As global markets continue to contend with a complex mix of macroeconomic pressures, development-stage biotech companies are being urged to proactively strengthen their financial resilience. The ability to anticipate and respond to liquidity challenges has become a defining factor in determining which companies emerge from this period of volatility with momentum and stability.
The post
GoodLifeSci
Latest from GoodLifeSci - Page 2
SEC Remains Focused on Public Disclosures Made By Life Sciences Companies
On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) announced a US$1.25 million settlement with biopharmaceutical company, FibroGen, Inc. (FibroGen), finding that FibroGen made false and misleading statements regarding the results of cardiovascular safety analyses of FibroGen’s anemia drug candidate, Roxadustat.
The post SEC Remains Focused on Public Disclosures Made By Life Sciences…
Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (September 2025)
The European Health Data Space Regulation took effect on March 26, 2025. While its key requirements regarding the secondary use of health data will not apply until March 2029, these provisions are set to bring about substantial changes for life sciences companies operating within the EU. This blog marks the beginning of a dedicated series…
Now Is The Right Time For A Hong Kong Biotech Listing
By Meng Ding
Hong Kong has recently emerged as the number one IPO venue globally, and one of the sectors driving this is biotech. For China-based biotechs looking to float, Hong Kong is a natural destination. But biotechs based anywhere in the world may wish to ride the current wave, as Meng Ding explains.
The post Now Is…
EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing
The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the European Union (“Council”), based on documents showing their positions (see draft Pharmaceutical Directive (“PD”) and…
Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.…
FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process for U.S.-based drug manufacturing facilities. Notably, the announcement also included information regarding an upcoming public meeting about the PreCheck framework and opportunity to comment and…
UK proposes to extend transitional chemical registration deadlines under UK REACH
GB based Chemical manufacturers or importers that relied on EU REACH registrations to continue marketing their products in Great Britain following Brexit have until 8 September 2025 to respond to a UK Government consultation on proposed revised transitional registration deadlines under UK REACH. Marie Manley and Victoria Kerr explain the background to the consultation, and…
Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech
The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers…
EU Critical Medicines Act Seeks to Enhance Supply and Access Requirements
The European Commission has proposed a new Critical Medicines Act aimed at reinforcing the security of supply and ensuring the availability of critical medicines and medicines of common interest across the EU. The Act introduces new obligations for pharmaceutical companies such as enhanced supply chain transparency, mandatory stockpiling, and regular reporting obligations. At the same…