Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
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
On October 31, 2024, the European Commission (EC) fined Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva) EUR462.6 million for abusing a dominant position in several EU Member States on the...more
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
As previously reported, the Federal Court of Appeal dismissed two decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce...more
SALIX PHARMACEUTICALS, LTD. v. NORWICH PHARMACEUTICALS., INC. Before Lourie, Chen, and Cunningham. Appeal from the District of Delaware Summary: The Federal Circuit ruled that an ANDA listing an infringing indication cannot...more
On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
Trends, triumphs and challenges – the first annual BakerHostetler IP Perspectives (BHIPP) provides insights on all three fronts in the complex world of intellectual property (IP). From the potential hazards associated with...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...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
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
Hikma and related companies have been awarded more than $31 million in damages on a $46 million bond because they were wrongfully restrained from launching or making any preparations to launch Mitigare or Mitigare AG —...more
As the use of 3-D printing has increased exponentially, so has its potential. Stella Wong, counsel focusing on patent litigation at our Hogan Lovells office in London, compares a 3-D printer to a sophisticated copying...more
Addressing the issue of whether a topical gel with an increased concentration of active ingredient would have been obvious over a prior art liquid product, the US District Court for the District of New Jersey concluded that...more
The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more
Addressing a motion to dismiss for lack of subject matter jurisdiction, a New Jersey district court held that Merck could maintain a Hatch-Waxman lawsuit against Actavis, Inc. n/k/a Allergan Finance LLC (Actavis), despite...more
We are delighted to announce the launch of our Combatting illegal pharma trade enforcement guide. This publication is a pharmaceutical industry-specific brochure which complements our suite of brand and trademark protection...more
Focus I: International black market trade - Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more
Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries - ...more
In the latest chapter of a year-long battle between an individual inventor and two companies, Lisa Duer (“Duer”), a resident of Woodstock, Georgia, filed her Third Amended Complaint alleging patent infringement, trademark...more
Second 100-Day ID Finds Complainant Has Standing In 949 Investigation – As mentioned in prior coverage, on March 12, 2015, the Commission issued a Notice of Investigation in Certain Audio Processing Hardware and Software,...more
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013 in the Northern...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alcon Research Ltd. v. Wockhardt Ltd. et al. 1:13-cv-02040; filed December 19, 2013 in the District Court of Delaware. ...more
What everybody doesn't seem to know is how to get Congress to listen to the needs of the innovation community when well-heeled sectors put their lobbying and financial support in favor of legislation purportedly aimed at...more