New York, July 24, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Europe Electronic Data Interchange Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Component, Type, Industry, and Country" - https://www.reportlinker.com/p05934804/?utm_source=GNWThe wide market fragmentation and high cross-border trade between European countries are among the factors driving the demand for efficient invoicing solutions.The solution segment led the Europe electronic data interchange market based on component in 2019. EDI solutions are used in a broad range of large and small to mid-sized enterprises in a multiple sectors across Europe, for interchanging commercial documents .The overall Europe electronic data interchange market size has been derived using both primary and secondary sources.To begin the research process, exhaustive secondary research has been conducted using internal and external sources to obtain qualitative and quantitative information related to the market.The process also serves the purpose of obtaining overview and forecast for the Europe electronic data interchange market with respects to all the segments pertaining to the region.Also, multiple primary interviews have been conducted with industry participants and commentators to validate the data, as well as to gain more analytical insights into the topic.The participants typically involved in this process include industry expert such as VPs, business development managers, market intelligence managers, and national sales managers along with external consultants such as valuation experts, research analysts, and key opinion leaders specializing in the Europe electronic data interchange market. Mulesoft, LLC; SPS Commerce, Inc.; TrueCommerce Inc.; IBM Corporation; Cleo; Descartes Systems Group Inc.; Data Masons Software LLC; Crossinx GmbH; EDICOM; and Comarch SAare among the major players in the market in this region..Read the full report: https://www.reportlinker.com/p05934804/?utm_source=GNWAbout ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________
STOCKHOLM, Oct. 12, 2020 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM).
The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await the results from the ongoing randomized, phase 3 OCEAN study before submitting an application for marketing authorization. Upon completion, the outcome from the OCEAN study comparing melflufen and pomalidomide in patients with RRMM, will be submitted to regulatory authorities to potentially expand the label of melflufen.
The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD).
"Key opinion leaders and clinics across Europe have gained extensive experience of melflufen from our clinical development program in multiple myeloma. We share a mutual interest to enable early access to this rapidly growing patient population in desperate need of new treatment options", says Klaas Bakker, CMO of Oncopeptides.
According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if; the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.
The US Food and Drug Administration, FDA, has granted priority review to Oncopeptides' New Drug Application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA has set a target date for the review of the New Drug Application, to February 28, 2021.
For more information, please contact:
Klaas BakkerCMO of OncopeptidesE-mail: firstname.lastname@example.org Telephone: +44-7818-523-903
Rein PiirHead of Investor Relations, OncopeptidesE-mail: email@example.com Cell phone: +46-70-853-72-92
The information was submitted for publication on October 12, 2020 at 08:00 (CET).
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company is focusing on the development of the lead product candidate melflufen, a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen (INN melphalan flufenamide) is in development as a new treatment for the hematological malignancy multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Based on the results from the HORIZON study Oncopeptides has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with triple-class refractory multiple myeloma. Oncopeptides' global Headquarters is in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.
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The following files are available for download:
Press release - Oncopeptides moves forward with intent to file for conditional approval of melflufen with EMA
India join the EU in attempts to slow down the import of aluminium and copper into the country
Crude oil prices closed 1.92% lower this week after gaining nearly 10% to close above the $40 mark
U.S. steel production rate is 20.1% down year-to-date, compared to the same period from last year
Copper prices fell 4.65% this week to follow the vast majority of other commodities lower. Crude oil prices also closed lower, nearly 2%, but still managed to force a close above $40 per barrel. Silver price crashed nearly 15% to log the 2-month low.
Copper imports limited
India aims to slow down the import of aluminium and copper into the country. On the other hand, oil prices moved up as several oil companies failed to reach their output cut targets. Also, the U.S. steel sector’s capacity utilization rate plunged after being on the rise for several past months.
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India is looking to follow the footsteps of the European Union and limit the influx of aluminium and copper entering the country. For this reason, India has issued an import surveillance program that will demand from importers to record and report their import levels, said Stuart Burns from MetalMiner.
“Only by accumulating hard data can the country develop sensible policies, promoters of the scheme argue,” he said.
“As such, China, Japan, Malaysia, Vietnam and Thailand are among the major exporters of copper. Those countries accounted for 45% of India’s $5 billion in copper imports for 2019-2020, the article reports.”
Copper mine output was also hit by the pandemic, especially in Peru. The output slipped 1% in the first half of the year, according to reports by the International Copper Study Group. Mine production in Peru plunged by 20% in H1 2020. Moreover, the output levels sank 38% from April through May, after shutdown measures because of the pandemic and unfavourable weather conditions.
Copper weekly chart (TradingView)
Burns said the logistics sector is full of uncertainty and high expenses. Individuals who cheer for the idea of a “decoupling” of the U.S.-China trade relationship, can slow down as this will likely be the case for the time being.
“A fair part of the current pressure on shipping space and costs is coming from increases in trade between Asia and the U.S.,” Burns said.
“The pandemic has spurred demand for Chinese-made goods from electricals like laptops and associated electronics to PPE equipment, including masks and gloves.”
Copper prices dipped over 4.5% to close below the important support line at $3.00. The bearish close has now opened the door for a deeper correction to $2.80 and $2.68.
Focus on oil output levels
Oil prices have recovered from its low levels earlier this year, but still lower than its 2019 levels, even after OPEC+ ordered output cuts. While this decision has contributed to price stabilization, some oil manufacturers haven’t strictly complied with reduction mandates.
“The incentive to cheat is huge,” Burns explained. “The sense by many smaller players that they suffer from output agreements more than the ‘big boys’ breeds a sense of resentment at times.
Burns noted that this is especially the case with parties that have nothing else in common except an intention to increase oil revenues.
Crude oil weekly chart (TradingView)
“So, the Saudi oil minister’s thinly veiled dressing down of OPEC partners UAE, Nigeria and Iraq for overproducing is met with protestations but little in the way of immediate compliance.”
Brent crude has bounced back in the past three months and stayed near the $40 a barrel mark, after oil traders pushed the “black gold” under $13 a barrel earlier this year. Crude oil prices closed the week 1.92% lower, a week after gaining nearly 10% to close above the $40 mark.
In case the fundamental aspect of the industry improves, crude oil prices could eventually exceed $50 before the end of the year.
Steel capacity utilization rate falling
The United States steel industry capacity utilization rate has also dipped last week, after being on the rise for most of the time in the past several months. For the week through September 19, the steel capacity utilization rate dropped to 64.5% from 65.1% last week.
U.S. steel production rate is 20.1% down year-to-date, compared to the same period from last year. In spite of weak domestic demand, India is now a net exporter of steel to China and other countries.
Steel Rebar weekly chart (TradingEconomics)
Indian steel manufacturing companies exported around 80% of their output in the period from April to August. During that same period, China accounted for 45% of India’s total steel exports.
Steel prices have fallen in September, just a few weeks after printing the annual high near $3,800.
India is planning to curb the import levels of aluminium and copper into the country just like the E.U. Elsewhere, oil prices have bounced back up after some oil producers failed to hit their output reduction targets. Furthermore, the U.S. steel sector’s capacity utilization rate also dipped after climbing for several past months.