U.S. President-elect Donald Trump has tapped Elon Musk and Vivek Ramaswamy to lead a new commission on cutting government spending and regulation. ...

Canada-based fintech firm Nuvei has announced that it has obtained all necessary regulatory approvals to move forward with its acquisition by Neon Maple Purchaser.

Trump has pledged to reverse many actions of the Biden administration using executive orders, the Congressional Review Act, and fewer and less-reaching rules.

The need for a strong, centralized regulatory structure for India's pharmaceutical industry has taken center stage, with experts calling for the establishment of a Central Drug Regulatory Cadre and a Central Drug

Laura Friedl-Hirst, managing direction at LFH Regulatory explores what regulatory intelligence is and how it can benefit businesses.

On November 12, 2024, the Central Board of Direct Taxes (CBDT) issued a notification granting tax-exempt status to the Petroleum and Natural Gas Regulatory Board (PNGRB) under section 10(46A)(b) of the Income-tax Act, 1961. ...

According to Compliance & Risks latest assessment, the top issues in the apparel industry include but are not limited to e-bike labelling, greenwashing and the EU strategy on for sustainable textiles. This level of comprehensive regulatory content supported by live-linked data is aiding companies in monitoring and maintaining their compliance obligations and positions in the marketplace.

Christmas has come and gone, but anybody struggling to keep a small business afloat or pondering an entrepreneurial venture might be digging under the desiccated blue spruce (take it out, already) for a missed present or two. The good news is that, as tough as politicians make it to launch your own firm, they've recently gifted us with a bit of relief from their depredations—and more may be on the way.

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Then, as the recovery progressed, taxes and regulations reemerged.   But over the last year, those two concerns have been displaced by the availability of qualified labor.  Finding qualified employees is always a concern in a growing economy and has certainly grown in importance in this expansion, even more prominent than in 2000, when the ratio of employment to the population hit a record high.

Assisting its rise to number one has been the decline in the concerns about taxes and the cost of regulatory compliance.  The sharp decline in concerns about taxes and regulatory compliance are most likely due to the policies of this administration.  Record levels of proposed regulations peaked in the last two years of the last administration but dropped to practically nothing early in this term.  Since then, many existing regulations and rules have been eliminated or scaled back.

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Aim/Purpose: This paper describes the regulatory affairs discipline as a useful case in the study of both inter- and transdisciplinary science and dynamics related to communication across multiple boundaries. We will 1) outline the process that led to the development of transnational competencies for regulatory affairs graduate education, 2) discuss how the process highlights the transdisciplinary character of regulatory affairs, 3) provide implications for how to communicate the influence of this characterization to future healthcare professionals, and 4) draw conclusions regarding how our lessons-learned might inform other programs of study. Background: In the past few decades, the regulatory affairs profession has become more internationalized. This prompted the need for new competencies grounded in the transnational and cross-disciplinary contexts in which these professionals are required to operate. Methodology: A convenience sample of experienced regulatory affairs professionals from multiple disciplines contributed to the development of transnational competencies for a master’s program in regulatory affairs using a transdisciplinary framework. Contribution: An applied exemplar in which to understand how transdisciplinary characteristics can be communicated and applied in higher education. Recommendations for Practitioners: This paper recommends how competencies developed from a regulatory affairs program can serve as exemplars for other applied transdisciplinary higher education programs. Impact on Society: This framework provides a seldom-used reflective approach to regulatory affairs education that utilizes cross-disciplinary theory to inform competence-based formation of professionals.

Drawing on resource drain theory, we introduce self-regulatory resource (ego) depletion stemming from family-to-work conflict (FWC) as an alternative theoretical perspective on why supervisors behave abusively toward subordinates. Our two-study examination of a cross-domain antecedent of abusive supervision stands in contrast to prior research, which has focused primarily on work-related factors that influence abusive supervision. Further, our investigation shows how ego depletion is proximally related to abusive supervision. In the first study, conducted at a Fortune 500 company and designed as a lagged survey study, we found that after controlling for alternative theoretical mechanisms, supervisors who experience FWC display more abusive behaviors toward subordinates, and that this relationship was stronger for female supervisors and for supervisors who operate in environments with greater situation-control. These results were then replicated and expanded in an experience sampling study using a multi-organization sample of supervisors. This allowed us to study the FWC-abusive supervision relationship as it emerges on a day-to-day basis and to examine ego depletion as an explanatory mechanism. Consistent with our hypotheses, we found that FWC is associated with abusive supervision, ego depletion acts as a mediator of the FWC-abusive supervision relationship, and that gender and situation-control serve as moderators.

We study the interplay between regulatory mandates and competition on a focal firm's new resource investments. While prior literature has separately pointed to the influence of competition and regulatory policy on a focal firm's resource decisions, less is known about how the policy effect interacts with the competitive effect. Studying how regulatory mandates moderate the effect of competition on a focal firm's new resource investments, we show that resource redeployment is not simply a function of internal firm decisions but a response to external forces. We find that regulatory mandates dampen the effect of competitors' new resource investments on a focal firm's new resource investments. Distinguishing between different clean technology types, we show that this dampening effect is the stronger, the more distant the new resource is from incumbents' old resource base, and the more established the mandate is. We test our hypotheses in the context of renewable energy investments in waste-to-energy, wind, and solar in the U.S. electricity industry. Our data comprises 1542 utilities and private energy firms and their renewable investments from 1999 to 2010.

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June … Continue reading →

Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →

Washington – OSHA expects to issue highly anticipated proposed rules for its Silica and Injury and Illness Prevention Program standards within the next few months, according to the Spring Regulatory Agenda, published July 3.

Silver Spring, MD – The AFL-CIO’s Executive Council has denounced efforts to roll back federal laws and regulations that “have protected working people on the job” for more than 50 years.

Boca Raton, FL — A new report from the National Council on Compensation Insurance provides an overview of key legislative, regulatory and other developments affecting the workers’ comp system.

Washington — The Department of Labor’s regulatory agenda for fall 2018, released Oct. 17, contains few changes for OSHA and the Mine Safety and Health Administration.

Washington — A planned update to OSHA’s Lockout/Tagout standard (1910.147) has been pushed to “long-term actions” under the Department of Labor’s Spring 2023 regulatory agenda.

Arlington, VA — The inclusion of a long-awaited Mine Safety and Health Administration proposed rule on respirable crystalline silica in the Department of Labor’s Fall 2022 regulatory agenda represents a milestone for which MSHA administrator Chris Williamson wants to “underscore the significance.”

Washington — The Federal Motor Carrier Safety Administration has announced temporary relief from hours-of-service requirements for commercial motor vehicle drivers delivering “direct assistance” to emergency efforts in states affected by severe winter weather.

Washington — The Federal Motor Carrier Safety Administration once again is extending temporary hours-of-service exemptions and other “regulatory relief” for commercial motor vehicle drivers transporting items intended to assist with COVID-19 pandemic relief efforts.

Washington — The Federal Motor Carrier Safety Administration is requesting public comment on a proposed rule that would “narrow the scope” of temporary hours-of-service exemptions and other regulatory relief for truckers during emergency declarations.

Washington — Temporary hours-of-service exemptions and other regulatory relief for truckers during regional emergency declarations will be limited under a recently published Federal Motor Carrier Safety Administration final rule.

Washington — The Department of Labor’s regulatory agenda for Fall 2021, released Dec. 10, includes a proposed rule that – should OSHA decide to move forward on it – would revoke Arizona’s State Plan status.

OSHA’s final rule on occupational exposure to beryllium is scheduled for publication in January, according to the Department of Labor’s fall regulatory agenda, released Nov. 17.

Washington — A handful of potential OSHA standards have advanced in the rulemaking process, according to the Department of Labor’s Spring 2024 regulatory agenda – released July 5.

Boca Raton, FL — “Mental injuries” (such as post-traumatic stress disorder), cannabis and independent contractors were among the top workers’ compensation-related issues that state legislatures focused on this year, a new report shows.

Washington — Public Citizen will not appeal the second dismissal of its lawsuit against President Donald Trump’s “2-for-1” deregulatory Executive Order, a spokesperson for the watchdog group told Safety+Health Jan. 16.

Washington — A hotly contested proposed rule that would require speed-limiting devices on heavy trucks has again been delayed.

Source: Andrew Fein 10/23/2024

H.C. Wainwright & Co. analysts Andrew S. Fein, Matthew Caufield, Dr. Andres Y. Maldonado, and Dr. Ananda Ghosh, in a research report published on October 23, 2024, maintained a Buy rating on DBV Technologies SA (DBVT:NASDAQ) while raising their price target to US$7.00 from US$5.00. The report follows DBV's announcement of regulatory clarity regarding the path forward for its Viaskin Peanut patch.

The analysts highlighted the significance of the FDA agreement, stating, "DBV Technologies has reached an agreement with the FDA regarding the regulatory pathway for the Viaskin Peanut patch in toddlers aged one to three, under the Accelerated Approval pathway."

Regarding the company's development timeline, the analysts noted, "The Biologics License Application (BLA) submission for Viaskin Peanut in this age group is expected to be supported by positive efficacy and safety data from DBV's completed EPITOPE Phase 3 study, as well as additional safety data from the upcoming six-month COMFORT Toddlers supplemental safety study, which is expected to begin in 2Q25."

The report emphasized the strength of DBV's regulatory position, stating, "The FDA has stated that DBV has already satisfied two of the three criteria: the product treats a serious condition, and the product candidate provides a meaningful advantage over available therapies."

The analysts also highlighted progress in Europe, noting, "The EMA confirmed that the successfully completed EPITOPE Phase 3 efficacy and safety trial in the one to three-year-old population, along with positive results from the VITESSE study in the four to seven-year-old population, and a new safety study using the modified circular patch in one to three-year-olds, could support an MAA for the one to seven-year-old indication with the modified patch."

The analysts' valuation methodology for DBV Technologies is based on a composite approach. They explained, "Our US$7 price target is based on an equally weighted composite of: (a) US$5.10/share, as a 20x multiple of taxed and diluted FY34 GAAP EPS of US$5.13 discounted back to FY24 at 35%; and (b) an NPV of US$8.52/share with a 13% discount rate and 1% growth rate."

The report included commercial projections, with the analysts stating, "We continue to model initial approval in 2027, with projected initial sales of US$17.5M, growing to US$1,182.8M by 2034."

The analysts also outlined several risk factors, including potential clinical study failures, regulatory approval challenges, and market size uncertainties.

In conclusion, H.C. Wainwright & Co.'s increased price target to US$7 reflects growing confidence in DBV Technologies' regulatory pathway for the Viaskin Peanut patch. The share price at the time of the report of US$0.70 represents a potential return of approximately 900% to the analysts' target price, highlighting the significant upside potential if the company successfully navigates the regulatory process and commercializes its product.

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Disclosures for H.C. Wainwright & Co. DBV Technologies S.A., October 23, 2024

Important Disclaimers This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of DBV Technologies S.A. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DBV Technologies S.A.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from DBV Technologies S.A. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from DBV Technologies S.A. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in DBV Technologies S.A. as of the date of this research report.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

( Companies Mentioned: DBVT:NASDAQ, )

A profusion of biotechnology products is expected over the next five to 10 years, and the number and diversity of new products has the potential to overwhelm the U.S. regulatory system, says a new report from the National Academies of Sciences, Engineering, and Medicine.

The number of patients in the U.S. awaiting organ transplantation outpaces the amount of transplants performed in the U.S., and many donated organs are not transplanted each year due to several factors, such as poor organ function, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Black lung disease cases in coal miners have been increasing since 2000 for uncertain reasons.

The U.S. Environmental Protection Agency has issued a proposed rule for strengthening transparency in regulatory science (April 30, 2018, 83 Federal Register 18768), which stipulates that EPA will ensure that the data and models underlying the pivotal science that informs significant regulatory actions are made publicly available, in a format that allows for outside analysis and validation.

The National Academy of Medicine (NAM) along with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) have named the 2018-2019 class of FDA Tobacco Regulatory Science Fellows.

The goal of achieving universal health coverage by 2030 — one of the United Nations’ Sustainable Development Goals — necessitates that countries strengthen their food and drug regulatory systems as a whole, says a new report from the National Academies of Sciences, Engineering, and Medicine.

The CDC’s Division of Global Migration and Quarantine should create an effective and innovative quarantine station model to confront new challenges in preventing the spread of infectious diseases in the U.S., and requires new investment and regulatory reforms to do so.

Should the payment of a ransomware demand be illegal? Should it be regulated in some way? These questions are some examples of the legal minefield that cybersecurity teams must deal with

The telecom regulator has recommended two categories for cable landing station (CLS) location – main CLS, and CLS point-of-presence (CLS-PoP).

Constellation said it is seeking guidance from regulators after FERC's decision about co-location, which had become a promising prospect for Big Tech's plans to quickly access large amounts of power for its AI expansion instead of waiting for years to connect to the grid.

Do you have your food defense plan in place? July 26, 2019 is the compliance deadline for the FDA's final rule on Mitigation Strategies to Protect Food Against International Adulteration under the Food Safety Modernization Act (FSMA).

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight major food allergen categories that accounted for more than 90 percent of all documented food allergies in the U.S.

Traceability takes a top spot in modern food industry food safety strategies, following every aspect of the supply chain through manufacturing and to the point of consumer purchase.

During and since the two-week government shutdown, there has been a lot of analysis from across the political spectrum. The analysis includes a lot of finger pointing and blame assessment. At the end of the day, it was the abdication of leadership by all parties and no coherent strategy for how to end the stalemate that lengthen the shutdown.

Many of us are asking ourselves where the summer went, and it is difficult to find a good answer. I hope you had some deserved downtime with family at some point.

With great trepidation that this column will become immediately obsolete or at least very dated in the short time from submitting it to publication, I want to address the whirlwind of regulatory relief announcements from the new Trump Administration.

During the tumultuous first year of the Trump Administration, the untold story has been the significant efforts to mitigate the numerous regulatory overreaches by the Obama Administration.