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New Kickback Law Targeting Opioid Treatment Facilities Could Affect Traditional Lab Arrangements
Dinsmore & Shohl LLP, January 2019

Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic.  EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S...

Health Law Vitals - A Healthcare Newsletter from Haynes and Boone, December 2018
Haynes and Boone, LLP, December 2018

Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a...

Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco
Patterson Belknap Webb & Tyler LLP, December 2018

In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc...

ISS and Glass Lewis 2019 Policy Updates
Haynes and Boone, LLP, December 2018

Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018...

FDA Proposes Changes to Clinical Trial Informed Consent Rules
Dinsmore & Shohl LLP, November 2018

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects...

Obstacles to IPOs Faced by Life Sciences Companies
Lowenstein Sandler LLP, October 2018

Initial public offerings (IPOs) are often seen as attractive by business owners in the life sciences or biotech field, writes Alan Wovsaniker, a partner with Lowenstein Sandler, in an Expert View column on the topic. The need for capital in a life sciences business tend to be great, as the cost to develop new drugs, therapies or medical devices is extremely expensive and it takes many years to receive regulatory approval to market and sell such drugs, therapies or medical devices...

Scotland in 2050: Life Sciences - Growth Ambitions and the Challenges Ahead
Shepherd and Wedderburn LLP, October 2018

From ground-breaking discoveries such as penicillin and insulin, to the development of the MRI body scanner and the creation of Dolly the sheep, the first mammal to be cloned from an adult cell...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, October 2018

The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities  1. Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth...

State Initiatives to Control Drug Prices
Lowenstein Sandler LLP, October 2018

While the Trump administration and Congress have talked a lot about controlling drug prices, and the administration did recently float a much-criticized proposal to require drug companies to include list prices in TV ads, state governments have grown tired of waiting and seized the initiative in this area in imaginative ways. Over the past several years, numerous states have taken a broad variety of measures to control and influence prescription drug spending and prices...

Readying Your Life Sciences Business for Investment: A Quick Guide: Scotland
Shepherd and Wedderburn LLP, October 2018

With investors such as the Scottish Investment Bank, the soon-to-be-launched Scottish National Investment Bank and the Epidarex Life Sciences Fund all increasingly paying attention to the life sciences sector against the backdrop of an increasingly competitive life sciences market in Scotland, now is a great time to consider whether your business is ready for investment, and how it could be standing out in order to attract investors...

The Challenge of Getting International Talent into the Life Science Sector in Scotland Continues
Shepherd and Wedderburn LLP, September 2018

Scotland is currently home to one of the largest life science clusters in Europe, with more than 700 organisations based here employing some 37,000 people. With 15 universities producing highly skilled graduates; the NHS as a massive single source of patient data; and world leading research centres in life sciences, Scotland attracts some of the brightest international scientists and life science businesses...

Pilot Scheme for Risk Sharing in the Reimbursement System as Part of the Growth Plan for Life Science
Plesner, July 2018

The Danish government has now published its life science growth plan, which aims at making Denmark a leading life science nation in Europe. The growth plan is based on the recommendations submitted by the Growth Team for Life Science. Plesner has previously reported on the topic.1  The growth plan contains 36 initiatives in 6 key areas. One of the many initiatives is a pilot scheme for risk sharing in the drug reimbursement system...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, July 2018

The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth...

Patents for Inventions Related to Zika Virus, Chikungunya Virus, and Rare Diseases may have Fast-Track Examination at the BPTO
Veirano Advogados, July 2018

Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System...

Gene Therapy Policies Can Strike An Ethical Balance
Morris, Manning & Martin, LLP, July 2018

On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy...

New System of Processing Customs Destination Certificates for Medical Devices Without a Sanitary Registration
Carey, July 2018

In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164”...

Dr. Robot at Your Service: Artificial Intelligence in Healthcare
Lavery Lawyers, June 2018

Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g...

Denmark Establishes National Genome Center
Plesner, June 2018

Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment...

Fed. Circ. Case May Change Biosimilar IPR Strategy
Patterson Belknap Webb & Tyler LLP, April 2018

 Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration...

From Talcum to Glyphosate: The Multi-Billion Dollar Battle to Define 'Risk'
Hunton Andrews Kurth LLP, April 2018

Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder...

Health Law Vitals - A Healthcare Newsletter from Haynes and Boone, March 2018
Haynes and Boone, LLP, March 2018

 More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs...

Mixed Results as IPR Petitions for Biosimilars Soar
Patterson Belknap Webb & Tyler LLP, December 2017

Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017...

Drug/Device Development Changes Imminent: 21st Century Cures Act Becomes Law
Lowenstein Sandler LLP, July 2017

Life sciences companies are navigating sweeping changes brought about by the 21st Century Cures Act (the “Cures Act” or the “Act”) signed in recent years. Of most interest to those companies is how the Act is changing the pathways and processes for developing and getting approval for new drugs and devices and new uses for existing products...

The New Act to Prohibit and Prevent Genetic Discrimination
Lavery Lawyers, July 2017

In recent months, the Senate passed the Act to prohibit and prevent genetic discrimination (Genetic Non-Discrimination Act). This Act also amended the Canada Labour Code and the Canadian Human Rights Act. The new Act aims to regulate the use of genetic tests, namely, tests that analyze the DNA1, RNA2 or chromosomes of a person for predictive or monitoring purposes or for establishing a diagnosis or prognosis, mainly within a contractual framework...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, July 2017

The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector.   Opportunities and Challenges – 6 Key Themes Three Key Opportunities 1...

 

 

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