Pai Life Sciences, Inc.

DUBLIN--( BUSINESS WIRE )--The "Parasitology and Mycology Rapid Tests and POC Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2023 Update" report has been added to ResearchAndMarkets.com's offering. Parasitology & Mycology Pipeline Report provides comprehensive information about the Parasitology & Mycology pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. This report provides extensive coverage of Parasitology & Mycology under development, offering comprehensive insights into pipeline products, major players, developmental activities, clinical trial data, and recent developments in the segment/industry. The report reviews the details of major pipeline products, including product descriptions, licensing and collaboration details, and other developmental activities related to Parasitology & Mycology. It also lists all the pipeline projects involving major players engaged in the development of Parasitology & Mycology. Coverage of pipeline products is based on various stages of development, ranging from Early Development to Approved/Issued stages, allowing readers to understand the progress of these products in the pipeline. Key clinical trial data related to ongoing trials specific to pipeline products in the Parasitology & Mycology segment is provided, offering valuable insights into the clinical development of these products. Reasons to Buy Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of Parasitology & Mycology under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered: 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Parasitology & Mycology Overview 3 Products under Development 3.1 Parasitology & Mycology - Pipeline Products by Stage of Development 3.2 Parasitology & Mycology - Pipeline Products by Territory 3.3 Parasitology & Mycology - Pipeline Products by Regulatory Path 3.4 Parasitology & Mycology - Pipeline Products by Estimated Approval Date 4 Parasitology & Mycology - Pipeline Products under Development by Companies 4.1 Parasitology & Mycology Companies - Pipeline Products by Stage of Development 4.2 Parasitology & Mycology - Pipeline Products by Stage of Development 5 Parasitology & Mycology Companies and Product Overview 6 Parasitology & Mycology- Recent Developments 7 Appendix A selection of companies mentioned in this report includes Abacus Diagnostica Ltd Access Bio Inc Acobiom Adaltis Srl All India Institute of Medical Sciences Antigen Discovery Inc Applied BioCode Inc Aptus Biotech SL Attogene Corp Auburn University Axxin Beckman Coulter Inc BioSynesis Inc Biotechnology Assets SA Biotype Innovation GmbH Cascade Biosystems Inc Cepheid Inc Cerebro Biosystems Ceres Nanosciences Inc Ellume Ltd EUROIMMUN US LLC FK-Biotecnologia SA Foundation for Innovative New Diagnostics Fungea AB G Medical Health and Wellness Genetag Technology, Inc Gennova Biopharmaceuticals Ltd Genome Diagnostics Pvt Ltd George Mason University Great Basin Scientific Inc. HealthTell Inc Immunetics Inc InBios International Inc Institute for Development Research Johns Hopkins University L2 Diagnostics LLC London School of Hygiene & Tropical Medicine Luminex Corp Mahidol Oxford Tropical Medicine Research Unit Masaryk University Massachusetts Institute of Technology McGill University Meridian Bioscience Inc Microbiologics Inc MiraVista Diagnostics LLC MND Diagnostic LTD MycoDART Inc Mylab Discovery Solutions Pvt Ltd Nagasaki University Nanosphere Inc (Inactive) NextGen Invitro Diagnostics Pvt Ltd Novacyt SA Ohio State University OpGen Inc OPKO Health Inc Oregon Health & Science University Ortho Clinical Diagnostics Holdings Plc Pai Life Sciences Inc Paramedical Srl Peruvian Cayetano Heredia University Phagolum Ltd. PixCell Medical Technologies Ltd Praxis Pharmaceutical SAU Proplex Technologies Llc Qiagen NV RealSeq Biosciences Inc Roche Diagnostics International Ltd Seegene Inc Serimmune Inc Siemens Healthcare Diagnostics Inc T2 Biosystems Inc Taizhou ZECEN Biotech Co Ltd Techinvention Lifecare Pvt Ltd The Walter and Eliza Hall Institute of Medical Research Transfusion & Transplantation Technologies (Inactive) University of California University of Colorado University of Edinburgh University of Georgia University of Grenoble Alpes University of Oxford University of Tennessee Virginia Commonwealth University Washington University in St Louis Washington University School of Medicine For more information about this report visit https://www.researchandmarkets.com/r/djd3pp About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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With the American Society of Clinical Oncology (ASCO) Annual Meeting being held over the weekend, it was a hectic week for clinical trial news and updates. Here’s a look at just some of them. COVID-19-Related The National Institutes of Health (NIH) reported results from part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trial, specifically its ACTIVE-1 Immune Modulators clinical trial. The study found that both Bristol Myers Squibb’s Orencia (abatacept) and Johnson & Johnson's Remicade (infliximab) demonstrated a strong but not statistically significant improvement in time to recovery by the day of discharge from the hospital. This was the primary endpoint of the study. There were also substantial improvements in the trial’s key secondary endpoints of mortality and clinical status at 28 days. Non-COVID-19-Related Immutep presented new interim data from Part A of its Phase II TACTI-002 in first-line non-small cell lung cancer (NSCLC). The study is evaluating eftilagimod alpha in combination with Merck’s anti-PD-L1 checkpoint inhibitor Keytruda (pembrolizumab). Eftilagimod is a soluble LAG-3 protein. The drug combination demonstrated an improved overall response rate (ORR) of 37.3% in its intent to treat population and compared to 36.1% presented at last year’s ASCO meeting. Responses were seen in all PD-L1 subgroups with 32% ORR in patients with no or low PD-L1 levels, and the combination demonstrated an improved disease control rate of 73.3% compared to 66.7% at last year’s meeting. The company is also presenting an abstract for the design of its ongoing Phase IIb TACTI-003 trial at the meeting. That trial is evaluating the same drug combination as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. InxMed presented data from its Phase Ib trial of IN10018 in platinum-resistant recurrent ovarian cancer. The drug is an oral inhibitor of focal adhesion kinase. It was dosed with pegylated liposomal doxorubicin. Denali Therapeutics and Biogen initiated dosing on the Phase IIb LUMA trial of BIIB122 in early-stage Parkinson’s disease. BIIB122 is an investigational small molecule inhibitor of LRRK2 discovered and developed by Denali. Secarna Pharmaceuticals announced its partner Lipigon Pharmaceutical dosed the first patient in its Phase I trial of Lipisense. Lipisense is an antisense oligonucleotide for rare lipid-related diseases. PDS Biotechnology announced the expansion of its VERSATILE-002 trial of PDS0101 in combination with Merck’s Keytruda. PDS0101 is based on the company’s Versamune system and Infectimune T-cell activating technology platforms. Celltrion Healthcare presented post-hoc analysis of pivotal Phase III studies showing that the subcutaneous formulation of Remsima (infliximab) was associated with significantly greater clinical outcomes than IV formulation of the drug at week 30 in patients with rheumatoid arthritis. The drug is biosimilar to infliximab. Attgeno completed its Phase I trial of Supernitro for acute pulmonary hypertension. Supernitro is a potent substance that works by releasing NO in the pulmonary blood vessels. Attgeno also received the go-ahead in Sweden to initiate a Phase II trial of Supernitro for acute pulmonary hypertension after cardiac surgery. RhoVac AB reported that its RV001 (onilcamotide) failed to demonstrate its superiority over placebo in the Phase IIb BRaVac trial in prostate cancer and biochemical recurrence after curative therapy. RV001 stimulates the T-cells to spot and destroy cells that carry the RhoC protein. BioMarin Pharmaceutical announced updated results from its ongoing Phase I/II trial of valoctocogene roxaparvovec in severe hemophilia A. The drug is investigational gene therapy. Eureka Therapeutics and City of Hope treated the first patient with GPC3-positive advanced hepatocellular carcinoma (HCC) with ECT204, an experimental T cell therapy. The therapy targets ARTEMIS T cells. Horizon Therapeutics announced data from the Phase III trial of Uplizna in neuromyelitis optica spectrum disorder (NMOSD) patients with genetic variations. Uplizna is a highly specific CD19 B-cell depleting agent that targets an extended range of B cells. TScan Therapeutics received the go-ahead from the FDA to evaluate TSC-101 for hematologic malignancy patients undergoing allogeneic hematopoietic cell transplantation. TSC-101 targets the minor histocompatibility antigen HA-2. PolyPid completed enrollment in the Phase III SHIELD I study of D-PLEX100 for the prevention of surgical site infections in abdominal surgery. D-PLEX100 leverages Polymer-Lipid Encapsulation matrix (PLEX) technology with Active Pharmaceutical Ingredients for a prolonged and continuous release of the broad-spectrum antibiotic doxycycline. AffaMed Therapeutics dosed the first patient in its Phase I trial of AM712 for retinal diseases. The drug is a bispecific biologic molecule blocking both VEGF and Ang-2. BlueRock Therapeutics completed enrollment of its Phase I trial of pluripotent stem cell-derived dopaminergic neurons in Parkinson’s disease. The goal is to evaluate the safety, tolerability and preliminary efficacy of BRT-DA01. Antengene Corporation dosed the first patient in the Phase I STAMINA-001 trial of ATG-037 for patients with locally advanced or metastatic solid tumors. It is being tested alone and in combination with Merck’s Keytruda. ATG-037 is an oral small molecule CD73 inhibitor. Eledon Pharmaceuticals announced positive topline data from its Phase IIa trial of Tegoprubart for amyotrophic lateral sclerosis (ALS). The drug is a humanized monoclonal antibody that inhibits CD40 Ligand (CD40L). PAI Life Sciences dosed the first patient in a trial of SchistoShield, the company’s preventive vaccine against schistosomiasis. Schistosomiasis is caused by parasitic flatworms. Memo Therapeutics initiated a Phase I trial of MTX-005 against BK polyomavirus infection in renal transplant patients. The drug is a therapeutic antibody that neutralizes all strains of BKV at extremely low concentrations. Axsome Therapeutics published results from the pivotal Phase III GEMINI trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). It was published in The Journal of Clinical Psychiatry. The study demonstrated rapid, substantial and statistically significant improvement in depressive symptoms and induction of remission. The drug is an NMDA receptor antagonist, using a proprietary formulation and dose of dextromethorphan and bupropion. Sage Therapeutics and Biogen reported their Phase III SKYLARD study demonstrated promising results for women with severe postpartum depression. The trial evaluated zuranolone, an oral GAMA signaling pathway modulator. NeuroSense Therapeutics enrolled the first patient in its Phase IIB PARADIGM trial of PrimeC for amyotrophic lateral sclerosis (ALS). The drug is a novel, patented formulation of specific doses of two FDA-approved drugs, ciprofloxacin and celecoxib. ReAlta Life Sciences dosed the first patient in its Phase Ib inhaled lipopolysaccharide (LPS) challenge trial in support of RLS-0071 for severe asthma. RLS-0071 is a dual-action complement inhibitor and innate anti-inflammatory peptide in development for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases. NeoTX completed the first stage of a Simon 2 stage Phase IIa trial of naptumomab estafenatox (NAP) in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) patients previously treated with chemotherapy and checkpoint inhibitors. NAP is a Tumor Targeted Superantigen (TTS) molecule; TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating an expanding tumor specific immune cells that are redirected from the periphery to the tumor. Indivior enrolled the first patient in the Phase IIb trial of AEF0117 for moderate to severe cannabis use disorder. The drug is a first-in-class synthetic Signaling Specific Inhibitor. TauRx Pharmaceuticals announced unblinding of initial data from the completion of the randomized part of their Phase III LUCIDITY trial of HMTM for Alzheimer’s disease. Participants receiving the drug showed a substantially slower rate of decline. AbbVie presented full results from two studies from the Phase III SELECT-AXIS 2 program of Rinvoq (upadacitinib) in active non-radiographic axial spondylarthritis and patients with treatment-refractory active ankylosing spondylitis with an inadequate response to biologic disease-modifying antirheumatic drugs. Both studies hit the primary endpoints. AlgoTx received clearance from the FDA for a Phase II trial of ATX01 for chemotherapy-induced peripheral neuropathy. The trial will be in the pain of CIPN in adult cancer survivors. SynDevRx opened a Phase Ib/II trial of evexomostat in triple-negative breast cancer and baseline insulin resistance. The drug will be tested in combination with standard-of-care treatment Halaven (eribulin). Evexomostat binds irreversibly to MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, regulation of key lipids, and inhibiting of the bFGF and VEGF-C. Dyve Biosciences presented data from the Phase II TARGETS study of DYV702 for pain associated with acute gout flares. DYV702 is a patented transdermal cream formulation of sodium bicarbonate. Trethera announced that the independent safety review committee unanimously recommends further trial advancement after reviewing favorable data from the Phase Ia dose escalation trial of TRE-515. The drug is a first-in-class deoxycytidine kinase inhibitor to treat solid tumors. Abivax published results from its Phase IIa trial of obefazimod for moderate to severe active rheumatoid arthritis. The drug has a novel mechanism of action based on the upregulation of a single, specific micro-RNA with anti-inflammatory properties called miR-124. Bristol Myers Squibb announced results from the primary analysis of the Phase II PILOT trial of Breyanzi (lisocabtagene maraleucel) in r/r large B-cell lymphoma after first-line therapy in patients who were not deemed candidates for high-dose chemotherapy and hematopoietic stem cell transplant. Breyanzi is a CAR-T therapy. Alterity Therapeutics initiated enrollment in its Phase II trial of ATH434 for Multiple System Atrophy. MSA is a rare neurodegenerative disease similar to Parkinson’s. ATH434 is engineered to decrease the toxic accumulation of alpha-synuclein and preserve nerve cells by restoring normal iron balance in the brain. Viracta Therapeutics announced that the Safety Monitoring Committee for its ongoing Phase Ib/II trial of Nana-val in patients with EBV+ solid tumors has approved advancing to the next dose level. Nana-val (nanatinostat and valganciclovir): nanatinostat is an oral histone deacetylase (HDAC) inhibitor being developed by Viracta. Valganciclovir is an antiviral agent. InVivo Therapeutics completed enrollment in the INSPIRE 2.0 Study for acute spinal cord injury patients. The trial is to evaluate the Neuro-Spinal Scaffold. MaaT Pharma announced the completion of its Phase Ib CIMON trial of MaaT033 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HRMS) having received intensive chemotherapy. The drug is a high-richness, high-diversity Microbiome Ecosystem Therapy (MET). VecctivBio dosed the first two patients in the Phase II STARGAZE trial of apraglutide in steroid-refractory gastrointestinal acute Graft-versus-Host Disease. The drug is a next-generation, long-acting GLP-2 analog. Vaxart reported positive preliminary data from its recently completed Phase Ib trial of its oral norovirus vaccine candidate in elderly adults. The data demonstrated a robust immune response across all doses. Braxia Scientific Corp. presented positive preliminary data from a Phase II trial of psilocybin-assisted therapy for treatment resistant depression. The data supported the feasibility of the company’s proprietary psilocybin-assisted therapy protocol with clinically meaningful improvements in depression severity. Cullinan Oncology presented updated data from its Phase I/IIa trial of CLN-081 in EGFR Exon 20 insertion mutation positive NSCLC. The drug is an orally available small molecule, next-generation, irreversible EGFR inhibitor. Biogen and Ionis Pharmaceuticals announced the Phase III VALOR trial results and an open-label extension (OLE) trial of tofersen for amyotrophic lateral sclerosis (ALS). Toferson is an antisense drug that binds to SOD1 messenger RNA (mRNA), helping it degrade by RNase-H, which decreases the synthesis of SOD1 protein production. Novo Nordisk announced results from two Phase IIIa trials of icodec, the company’s once-weekly insulin. It was non-inferior to Sanofi’s insulin glargine, Lantus. Acelyrin, Affibody and Inmagene Biopharmaceuticals reported positive Phase II data of izokibep in psoriatic arthritis. The drug appears to have better efficacy than current standard of care. Izokibep is an antibody mimetic, IL-17A inhibitor. Legend Biotech received clearance from the FDA for a Phase I trial of LB1908. The drug is an autologous CAR T-cell therapy targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with r/r gastric, esophageal or pancreatic cancers. Daiichi Sankyo presented data from a Phase I/II trial demonstrating patritumab deruxtecan demonstrated clinically meaningful and durable responses in two early-stage trials in previously treated patients with HER3 expressing metastatic breast cancer or advanced NSCLC without EGFR-activating mutations. The drug is a potential first-in-class HER3 directed antibody drug conjugate. Novocure and Zai Lab announced that their Phase II pilot study of Tumor Treating Fields (TTF) with standard-of-care as first-line treatment in gastric adenocarcinoma hit its primary endpoint of objective response rate with supportive signals across secondary endpoints. TTF is an investigational device for the treatment of gastric cancer, using electric fields that disrupt cancer cell division. OliX Pharmaceuticals completed patient enrollment in the Phase IIa trial of OLX101A. OLX101A is an investigational therapy for the treatment of hypertrophic scars. Incannex Healthcare announced positive data from the Phase II trial of IHL-42X for obstructive sleep apnea. The drug is a form of unique medical cannabis. Biogen and Bio-Thera Solutions presented positive Phase III data for BIIB800. The drug is a biosimilar candidate referencing Genentech’s Actemra/Roactemra (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. OncXerna Therapeutics presented new clinical data from an investigator-sponsored Phase II trial of bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients. Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor. Kazia presented positive final data from a Phase II trial of paxalisib in newly diagnosed GBM. The drug is a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway. PTC Therapeutics announced encouraging preliminary safety and efficacy data from its Phase Ib trial of unesbulin in advanced leiomyosarcoma (LMS) patients. The drug is an oral tubulin binding agent that arrests tumor cells in the G2/M phase, including cancer stem cells. The Janssen Pharmaceutical Companies of Johnson & Johnson announced primary data from the Phase III SHINE trial. It demonstrated that the combination of once-daily oral Umbruvica (ibrutinib) plus bendamustine-rituximab (BR) and rituximab maintenance significantly decreased the risk of disease progression or death by 25% in patients 65 years or older with newly diagnosed mantle cell lymphoma (MCL).

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020. News information is not all-inclusive. Please check back for updates. FDA Actions Emergency Use Authorizations (EUAs): The FDA issued two EUAs for tests to detect coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics and Chembio Diagnostic Systems . The FDA issued a EUA to Stryker for emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle to decontaminate N95 and N95 equivalent respirators. New Information Resource: The FDA launched “ At-a-Glance Summary ” identifying the agency’s major activities in fight for COVID-19. Warning Letter: The FDA and FTC issued a warning letter to Earth Angel Oils for selling fraudulent COVID-19 products. Diagnostics Update : The FDA has worked with more than 315 test developers who plan to submit EUA requests to detect COVID-19. Also, 36 EUAs have been issued. The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. Diagnostics As numerous clinical diagnostic companies roll out tests for SARS-CoV-2, the novel coronavirus that causes COVID-19, they all tend to use similar methods—a variation on antibodies that detect viral antigens or PCR-based tests that detect viral DNA or RNA. San Francisco-based Mammoth Biosciences just published the first peer-reviewed study validating its CRISPR-based diagnostic method for COVID-19. It appeared in the journal Nature Biotechnology . The FDA issued two EUAs for tests to detect coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics and Chembio Diagnostic Systems . Sanofi is increasing its odds to develop a vaccine for COVID-19 through a new partnership with Luminostics . The two companies will evaluate a smartphone-based self-testing solution for COVID-19, using Luminostics’ innovative technology and Sanofi’s clinical research abilities. Dynavax Technologies and Sinovac Biotech partner on a COVID-19 vaccine. They will work together to develop the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate with Dynavax’s advanced adjuvant, CpG 1018. CpG 1018 is the adjuvant used in HEPLISAV-B, a hepatitis B vaccine approved by the FDA. PHASE Scientific , a biotech company founded by UCLA Samueli School of Engineering bioengineers launched a product to improve the accuracy of COVID-19 testing. The company’s Phasify liquid technology increases the yield and concentration of RNA from trace amounts of SARS-CoV-2 that might be in a patient sample. Boston Heart Diagnostics began antibody testing for COVID-19. It started offering it to hospitals in the acute-care setting but plans to offer it more broadly through its parent company, Luxembourg-based Eurofins . The testing is to determine if a person has developed antibodies to the virus, either through recovery or previous exposure, which is presumed to give immunity to the illness. Hemex Health is collaborating with PAI Life Sciences to develop an affordable COVID-19 six-minute diagnostic test for use in low resourced countries. Hemex’s Gazelle Diagnostic platform combines traditional testing with cloud-based reporting and uses a reader small than a shoebox that is battery powered and chargeable with a cell phone charger. Hemex’s technology was developed in collaboration with Case Western Reserve University . PAI is developing the biochemical assay needed to detect a protein on the virus’s surface. Testing Therapies, Antivirals and Vaccines Ligandal isn’t the only company developing peptide-based vaccines for COVID-19, but it is the only one developing a prospective “antidote” and vaccine in a single platform. The company suggests its approach can actually help eliminate the virus from an already-infected host, while also bolstering the immune response. The catch is that the company’s research is still in silico . Following the demonstration of antiviral activity in lab tests, Eagle Pharmaceuticals is planning a Phase II trial that will assess the efficacy and safety of Malignant Hypothermia drug Ryanodex as a treatment for COVID-19. Washington, DC-based Vanda Pharmaceuticals and Manhasset, New York-based The Feinstein Institutes for Medical Research , the research division of Northwell Health, enrolled the first patient in the ODYSSEY VLY-686-3501 clinical trial for COVID-19. It will test the use of tradipitant for neurogenic inflammation of the lung secondary to SARS-CoV-2 infection. PDS Biotechnology Corporation expanded its infectious disease pandemic development program with Farmacore Biotechnology. The expanded partnership includes novel vaccines for COVID-19 and universal influenza. Additionally, the company also announced that initiation of its multi-center Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer has been delayed due to the severe adverse impact on clinical trial operations from the COVID-19 pandemic. Applied DNA Sciences Inc. has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech. The candidates will support preclinical animal testing expected to begin immediately. The vaccine candidates were produced by the company’s proprietary PCR-based LinearDNA manufacturing systems. Australia-based Starpharma Holdings Ltd . announced Wednesday that its proprietary VivaGel active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19. SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against Gilead’s remdesivir. Starpharma anticipates it should be possible to fast-track certain aspects of the development path for products targeted at COVID‑19. ViralClear, a subsidiary of BioSig Technologies announced an update to its clinical development program for Vicromax™ and will be considered as a treatment for COVID-19. A Phase II clinical trial will be conducted at Mayo Clinic. Results from the trial will be expected within three months. Mesoblast Limited has received clearance from the FDA for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19) with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L. Remestemcel-L is being developed for various inflammatory conditions and is believed to counteract the inflammatory processes implicated in COVID-19. California-based Dynavax Technologies Corporation has entered the race alongside Sinovac Biotech to develop a vaccine candidate against COVID-19 . The two companies will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018. Beyond Air has the approval to initiate a clinical trial in the U.S. using its LungFit system to treat COVID-19 patients. It will treat 20 patients between the ages of 22 and 65 hospitalized with COVID-19. LungFit uses nitrous oxide generated from ambient air to deliver precise volumes of NO to the lungs for possible treatment for a range of pulmonary diseases. CalciMedica partnered with Regions Hospital St. Paul, Minnesota and Henry Ford Hospital in Detroit to test CM4620-IE in a Phase II study for COVID-19. CM4620-IE is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation, which can lead to pulmonary endothelial damage and cytokine storm in the disease. It has shown clinical safety and potential efficacy in hypoxemia secondary to systemic inflammatory response syndrome (SIRS) from acute pancreatitis. Company Actions Today, Biogen , Broad Institute of MIT and Harvard , and Partners HealthCare announced that they will build and share a COVID-19 biobank. The biobank will help scientists in the search for potential vaccines and treatments. SDL is providing global health science professionals with free access to its SDL Machine Translation. The tool is available to all organizations, researchers and professionals associated in COVID-19 medical research, discovery and development. Sino Biological, Inc. announced an agreement with Nanommune Inc. , to jointly develop coronavirus antigen array products for serological studies of COVID-19 and other infectious diseases. The University of Louisville (Kentucky) has developed solutions to various personal protective equipment for healthcare providers. Faculty and students in UofL’s Additive Manufacturing Institute of Science & Technology (AMIST), the Schools of Dentistry, Engineering and Medicine, have developed a 3D printed swab made of a pliable resin. The university has also developed 3D printed face shields, respirators and ventilators. Zymergen ’s Emeryville, California facility was chosen by the Chan Zuckerberg Initiative and UC San Francisco to test a buffer solution used to collect and analyze swab samples for COVID-19 testing. The focus is on determining if a robotic system can more precisely and accurately speed up the tests for the disease. Other Industry News The FDA issued a EUA to Boston Scientific and its partner, the University of Minnesota , to manufacture a low-cost ventilator. The devices would be sold for less than $1,000. Elizabeth Holmes, the founder and former chief executive officer of Theranos, will have to wait a few months longer before she gets her day in court. Her fraud case has been delayed from July until October due to concerns regarding COVID-19.