LabCorp (NYSE: LH), a world leader in life sciences aimed at improving fitness and guiding patient care decisions, today announced that it is the first advertising lab to obtain an Emergency Use Authorization (USA) from the US Food and Drug Administration. ) for a new high-speed approach that uses heat and generation to extract RNA from collected samples to test molecular COVID-19. This breakthrough will help the company speed and effectiveness of RT-PCR testing, considered to be the popular gold for active infections. 1
Innovation and clinical progress will eventually solve this public fitness crisis, said Marcia Eisenberg, Ph. D. , chief scientific officer for LabCorp Diagnostics. We are constantly comparing new technologies and strategies to the testing process, and we are excited to launch and introduce a free RNA-Method in our laboratories and in the diagnostic network in general.
The state-of-the-art thermal extraction process, which has a sensitivity comparable to existing extraction approaches, traps viral particles, eliminating the need for RNA extraction reagents to capture and concentrate viral nucleic acid. This dramatically improves the power of control and decreases LabCorps’ reliance on control materials, streamlining resources and reducing the time it takes to complete and report molecular control results. The approach adds to labcorp’s other molecular control inventions, such as its short nasal swab for home collection, which is less difficult to use and more comfortable for patients. LabCorps’ existing average delivery time for COVID-19 molecular verification is 24 hours.
The company also announced that it is the first advertising lab to obtain an FDA U. S. for use in the combination of sample matrices collected outdoors at a health care facility through its Pixel check collection kits. labcorp and LabCorp At Home COVID-19. Matrix Pooling Authorization for Home Collection is an FDA U. S. extension published on July 24, allowing LabCorp to verify larger sample equipment at the same time in samples taken through a healthcare professional. The grouping is helping to develop verification capability and can temporarily provide quality verification effects for Americans within the group, without re-verifying in most cases. Joint verification can be used for populations with low COVID-19 threat, when the verification call exceeds laboratory capacity, or when verification reagents are scarce.
LabCorp has performed more than 15 million molecular controls since the COVID-19 control was first performed in March and can now process 200,000 controls according to the day with plans to increase additional capacity.
Lacheck authorizations are a continuation of LabCorps’ commitment to helping physicians, health care systems and patients manage the pandemic, building a long line of controls for an advertising lab, such as: first FDA USA for RT-PCR control (March 5), The FIRST FDA USA for home collection (April 20) , the first online antibody check initiated by the consumer, the first virtual service for patient collection on the Home Physician Initiative (LabCorp At Home, July 7), the FDA’s first USA for the verification of matrice and asymptomatic sets (July 24) and first combined control of respiratory infections, adding COVID-19 and influenza (September 8).
The LabCorps COVID-19 Molecular Control is legal through the FDA as a component of an EUA only for the detection of NUcleic acid from SARS-CoV-2, not for other viruses or pathogens, and has not been legal or FDA approved . It is allowed only for the duration of the declaration of the lifestyles of the cases that justify the authorization of the emergency use of in vitro diagnostic controls for the detection and / or diagnosis of COVID-19 under segment 564 (b) (1) of the Law, 21 USC360bbb-3 (b) (1), unless the authorization is canceled or revoked earlier.
This EUA is in effect until the declaration of the lifestyles of the cases that justify the authorization of the emergency use of the in vitro diagnostics for the detection and / or the diagnosis of COVID-19 is rescinded Section 564 (b) (2) of the Law or the USA, section 564 (g) of the Law is revoked.
1 Centers for Disease Control and Prevention, Interim Guide to Rapid Antigen Testing for SARS-CoV-2 Antigen Testing, September 4, 2020.
About LabCorp
LabCorp (NYSE: LH), a S-company
To be more informed about LabCorp, www. LabCorp. com, and to be more informed about LabCorps’ drug progression business, Covance, www. Covance. com.
Caution related to forward-looking statements
This press release includes forward-looking statements, which add to, but are not limited to, statements regarding clinical laboratory verification, the prospective benefits of COVID-19 verification, our reactions, and the expected long-term effect of the pandemic of COVID-19. . Organize long-term company operations, expansion of offerings and capabilities, and long-term growth opportunities. Each of the forward-looking statements is a repositioning issue based on a variety of vital factors, many of which are beyond the company’s control, adding, without limitation, whether our reaction to the COVID-19 pandemic will turn out to be effective. , have an effect of the COVID-19 pandemic on our business and monetary situation, as well as general economic, business and market position conditions, competitive movements and other unforeseen adjustments and general uncertainties in market position, adjustments in government regulations, adding health care reform, visitor buying decisions that add adjustments to payer regulations or policies, other adverse moves through government and third-party payers, corporate satisfaction with regulatory and other requirements, concerns about the patient protection, adjustments in check rules or recommendations, federal, state and local government reactions to the COVID-19 pandemic, adverse effects in primary litigation, ability to further expand visitor relationships, our ability to expand or acquire new products and adapt to technological adjustments, gene ration of disorder of data, systems or security of knowledge and labor relations. These factors, in some cases, have occurred and, in the long term (as well as other factors) may only be the Company’s ability to execute the Company’s business strategy and the actual effects may differ materially from those advised through the statements. Accordingly, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no legal responsibility to provide updates to those forward-looking statements, even if your expectations are repositioned. All forward-looking statements are expressly qualified in their entirety through this cautionary statement. More information on forward-looking factors, hazards and uncertainties that may only have operational and monetary effects is included in the company’s annual lacheck report on Form 10-K and the following Form 10-Q, adding in each case under the heading FACTORS OF RISK, and in the Companys other filings with the SEC.
UNCF and Bristol Myers Squibb Announce Ernest E. Justo Graduate Scholarship Cohort and Partnership Extension through 2026
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Rockwell Automation, Inc. (NYSE: ROK), a global leader in business automation and virtual transformation, announced today that it has acquired Oylo, a personal business cybersecurity service provider founded in Barcelona, Spain. Oylo is committed to offering a wide diversity of Commercial Formula Cybersecurity (ICS) Facilities and Solutions, adding assessments, turnkey deployments, controlled facilities, and incident response.
As smart connected devices are brought into the factory, it is more important than ever to have a comprehensive cybersecurity strategy that spans business operational generation (OT) and data generation (IT). We are committed to the good fortune of our customers on their connected business journey, and the deep domain expertise that Oylo brings to Rockwell Automation will further drive our ability to deliver that expertise globally, said Frank Kulaszewicz, Senior Vice President, Lifecycle Services. at Rockwell Automation.
The acquisition of Oylo demonstrates Rockwell Automations’ commitment to providing the most productive cybersecurity facilities and solutions. this market is coming and expands the diversity of cybersecurity facilities available in the commercial market.
We look forward to continuing to serve our unwavering consumers and partners as we expand to organizations around the world, said Eduardo Di Monte, founder and CEO of Oylo.
Oylo will be presented as part of the Lifecycle Services operating segment.
The terms of the contract are disclosed.
About Rockwell Automation
Rockwell Automation Inc. (NYSE: ROK) is a global leader in commercial automation and virtual transformation. We link other people’s imaginations to the generation’s perspective to expand what is humanly possible, making the world more productive and more sustainable. Rockwell Automation, based in Milwaukee, Wisconsin, employs approximately 23,000 challenge solvers committed to our consumers in more than a hundred countries. To be more informed about how we are giving Life to The Connected Enterprise in commercial enterprises, www. rockwellautomation. com.
About Oylo
Oylo is an OT cybersecurity facility company focused entirely on critical protection processes and automated business systems (ICS). Oylo was founded in 2017 and is founded in Barcelona, Spain. For more information, scale www. trustoylo. com.
Humanigen, Inc. , (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company targeting the prevention and remediation of an immune hyper-response called cytokine typhoon with its flagship drug candidate, lenzilumab „¢, today announced updates on its lenzilumab in the COVID -19 progression program, adding written title earned from the United States Food and Drug Administration (FDA) following a Type B meeting to download comments on the Use Authorization plans for Emergency (USA). The FDA agreed that the planned submission of Companys would possibly be sufficient to assist a US application, topic for Phase 3 test data, and provided recommendations and assistance for the Companys Biologics license application and approval path. The company also announced several updates to its Phase 3 registration exam with lenzilumab, which continues to be contracted in the United States and Brazil, and which has now been approved for expansion into Mexico. The randomized, double-blind, placebo-controlled phase 3 trial lately has a total of 29 approved sites with 24 hospitalized adult COVID-19 patients who are actively recruiting hospitalized adult patients who require supplemental oxygen and are at greatest threat of progression from the illness.
The FDA has been very helpful and has provided a transparent recommendation on our U. S. filing plan, said Cameron Durrant, MD, MBA, Managing Director of Humanigen. We are encouraged through our Type B assembly and maintain safety in our program and plans to prepare for a imaginable AMERICA.
Lenzilumab is one of the few Phase 3 remedy functions in progression for COVID-19 and has the prospect of being a first-line remedy to improve recovery time and avoid serious and life-threatening outcomes in patients hospitalized by COVID-19. of new verification sites in Brazil and Mexico expands access to this study, which is especially critical for regions experiencing case accumulation, adding centers that are already enrolling in the United States in spaces called ‘hot spots’, said Dale ChappellArray MD, MBA, Scientific Director of Humanigen. The test record continues as we prepare to announce high-level knowledge in the fourth quarter. At the same time, we continue our large-scale commercial production efforts, having recently announced agreements with Thermo Fisher and Lonza, in addition to Catalent, which deserve to ensure access to lenzilumab if granted the U. S.
Key updates to the lenzilumab COVID-19 program include:
FDA Type B Updates:
Phase 3 Trial Program Updates in the United States:
Update of the program of 3 clinical trials in Brazil:
Updates to mexico’s phase clinical trial program:
More highlights on Humanigens systems in COVID-19 can be found on the Company’s online page at www. humanigen. com under the COVID-19 tab, and highlights from the prospective Phase 3 registration exam in the States . United can be found at Clinicaltrials. gov under the identifier NCT04351152.
About Humanigen, Inc.
Humanigen, Inc. is expanding its portfolio of preclinical and clinical remedies for the treatment of cancers and infectious diseases through its new gene neutralization and GM-CSF neutralization platforms. We believe that our GM-CSF gene editing and neutralization platform technologies have the potential to decrease the inflammatory cascade related to coronavirus infection. The company’s immediate goal is to save you or minimize the cytokine release syndrome that precedes severe lung disorder and ARDS in severe cases of SARS-CoV-2 infection. The company also aims to create next-generation gene-edited combinatorial CAR-T remedies that employ methods to improve efficacy while employing GM-CSF gene suppression technologies to control toxicity. Additionally, the company is developing its own portfolio of world-class EphA3-CAR-T for various counterfeit cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the efficacy of its GM-CSF neutralization technologies (either by using lenzilumab as a neutralizing antibody or by deleting the GM-CSF gene) in admixture with other CAR-T bispecific T mobiles. or herbal killers (NK). Initiate immunotherapy remedies to break the efficacy / toxicity link, adding to save and / or treat graft versus host disease (GVHD) in patients undergoing mobile allogeneic hematopoietic stem transplantation (HSCT). In addition, Humanigen and Kite, a Gilead company, are comparing lenzilumab as a sequenced remedy with Yescarta (ciloleucel axicabtagene) in patients with relapsed or refractory giant mobile B lymphoma in a clinical collaboration. For more information, stop over at www. humanigen. com.
This press release includes forward-looking statements. Forward-looking statements reflect knowledge, assumptions, judgment, and control expectations regarding long-term functionality or occasions. While the control believes that the expectations reflected in those statements are reasonable, they cannot guarantee that such expectations will turn out to be adequate and you deserve to be aware that the actual occasions or effects may differ materially from those contained in the future. gaze statements. Words such as “will”, “expect”, “intention”, “plan”, “forward-looking”, “imaginable”, “objectives”, “expedite”, “continue” and similar expressions identify forward-looking statements, including: without limitation , statements regarding our expectations for the Phase 3 review and long-term forward-looking progression of lenzilumab, our path to our planned submission and prospective receipt of an emergency use authorization and the next conceivable FDA BLA, and statements related to lenzilumab for use in the prevention or treatment of GVHD and, as a sequenced remedy with Kites Yescarta, in CAR-T therapies. Forward-looking statements are subject to a number of dangers and uncertainties, including, but not limited to, the dangers inherent in our lack of profitability; our reliance on partners to further expand our candidate products; prices related to CMC paints and the uncertainties inherent in the progression and launch of any new pharmaceutical product; the final results of an ongoing or long-term dispute; and the various dangers and uncertainties described in the “Risk Factors” sections and elsewhere in the Company’s periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety through this warning. You deserve not to place undue reliance on forward-going statements, which relate only to the date of this release. We assume no legal responsibility to review or update any -Statements made in this press release to reflect occasions or cases after the date of this fact or to reflect new data or the occurrence of unforeseen occasions, as required by law.
1 Johns Hopkins University and Coronavirus Resource Center in Medicine. COVID-19 case in the US. Updated October 1, 2020. Retrieved October 1, 2020. https: //coronavirus. jhu. edu/us-map 2 The New York Times. Map of Covid of Brazil and number of cases. Updated October 1, 2020. Retrieved October 1, 2020. https: //www. nytimes. com/interactive/2020/world/americas/brazil-coronavirus-cases. html 3 The New York Times. Covid World Map: Tracking the Global Epidemic. Updated October 1, 2020. Retrieved October 1, 2020. https: //www. nytimes. com/interactive/2020/world/americas/mexico-coronavirus-cases. html
AstraZenecas FARXIGA (dapagliflozin) has been designation of Revolutionary Therapy (BTD) in the United States for patients with chronic kidney disease (CKD), with type 2 diabetes (DM2).
CRF is a serious and progressive disease that is explained by decreased kidney function and is related to an increased threat of central disease or stroke. In the United States, an estimated 37 million other people have CRI. 1
The Food and Drug Administration (FDA) BTD is designed to drive the progression and regulatory review of potential new drugs to treat serious illness and address an unmet medical need. The new drug should have shown encouraging early clinical effects that demonstrate a really large improvement in a clinically significant parameter compared to the drugs available.
Mene Pangalos, Executive Vice President, R
The FDA granted a BTD based on clinical evidence from the DAPA-CKD trial. The detailed effects presented in August showed that FARXIGA, in addition to popular treatment, reduced the combined measure of kidney worsening as either a threat of cardiovascular (CV) or renal mortality. up to 39% to placebo (absolute threat relief [ARR] – 5. 3%, p
In the United States, FARXIGA is indicated in addition to nutrition and training for glycaemic control in adults with DM2 and to reduce the threat of hospitalization due to center failure in patients with DM2 and established CV disease or multiple CV threat factors. approved in the United States to reduce the threat of cardiovascular death and central failure hospitalization (hHF) in adults with central failure (IC) (NYHA Class II-IV) with minor ejection fraction (HFrEF) with and without T2D. FARXIGA is not indicated to mitigate worsening renal function or death in patients with CR.
FARXIGA (dapagliflozin)
FARXIGA is displayed:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION for FARXIGA tablets (dapagliflozin) in doses of five mg and 10 mg
Contraindications
Warnings and precautions
Side effects
In a group of 12 controlled rather than placebo-controlled studies, the maximum non-unusual side effects (up to five%) RELATED to FARXIGA five mg, 10 mg and placebo respectively were female genital fungi (8. 4% vs. 6. 9% vs. 1. 5%). %), rhinopharyngitis (6. 6% vs. 6. 3% vs. 6. 2%) urinary tract infections (5. 7% vs. 4. 3% vs. 3. 7%).
Use in populations
Determination
See the full dose of EE. But it’s not the first time And FARXIGA’s drug advisor.
Chronic kidney disease
CKD is a serious and progressive disease explained by decreased kidney function (illustrated through relief in the estimated glomerular filtration rate [eGFR] or markers of kidney damage, or both, for at least 3 months) that affects approximately 700 million other people around the world, many of whom remain undiagnosed. Matrix2. 3 The main common causes of CKD are diabetes, high blood pressure, and glomerulonephritis. 4 CKD is related to significant patient morbidity and increased threat of cardiovascular events3, such as HF and premature death. 5 In its most severe form, known as end-level kidney disease (ERT), kidney damage and kidney deterioration serve as you have progressed to the level at which dialysis or transplantation is needed. kidney disease. 1 Most CKD patients will die for CV reasons before reaching CKD. 6
DAPA-CKD
DAPA-CKD is an international, multicenter, randomized, double-blind examination of 4304 patients, designed to compare the efficacy of FARXIGA 10 mg, compared to placebo, in patients with level 2″4 CKD and upper urinary excretion of albumin, with and without T2D. FARXIGA is given once a day in addition to popular care. The main combined assessment criterion is worsening renal function or death threat (defined as a combination of a minimum in DFGe – 50%, the onset of ERT and death by CV or renal origin). Secondary assessment criteria included the time to first onset of the renal compound (sustained decrease of 50% DFGe, ESKD and renal death), CV or compound hHF death and death regardless of the cause. countries and high-level effects were announced in July 2020.
AstraZeneca in CV, Kidney and Metabolism (CVMD)
CV, kidney and metabolism in combination shape one of the key healing spaces of AstraZenecas and a key driving force for the company. Following the science to more obviously perceive the underlying links between the heart, kidneys and pancreas, AstraZeneca invests in a drug portfolio to protect organs and improve outcomes through slowing disease progression, reducing the threat and addressing comorities. Our ambition is to modify or prevent the herbal evolution of CVM diseases and potentially regenerate organs and repair function, proceeding to provide a transformative science that improves the cardiovascular remedy and fitness practices of millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global biopharmaceutical corporation, led by science, focused on the discovery, progression and marketing of prescription drugs, mainly for the remedy of diseases in 3 areas of healing: oncology, cardiovascular, renal and metabolism and respiratory and immune. One hundred countries and their state-of-the-art medicines are used through millions of patients worldwide. For more information, visit www. astrazeneca-us. com and stay with us on Twitter @AstraZenecaUS.
references
Rockwell Automation, Inc. (NYSE: ROK), a world leader in business automation and virtual transformation, announced that it has acquired Array . .
AstraZenecas FARXIGA (dapagliflozin) has been awarded the designation of Revolutionary Therapy (BTD) in the United States for patients with chronic kidney (CKD), Array. .
Humanigen, Inc. , (Nasdaq: HGEN) (Humanigen), a clinically staged biopharmaceutical company aimed at the prevention and remedy of an immune hyperresposed called ‘cytokine . . .
Bristol Myers Squibb (NYSE: BMY) announced that the company will host a virtual occasion for investors on Monday, October 12, 2020.
Palantir Technologies Inc. (NYSE: PLTR) announced that it has been awarded an unlimited one-year, $36 million delivery contract with theArray.
UNCF and Bristol Myers Squibb (NYSE: BMY) announced the cohort of the Ernest E scholarship. Just Postgraduate FellowshipArray . .
LabCorp (NYSE: LH), a leading life sciences company aimed at improving fitness and guiding patient care decisions, Array. .
AECOM (NYSE: ACM), the world’s fourteenth infrastructure advisory firm, announced that it plans to complete a repurchase percentage of approximately $155 million.
RiverNorth / DoubleLine Strategic Opportunity Fund, Inc. (NYSE: OPP) announced the initial effects of its transferable rights offering (theArray. .
Telenav, Inc. (NASDAQ: TNAV), one of the leading providers of geolocation services and connected cars, demonstrated that it has won Array. .
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