After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, Regeneron, discussed the utility of AI and how it can benefit R&D work.

Ken Keller, president and CEO, Daiichi Sankyo, discusses the foundation of partnership and takes a look at the future of biotech partnerships at the US Pharma and Biotech Summit.

TekniPlex recently acquired Seisa Medical, which has expanded the company's services into that of a CDMO.

The new 80,000-square-foot facility will increase production of the company’s freeze-drying equipment.

The drug discovery company intends for this new site to increase its reach in the region, supporting growing demands from its Asia-Pacific consumers.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Phillip Gregory, PhD, senior vice-president and head of Regeneron Cell Medicines, Regeneron, discussed how engineering receptor architecture can be a tool to improve CAR-T cell sensitivity to tumor antigens.

At CPHI NA, Rachel Harris, AstraZeneca, spoke on her work at BioPhorum to enable industry consensus and action for sustainability with drug delivery devices.

Tara Dougal, content director, Pharma, Informa Markets, discusses successes and insights from this year’s CPHI North America and the agenda for the upcoming CPHI Milan.

Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

Novel delivery technologies enhance brain penetration to target neurodegenerative diseases and glioblastomas.

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

The request for more information was received weeks after an application to the FTC was refiled to approve the deal.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.

Pharmaceutical company, Nanomerics, and several companies that work with the pharmaceutical industry have been recognized by King Charles III for business achievements.

The loan is intended to support Ennogen’s growth as it looks to international acquisitions.

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.