on a chip. The Cambridge, U.K.-based synthetic biology company said the funding round, led by new investor Foresite Capital, is slated to fund the company through to the introduction of its desktop DNA platform,…

IBM (NYSE:IBM) announced today that it plans to work with medical institutions and practitioners by offering support in the development of drugs to combat the recent coronavirus outbreak. The company said in a news release that it intends to leverage its IBM clinical development (ICD) system to help accelerate the development of key drugs in…