Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

The companies will develop treatments for a range of neurological and inflammatory diseases.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

While recognizing the unsung work of scientists in corporate research and development, the Galien Awards remind the industry of its priorities: patients and future patients within the global community.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

Ardena has moved into its expanded headquarters, located in Gent, Belgium, as a result of continued growth.

Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.

New analysis from the OECD highlights that spending just a couple of dollars per person could help prevent deaths from antimicrobial resistance.

Medherant has announced positive results from two Phase I trials evaluating its transdermal drug delivery patch loaded with ibuprofen.

Leaders of the two parties are open to challenging the status quo on drug costs and spending.

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.

The International Society for Pharmaceutical Engineering (ISPE) named Shire as the ISPE 2018 Facility of the Year Awards Overall Winner for a facility integration project in Los Angeles, CA.

Pharmatech Associates International Contracting and Services is a new company headquartered in Doha, Qatar, that will provide product development, facility design, and construction for high quality pharmaceutical and biotech products at low cost.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.