Drug Development

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.

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.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

The collaboration will utilize Genesis’ proprietary AI platform, initially focusing on targets selected by Incyte.

A capsule formulation may offer more consistent and reliable uptake versus a syringe, while being less dependent on food intake.

The AI co-scientist is a multi-agent AI system that can work as a virtual scientific collaborator.

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

In seeking a data-driven approach to efficient drug development, MMS aims to enhance its capabilities in advanced clinical trial design, innovative statistics, and data science with the acquisition.

Investing in STEM programs for girls in an education setting and then supporting women as they excel in their professional careers is key to ensuring that vital highly skilled personnel are not left behind.

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs.

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.