Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Les nouveaux avenants à l’accord cadre. La mise en pratique des préparations hospitalières spéciales et l'avenant à l'accord-cadre sur les hausses de prix à l'aune de la souveraineté sanitaire....more
The new amendments to the French framework agreement. The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical...more
Publication of the French decree regarding the experimentation of the "direct access" to pharmaceutical products with anticipated reimbursement: a half-hearted step forward for pharmaceutical innovations....more
Publication du décret relatif à l’expérimentation du dispositif d’accès direct des médicaments à un financement anticipé : une avancée en demi-teinte s’agissant de l’accès au marché des innovations pharmaceutiques en France....more
The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
France is generally known for its high quality and also highly regulated healthcare system. As an EU Member State, France has implemented the EU medicines and medical devices regimes. This chapter should therefore be read in...more
Le Conseil d’Etat confirme que seule la décision d’autorisation de mise sur le marché peut définir un médicament en tant que générique. Par deux décisions récentes du 7 juillet 2021 (Johnson & Johnson, req. n° 437803 et...more
The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic. In two recent decisions of 7 July 2021 (Johnson & Johnson, req. no....more
Dans un rapport publié le 23 juin 2021, la mission d’information sur les médicaments de l’Assemblée préconise notamment la création d’un haut-commissaire aux produits de santé dont on peut légitimement se demander s’il sera...more
Les textes réglementaires d’application du nouveau dispositif d’accès précoce au 1er juillet ont été publiés. Les dispositions se veulent précises sur le cadre juridique d’instruction des demandes et la HAS et l’ANSM...more
On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more
In Washington: The Internal Revenue Service (IRS) is planning to extend the tax-filing deadline to mid-May, according to two top House Democrats. A news release Wednesday from House Ways and Means Committee Chairman Richard...more
Retour sur la lettre de mission que les Ministres de tutelle du Comité économique des produits de santé viennent d’adresser à son Président alors que le nouvel accord-cadre « médicaments » est en passe d’être publié....more
Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more
Since October 1, 2020, healthcare companies have been required to implement the new French anti-gift legal framework, as substantially strengthened by the Ordinance No. 2017-49 dated January 19, 2017....more
On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...more
In the context of the pandemic, Decree No. 2020-1090 of 25 August 2020 on various measures relating to the reimbursement of health products (the “Decree”) could have been overseen as merely being a technical document. ...more
Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020...more
The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more
On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms....more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more