Novavax (NSDQ:NVAX) today announced that it has begun its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373. The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18…
Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based…
J&J launches fourth large-scale COVID-19 vaccine trial
Johnson & Johnson (NYSE:JNJ) has begun enrollment of adult volunteers for a fourth Phase 3 clinical trial of a COVID-19 vaccine candidate. The National Institutes of Health announced today that J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) has begun the Phase 3 trial to evaluate if it can prevent symptomatic COVID-19 after a single dose regimen. Get the…
Canada lining up millions of doses of COVID-19 vaccines
Sanofi (NYSE:SNY), GlaxoSmithKline (NYSE:GSK) and Moderna (NSDQ:MRNA) have all agreed to supply Canada with a total of more than 90 million doses of a COVID-19 vaccine. Beginning in 2021, Government of Canada is set to receive up to 72 million doses of an adjuvanted COVID-19 vaccine from Sanofi and GSK, while the country also increased its confirmed…
BARDA awards $12.9M to Ortho Clinical for coronavirus antigen test
Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test. Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts,…
Siemens, Novartis team up on MS drug development
Siemens Healthineers (ETR:SHL) and Novartis (NYSE:NVS) have agreed to jointly design, develop and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline, the companies announced today. The first project will be a serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis (MS) and other neurological diseases. NfL is a highly specific biomarker for nerve…
BioAscent spending £1M to boost drug discovery service offering
BioAscent (Newhouse, U.K.) recently announced that it will spend £1 million ($1.3 million) on new instrumentation and equipment. The investment is meant to further enhance the company’s offerings in integrated drug discovery and compound management. The new instrumentation will include a FLIPR Penta screening system and a Biacore 8k Surface Plasmon Resonance (SPR) system, as…
Pfizer touts animal trial results for COVID-19 vaccine candidate
Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials. The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release. In a viral…
AstraZeneca puts COVID-19 vaccine trial on hold
AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness. The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III…
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as…
How Navitor could improve the way you age gracefully
Officials at Navitor Pharmaceuticals (Cambridge, Mass.) think they could help people increase their healthy years by developing more targeted therapeutics. Products from its pipeline may soon pave the way for more effective treatments for conditions such as kidney disease, but how could the company shape the way we look at “aging gracefully?” Drug Discovery &…
Nestlé to acquire peanut allergy drugmaker for $2.6B
Nestlé (VTX:NESN) announced today that it entered into a definitive agreement to acquire food allergy treatment developer Aimmune Therapeutics (NSDQ:AIMT). Under the agreement, Nestlé Health Science (NHSc) would acquire Aimmune with a cash offer for $34.50 per share, totaling approximately $2.6 billion. The per-share price for Aimmune represents a 174% premium to the company’s closing share…
Report: Top FDA official vows to quit if vaccine approved prematurely
A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective,…
A promising drug for COVID-19 survival?
Researchers at Hackensack Meridian Health are touting the drug tocilizumab as a treatment for critically ill COVID-19 patients in the ICU. Observational data of hospitalized COVID-19 patients shows that tocilizumab, generally used to treat rheumatoid arthritis and cancer, improves hospital survival in the critically ill ICU patients, according to a news release. The researchers published…
Johnson & Johnson to acquire Momenta for $6.5B
Johnson & Johnson (NYSE:JNJ) announced today that it entered into an agreement to purchase Momenta Pharmaceuticals (NSDQ:MNTA) for $6.5 billion. New Brunswick, N.J.-based Johnson & Johnson will pay $6.5 billion in an all-cash transaction for the developer of novel therapies for immune-mediated diseases, according to a news release. Momenta felt the full effect of the news…
Medtech stocks help boost S&P rally
Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic. Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more than 50% since the index’s…
European initiative launched to develop COVID-19 treatment
The Corona Accelerated R&D in Europe (CARE) consortium today announced its launch to accelerate the development of COVID-19 treatments. Supported by the Innovative Medicines Initiative, the new consortium has collected $92.7 million (€77.7 million) in grant funding in an effort to conduct a 5-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany,…
Report: Chinese government grants COVID-19 vaccine patent
Chinese pharmaceutical company CanSino Biologics‘ COVID-19 vaccine candidate has received a patent from the Chinese government — the first such patent granted in the country. Chinese state media outlet People’s Daily reported Sunday that the country’s National Intellectual Property Administration granted the patent for Ad5-nCoV, which uses a weakened human common cold virus to deliver genetic material that…
FDA approves Genentech’s drug for rare disease affecting optic nerves, spinal cord
The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a certain antibody — patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng, made by Genentech, is the…
Sanofi to acquire MS drug-development partner for $3.68B
Sanofi (NYSE:SNY) announced today that it agreed to acquire all outstanding shares of Principia Biopharma (NSDQ:PRNB) in a deal worth approximately $3.68 billion. The deal sets all outstanding shares of Principia at $100 per share, which will be acquired in cash. Sanofi and Principia both received unanimous approval from their respective boards of directors, according to…
The top digital health startups in the world
CB Insights’ second annual Digital Health 150 list includes 26 startups seeking to improve drug research and development, an area hard-hit as the COVID-19 pandemic interrupts clinical trials. Drug discovery companies include Healx (rare diseases) and ProteinQure (quantum computing). (Download the full report here.) Get the full story on our sister site Medical Design & Outsourcing. …
Yale studying possible COVID-19 treatment
Yale School of Medicine and AI Therapeutics announced the launch of a multi-institutional clinical trial for a drug for treating COVID-19. LAM-002A (apilimod) has a proven safety record and preliminary research has shown that it can block the cellular entry and trafficking of the SARS-CoV-2 virus that is causing COVID-19, according to a news release.…
J&J starts clinical trial on vaccine candidate after strong non-human results
Johnson & Johnson (NYSE:JNJ) announced that its lead SARS-CoV-2 vaccine candidate protected against infection of the virus causing COVID-19 in pre-clinical studies. New Brunswick, N.J.-based J&J published data in Nature that showed the company’s investigational adenovirus serotype 26 (Ad26), vector-based vaccine elicited a robust immune response with “neutralizing antibodies” to prevent subsequent infection and provide complete or…
Sanofi, GSK to supply up to 60 million doses of COVID-19 vaccine to UK
Sanofi (NYSE:SNY) and GlaxoSmithKline (NYSE:GSK) announced that they reached an agreement with the UK government to supply up to 60 million doses of a COVID-19 vaccine. Subject to a final contract, the UK government will receive the doses of a vaccine candidate developed by the two companies in partnership and based on the recombinant protein-based technology Sanofi used to…
The most innovative pharmaceutical agents of 2020
The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien…