Topic
Pharmaceuticals
1,008 published works
India Corporate Law
From Awareness to Advertising: Re-examining the GLP-1 drug boundaries (Part 1)
By Biplab Lenin Vineet Unnikrishnan, Sonu Bhasi, Kashish Gupta
Summary: Part 1 of this Article examines the CDSCO’s March 2026 Advisory directed at manufacturers, importers and marketing authorisation holders of GLP-1 receptor agonists, reinforcing that regulatory scrutiny of prescription-only…
Garrigues | Intellectual Property Blog
Supplementary protection certificates in Europe: towards a unified system and the extension of biotech protection
By Garrigues
The European regime on supplementary protection certificates could undergo a huge transformation. The EU has proposed measures such as introducing a centralized examination procedure at the European Union Intellectual Property…
Patent Law Weblog
Hikma v. Amarin at the Supreme Court: The Parties’ Opening Briefs
By Kevin E. Noonan – In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label”…
Big Molecule Watch
FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept)
By Sam Herron
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related…
Medicaid & Medicare: A Legal Blog
Lights Out—Until the Court Stepped In: The SmartCareRx Preliminary Injunction
The government can immediately suspend Medicare or Medicaid reimbursements for a variety of reasons; the most common being credible allegations of fraud. My law partner, Jillian Willis, fought back and…
Substance Law Blog
Food and Drug Regulations (Canada) Guide
By Publisher
Understanding Food and Drug Regulations in Canada The regulatory framework governing food and drugs in Canada is designed to safeguard public health and safety. At its core, this system is…
International Trade Insights
President Trump Imposes Section 232 Tariffs on Patented Pharmaceuticals and Active Pharmaceutical Ingredients
By Cortney Morgan, Nithya Nagarajan, Bilal Hassan
On April 2, 2026, the Trump Administration issued a proclamation imposing Section 232 tariffs on imports of patented pharmaceutical products and active pharmaceutical ingredients (“APIs”) pursuant to Section 232 of…
Searcy Law Blog
Where Can You Find FDA Warnings About Defective Drugs?
By Searcy Law
Defective drugs are, unfortunately, a very real concern for patients across the United States. While pharmaceutical companies have an obligation to ensure that their drugs are reasonably safe and provide…
BioSlice Blog
Final text of the reform to the EU Regulatory Framework for Medicinal Products published
By Libby Amos-Stone, Alexander Roussanov, Carla Schoonderbeek, Adela Williams, Heba Jalil
The EU institutions have now published the updated text on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European…
As Prescribed
The Impact of the EU Pharma Package on the UK
By Morgan Lewis
As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the…