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
The Competition Director General has issued a precedent-setting determination against the pharmaceutical marketing company MBI Pharma Ltd. (MBI). The Director General determined that MBI abused its monopolistic position and...more
On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more
On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more
In September 2017, the Patented Medicine Prices Review Board (PMPRB) decided that Alexion’s SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines, in finding the appropriate...more
On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
As previously reported, the Federal Court of Appeal set aside the Federal Court’s decision dismissing Alexion’s application for judicial review and remitted the matter of whether Alexion’s SOLIRIS (eculizumab) was sold at an...more
On September 29, 2021, the Attorney General of Canada sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 157) setting aside the decision of the Federal Court dismissing Alexion’s application for...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more
ANTITRUST AND COMPETITION - The European Commission Accepts Commitments from a Pharma Company to Stop Its Excessive Prices - On 15 May 2017, the European Commission (Commission) announced that it had opened formal proceedings...more
On March 10, 2020, the England and Wales Court of Appeal (CoA) handed down its judgment in the appeals by the U.K. Competition and Markets Authority (CMA) and Flynn Pharma Ltd. against a June 2018 Competition Appeal...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
On 28 June 2018, the UK Competition and Markets Authority (CMA) announced that it has applied to the Competition Appeal Tribunal (CAT) for permission to appeal against the CAT’s judgment on appeals by Pfizer and Flynn against...more
On 7 June 2017, the Competition Appeal Tribunal (“CAT”) set aside parts of the Competition & Market Authority’s (“CMA”) decision in relation to the CMA’s finding that Pfizer and Flynn charged excessive and unfair prices for...more
The European Commission (EC) and other national competition authorities (NCAs) have traditionally shied away from investigating allegations of excessive pricing and appearing as price regulators. Commissioner Vestager warned...more
On November 21, 2017, the French Competition Authority (“FCA”) announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector....more
On November 21, 2017, the French Competition Authority ("FCA") announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector....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
In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...more
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more