Drug Discovery and Development Archives - Page 155 of 159

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 five-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the U.S.

Leading the initiative is VRI-Inserm, Johnson & Johnson‘s (NYSE:JNJ) Janssen Pharmaceutical and Takeda Pharmaceutical (TSE:4502;NYSE:TAK) as the companies integrate partners’ COVID-19 projects that have been ongoing since February.

CARE aims to combine the researchers to accelerate the discovery and development of solutions for the current COVID-19 pandemic, as well as future coronavirus outbreaks, with the most promising drug candidates set to advance to clinical trials in humans after testing…

Report: Chinese government grants COVID-19 vaccine patent

(Image from the CDC)

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 codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein, and travel to the lymph nodes where the immune system creates antibodies that will recognize that spike protein and fight off the coronavirus, according to research published in The Lancet in July.

Get the full story on our sister site, MassDevice.

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 third approved treatment for the disorder.

In patients with NMOSD, the immune system mistakenly attacks healthy cells and proteins, most often those in the optic nerves and spinal cord. This typically results in attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. Estimates vary, but NMOSD is thought to affect approximately 4,000 to 8,000 Americans.

NMOSD may be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antib…

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 a news release.

San Francisco-based Principia develops Bruton tyrosine kinase (BTK) inhibitors that are present in the signaling pathways of key innate and adaptive cell types in the immune system. Blocking or disrupting the signaling processes associated with BTK inhibitors can help in stopping inflammation and tissue destruction related to autoimmune diseases, while also targeting underlying pathophysiology.

Principia’s BTK inhibitor franchise is based on its proprietary Tailored Covalency platform designed to allow both reversible covalent and irreversible covalent small molecul…

Mission Bio Completes $70M Series C

Mission Bio has secured $70 million for Series C financing to scale its single-cell multi-omics technology, according to the company.

Novo Growth, the growth equity of Novo Holdings, led the round that included new investor Soleus Capital. Previous investors Mayfield, Cota, and Agilent also participated in the financing, which brings the company’s total funding to more than $120 million.

The South San Francisco-based startup says the funds will be used to expand its reach in more effective clinical trials for novel cancer treatments, as well as characterization for cell and gene therapy.

“We are on a mission to help our customers eliminate cancer,” said Charlie Silver, CEO, and Co-founder of Mission Bio. “With access to multiple layers of the cellular profile, the Tapestri Platform can help identify novel biomarkers in diseased cells, monitor therapy resistance and response, and accelerate novel therapies through clinical trials. We are delighted …

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.

Check out this chart with the logos of the 150 companies:

Report: BD, Quidel struggle to supply antigen tests for COVID-19

(Image from the CDC)

Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal.

The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep up with demand and that the Department of Defense is preparing another major order. The companies sell the analyzer equipment to perform the tests as well as the actual tests. Quidel told the Journal that it is having trouble meeting demand for analyzers, while BD is struggling to produce enough tests, the newspaper reported. Neither company immediately responded to requests for comment.

Get the full story on our sister site, Medical Design & Outsourcing.

Russia claims to have first COVID-19 vaccine

Russian officials announced today that they will make a COVID-19 vaccine available to its citizens on a voluntary basis, with President Vladimir Putin saying the vaccine has gone through all necessary tests.

The vaccine, developed at by the Gamaleya Institute in Moscow, will first become available to medical workers, teachers and at-risk groups. Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that funded the vaccine effort, told reporters that tens of thousands of volunteers will receive vaccinations in the coming months, according to The Associated Press.

Experts even in Russia greeted the news with some skepticism, since the vaccine has not gone through a Phase 3 clinical trial in which its safety and effectiveness is evaluated among a large population with a placebo control group.

NPR reports that the executive director of the Moscow-based Association of Clinical Trials Organizations (ACTO) described the situation as a “Pa…

Yale studying possible COVID-19 treatment

[Photo by Fusion Medical Animation on Unsplash]

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. Guilford, Conn.-based AI Therapeutics owns the intellectual property rights to the drug.

Enrollment has now begun for a Phase II trial for the drug’s use as a COVID-19 treatment, with the expectation of enrolling 142 newly diagnosed patients to test the safety and efficacy of the drug in reducing virus levels in infected individuals. Previous trials of more than 700 patients have shown LAM-002A to be safe in treating autoimmune diseases and follicular lymphoma, as well.

A study published in Natur…

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 near-complete protection in the lungs from the virus in non-human primates.

Researchers immunized the non-human primates with a panel of vaccine prototypes before challenging them with SARS-CoV-2 infection. Of seven vaccine prototypes tested, Ad26.COV2.S elicited the highest level of neutralizing antibodies, which correlated with the level of protection, confirming early suggestions that they could be a potential biomarker for vaccine-mediated protection.

The six non-human primates that received a sing…

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 produce an influenza vaccine, along with GSK’s pandemic adjuvant technology, according to a news release.

Sanofi expects a Phase 1/2 study for the vaccine candidate to begin in September, followed by a Phase 3 study by the end of 2020. If the sudies report positive data, regulatory approval could be garnered by the first half of 2021, while the two companies are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.

“With our partner GSK, we are pleased to cooperate with the UK government as well as several other…

The 26 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 process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…