When a large and successful institutional investing company like Alpha Capital Anstalt decides to invest in a certain field, it studies it in depth. The investment is always carefully screened before management gets the green light. Alpha Capital Anstalt investment strategy focuses on diverse but prominent areas, including startup companies,...
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Category Archives: regulatory
cCam Starts Phase I Cancer
cCAM Biotherapeutics has received approval form the US Food and Drug Administration to commence a Phase 1 trial for CM-24, a first-in-class immunomodulatory monoclonal antibody (mAb) for the treatment of various types of cancers. The study is expected to commence during the first quarter of 2015. CM-24 is directed against...
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Israel’s MD Biosciences Among CROs at Biotech China
MD Biosciences is a pre-clinical contract research organization (CRO) providing in vitro and in vivo nonclinical efficacy studies as well as a clinical biomarker and general chemistry analysis. The company’s focus is on inflammation, neurological and cardiovascular conditions. MD BioSciences’ approach is to understand the need in the clinic and...
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How Much Is Your Patent Worth
In collaboration with a senior patent licensing expert, BioIsrael is offering a new service that enables companies and individuals to establish the worth of a patent that they are holding in today’s market: The new service analyzes the following value indicators: Backward citations, forward citations, the number of claims, the...
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MediWound gets EU Approval
The European Medicines Agency (EMA) has recommended to grant MediWound marketing authorization for NexoBrid™ in the European Union (EU) for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burns. This approval follows EMA’s Good Manufacturing Practices (cGMP) approval for MediWound’s sterile manufacturing plant and laboratories. NexoBrid™...
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Bio-Chem Offers Data Loggers for Critical Parameter Monitoring
Bio-Chem Engineering is now offering the monitoring and analysis of temperature, relative humidity and other critical parameters using the most accurately-calibrated data loggers available. The software for the data loggers is FDA 21CFR part 11 compliant and meets all the standards of the biopharma industry. Uses for the data loggers...
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Patent Paralegal Course Nov. 18-20
THE PATENT PARALEGAL A-Z GUIDE will take place on Nov. 18-20 in Tel Aviv. The course, presented by a senior intellectual property paralegal with nearly two decades of experience in IP procedures, regulations and training, is directed to both the novice paralegal and the experienced paralegal. The sessions are designed...
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New Reasons for Doing Clinical Research in the UK: Nov.7-8 in Ramat Gan
“Israeli companies that have overlooked the UK as a trial site, now can take advantage of streamlined access that is being offered locally by the UK Israel Tech Hub and in the UK by a new agency, NOCRI, the NIHR Organization for Clinical Research Infrastructure in the UK,” says Iris...
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CollPlant Wound Closure Trial Success
CollPlant has successfully completed a wound closure clinical study opening the path toward regulatory certifications required for commercialization of CollPlant’s products. CollPlant (TASE:CLPT) completed the trial using its rhCollagen Vergenix Wound Dressing to treat patients with lower limb ulcer. The objective of the study was to assess the safety and...
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New Reasons for Doing Clinical Trials in UK: Seminar Nov.7-8 in Ramat Gan
“Israeli companies may have overlooked the UK as a trial site in the past, but now they can take advantage of streamlined access that is being offered locally by the UK Israel Tech Hub and by a new agency, NOCRI, the NIHR Organization for At – back with stylish http://www.sunsethillsacupuncture.com/vut/ppw-pharmacy-in-india...
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RedHill To List on NASDAQ / Successful MS Studies
RedHill Biopharma has filed with the U.S. Securities and Exchange Commission a non-public first draft registration statement to enable the listing of Company’s shares through a Level II ADR (American Depository Receipt) facility. Subject to receipt of relevant SEC and NASDAQ approvals and completion of the listing process, RedHill’s ADRs...
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Pluristem Applies for Orphan Drug Status for Aplastic Anemia
Pluristem has filed documents requesting that the U.S. Food and Drug Administration (FDA) grant orphan drug status to its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia. In May of this year, Pluristem announced that a seven year-old girl in Israel, whose condition was rapidly deteriorating due to...
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Orphan Drug Status for Medgenics Biopump
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) has received Orphan Drug Designation from the FDA for the treatment of hepatitis D using its Biopump technology. INFRADURE is the version of Medgenics’ Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan...
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