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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Two updates to the French national clinical trial template agreements (Convention Unique) were published on August 5, 2024. They update the previous templates to take into account evolving practices in clinical trials. In...more
At the mid-year point, 2024 is shaping up to be an eventful year in cartel enforcement. In the United States, the U.S. Department of Justice (DOJ)’s Antitrust Division (Division) enjoyed two significant victories and finally...more
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
Un nouveau dispositif, porté par le projet de loi de financement de la sécurité sociale pour 2024, pourrait aboutir à imposer aux entreprises exploitant un médicament mature d’intérêt thérapeutique majeur qui souhaiterait en...more
A new draft measure, included in the Social Security Financing Bill for 2024, aims to require companies operating a mature medicinal product of major therapeutic interest (MITM) that wishes to suspend or cease marketing it,...more
Le rapport Borne sur la régulation des produits de santé qui était très attendu est bien en deçà des attentes des acteurs du secteur. Très peu de propositions concrètes y figurent. La Première ministre Elisabeth Borne a lancé...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
Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....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
Distribution: In two rulings issued on 28 September 2022, the French Supreme Court clarified the conditions under which suppliers can be held liable for failure to comply with their duty to communicate - Article L.441-1...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...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
UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more
Le 15 février 2022, la CNIL a publié deux projets de référentiels. Ces référentiels étaient très attendus car l’Autorisation Unique 041 sur les traitements de données personnelles dans le cadre des Autorisations Temporaires...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
Patent and trademark issues effecting pharmaceutical laboratories, biotechs, food supplements and dietary products professionals, cosmetics companies and medical devices manufacturers is continually evolving across France and...more
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more