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COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. 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Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. 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According to media reports, pharmaceutical company Abbott Laboratories is looking to auction off its influenza vaccine business in a deal that could be worth up to $600m. Abbott’s established link to the Russian flu market and its advanced cell-based technology make the business an attractive prospect for would-be buyers, which may include the likes of GlaxoSmithKline and MedImmune.Abbott’s decision does not come as a surpriseDriven mainly by the H5N1 pandemic threat and the recent H1N1 influenza pandemic, influenza vaccines have become an area of significant interest for pharmaceutical and biotech companies over the past decade. The market for seasonal influenza vaccines, valued at $2.8 billion in 2008-09 across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK), has grown at a strong compound annual growth rate of 12.6% since 2005-06. In addition, during 2009-10, the H1N1 pandemic translated into large commercial windfalls of several billion dollars for manufacturers of pandemic influenza vaccines. Three large players dominate the market: GlaxoSmithKline, Sanofi Pasteur and Novartis. However, owing to an increasing market opportunity and generous government funding for influenza vaccine-related products and technologies, a number of new market entrants have recently embarked on the development of influenza vaccines. Considering the increasing competition and commoditization in this sector, where commercial success requires a critical mass, significant consolidation has begun to occur. The latest example of this is Abbott’s recent decision to auction off its flu vaccine unit.Solvay’s vaccine business has not lived up to expectationsThe influenza vaccine business has been part of Abbott since its acquisition of the pharmaceutical unit of Belgian conglomerate Solvay in September 2009. Solvay had been manufacturing influenza vaccines for several decades, but remained a niche player with annual influenza vaccine sales of approximately $300m in 2009. Solvay’s operations in the flu vaccine sector were largely limited to Europe, where the company has two egg-based seasonal influenza vaccines in distribution: Influvac and Invivac. Solvay’s lead product, Influvac, accounted for 82% of the company’s total influenza vaccine sales in 2009.In the pandemic sector, the company lost out on commercial windfalls from the H1N1 pandemic. Despite having initially been eager to participate in the race for H1N1 vaccine stockpiling contracts, Solvay failed to secure a contract to supply the Dutch government with an H1N1 vaccine in June 2009 after it said that it could not meet the production deadline. Considering the lack of portfolio fit and a vaccine franchise beyond Solvay’s relatively small influenza business, Abbott’s decision to sell off this segment does not come as a surprise nine months after its takeover of Solvay.Abbott’s presence in the lucrative Russian market is an attractive selling pointOne of the most attractive propositions for potential buyers of Abbott’s flu vaccine business is the company’s established presence in the Russian influenza market. In 2004, Solvay established a presence in Russia through a partnership agreement with Petrovax Pharm. As a result, Solvay is developing both egg- and cell-based formulations of a seasonal influenza vaccine incorporating Petrovax Pharm’s adjuvant polyoxidonium, targeted at markets within the Commonwealth of Independent States.Russian approval for an egg-based seasonal influenza vaccine was granted in September 2008, while the adjuvanted cell-based vaccine Grippol Neo was registered in Russia in September 2009. Considering the high market-entry hurdles for external companies into the Russian pharmaceutical market, this relationship is a very attractive selling point for other flu vaccine players looking to expand their geographic coverage into emerging markets.Abbott’s cell-based manufacturing technology is interesting, but competitive advantage has been lostSome 10 years ago, Solvay was the clear leader in the development of a cell-based seasonal influenza vaccine. Its cell-based version of Influvac, named Influvac TC, was approved in the Netherlands in 2001 as the first vaccine to be manufactured in MDCK cells. However, despite benefiting from a $298m US grant which it received in 2006 for the development of Influvac TC, Solvay failed to capitalize on this competitive advantage in the following years.While Influvac TC is still in clinical trials in 2010, Novartis gained EU approval for its own cell-based seasonal influenza vaccine Optaflu in 2007. Solvay cancelled its plans to build a US cell-based manufacturing facility in 2008. While its cell-based manufacturing technology may remain interesting for some potential buyers, it is questionable whether Influvac TC will become a commercial success, particularly considering the generally low tolerance of high-priced vaccines in this increasingly competitive market.Several existing flu vaccine players may look to strike a dealDatamonitor believes that several different influenza vaccine players could be interested in acquiring Abbott’s influenza vaccine unit. One of the most likely contenders is GlaxoSmithKline. The British pharmaceutical giant is one of the most successful influenza vaccine players, marketing a wide portfolio of seasonal and pandemic influenza vaccines. In 2009, GlaxoSmithKline reported global influenza vaccine sales of $1.7 billion, making the company market-leader in the field in that year ahead of its fiercest competitors Sanofi Pasteur and Novartis. However, the company’s outstanding financial results were mainly driven by pandemic stockpiling, with H1N1 vaccines accounting for over 80% of total influenza vaccine sales. In the seasonal flu segment, both Sanofi Pasteur and Novartis continue to outperform GlaxoSmithKline, having invested in new technologies for their seasonal vaccine portfolios. In this light, Abbott’s cell-based manufacturing technology could provide an incentive to GlaxoSmithKline, which is lagging behind other flu vaccine players with regards to cell-based manufacturing. Furthermore, considering GlaxoSmithKline’s reported strategic plans to increase its footprint in the emerging markets, Abbott’s established Russian business constitutes an even more attractive proposition for a potential deal.Another scenario could see a smaller player such as MedImmune combine Abbott’s flu business with its own influenza unit to achieve a critical mass in the sector. As of 2010, the only marketed influenza vaccine of MedImmune (which was acquired by AstraZeneca in 2007) is the inhaled seasonal vaccine FluMist, currently marketed in the US but not approved in Europe.Handicapped by its premium price and narrow approved age range, FluMist has failed to claim significant market share since its launch in 2003. Indeed, in 2009, MedImmune recorded sales of only $145m for seasonal FluMist. A potential acquisition of Abbott’s influenza vaccine business would provide MedImmune with two marketed seasonal influenza vaccines in Europe, Abbott’s Influvac and Invivac, and consequently provide access to the European influenza market. This would allow MedImmune and, by extension, AstraZeneca to increase the competitiveness of their influenza vaccine business compared to the main players in the field.Related research• • Abbott Laboratories: PharmaVitae Profile • • Commercial Insight: Influenza Vaccines and Antivirals - The pandemic’s long-term impact • The Vaccines Market Outlook To 2014: Competitive landscape, pipeline analysis, growth opportunities and market forecasts