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Chi-Med Highlights Surufatinib Phase III Results in Neuroendocrine Tumors at ESMO 2020 and Publications in The Lancet Oncology

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― Phase III SANET-p demonstrated surufatinib reduces the risk of disease progression or death by 51% in patients with pancreatic neuroendocrine tumors (“NET”) ―

― SANET-p results complement previously presented positive Phase III SANET-ep results in patients with non-pancreatic NET, including across multiple subgroups ―

― Results of both SANET-p and SANET-ep studies published in The Lancet Oncology –

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 20, 2020 — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that positive results of the Phase III study of surufatinib in advanced neuroendocrine tumors – pancreatic (“SANET-p”) were presented as a proffered paper session at the European Society for Medical Oncology (“ESMO”) Virtual Congress 2020 (Abstract Number 1156O). Results from SANET-p, in addition to previously presented results from Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic (“SANET-ep”), are published today in The Lancet Oncology.

“Surufatinib demonstrated statistically significant and clinically meaningful benefits in patients with advanced pancreatic NET. These results, combined with positive results from the parallel study of surufatinib in patients with non-pancreatic NET, support surufatinib as a promising treatment option for well-differentiated NET patients regardless of tumor origin,” commented Dr. Jianming Xu, lead investigator for the SANET-p study, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA in Beijing.

As announced in January 2020, the Independent Data Monitoring Committee (“IDMC”) for the SANET-p trial recommended that the study stop early because it had met the pre-defined primary endpoint of progression free survival (“PFS”) during a planned interim analysis. At data cut-off as of November 11, 2019, 172 patients were randomized 2:1 to treatment with either 300 mg of surufatinib orally daily (N=113) or placebo control (N=59), on a 28-day cycle. Median PFS was 10.9 months for patients treated with surufatinib, as compared to 3.7 months for patients in the placebo group (hazard ratio [“HR”] 0.491; 95% confidence interval [“CI”] 0.391-0.755; p=0.0011). Benefit was observed across most major subgroups of pNET patients. Objective response rates (ORR) were 19.2%1 for the 104 efficacy evaluable patients in the surufatinib group versus 1.9%2 for the 53 efficacy evaluable patients in the placebo group, with a disease control rate (DCR) of 80.8% versus 66.0%, respectively. Most patients in the trial had Grade 2 disease with heavy tumor burden, including liver metastasis and multiple organ involvement. Efficacy was also supported by Blinded Independent Image Review Committee (BIIRC) assessment, with a median PFS of 13.9 months for surufatinib as compared to 4.6 months for placebo (HR 0.339; 95% CI 0.209-0.549; p<0.0001).

The safety profile of surufatinib was manageable and consistent with observations in prior studies. Treatment was well tolerated for most patients, with discontinuation rates as a result of treatment emergent adverse events of 10.6% in the surufatinib group as compared to 6.8% in the placebo group.

In the U.S., the Food and Drug Administration (“FDA”) granted surufatinib two Fast Track Designations, for both the non-pancreatic NET and pancreatic NET development programs, and Orphan Drug Designation for pancreatic NET development. A rolling new drug application (“NDA”) submission is being prepared, to be followed by a marketing authorization application (“MAA”) submission to the European Medicines Agency (“EMA”) in Europe, based on the robust data from the two studies and the ongoing multi-cohort Phase Ib study in the U.S. In December 2019, an NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was granted Priority Review status by the China National Medical Products Administration (“NMPA”). A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET has also been accepted by the NMPA.

About NET

NET form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NET are typically classified as pancreatic NET or non-pancreatic NET. Approved targeted therapies include Sutent® and Afinitor® for pancreatic NET, or well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2018. Importantly, NET are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NET in the U.S. in 2018.

In China, there were approximately 67,600 newly diagnosed NET patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country.3  

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Chi-Med currently retains all rights to surufatinib worldwide.

About Surufatinib Development

NET in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019. A U.S. FDA NDA submission is being prepared, to be followed by a MAA submission to the EMA in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov identifier: NCT02549937).

Non-pancreatic NET in China: In November 2019, a NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the NMPA and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in patients with advanced non-pancreatic NET in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the IDMC to determine that the study met the pre-defined primary endpoint of PFS and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress (clinicaltrials.gov identifier: NCT02588170) and published in The Lancet Oncology in September 2020. 4 Median PFS was 9.2 months for patients treated with surufatinib, as compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001).

Pancreatic NET in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. Following an interim analysis review conducted in January 2020 by the IDMC that recommended the registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821), leading to a second NDA accepted by the China NMPA. The results of this study were presented at the ESMO Virtual Congress 2020 and published simultaneously in The Lancet Oncology. 5

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tuoyi® (toripalimab, developed by Shanghai Junshi Biosciences Co. Ltd.) and Tyvyt® (sintilimab, developed by Innovent Biologics, Inc.), which are approved in China.

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the submission of an NDA for surufatinib for the treatment of NET in the U.S., China and other jurisdictions, the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development for surufatinib in this and other indications, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of the clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S. and China or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of surufatinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, its ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi®, and Tyvyt® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries  
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
   
Media Enquiries  
Americas – Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile) [email protected]
Europe – Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) [email protected]
Asia – Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), [email protected] / +852 9783 6894 (Mobile), y[email protected]
   
Nominated Advisor  
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500

___________________________________________

1 Responses in the surufatinib group included 13 confirmed partial responses and 7 unconfirmed partial responses. 2 There was 1 confirmed partial response in the placebo group. 3 According to Frost & Sullivan, in 2018, there were 19,000 newly diagnosed cases of NETs in the U.S and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options. 4 Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020;S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4. 5 Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.

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Global Construction Equipment Rental Market to grow by 5% during 2020-2024, Caterpillar Inc. and Cramo Plc Emerge as Key Contributors to growth | Technavio

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Technavio has been monitoring the global construction equipment rental market and it is poised to grow by USD 28.86 billion during 2020-2024, progressing at a CAGR of 5% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment. Download a Free Sample Report on COVID-19

Impact of COVID-19

The COVID-19 pandemic continues to transform the growth of various industries, however, the immediate impact of the outbreak is varied. While a few industries will register a drop in demand, numerous others will continue to remain unscathed and show promising growth opportunities. COVID-19 will have at Par impact on the construction equipment rental market. The market growth in 2020 is likely to Increase compared to the market growth in 2019.

Frequently Asked Questions:

  • Based on segmentation by product, which is the leading segment in the market? ECRCE segment led the growth of the market in 2019.
  • What are the major trends in the market? The increasing focus on AGVs is one of the key trends in the market
  • At what rate is the market projected to grow? The market is expected to grow at a CAGR of 5% during the forecast period.
  • Who are the top players in the market? Caterpillar Inc., Cramo Plc, HERC HOLDINGS INC., Jungheinrich AG, KION GROUP AG, Komatsu Ltd., LOXAM SAS, Sarens Bestuur NV, Toyota Industries Corp., and United Rentals Inc. are some of the major market participants.
  • What are the key market drivers? The increased investment in infrastructure will offer immense growth opportunities.
  • How big is the NORTH AMERICA market?

The market in North America is expected to grow by 39% during the forecast period.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

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The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Caterpillar Inc., Cramo Plc, HERC HOLDINGS INC., Jungheinrich AG, KION GROUP AG, Komatsu Ltd., LOXAM SAS, Sarens Bestuur NV, Toyota Industries Corp., and United Rentals Inc. are some of the major market participants. The increased investment in infrastructure will offer immense growth opportunities. In a bid to help players strengthen their market foothold, this construction equipment rental market forecast report provides a detailed analysis of the leading market vendors. The report also empowers industry honchos with information on the competitive landscape and insights into the different product offerings offered by various companies.

Technavio’s custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations.

Construction Equipment Rental Market 2020-2024: Segmentation

Construction Equipment Rental Market is segmented as below:

  • Product
    • ECRCE
    • MHE
  • Geographic Landscape
    • APAC
    • Europe
    • MEA
    • North America
    • South America

To learn more about the global trends impacting the future of market research, download a free sample: https://www.technavio.com/talk-to-us?report=IRTNTR41362

Construction Equipment Rental Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. The construction equipment rental market report covers the following areas:

  • Construction Equipment Rental Market Size
  • Construction Equipment Rental Market Trends
  • Construction Equipment Rental Market Industry Analysis

This study identifies the increasing focus on AGVs as one of the prime reasons driving the Construction Equipment Rental Market growth during the next few years.

Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Technavios in-depth research has direct and indirect COVID-19 impacted market research reports.

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Construction Equipment Rental Market 2020-2024: Key Highlights

  • CAGR of the market during the forecast period 2020-2024
  • Detailed information on factors that will assist construction equipment rental market growth during the next five years
  • Estimation of the construction equipment rental market size and its contribution to the parent market
  • Predictions on upcoming trends and changes in consumer behavior
  • The growth of the construction equipment rental market
  • Analysis of the markets competitive landscape and detailed information on vendors
  • Comprehensive details of factors that will challenge the growth of construction equipment rental market vendors

Table of Contents:

Executive Summary

  • Market Overview

Market Landscape

  • Market ecosystem
  • Value chain analysis

Market Sizing

  • Market definition
  • Market segment analysis
  • Market size 2019
  • Market outlook: Forecast for 2019 – 2024

Five Forces Analysis

  • Bargaining power of buyers
  • Bargaining power of suppliers
  • Threat of new entrants
  • Threat of substitutes
  • Threat of rivalry
  • Market condition

Market Segmentation by Product

  • Market segments
  • Comparison by Product placement
  • ECRCE – Market size and forecast 2019-2024
  • MHE – Market size and forecast 2019-2024
  • Market opportunity by Product

Customer landscape

  • Overview

Geographic Landscape

  • Geographic segmentation
  • Geographic comparison
  • North America – Market size and forecast 2019-2024
  • Europe – Market size and forecast 2019-2024
  • APAC – Market size and forecast 2019-2024
  • MEA – Market size and forecast 2019-2024
  • South America – Market size and forecast 2019-2024
  • Key leading countries
  • Market opportunity by geography

Drivers, Challenges, and Trends

  • Market drivers
  • Volume driver – Demand led growth
  • Volume driver – Supply led growth
  • Volume driver – External factors
  • Volume driver – Demand shift in adjacent markets
  • Price driver – Inflation
  • Price driver – Shift from lower to higher-priced units
  • Market challenges
  • Market trends

Vendor Landscape

  • Overview
  • Vendor landscape
  • Landscape disruption

Vendor Analysis

  • Vendors covered
  • Market positioning of vendors
  • Caterpillar Inc.
  • Cramo Plc
  • HERC HOLDINGS INC.
  • Jungheinrich AG
  • KION GROUP AG
  • Komatsu Ltd.
  • LOXAM SAS
  • Sarens Bestuur NV
  • Toyota Industries Corp.
  • United Rentals, Inc.

Appendix

  • Scope of the report
  • Currency conversion rates for US$
  • Research methodology
  • List of abbreviations

     

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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Shareholder Alert: Robbins LLP Announces It Is Investigating Innate Pharma S.A. (IPHA) for Misleading Shareholders

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Shareholder rights law firm Robbins LLP announces it is investigating whether certain officers and directors of Innate Pharma S.A. (NASDAQ: IPHA) violated federal securities laws. Innate Pharma S.A. is a biotechnology company that discovers and develops therapeutic antibodies for the treatment of oncology indications in France and internationally.

If you suffered a loss due to Innate Pharma’s misconduct, click here.

Innate Pharma S.A. (IPHA) Accused of Misleading Shareholders about Partnership with AstraZeneca PLC

In October 2018, Innate Pharma announced a long-term strategic partnership with AstraZeneca PLC. The deal included a $100 million in milestone payments paid to Innate Pharma at the start of the first Phase 3 clinical trial for monalizumab. Throughout 2019 and early 2020, Innate not only confirmed the $100 million payment, but also affirmed the results of the trial as being on track. On September 8, 2020, the Company announced a change to the $100 million payment. Instead of a one-time payment at the start of the first Phase 3 clinical trial, Innate would receive $50 million at the start, and an additional $50 million after the interim analysis demonstrated a pre-defined threshold of clinical activity. On this news, Innate Pharma’s ADS’s fell 26.6%, to open at $4.82 on September 8, 2020, continued to decline throughout the day to close at $4.45, and has yet to recover.

Contact us to learn more: Lauren Levi (800) 350-6003 [email protected] Shareholder Information Form

Robbins LLP is a nationally recognized leader in shareholder rights law. To be notified if a class action against Innate Pharma settles or to receive free alerts about companies engaged in wrongdoing, sign up for Stock Watch today.

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GreySuits CPA Advises How Businesses Can Manage The Fallout From COVID

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Chartered Professional Accountant, Rodney Davis of GreySuits Inc., a strategic accounting firm, speaks about how business can adapt to the fallout from COVID and how they can prepare for future challenges.

Q: This year has been a major upheaval. There really is no new normal. Companies have faced untold financial challenges, many not surviving. How can I as a business adapt to the current situation?

Rodney Davis: In a previous conversation, we talked about the cultural impediments to change. COVID is a classic example. Organizations that were not culturally built for change, probably had a worst time dealing with COVID. They probably had far more difficulty in adjusting to the new reality. But the reality is, you have to have a culture that understands that the customer is the number one driver for everything you do. If you have that, you’re putting in place things that enable you to respond to what the customer needs, and if you don’t, it’s harder.

And finance isn’t the custodian of the customer relationship. Finance is the custodian of the outcome of not taking care of the customer, which is the financial implications of losing customers. They are the monitor that says you’re losing customers, or you’re gaining customers, or your service delivery costs are too high, or your product costs are too high. So if you have that customer relationship in a particular place, you can have changes with less impact on the business. And if you don’t, then you may have a much more difficult situation.

Q: Can finance help prepare businesses for future problems?

Rodney Davis: The short answer is, yes. In a time like that, where you have a sudden change to your business that was completely unexpected, completely outside of your control, and it affects your customers or your ability to do business, the more variable the costs are that are associated with your business, the more resilient you are. There are businesses in our economy that have costs of 80 to 90% before you get to make a penny. So the gross margins are very small. These businesses that have a high fixed cost have to generate a considerable amount of revenue before they cover those fixed costs. I would be willing to bet you that a lot of businesses in that situation have looked for ways to reduce their fixed costs because that makes them more resilient during a difficult time. But if I’m going to deaden or lessen the impact of the unexpected, then I’ve got to know what I have available and also what it’s going to cost to continue to operate.

Q: Why is it important to stay close to the money?

Rodney Davis: You have to understand what the actual money impact of decisions are. So, when I talk about costs, I’m not talking about notional costs when I’m making a management decision. I have to know how a decision to pursue a particular line or course of action translates into money “ the money that comes in, the money that goes out and the money that’s left after we’ve covered all our costs. Good finance teams understand that and can help the business in evaluating decisions by pointing them to the residual cash that’s available because at the end of the day, the manifestation of every business is cash.

Q: What advice do you have for businesses at this time?

Rodney Davis: Be very aware of your financial position. Be as close to the completion of your financial periods as possible. A lot of the companies that I deal with that faced scrutiny, whether from potential new customers, potential new suppliers, their financial institutions, or the financial backers of that organization have one concern from a stakeholder “ are you going to be around? So to give them that comfort, the closer you are to your numbers, and the more you have a framework for reporting and the ability to respond to the questions that arise, the more likely you give confidence to the people who make decisions about whether or not they are going to support you.

Most of the new clients that we picked up during COVID, were people who were saying, I wasn’t close enough to my numbers. I didn’t realize how much of a deficit I had. There was no immediate awareness of what their underlying financial condition or my underlying financial performance was.

Having money in the bank, without having an understanding of how that money turns into more money or how fast that money has the potential to disappear makes you as vulnerable as someone who has no money.

But knowing how to make more money and knowing how to retain money after you finished delivering your services is probably the most ideal scenario for a business.

Rodney Davis, CA, CPA is a partner and practice leader at GreySuits Advisors Inc. (www.greysuits.ca) He has been working with private and public organizations since 1990 in change management.

Video of interview available (full rights granted for any news media platform): Link to full video interview and Rodney Davis photo: https://drive.google.com/drive/folders/1CGLIoqt2QzMaYf2Ls_jvef9QNjNPiGuE?usp=sharing

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