News & Analysis as of

Medical Research

Health Alert (Australia) 18 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 6 September 2017 - Finding of inquest into death of Phillip William Michell - Phillip William Michell died on 11 July 2015 at the...more

Research into Cannabidiol (CBD) Progresses

by Knobbe Martens on

Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This...more

Takeda Pharmaceuticals Explores GI Devices in New Partnership with Nanotechnology Company

by Knobbe Martens on

Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the...more

CRISPR Therapeutics Announces Two-Year Collaboration Agreement with Massachusetts General Hospital

by Allen & Overy LLP on

CRISPR Therapeutics and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop novel T-cell therapies for cancer. CRISPR/Cas9 gene...more

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

0.44% of NFL Brains

by Wilson Elser on

When The New York Times reports that 110 out of 111 NFL brains (99.09%) have chronic traumatic encephalopathy (CTE), everyone pays attention. Mothers worry about their kids. Some worry about their jobs. Senate subcommittees...more

August 2017 – Regulating CRISPR genome editing in humans: where do we go from here?

by Allen & Overy LLP on

The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Health Alert (Australia) 7 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 July 2017 - Spragg and Australian Health Practitioner Regulation Agency [2017] WASAT 103 - The applicant made a complaint to the...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Health Alert (Australia) 31 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 24 July 2017 - Medical Board of Australia v Soo [2017] SAHPT 10 - In this proceeding, the respondent, a physiotherapist, was alleged to have...more

FDA User Fee Reauthorization Legislation Enacted by Congress

by Ropes & Gray LLP on

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1. The President...more

New Information on Photophobia following TBI

One of the most common symptoms following TBI is photophobia, an intense intolerance to light that can cause significant discomfort, interfere with activities of daily living, and contribute to post traumatic headaches. It...more

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

by Butler Snow LLP on

It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

Health Alert (Australia) 24 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 18 July 2017 - Ms Shahin Tavassoli v Bupa Aged Care Mosman [2017] FWC 3200 - Application for an unfair dismissal remedy. The...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

Health Alert (Australia) 17 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 June 2017 - Dr Praneal Dutt Sharma v Dr Phillip Segal and Dr Greg Chen [2017] NSWSC 867 - CONTRACT – commercial agreement...more

Biomedical Research Advocacy

by Fox Rothschild LLP on

Like many other animal-related businesses universities, researchers, pharmaceutical companies, their suppliers, associated businesses and non-profit trade associations, are facing increasing scrutiny by the public who...more

IARC Will Convene Advisory Group in 2018/2019 to Consider Nominations

To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations...more

New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

“Come See Our World” Presented By Americans For Medical Progress

by Fox Rothschild LLP on

American for Medical Progress (AMP), “a nonprofit organization dedicated to protecting society’s investment in biomedical research,” just launched an important new educational tool for the public to see and understand the...more

Health Alert (Australia) 29 May 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 12 May 2017 - White v State of Queensland (Central Queensland Hospital and Health Service) [2017] QIRC 41 - INDUSTRIAL LAW –...more

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