Drug Development

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.

Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.

With financing led by Blue Owl Capital, Latigo will use the funds to further develop non-opioid pain treatments as well as develop other candidates in its pipeline.

Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.

PharmTech Group spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

In an interview with Pharmaceutical Technology®, Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.

The partnership aims to develop and commercialize a novel checkpoint inhibitor for immuno-oncology applications.

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

Webinar Date/Time: Wed, Mar 26, 2025 1:30 PM EDT

Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.

The Biotech and Biomanufacturing Hub will help European companies access funding, navigate regulations, and speed up market access.

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Jaypirca (pirtobrutinib) has received a conditional marketing authorization from EMA for mantle cell lymphoma. The drug was approved in the United States in 2023 for several indications.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

Webinar Date/Time: Fri, Mar 21, 2025 11:00 AM EDT

While the boards of directors of both companies have approved the transaction, it is not expected to close until the second quarter of 2025, as Mayne Pharma’s shareholders must still vote in favor of the acquisition.