As the Trump administration is pushing forward on its deregulatory agenda and, in particular, its efforts to improve the Endangered Species Act (ESA) and its implementation by the US Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (together, the Services), the Supreme Court is poised to hear a landmark case on designation of critical habitat under the ESA that could provide some guideposts for the Services’ new regulations ...
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 ...
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” ...
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 ...
The Corps Struggles to Balance Competing Constitutional and Statutory Duties Federal agencies must often balance competing policy concerns and legal requirements. This process may be difficult and fraught with intense public feedback, and frequently results in litigation. The U.S. Army Corps of Engineers (the Corps) has found itself in the hot seat over how it manages the nation’s rivers, pitting its obligations under the Endangered Species Act (ESA) against private property rights ...
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 ...
Geographical indication of origin, this very peculiar form of industrial property protection, has undergone a revival phase over the past few years, thus becoming more omnipresent not only within the circles of interest, but also amongst the Serbian public at large. Although, up to this day, there are only a few dozen geographical indications of origin registered before the Serbian Intellectual Property office, for a country of little over 7 million spread over 80 ...
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 ...
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 ...
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 ...
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 ...
While the Ukrainian Parliament continues heated debates over the open market for agricultural land, one thing remains clear - the lifting of the moratorium on sale of agricultural land is an inevitable process, which is largely driven by globalization and the expansion of influence of major world corporate groups in Ukraine. However, for the land market and agribusiness to become transparent and efficient, the relevant risk management systems have to be implemented ...
A successful appeal against a remediation notice has highlighted the difficulties faced by local authorities when trying to secure the remediation of contaminated land. The appeal is only the second appeal to the Secretary of State for Environment, Food and Rural Affairs (SoS) since the contaminated land regime in Part 2A of the Environmental Protection Act 1990 was implemented in 2000 ...
2017 is a year of opportunity and challenge for the Australian food and agribusiness sector. We anticipate an uplift in food and agribusiness M&A activity, and have identified 6 key themes that are likely to play out in the remainder of 2017. Opportunities and Challenges – 6 key themes Three Key Opportunities 1 ...
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 ...
Brazil has a very small Muslim community. In any event, this is a country which, despite economic and/or political crises, foreign investors are always looking at. At this moment, one can see foreign investors acquiring assets in Brazil because of their low prices ...
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 ...
The Danish Government's Growth Team has just Presented its Recommendations for how to Strengthen Denmark's International Position within Life Science. This happened at a Press Conference with the Participation of the Chair of the Growth Team, Kåre Schultz and the Minister for Industry, Business and Financial Affairs, Brian Mikkelsen ...
Today, we are at a time where two-generation professionals are actively developing and competing with each other within their own career. The well-known "millenials" or generation "Y", born according to some analysts between the years 1981 to 1999, and where the majors of this generation are already in the 36 years of life, and those of the generation X ...
2017 is a year of opportunity and challenge for the Australian food and agribusiness sector. We anticipate an uplift in food and agribusiness M&A activity, and have identified 6 key themes that are likely to play out in the remainder of 2017. Download our report: Australian Food and Agribusiness 2017: Key themes Opportunities and Challenges – 6 key themes Three key opportunities 1 ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The World Bank Group has released Enabling the Business of Agriculture 2017. The report presents data on legal barriers for farmers, entrepreneurs and businesses operating in agriculture in 62 countries and across the topics of land, seed, fertilizer, machinery, water, livestock, finance, markets, transport, and information and communication technology (ICT). SyCipLaw's Rose Marie M. King-Dominguez, Alan C. Fontanosa, Franco Aristotle G. Larcina and Ruben P ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
Dangro Invest A/S that has farm land investments in Poland has just been sold to an American pension fund. Plesner has advised Dangro Invest A/S's board of directors with respect to the transaction.Dangro Invest A/S was previously owned by 416 private shareholders, primarily Danish farmers, and over a number of years the company has built up a commercial plant cultivation business in Poland ...
Ever since Serbia’s Stabilisation andAssociation Agreement with the EU (‘SAA’) entered into force in September 2013, Serbian media have paidsignificant attention to the country’s obligations concerning the acquisitionof agricultural land by foreigners. The fear of one part of the public appearsto be that, due to the application of the SAA, large portions of Serbianagricultural land will be sold out to foreigners ...
