News & Analysis as of

Medical Research Pharmaceutical Industry

Combining Ritalin and Cognitive Behavioral Rehabilitation Shows Promise Following TBI

by Downs Rachlin Martin PLLC on

A treatment protocol combining Ritalin, a stimulant commonly used for ADHD, and a form of Cognitive Behavioral Rehabilitation known as “Memory and Attention Adaptation Training” (MAAT) shows great promise for improving...more

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

by Goodwin on

The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Health Alert (Australia) 11 December 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 1 December 2017 - Laerdal Medical Pty Ltd and Comptroller-General of Customs AATA 2427 - CUSTOMS – whether subject goods accessory –...more

Health Alert (Australia) 23 October 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Australian Capital Territory 19 October 2017 - Medical Board of Australia v Helmy (Occupational Discipline) [2017] ACAT 85 -...more

Study concludes that data supports switching from Remicade® to biosimilar Renflexis®

by Goodwin on

A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe...more

Health Alert (Australia) 25 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 20 September 2017 - Non-inquest findings into the death of RO'H 2013/761 - 'Mr RO'H died at Logan Hospital after being...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

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

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

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

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

Health Alert (Australia) May 1, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 21 April 2017 - ILS Rehab Pty Ltd v Josephine Borg (as administrator of the estate of the late Damien Robert Borg) [2017] NSWSC 442...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Health Alert (Australia) January 30, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 23 January 2017 - Shales and Commonwealth Bank of Australia [2017] AATA 53 -...more

21st Century Cures Act offers array of holiday gifts to healthcare providers

by DLA Piper on

The 21st Century Cures Act, a rare beneficiary of broad bipartisan support, has been signed into law by President Barack Obama. The law has received much public acclaim for its $4.8 billion in new funding over the next...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

by Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

by Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Health Alert (Australia) November 28 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 23 November 2016 - Tolley v Secretary, NSW Ministry of Health in respect of Northern NSW Local...more

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

As Nobel season opens, a reminder how slowly science actually advances

Just in time for the annual awards of the Nobel prizes, Stat, the online health news site, provides a trenchant reminder that science advances slowly. That’s especially true in medical science. So as international attention...more

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