Tuesday, April 3, 2018
Monday, April 2, 2018
Global Epigenetics Market is Expected to Reach $1891.9 million by 2023
Report Sellers has added a new market research report “Epigenetics – Global Market Outlook (2017-23)” to its offerings.
According to Report, Global Epigenetics Market is accounted for $752.8 million in 2016 and expected to grow at a CAGR of 14.0% to reach $1891.9 million by 2023. Growing prevalence of cancer and other chronic diseases are helping the market to compete across the globe. Some of the major factors that are influencing the market include growing technological advancements, rising R&D expenditure, growing usage for non-oncology diseases, improving collaborations between pharmaceutical, biotechnology companies & academic research institutes and increasing geriatric population base. However, huge equipment cost, lack of predictive markers, inefficiency in identification and validation of biomarkers, presence of complicated regulatory framework and shortage of skilled professional are hampering the market growth.
Based on Technology, DNA methylation can be classified as hyper and hypomethylation. Reduced representation bisulfite sequencing (RRBS) is a DNA wide methylation analysis technique for a combination of enrichment and modifying techniques. DNA methylation is also used as a biomarker for early cancer diagnosis. The FDA-approved epigenetic drugs are demethylating agents, and most of the diagnostic activity to date in epigenetics has focused on methylation markers.
Based on End User, with in the pharmaceutical sector, the therapeutic applications of epigenetics have fascinated a large and growing number of pharmaceutical and biopharmaceutical companies. Over 40 companies that are now active. Venture capital-funded companies in epigenetics include Constellation Pharmaceuticals and Syndax Pharmaceuticals.
North America dominated the overall revenue, due to the, increasing funds for R&D, growing collaborations between large pharmaceutical firms and demand for epigenetic drugs and diagnostic technologies. However, Asia-Pacific is anticipated to grow rapidly, due to high incidence of cancer, large prevalence of target diseases and rise in healthcare expenditure.
Some of the key players in Global Epigenetics market are Celgene Corporation, CellCentric Ltd, Chroma Therapeutics Ltd, Covaris Inc, DIAGENODE, INC., Ribimed Biotechnologies, Epigenomics AG, Epitherapeutics, Epizyme, Karus Therapeutics, Merck Millipore, Novartis International AG, Oncolys Biopharma Inc, OncoMethylome Sciences, Qiagen, Sigma-Aldrich Corporation, Syndax Pharmaceuticals and ZYMO RESEARCH CORPORATION (ZYMO).
Browse through the complete description and in-depth TOC on “Global Anti-Infective Agents Market”
https://www.reportsellers.com/market-research-report/Epigenetics—Global-Market
What does the Report Offers
Market share assessments for the regional and country level segments
Market share analysis of the top industry players
Strategic recommendations for the new entrants
Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets
Strategic recommendations in key business segments based on the market estimations
Competitive landscaping mapping the key common trends
Company profiling with detailed strategies, financials, and recent developments
Report Scope
Global Epigenetics Market has been segmented by products covered, technologies covered, applications covered, end users covered and regions covered
Products Covered:
Enzymes
Reagents
Kits
Instruments and Consumables
Technologies Covered:
Histone Methylation
DNA Methylation
Histone Acetylation
Large noncoding RNA
Chromatin structures
MicroRNA Modification
Other Technologies
Applications Covered:
Cardiovascular Diseases
Developmental Biology
Immunology
Metabolic Diseases
Inflammatory Disease
Oncology
Other Applications
End Users Covered:
Pharmaceutical
Contract Research Organizations
Academic and Research Institutes
Biotechnology Companies
Regions Covered:
North America
US
Canada
Mexico
Europe
Germany
France
Italy
UK
Spain
Rest of Europe
Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
South America
Argentina
Brazil
Chile
Rest of South America
Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa
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Cardiome Highlights Partner SteadyMed’s Progress Towards Trevyent NDA Resubmission
NASDAQ: CRME TSX: COM
VANCOUVER, April 2, 2018 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ:CRME / TSX:COM), a revenue-generating, specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted progress by its partner SteadyMed Therapeutics (NASDAQ:STDY) towards the resubmission of a New Drug Application (NDA) for Trevyent® for the treatment of pulmonary arterial hypertension (PAH) to the U.S. Food and Drug Administration (FDA).
Following an in-person Type A meeting in November 2017 and written feedback received from the FDA, SteadyMed indicated that it is not required to conduct any further clinical trials to prove Trevyent’s safety or efficacy and that the FDA has agreed that certain in vitro pre-design verification (pre-DV) tests on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and process validation, would be adequate for the resubmission and acceptance of the NDA under the 505(b)(2) pathway. SteadyMed has announced that these pre-DV tests are proceeding to plan and that the company remains on track to resubmit the NDA and, subject to review by the Agency, have it accepted for filing by the end of 2018. Cardiome plans to submit a regulatory filing for Trevyent in Europe shortly following SteadyMed’s NDA resubmission to the FDA.
“We are pleased with SteadyMed’s progress towards bringing this important therapy to market to help patients suffering from PAH around the world after receiving clarity from the Agency on the necessary steps, including pre-DV testing, for resubmitting the NDA,” stated William Hunter, MD, CEO and President of Cardiome. “In tandem, we will continue to prepare our planned MAA for Trevyent in Europe, which we anticipate submitting shortly after SteadyMed’s NDA filing in the U.S.”
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a type of high blood pressure that occurs in the right side of the heart and in the arteries that supply blood to the lungs. PAH worsens over time and is life-threatening because the pressure in a patient’s pulmonary arteries rises to dangerously high levels, putting a strain on the heart. There is no cure for PAH, but several medications are available to treat symptoms, such as the market-leading prostacyclin PAH therapy, Remodulin® (treprostinil sodium), which is produced by United Therapeutics Corporation. The annual cost of Remodulin is reported to be between approximately $125,000 and $175,000 per patient and United Therapeutics reported Remodulin revenues of $602 million in 2016.
About Trevyent®
Designed to address the limitations of existing pulmonary arterial hypertension (PAH) therapies, SteadyMed’s Trevyent is an investigational drug product which combines a preservative-free, parenteral formulation of treprostinil, a vasodilatory prostacyclin analogue, with SteadyMed’s proprietary PatchPump®. Trevyent is a sterile, pre-filled, pre-programmed, single use disposable infusion system that is in development for the initial indication of continuous subcutaneous infusion of treprostinil for the treatment PAH. Cardiome licensed the commercial rights to Trevyent for the international markets of Europe, Canada and the Middle East and plans to file regulatory submissions for Trevyent in Europe and Canada following SteadyMed’s filing of a New Drug Application in the U.S. in 2018.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Cardiome develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company’s portfolio of approved and marketed brands includes: Xydalba
(dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications. Cardiome’s pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver treprostinil, the world’s leading treatment for pulmonary arterial hypertension.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (“forward-looking statements”) that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. A discussion of the risks and uncertainties facing Cardiome are discussed in our most recent annual and quarterly reports and detailed from time to time in our other filings with the Securities and Exchange Commission (“SEC”) available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. All of the risks and certainties disclosed in these filings are hereby incorporated by reference in their entirety. While Cardiome makes these forward-looking statements in good faith, given these risks, uncertainties and factors, you are cautioned not to place undue reliance on any forward-looking statements made in this press release. All forward-looking statements made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
Cardiome® and the Cardiome Logo are the proprietary trademarks of Cardiome Pharma Corp.
Aggrastat® and Brinavess® are trademarks owned by Cardiome and its affiliates worldwide.
Xydalba® is a trademark of Durata Therapeutics Holding C.V., and used under license.
Zevtera® and Mabelio® are trademarks owned by Basilea Pharmaceutica International Ltd., and used under license.
Esmocard® and Esmocard Lyo® are trademarks owned by Orpha-Devel Handels und Vertriebs GmbH, and used under license.
Trevyent® is a trademark of SteadyMed and used under license.
DALVANCE® is a trademark of Allergan Pharmaceuticals International Limited.
All other trademarks are the property of their respective owners.
SOURCE Cardiome Pharma Corp.
Sunday, April 1, 2018
Validation of European Patents in Cambodia
Paris, 13 March 2018 An agreement allowing the validation of European patents for Cambodia entered into force on March 1, 2018, allowing inventors and companies filing an application for European patent, to ask for Cambodia validation.
The European patents delivered by the EPO and validated in Cambodge will have the same legal effects than the same corresponding Cambodian patent and will be subject to Cambodian patent law.
However, it should be noted that pharmaceutical products are excluded from patent protection in Cambodia. This exception will also apply to European patents protecting pharmaceutical products and for which a validation would be required in Cambodia.
In order to obtain the validation of a European patent in Cambodia, it will be necessary to submit to the EPO a request for validation of the European patent for Cambodia, together with the payment of a validation fee, at the current rate of 180, within 6 months from the publication of the European search report in the European patent Bulletin or, when appropriate, within the time limit for performing the acts required for the entry of an international application into the European phase. This possibility only applies to European or international patent applications filed on or after March 1, 2018.
The agreement, signed in 2017 and the fourth of its kind to enter into force after similar agreements with Morocco, the Republic of Moldova and Tunisia, brings to 44 the number of countries for which patent protection can be obtained from basis of a European patent application.