Drug Discovery and Development

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…

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…

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.…

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…

Fountain Therapeutics, a biopharmaceutical company building a pipeline of therapeutics to treat age-related diseases by reversing cellular age, closed on an additional $6 million in a Series A, bringing its total to $11 million. Khosla Ventures led the round that drew capital from Nan Fung Life Sciences, the provider of initial $5 million in 2018.…

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 U.S. Patent and Trademark Office (USPTO) today announced a webpage to help small and micro businesses apply for streamlined consideration for products that require FDA approval for COVID-19 use. The COVID-19 Prioritized Examination Pilot Program, announced May 8, will allow up to 500 qualifying patent applications to be accepted for priority examination and be…

Too much bureaucracy often leaves corporate R&D departments hamstrung. It’s little wonder that biotechs were responsible for 38 of the 59 new therapies approved in 2018 compared with 21 for the big pharmaceutical companies, according to Biotechnology Innovation Organization research cited in a recent Harvard Business Review article. The authors of the HBR article were…

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19. The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127…

The Biomedical Advanced Research and Development Authority (BARDA) has awarded Selux Diagnostics $9.6 million to fund its development of a next-generation phenotyping (NGP) platform to treat superbug infections and combat antibiotic resistance. The $9.6 million is the third funding tranche the company has received from BARDA as part of the company’s milestone-based contract. BARDA has…

Pfizer and Valneva recently announced that they will collaborate on developing Valneva’s Lyme disease vaccine candidate VLA15, presently in Phase 2 clinical studies. Valneva is eligible to receive a total of $308 million, including $130 million upfront, according to an April 30 news release. Get the full story on our WTWH Media sister site R&D…

AI VIVO (Cambridge, UK) says it is looking for pharma and biotech companies interested in working on therapeutic candidates that its artificial intelligence has identified as “top-ranked” for COVID-19. The company says it has found that multiple groups around the world already are conducting clinical trials for 41 of the candidate drugs from its top-ranked…

Researchers at Sandia National Laboratories are using genetic resequencing tools to find ways to stop the virus behind the COVID-19 pandemic. Biochemist Joe Schoeniger and virologist Oscar Negrete’s work involves genetically engineering a deployable antiviral countermeasure for COVID-19 using CRISPR-based technology. “The goal is to find new ‘reloadable’ countermeasures for viral outbreaks that do not…

International antibodies producer ProteoGenix recently announced what it touts as the first Human Immune COVID-19 library for the fast discovery of potent antibodies against SARS-CoV-2. “Highly sensitive and specific antibodies are critical for the development of diagnostics, therapeutics, and prophylactics to fight against COVID-19,” said Philippe Funfrock, co-founder and president of ProteoGenix. “The new Human…

The FDA this afternoon issued an emergency use authorization for the investigational antiviral drug remdesivir to treat severely ill COVID-19 patients. The authorization for the drug, made by Gilead Sciences’ (NSDQ:GILD), will allow both adults and children to  be treated with the remdesivir, the first drug believed to have any effect on the virus that has sickened…

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…

Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If the second…

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…

  Quest Diagnostics (NYSE:DGX) announced today that consumers can now order a COVID-19 antibody test it launched last week directly from the company, without visiting a doctor’s office. The Secaucus, N.J.-based testing giant said consumers can purchase the antibody test service online for $119 through its QuestDirect business. They will be prompted to schedule an appointment…

PerkinElmer recently announced that it has expanded its analysis and automation portfolio for quality, safety and content testing. The company geared the new offerings for pharmaceutical, semiconductor, biomonitoring, food, materials and academia labs. They’re supposed to help streamline workflows, sharpen insights and meet regulations. Go to our WTWH Media sister site R&D World for the…