Clinical Intelligence

NIH’s All of Us Research Program, NLM collaborate on outreach efforts through libraries

Monday, December 11, 2017

NIH’s All of Us Research Program and the National Library of Medicine (NLM) have teamed up in a landmark effort to advance precision medicine for the benefit of communities through local libraries. Traditional healthcare takes a “one-size fits all” approach, but precision medicine is healthcare that is “tailored to a person based on things unique to that individual, such as their lifestyle, environment and their biology,” said Dara Richardson-Heron, M.D., chief engagement officer, NIH’s All of Us Research Program. 

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FDA approves first biosimilar for certain breast and stomach cancers

Friday, December 8, 2017

The FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

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Johnson & Johnson and partners launch Mosaic HIV-1 Preventive Vaccine

Friday, December 8, 2017

Johnson & Johnson announced that its Janssen Pharmaceutical Companies, together with a consortium of global partners, have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine. The Bill & Melinda Gates Foundation and National Institutes of Health are joining forces with Johnson & Johnson to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic.

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Amsterdam deemed a good choice as EMA’s new home, but transition will not be easy

Monday, December 4, 2017

The EMA, a multi-national regulatory agency that serves more than 500 million people living in Europe, will relocate from London to Amsterdam as a direct result of Britain’s vote to leave the European Union (EU), known as Brexit. While the move will be devastating for Britain’s pharmaceutical and health sciences industries, it will bring nearly 1,000 new jobs and an injection of capital to Amsterdam, which will become the EMA’s new home when the U.K. officially leaves the EU in March 2019. Overall, 19 European cities bid on the highly sought-after spot. After a complex voting process, a tie-breaking draw of lots crowned Amsterdam the winner over Milan. 

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Balancing new with common recruitment tactics

Friday, December 1, 2017

For sponsors and CROs, patient recruit­ment has become a moving target. Re­cruitment tactics are shifting from the use of traditional, centralized advertising to digital and online media. Outreach strate­gies have become more targeted and com­panies are moving toward leveraging net­works of electronic medical records (EMRs) and other data to support more effective recruitment for clinical trials. Yet there are mixed opinions about the value of digital or social media campaigns. While drug development executives ex­pect EMRs and health records to play a major role in patient recruitment within five years, according to the Tufts Center for the Study of Drug Development (CSDD), much of the data needed to identify eligi­ble clinical trial participants doesn’t exist in EMRs. The systems weren’t designed for simplifying searches across files.

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FDA grants orphan designation for Hemophilic Arthropathy treatment TRM-201

Monday, November 27, 2017

Tremeau Pharmaceuticals, a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced that the FDA has granted an orphan drug designation, on a first cycle review, for TRM-201 (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), for the treatment of degenerative joint disease in patients with hemophilia, also known as hemophilic arthropathy (HA). 

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Eureka to start phase I ET190L1-ARTEMIS T cell therapy trial

Monday, November 27, 2017

Eureka Therapeutics, a clinical stage biotechnology company focused on improving the safety profile of T cell therapies and developing novel T cell therapies for the treatment of solid tumors, announced FDA allowance of its investigational new drug (IND) application and authorization to commence a phase I clinical trial for ET190L1-ARTEMIS T cells in Relapsed and Refractory CD19+ Non-Hodgkin Lymphoma (NHL), including Chronic Lymphocytic Leukemia (CLL). Eureka expects to enroll the first patient in this trial in the first quarter of 2018.

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New patient adherence tech tests the limits

Monday, November 27, 2017

With the FDA’s recent approval of Abilify MyCite, a “digital pill” that can indicate whether a patient has taken his or her medication, physicians may finally have an effective way of attacking the problem of medication nonadherence. Abilify MyCite is a drug-device combina-tion product that consists of Otsuka Pharmaceutical’s oral Abilify (aripiprazole) tablets that have been embedded with an ingestible biosensor developed by Proteus Digital Health.

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Khondrion presents phase II KHENERGY trial data

Wednesday, November 22, 2017

Khondrion, a clinical-stage pharmaceutical company focusing on small molecule therapeutics for mitochondrial diseases, announced results from its KHENERGY study, a phase II exploratory trial with oral KH176 in the m.3243A>G multisystem mitochondrial MELAS and MIDD syndromes and mixed phenotypes. The results of the trial were presented by Prof. Jan Smeitink, Khondrion’s CEO, at the Dutch Life Sciences Conference.

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