Remdesivir

Coronavirus (COVID19): Updates

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Glenmark Pharmaceuticals had launched FabiFlu, India’s first COVID-19 drug

Glenmark Pharmaceuticals had launched FabiFlu, an antiviral drug Favipiravir, to cure patients with mild to moderate coronavirus at a price tag of about Rs 103 per tablet. FabiFlu would be available in the form of a 200 mg tablet and will be at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets. It is the first oral favipiravir-approved medication for the treatment of COVID-19 in India. FabiFlu is a prescription-based medication with a recommended dose being at 1,800 mg twice daily on day one, followed by 800 mg twice daily up till day 14.

Cipla had launched Cipremi, a COVID-19 Antiviral Drug

Cipla had launched antiviral drug i.e., Cipremi for the treatment of COVID-19. Cipremi is available in the form of lyophilized powder (freeze dry) for injection 100mg. It has been approved for adult and pediatric patients who have been hospitalized. This drug has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in India as part of the accelerated approval process considering the urgent and unmet medical need. The clinical trials have demonstrated the efficacy of Cipremi for the patients on oxygen support after falling ill to coronavirus. 

United States provided $2 Billion to Novavax & Regeneron for Covid-19 Vaccine

The federal government awarded $2 billion to Novavax Inc. & Regeneron Pharmaceuticals for the development and manufacturing of an experimental drug and a potential vaccine against Covid-19. Novavax Inc. has received $1.6 billion from the federal government’ to fund clinical studies of its experimental coronavirus vaccine and establish large-scale manufacturing of doses. Regeneron Pharmaceuticals Inc. has received a $450 million federal contract to manufacture thousands of doses of its experimental Covid-19 treatment that the government would distribute for free to the public if the drug is authorized for use by regulators.

BioSig Technologies Collaborates with Albany Molecular for its Drug Merimepodib, a Coronavirus Treatment

BioSig Technologies had entered into the collaboration with Albany Molecular Research Inc to evaluate the merimepodib for the treatment of SARS-CoV-2, the virus that causes Covid-19. Under the terms of the collaboration, both companies would evaluate the drug as a standalone treatment and in combination with other antiviral agents or immune modulators. This collaboration would help in rapid transfer, scale-up and validation of merimepodib API manufacture as the future supply chain and commercialization strategy.

Hetero Receive the Approval to Produce & Market Remdesivir

Indian pharmaceutical firm Hetero had received approval from the Drug Controller General of India to manufacture and market the experimental antiviral drug remdesivir for the treatment of coronavirus. Hetero’s generic version of Remdesivir would be sold under the brand name Covifor in India. Covifor would be available in 100 mg vials that would be injected into the patient at a hospital facility under the proper supervision of a doctor or trained healthcare worker. The drug would be launched in India under a licensing agreement with Gilead Sciences Inc, an American biopharmaceutical firm, to expand access to Covid-19 medication in poor countries.

Mateon Therapeutics Secured a $2 Million Financing with Golden Mountain Partners (GMP) to Conduct Clinical Trial Evaluating OT-101 against COVID-19

Mateon Therapeutics had secured a $2 million in debt financing with Golden Mountain Partners (GMP) for the conduct of a clinical trial evaluating OT-101 against COVID-19. OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome.

Coronavirus Recent Updates

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Moderna Vaccine’s Progress, Excites COVID-19 Markets

Moderna Inc’s experimental COVID-19 vaccine, the first to be tested in the United States, produced protective antibodies in a small group of healthy volunteers. However, the data comes from eight people who took part in a 45-subject safety trial that kicked off in March. Afterward, Phase I trial results of the vaccine, mRNA-1273, have been found promising. On May 7, the company has received regulatory clearance for the Phase II trial that would involve a much larger sample size. The imminent Phase II study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase III study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. In addition, Moderna launched a $1.34 billion share offering at an offer price of $76 per share. The company had earlier said it plans to sell $1.25 billion in common stock to raise money for vaccine development and manufacturing.

Canada Approves the First Clinical Trial for potential Covid-19 Vaccine

The race is on to find a vaccine for COVID-19 and Canada’s government may have taken the lead after its national drug regulator cleared a plan to begin studying the front-running candidate. This investigation drug is an adenovirus-based vaccine developed jointly by China’s CanSino Biological and the National Research Council of Canada and is one of eight to have made it to the clinic, and is already in phase II development in China. 

Gilead Signs Licensing Agreement With Cipla, Jubilant Life, Mylan, Hetero Labs & Ferozsons Labs

Gilead signed non-exclusive licensing agreements with five companies based out of India and Pakistan for their investigational drug remdesivir, to treat COVID-19 patients. Gilead signed licenses with Cipla, Jubilant Lifesciences, Hetero Labs, Mylan, and Ferozsons Labs. Under the agreement for remdesivir, Gilead would transfer its technology on how the API and formulations are developed to the companies and distribute it in 127 countries including India.

The deal would ensure accessibility and affordability of remdesivir in especially lower income countries with poor health infrastructure. Besides India, this license agreement extends to countries such as Afghanistan, Bhutan, Cambodia, South Africa and Egypt to name a few. It does not extend to larger and more developed countries such as US, UK, Europe, China, Australia amongst others. Hence, the drug was given emergency use authorization (EUA) by the USFDA for treating COVID-19 patients, but is yet to be formally approved by the drug regulator. Further, this is the second voluntary license agreement that Gilead has signed.

China Tests Coronavirus Drug That Aims to Stop Pandemic Sans Vaccine

A Chinese laboratory has been developing a drug it believes has the power to bring the coronavirus (COVID-19) pandemic to a halt. A drug being tested by scientists at China’s prestigious Peking University could not only shorten the recovery time for those infected but even offer short-term immunity from the virus. It is isolated from the blood of 60 recovered patients. The drug has been successful at the animal testing stage. The injection of the neutralizing antibodies into infected mice resulted in reducing the viral load was reduced by a factor of 2,500 This potential drug has a therapeutic effect.

Oxford’s Jenner Institute & AstraZeneca Collaborate Together

Oxford’s Jenner Institute had entered into the collaboration with the AstraZeneca for the development of the vaccine. The experimental vaccine, known as ChAdOx1 nCoV-19, is one of the front runners in the global race to provide protection against the new coronavirus causing the COVID-19 pandemic.

Microsoft & UnitedHealth Launch COVID-19 Screening App For The Workplace

Microsoft and UnitedHealth Group are launching a free smartphone app that businesses and employees can use to digitally screen for COVID-19 symptoms and clear those who can return to work. Based on guidelines from the Centers for Disease Control and Prevention, the ProtectWell app uses Microsoft’s chatbot interface to ask the user a series of daily questions, such as whether they have had a fever or any respiratory symptoms or whether they’ve been in contact with anyone diagnosed with COVID-19.

Fitbit to Develop Emergency COVID-19 Ventilator

Fitbit aims to wield its fitness-focused supply chain to start building its own COVID-19 ventilator and plans to submit its designs to the FDA in the near future. This device would include more features than the typical emergency alternatives developed in response to the spreading coronavirus pandemic, which are largely made to be built quickly and at scale using off-the-shelf components and mechanically deliver puffs of air at a fixed rate. 

Novel Coronavirus: Recent Updates

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Novel Coronavirus: Recent Updates

Sanofi and GSK Collaborate to Develop Vaccine for COVID-19

Sanofi and GlaxoSmithKline have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology. Sanofi would contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology whereas the GSK would contribute its pandemic adjuvant technology. The use of an adjuvant technology would help in reducing the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore help in protecting the more people.

China Approves Two Experimental Coronavirus Vaccines to enter Clinical Trials

China has approved early-stage human tests for two experimental vaccines to combat the new coronavirus. One vaccine is being developed by a Beijing-based unit of Nasdaq-listed Sinovac Biotech, and another vaccine is being developed by the Wuhan Institute of Biological Products.

AstraZeneca to Test the Impact of Cancer Drug Calquence on Coronavirus Patients

AstraZeneca is planning to start a clinical trial of its cancer drug i.e. Calquence to assess its potential to control the exaggerated immune system response associated with COVID-19 infection in severely ill patients.

Calquence (acalabrutinib) belongs to a class of drugs called Bruton’s tyrosine kinase (BTK) inhibitors which can suppress autoimmune diseases. Calquence is currently used to treat certain types of blood cancers, has already been approved for the treatment of adult patients with chronic lymphocytic leukaemia in the United States and several other countries.

Celltrion Identifies Antibody Candidates against COVID-19

Celltrion has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2, the virus causing COVID-19. Celltrion will begin cell-line development mass production of the selected therapeutic monoclonal antibody. The Company would conduct the efficacy and toxicity testing with Korea Centers for Disease Control and Prevention (KCDC) of the selected therapeutic monoclonal antibody in mice and non-human primates.

Immunomic collaborates with PharmaJet and EpiVax for COVID-19 Vaccine

Immunomic Therapeutics has entered into a collaboration with PharmaJet and EpiVax to develop a nucleic acid vaccine candidate against COVID-19. This collaboration would help in developing a vaccine that is scalable, heat-stable and easy to administer using PharmaJet’s Tropis needle-free injection system.

Vir selects Samsung Biologics to Produce COVID-19 Antibodies

Vir Biotechnology has selected South Korea-based Samsung Biologics for large-scale production of antibodies to potentially treat Covid-19. Under the terms of the collaboration, Samsung Biologics would provide the manufacturing services for Vir’s monoclonal antibody (mAb) programme targeting the novel coronavirus, SARS-CoV-2. Vir’s lead mAb candidates, VIR-7831 and VIR-7832, had showed high affinity for the spike protein of SARS-CoV-2 and ability

Eli Lilly to Begin Testing RA Drug Olumiant and an Anti-Ang2 Drug in COVID-19 Patients

Eli Lilly plans to explore the use of its rheumatoid arthritis drug i.e.,  Olumiant (oral JAK1/JAK2 inhibitor)  as a treatment for hospitalized patients with COVID-19. Olumiant (Baricitinib) is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. The clinical trial of  Olumiant for COVID-19 would begin this month and results are expected within the next two months.

Moreover, the company is planning to advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase II testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to Acute Respiratory Distress Syndrome (ARDS). Ang2 is known to be elevated in ARDS patients and Lilly will test whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients

Promising Clinical Trial Results of Gilead Sciences’ Antiviral Drug Remdesivir for COVID-19

Gilead Sciences Inc.’s experimental drug i.e. remdesivir has shown the promise results in early analysis. All the patients received remdesivir for up to 10 days on a compassionate use basis. The clinical trial demonstrated the clinical improvement was observed in 36 of 53 patients (68%) over the 18 days with 17 of the 30 patients on mechanical ventilation being able to get off the breathing device. Almost half of the patients studied were ultimately discharged, while 13% died. Mortality was highest among those who were on a ventilator, with 18% of them dying. Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy

FDA Approves Rutgers’ Saliva Test for COVID-19

The diagnostic saliva test developed by RUCDR Infinite Biologics with Spectrum Solutions and Accurate Diagnostic Labs (ADL) has received the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test involves the use of the saliva for the diagnosis of the COVID-19.

This test has eliminated the need for collecting the sample through nasopharyngeal or oropharyngeal as the current COVID 19 diagnostic test requires a swab from deep in the nasal passages or the back of the throat. It puts the healthcare workers at risk of catching an infection. The diagnostic saliva test uses easy-to-collect saliva samples instead of the more difficult deep nose swabs in comparison to the existing diagnostic tests and would reduce the risk of healthcare workers from getting the infection.