Features

President Donald Trump signed an Executive Order this week to facilitate drug manufacturing in the US, including calling for measures to streamline FDA and EPA review of domestic pharma manufacturing facilities and enhance review of foreign drug-manufacturing facilities. What’s next?

Riding the strength of GLP-1 agonists and renewed interest in peptide-based development, several CDMOs are proceeding with large-scale investments in peptide development and manufacturing as other companies are joining the peptide space.

What stands out in the first quarter 2025 results and year-to-date activity of the large bio/pharmaceutical companies? Is it business as usual? What developments stand out, and what may be in store for the balance of 2025?

Orphan drugs have accounted for more than 50% of new drug approvals over the past five years and are projected to account for 20% of the global Rx drug market by 2030, but are market prospects slowing?

Expansions in biomanufacturing (biologic drug substances) continues to be an active area of investment by CDMOs/CMOs. Which companies are expanding? DCAT Value Chain Insights rounds up the latest developments.

Biotech industry groups, Biotechnology Innovation Organization (US) and EuropaBio (Europe), weigh in on evolving US trade policy and how to strengthen the life-sciences industry’s competitiveness.

The US Secretary of Commerce has initiated an investigation to determine the effects on US national security of imports of pharmaceuticals, including finished drug products, active pharmaceutical ingredients (APIs), and key starting materials, potentially paving the way for pharmaceutical industry-specific tariffs.

President Donald Trump has signed an Executive Order on drug pricing, which calls for eliminating the so-called “pill penalty” under the Medicare Prescription Drug Negotiation Program to equalize the post-approval time frame for drugs subject to negotiation for small-molecule drugs and biologics.

Global volatility on the trade front continued this week as the US put a 90-day pause on implementing its plan for reciprocal tariffs on a country-by-country basis, but uncertainty remains, particularly for certain trading partners, notably China. What is the impact on the pharma industry and what may in store.   

The European Federation of Pharmaceutical Industries and Associations, representing innovator drug companies in Europe, and Medicines for Europe, representing generics and biosimilars producers in Europe, speak out on  the impact of a changing tariff scheme on the bio/pharma industry in the EU and propose action plans.