ATCC and BioAgilytix to host first ’Trends in Cell-Based Assays’ Forum

Shire Pharmaceuticals, Takeda Pharmaceuticals, Visterra, as well as the former senior advisor of Science Innovation and Policy for the Food and Drug Administration (FDA), will partner with ATCC and BioAgilytix to cover topics such as recent advances in the development of in vitro cell models, innovative technologies in antibody-drug conjugate assay development, and discuss the challenges in analytical method transfer in pharmaceuticals.

The forum is designed to benefit scientists currently working in the biopharmaceutical industry who want to improve their awareness of the latest advancements in cell-based assay development, and non-scientists who seek a better understanding of the processes, challenges, regulatory landscape, and opportunities in the industry.

“ATCC is pleased to partner with BioAgilytix to provide scientists with a unique opportunity to hear from some of the most respected and accomplished thought leaders in the discovery, development and commercialization life cycle of cell-based assay advancements,” said Dr. Maryellen de Mars, Vice President, Standards Resource Center, ATCC Global. “We believe this educational forum will generate quality discussions and give participants important access to the latest industry knowledge and key trends,” said Dr. de Mars.

About ATCC
ATCC is a leader in biological materials management, providing the worldwide scientific community and U.S. government with research and development, standardized products, and services in support of global health issues. With a history of innovation spanning more than 90 years, ATCC offers the world’s largest and most diverse collection of human and animal cell lines, microorganisms, biological products, and standards. ATCC is a non-profit organization with headquarters in Manassas, VA, and an R&D and services center in Gaithersburg, MD. For more information about ATCC, visit us at www.atcc.org.

About BIOAGILYTIX
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, GCP, and GCLP, as well as product release testing under GMP.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.

View full agenda online at www.atcc.org/forum

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SOURCE American Type Culture Collection

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CURE Pharmaceutical Reports Strong Progress and Sets Growth Roadmap for Remainder of Year

CURE Pharmaceutical Reports Strong Progress and Sets Growth Roadmap for Remainder of Year

Tuesday, April 3, 2018 12:57 PM UTC

OXNARD, Calif., April 03, 2018 — CURE Pharmaceutical (OTC:CURR), an innovative drug delivery company, today reported the company’s Q1 2018 accomplishments. The company strengthened its leadership team with biopharmaceutical expertise, secured additional financing, and boosted nutraceutical product distribution, while advancing towards the launch of its first pharmaceutical CUREfilm product.

“We see solid growth this quarter that offers a strong jumping off point for the year ahead,” said Rob Davidson, CEO CURE Pharmaceutical. “We are already seeing benefits from the additional operational and manufacturing talent that has streamlined manufacturing to support growth in production. Each step is vital to our company’s growth to make medications easier to take, more efficient, and with fewer side effects.”

In the first quarter of 2018, CURE Pharmaceutical has reported developments in the following key areas:

• Financing: Dr. Gene Salkind was named to CURE Pharmaceutical’s Advisory Board and invested $1 million in the company. Additionally, Alexander Capital raised a $1 million bridge financing transaction for working capital to expand production capabilities and accelerate product development.
• Three Strategic Hires: The company bolstered its leadership team with the addition of Jessica Rousset as Chief Operating Officer, Dr. Vered Gigi as its VP of Business Development and Strategy, and former Amgen executive, Steven Ruhl as the VP of Manufacturing.
• Nutraceutical Sleep Demand Increase: The company grew product demand this quarter, including two new purchase orders worth more than $500,000 in the nutraceutical sleep category. Due to leadership additions and improvements in manufacturing this quarter, the company has increased its shipments by more than 300 percent over the average quarterly shipments.
• Advanced ED CUREfilm product development: The company has advanced its erectile dysfunction (ED) CUREfilm product through manufacturing validation. CURE Pharmaceutical anticipates launching this product in Asia in Q2 2019. The global ED drugs market is expected to reach USD 3.2 billion by 2022, according to a report by Grand View Research Inc.
• Research: The first year of sponsored research at Israel’s Technion Institute of Technology has concluded. Specific cannabis extracts and extraction methods that result in tumor cell death in vitro have been identified, demonstrating that specific combinations of actives in the cannabis plant are responsible for the observed therapeutic effects, and that those therapeutic effects are specific to the type of cancer.

About CURE Pharmaceutical
CURE Pharmaceutical is a vertically integrated drug delivery and development company committed to improving drug efficacy, safety and the patient experience through its proprietary drug dosage forms and delivery systems. CURE has a full-service cGMP manufacturing facility and is a pioneering developer and manufacturer of a patented and proprietary delivery system (CUREfilm), one of the most advanced oral thin film on the market today. CURE is developing an array of products in cutting-edge delivery platforms and partners with biotech and pharmaceutical companies. CURE has positioned itself to advance numerous therapeutic categories, including the pharmaceutical cannabis sector with partnerships in the U.S., Canada, Israel and Germany, among other markets. The company’s mission is to improve people’s lives by redefining how medicines are delivered and experienced.

For more information about CURE Pharmaceutical, please visit its website at https://ift.tt/2lZPSq4.

Forward-looking Statement
This press release contains forward-looking statements, which are subject to risks and uncertainties. All statements, other than statements of fact, including those statements with respect to the Company’s business development, are forward-looking statements. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly update or revise any forward-looking statements.

Contact: Ashley Ray
(310) 824-9000
[email protected]

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Titan Pharmaceuticals’ (TTNP) CEO Sunil Bhonsle on Q4 2017 Results – Earnings Call Transcript

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

Request sample here https://www.reportsellers.com/market-research-report/Epigenetics—Global-Market

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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.

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