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Tracy Beth Hoeg has been appointed as the FDA’s new CDER lead, making her the fifth person to take this position in 2025. Credit: Tada Images/Shutterstock.com

The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and evaluation.

Høeg’s appointment closely follows the sudden retirement of longtime FDA employee and previous Center for Drug Evaluation and Research (CDER) director, Richard Padzur, who only took the helm at the division less than a month ago.

Padzur was originally encouraged to take charge of CDER by FDA Commissioner Marty Makary after previous leader, George Tidmarsh, resigned following an investigation into his personal conduct.

Høeg is sports medicine physician and epidemiologist by training. She first joined the FDA as a special assistant to Makary in March 2025, and has since worked in two senior advisory positions within CBER and the Office of the Commissioner.

During her short time at the agency, Høeg has voiced her scepticism towards the safety and value of Covid vaccines – specifically focusing on mask mandates, as well as the approval of booster jabs for use in children.

Pharmaceutical companies marketing products in Europe could be set for a commercial boost, after legislators have agreed on a new regulatory framework in a bid to increase competitiveness.

The European Parliament (EP) and EU Council negotiators reached a provisional agreement that proposes the introduction of a regulatory protection period and the granting of market protection for certain new medications.

The deal, which was reached after a negotiation between co-legislators, is expected to be formally adopted by the EU Council. EP will then endorse the legislation in a second reading, a crucial phase of law propositions.

At the core of the new frameworks are enhanced incentives for pharmaceutical companies to continue innovation and place new drugs on the market. The package includes a regulatory data protection period of eight years, during which other companies cannot access product data. There is also one additional year of market protection, protecting financial headwinds from biosimilar or generic competition.

Pharma manufacturer Evonik is piloting a new ‘handprint’ metric to quantify the socioeconomic benefits of manufacturing practices, a move that the company says can expand understanding of the pharma industry’s impact beyond a focus on carbon footprints.

Based in Essen, Germany, Evonik has implemented the handprint methodology to assess the positive economic impacts of its drug delivery product PhytoChol, an ingredient of lipid nanoparticles used in mRNA vaccines such as Pfizer and BioNTech’s Covid-19 vaccine Comirnaty, according to Evonik’s sustainability development manager Ranjan Fletcher.

She added that Evonik is also looking to expand use of the metric across other products.

The initiative is being implemented in collaboration with its originator, the WifOR Institute, an economic research institute based in Darmstadt, Germany.

Europe’s biopharma stakeholders should seek innovation through AI to meet the challenges of treatment resistance, drug affordability, and a creeping patent cliff, channelling the continent’s health data to catch up to more competitive industries in the US and China.

This was the view Montserrat Daban outlined in her keynote address at the 2025 CPHI conference, which took place on 28–30 October in Frankfurt. Daban is the director of strategic foresight and international relations at Biocat, a public-private entity to support the healthcare ecosystem in Catalonia, Spain.

She said that stakeholders in the European biopharma industry could find innovative solutions to challenges in several key areas by using AI to leverage the vast amounts of data collected by health systems for drug discovery and improved trial design.

Daban identified several key challenges faced by the global biopharma industry today, including logistical ones like scaling up cell and gene therapies, improving clinical trial speeds, drug affordability, as well as the uncertainties of supply chain resilience, sustainability, and pandemic preparedness.

Antibody-drug conjugate (ADC) developers say innovations to linkers, the proteins bridging antibodies to their therapeutic payloads, are opening the door to more stable, selective ADCs with application beyond the class’s traditional scope.

Experts discussed the opportunities and challenges of linker innovation as part of a panel at the 2025 CPHI conference, which took place 28–30 October in Frankfurt, Germany. By engineering the molecular make-up of these proteins, they said that new ADCs are being developed able to carry previously unexplored drug payloads with improved stability and more targeted selectivity.

ADCs remain a relatively nascent class, with fewer than 20 approved by regulators worldwide, noted Bikash Chatterjee, CSO of consultancy Pharmatech Associates and the panel’s moderator.

“The linker has been neglected for years. Especially for first generation ADCs, not many people really paid attention to linkers,” said Kern Chang, PhD, chief technical officer at contract development and manufacturing organisation (CDMO) Lotte Biologics.