Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. (Source: World Pharma News)
Source: World Pharma News - December 2, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. (Source: World Pharma News)
Source: World Pharma News - December 1, 2020 Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news

EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine known as Moderna COVID-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. (Source: World Pharma News)
Source: World Pharma News - December 1, 2020 Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news

Moderna announces primary efficacy analysis in Phase 3 COVE study for its COVID-19 vaccine candidate and filing today with U.S. FDA for Emergency Use Authorization
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. (Source: World Pharma News)
Source: World Pharma News - November 30, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Predict cellular drug targets against COVID-19
This study helps understand how the virus uses the host to survive, and enable drug predictions for treating the virus to be made. (Source: World Pharma News)
Source: World Pharma News - November 27, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate
The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide. (Source: World Pharma News)
Source: World Pharma News - November 26, 2020 Category: Pharmaceuticals Tags: Featured Johnson & Business and Industry Source Type: news

Doctors use existing treatment earlier to save the lives of COVID-19 patients
The lives of patients hospitalised with COVID-19 are being saved by doctors who are using an existing medical treatment at an earlier stage. Dr Luigi Sedda of Lancaster University analysed the results from the team at Wrightington, Wigan and Leigh Teaching Hospitals NHS Trust (WWL). Their research has now been published in the prestigious medical journal BMJ Respiratory Open. (Source: World Pharma News)
Source: World Pharma News - November 25, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

European Commission approves contract with Moderna to ensure access to a potential vaccine
Today, the European Commission approved a sixth contract under the EU Vaccines Strategy, this time with the pharmaceutical company Moderna. The contract provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 25, 2020 Category: Pharmaceuticals Tags: Featured Development Research and Development Source Type: news

Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19
Health Canada granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization, Eli Lilly and Company (NYSE: LLY) announced. (Source: World Pharma News)
Source: World Pharma News - November 24, 2020 Category: Pharmaceuticals Tags: Featured Eli Lilly and Company Business and Industry Source Type: news

New therapy for flu may help in fight against COVID-19
A new therapy for influenza virus infections that may also prove effective against many other pathogenic virus infections, including HIV and COVID-19, has been developed by Purdue University scientists. In an average year, more than 2 million people in the United States are hospitalized with the flu, and 30,000 to 80,000 of them die from the flu or related complications. (Source: World Pharma News)
Source: World Pharma News - November 24, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

The drug aprotinin inhibits entry of SARS-CoV2 in host cells
The surface of the SARS-CoV-2 virus is studded with spike proteins. The virus needs these in order to dock onto proteins (ACE2 receptors) on the surface of the host cell. Before this docking is possible, parts of the spike protein have to be cleaved by the host cell's enzymes - proteases. (Source: World Pharma News)
Source: World Pharma News - November 23, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis. (Source: World Pharma News)
Source: World Pharma News - November 23, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

FDA authorizes monoclonal antibodies for treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 21, 2020 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Pfizer and BioNTech to submit Emergency Use Authorization request today to the U.S. FDA for COVID-19 vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. (Source: World Pharma News)
Source: World Pharma News - November 20, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Chinese vaccine candidate based on inactivated SARS-CoV-2 virus appears safe and induces an immune response in healthy volunteers
Results from an early-phase randomised clinical trial of a Chinese vaccine candidate based on the inactivated whole SARS-CoV-2 virus (CoronaVac) are published in The Lancet Infectious Diseases journal, finding the formulation appears safe and induces an antibody response in healthy volunteers aged 18 to 59 years. (Source: World Pharma News)
Source: World Pharma News - November 19, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Phase 2 trial of Oxford COVID-19 vaccine in healthy older adults finds it is safe and provokes immune response
The UK's vaccine against SARS-CoV-2 shows similar safety and immunogenicity results in healthy older adults (aged 56 years and over) to those seen in adults aged 18-55 years. The promising early stage results are published in The Lancet. The phase 2 trial finds that the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups and at low and standard dose - (Source: World Pharma News)
Source: World Pharma News - November 19, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study's primary efficacy endpoints. (Source: World Pharma News)
Source: World Pharma News - November 18, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Immunological memory after cured Sars-CoV-2 infection
Until now, it was unclear whether a survived SARS-CoV-2 infection or COVID-19 leads to a persistent immunological memory and thus can protect against a new infection. Several studies had shown that SARS-CoV-2 specific antibodies are only detectable for a few months in many people who have survived COVID-19 and may therefore only provide temporary protection against re-infection. (Source: World Pharma News)
Source: World Pharma News - November 17, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

European Commission approves contract with CureVac to ensure access to a potential vaccine
Today, the European Commission approved a fifth contract with the European pharmaceutical company CureVac, which provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 17, 2020 Category: Pharmaceuticals Tags: Featured Development Research and Development Source Type: news

Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. (Source: World Pharma News)
Source: World Pharma News - November 16, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Cytokine storms play a limited role in moderate-to-severe COVID-19
Rather than life-threatening hyperinflammation, most adults with moderate-to-severe COVID-19 have a suppressed viral immune response when compared to adults with another viral respiratory infection, influenza. St. Jude Children's Research Hospital and Washington University School of Medicine in St. Louis led research that suggests most COVID-19 patients are not candidates for treatment with steroids such as dexamethasone. (Source: World Pharma News)
Source: World Pharma News - November 16, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that Swissmedic has started a rolling review of mRNA-1273, the Company's vaccine candidate against COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 13, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. (Source: World Pharma News)
Source: World Pharma News - November 13, 2020 Category: Pharmaceuticals Tags: Featured Eli Lilly and Company Business and Industry Source Type: news

Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate
Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK have announced the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant. (Source: World Pharma News)
Source: World Pharma News - November 12, 2020 Category: Pharmaceuticals Tags: Featured GlaxoSmithKline Business and Industry Source Type: news

Fluvoxamine may prevent serious illness in COVID-19 patients
In a preliminary study of COVID-19 patients with mild-to-moderate disease who were attempting to recover in their homes, researchers at Washington University School of Medicine in St. Louis have found that the drug fluvoxamine seems to prevent some of the most serious complications of the illness and make hospitalization and the need for supplemental oxygen less likely. (Source: World Pharma News)
Source: World Pharma News - November 12, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

European Commission approves contract with BioNTech-Pfizer alliance
Today, the European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 11, 2020 Category: Pharmaceuticals Tags: Featured Development Research and Development Source Type: news

The Sputnik V COVID-19 vaccine efficacy amounted to 92% in Phase III clinical trials
The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), announce that the Sputnik V vaccine, the world's first registered vaccine against coronavirus (registered on the 11 th of August under the emergency use authorization mechanism) created on the well-studied platform of human adenoviral vectors, demonstrated high efficacy. (Source: World Pharma News)
Source: World Pharma News - November 11, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Novavax COVID-19 vaccine granted Fast Track Designation by U.S. FDA
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant. (Source: World Pharma News)
Source: World Pharma News - November 10, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

RNA structures of coronavirus reveal potential drug targets
The SARS-CoV-2 coronavirus RNA genome structure was studied in detail by researchers from the University of Groningen, the International Institute of Molecular and Cell Biology in Warsaw, and Leiden University. The RNA structures are potential targets for the development of drugs against the virus. The results were published on 10 November as 'Breakthrough paper' in the journal Nucleic Acid Research. (Source: World Pharma News)
Source: World Pharma News - November 10, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in first interim analysis from Phase 3 study
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. (Source: World Pharma News)
Source: World Pharma News - November 9, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Llama nanobodies could be a powerful weapon against COVID-19
The researchers at the University of Pittsburgh School of Medicine describe a new method to extract tiny but extremely powerful SARS-CoV-2 antibody fragments from llamas, which could be fashioned into inhalable therapeutics with the potential to prevent and treat COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 9, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Pre-existing coronavirus antibodies could help protect children against new pandemic strain
Researchers at the Francis Crick Institute and University College London have found that some antibodies, created by the immune system during infection with common cold coronaviruses, can also target SARS-CoV-2 and may confer a degree of protection against the new viral strain. In response to infection with a virus, the immune system creates antibodies to help fight it. These antibodies remain in the blood for a period after infection, and in the case of re-infection, they are able to tackle the virus again. (Source: World Pharma News)
Source: World Pharma News - November 6, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)
Novartis today announced new data from an interim analysis for the randomized, double-blind, placebo-controlled CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)(6). The ongoing trial failed to meet its primary endpoint showing that treatment with canakinumab plus standard of care (SoC) did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 29(1). (Source: World Pharma News)
Source: World Pharma News - November 6, 2020 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

Sanofi offers to acquire Kiadis for €308 million
Sanofi and Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS) have entered into a definitive merger agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares of Kiadis at a price per Kiadis share of €5.45 in cash (272% premium to the closing price on 30 October 2020), representing an aggregate adjusted equity value of approximately €308 million. (Source: World Pharma News)
Source: World Pharma News - November 5, 2020 Category: Pharmaceuticals Tags: Featured Sanofi Business and Industry Source Type: news

Novavax and Commonwealth of Australia announce agreement in principle for acquisition of Novavax COVID-19 vaccine
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company’s COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community. (Source: World Pharma News)
Source: World Pharma News - November 5, 2020 Category: Pharmaceuticals Tags: Featured Business and Industry Source Type: news

Data for Lilly's bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine
The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Eli Lilly and Company's (NYSE: LLY) bamlanivimab (LY-CoV555) - a neutralizing antibody - in the COVID-19 outpatient setting. (Source: World Pharma News)
Source: World Pharma News - November 4, 2020 Category: Pharmaceuticals Tags: Featured Eli Lilly and Company Business and Industry Source Type: news

Scientists identify synthetic mini-antibody to combat COVID-19
The ability of SARS-CoV-2 to infect cells depends on interactions between the viral spike protein and the human cell surface protein ACE2. To enable the virus to hook onto the cell surface, the spike protein binds ACE2 using three finger-like protrusions, called the receptor binding domains (RBDs). Blocking the RBDs therefore has the potential to stop the virus from entering human cells. (Source: World Pharma News)
Source: World Pharma News - November 4, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Novartis announces collaboration with Molecular Partners to develop two DARPin ® therapies designed for potential use against COVID-19
Novartis and Molecular Partners AG announced a collaboration in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners' anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423. The collaboration aims to leverage Molecular Partners' proprietary DARPin® technologies and Novartis broad expertise in (Source: World Pharma News)
Source: World Pharma News - November 3, 2020 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

Cancer treatment could be replicated for COVID-19
Beta-blockers could potentially be used to treat COVID-19, according to a new international study by Italian and Australian scientists. University of South Australia cancer researcher, Dr Nirmal Robinson, working with a team in Naples, has found evidence in animal models that the beta-blocker Propranolol helps suppress the spread of cancer in the lung which has an inflammatory profile very similar to COVID-19. (Source: World Pharma News)
Source: World Pharma News - November 3, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Novavax announces facility expansion to support global vaccine development
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company's rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. (Source: World Pharma News)
Source: World Pharma News - November 2, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Ultrapotent COVID-19 vaccine candidate designed via computer
An innovative nanoparticle vaccine candidate for the pandemic coronavirus produces virus-neutralizing antibodies in mice at levels ten-times greater than is seen in people who have recovered from COVID-19 infections. Designed by scientists at the University of Washington School of Medicine in Seattle, the vaccine candidate has been transferred to two companies for clinical development. (Source: World Pharma News)
Source: World Pharma News - November 2, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

New drug candidate for the treatment of COVID-19
Researchers from the University of Kent, the Goethe-University in Frankfurt am Main (Germany), and the Hannover Medical School (Germany) have identified a drug with the potential to provide a treatment for COVID-19. The international team led by Professor Martin Michaelis, Dr Mark Wass (both School of Biosciences, University of Kent), and Professor Jindrich Cinatl (Institute of Medical Virology, Goethe-University) found that (Source: World Pharma News)
Source: World Pharma News - October 30, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

RDIF and Uni ão Química file documents for registration of Sputnik V vaccine with regulator in Brazil
The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), União Química Farmacêutica Nacional and the Government of the State of Paraná announce the pre-submission of preliminary documents to Brazil's National Health Surveillance Agency (ANVISA), in order to register Russia's Sputnik V vaccine, the world's first registered vaccine against coronavirus infection, in conformity with the Brazilian regulatory procedures. (Source: World Pharma News)
Source: World Pharma News - October 30, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Takeda expands COVID-19 vaccine supply in Japan through partnership with Moderna and Government of Japan
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that it will import and distribute 50 million doses of Moderna's COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. This effort is part of a three-way agreement among Takeda, Moderna and the Government of Japan's Ministry of Health Labour and Welfare (MHLW). (Source: World Pharma News)
Source: World Pharma News - October 29, 2020 Category: Pharmaceuticals Tags: Featured Takeda Business and Industry Source Type: news

Remdesivir for COVID-19: FDA approved but still unproven
The United States has become the epicenter of the world in the ever increasing pandemic of COVID-19. While public health prevention strategies of social distancing, crowd avoidance, masking and frequent hand washing are of proven benefit, effective drug therapies for treatment are sparse. Not surprisingly, remdesivir has attracted worldwide attention, first receiving an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and especially with U.S. President Donald Trump taking the drug for COVID-19 earlier this month. (Source: World Pharma News)
Source: World Pharma News - October 29, 2020 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. (Source: World Pharma News)
Source: World Pharma News - October 28, 2020 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine
Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility. (Source: World Pharma News)
Source: World Pharma News - October 28, 2020 Category: Pharmaceuticals Tags: Featured Sanofi Business and Industry Source Type: news

Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted
The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world's first registered vaccine against the coronavirus Sputnik V, which is based on a well-studied platform of human adenoviral vectors. The Russian Federation has become one of the first countries to apply to WHO for prequalification of its vaccine against the novel coronavirus infection. (Source: World Pharma News)
Source: World Pharma News - October 27, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Novavax provides Phase 3 COVID-19 vaccine clinical development update
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. (Source: World Pharma News)
Source: World Pharma News - October 27, 2020 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news