In preparation for the upcoming US Drug Supply Chain Security Act deadline, Metrics Contract Services has expanded serialization capabilities at its oral solid-dose commercial manufacturing site in Greenville, NC.

Pharmapack Europe expects further increases in innovation across packaging and drug delivery to mirror overall industry trends.

Pharma industry welcomes announcement of a draft withdrawal agreement, stating it is an important step towards securing a Brexit deal.

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

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.

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.

KORSCH America received an award from the Massachusetts Legislative Manufacturing Caucus.

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.