Medical Research Pharmaceutical Industry

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

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

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,...

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

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

FDA, research institutions criticized for trying to control public information

It may sound like inside baseball but it’s not. It’s a critical aspect of how federal bureaucrats who work for us, the taxpayers, need to stop advancing their own agendas, and how they should stop trying to control not only...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

The Marijuana Industry’s Big Win: The DEA’s Refusal to Reschedule

Earlier this year, when the U.S. Drug Enforcement Agency (DEA) indicated it would have an announcement regarding a now five-year-old petition to reschedule cannabis, numerous industries on the “outside looking in” were...more

Health Alert (Australia) - May 9, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: JUDGMENTS Commonwealth. Federal Court 29 April 2016 - Australian Competition and Consumer Commission v Reckitt...more

Health Alert (Australia) - February 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: South Australia 28 January 2016 - Inquest into the death of Ebony Simone Napier The South Australian Coroner has...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part Two of Two

The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

Health Alert (Australia) - June 22, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria. Inquest Into the Death of Baby Chloe Lee Kellett - The Victorian Coroner investigated an infant's death from...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

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