Biologic Drugs

Researchers in China are playing a role in advancing gene therapy development.

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

FDA and USP take sides in debate on biologic drug standards.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

Expansion at GSK’s Hamilton, MT site is designed to boost vaccine production capacity.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.