Tag: Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

CellGenix expands its German facility

CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion.

BrainStorm Cell Therapeutics develops NurOwn: ALS therapy

The first company has provided a potential out-of-pocket price for patients who seek access through the recently passed federal Right-to-Try legislation and it’s not cheap. BrainStorm Cell Therapeutics could charge more than $300,000 for its Phase III experimental amyotrophic lateral sclerosis therapy NurOwn.

Moleculin Biotech gets Polish approval for clinical studies

drug development
Moleculin Biotech, a clinical stage pharmaceutical company, announced it has received Polish National Office approval to begin its second Phase I/II clinical trial to study Annamycin.

Targovax secures a patent from the European Patent Office

Targovax, is a Norwegian clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, announced that the European Patent Office had granted European Patent.

Stealth BioTherapeutics obtains financing for development of clinical program

Stealth BioTherapeutics, a clinical-stage biopharmaceutical company developing a platform of novel therapeutic compounds for the treatment of mitochondrial dysfunction, announced the closing of $100 million of financing.

LakePharma and Harbour Antibodies entered into technology partnership

LakePharma and Harbour Antibodies BV announced a technology partnership providing LakePharma the right to utilize Harbour Antibodies' patented, H2L2 transgenic mouse platform in its therapeutic antibody discovery service.

CRO Optimapharm enters the US market

Optimapharm, a clinical research organization, headquartered in Croatia, announced the launch of the first U.S. office . The new office is located in New York and this will be a huge step for Optimapharm into the USA market.

ViiV Healthcare’s HIV treatment showed positive results in phase III studies

viiv healthcare
The GEMINI studies are part of innovative clinical trial programme for two-drug regimens that seeks to address long-term toxicity concerns of people living with HIV by reducing the number of medicines used in their treatment.

Cancer Research UK and Asterias started a trial of immunotherapy vaccine

A first of its kind treatment vaccine has moved into a phase I clinical trial for patients with non-small cell lung cancer (NSCLC), under a collaboration agreement between Cancer Research UK and Asterias Biotherapeutics.

Amarin entered into collaboration with Mochida Pharmaceutical

drug development
Amarin Corporation, a biopharmaceutical company focused on the development of therapeutics to improve cardiovascular health, announced that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical.

EMA held its 100th Management Board meeting

On June 6-7th, 2018, the European Medicines Agency (EMA) held the 100th meeting of its Management Board. Former chairs of the Board, plus all former Executive Directors of the Agency came to EMA to mark the occasion.

PPD and NeoGenomics created a strategic alliance

Pharmaceutical Product Development, LLC (PPD) and NeoGenomics Laboratories are forming a strategic alliance to provide a seamless and fully integrated global pathology and molecular testing solution.

Microbiotica and Genentech entered into collaboration

drug development
Microbiotica, a leading player in microbiome-based therapeutics spun out of the Wellcome Sanger Institute, announced that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group.

New Microgen drug will allow to treat cerebral palsy

NPO Microgen of Nacimbio holding company, a part of Rostec, has completed the studies on new indications for the use of Relatox, a drug for the treatment of spastic forms of cerebral palsy (CP) in patients aged 7-12 years old.

New digital platform is expected to revolutionize drug discovery

The launch date of the new iPlexus will be on June 30, 2018. The platform is expected to transform the exchange of research work not only in preclinical life research but also in drug discovery.

BioTime received $1.9 million grant from the Israel Innovation Authority

BioTime, a clinical-stage biotechnology company focused on degenerative diseases, has been awarded a new grant for 2018 of up to $1.9 million from the Israel Innovation Authority (IIA).