GSK has filed for a sBLA to FDA for the expansion of the indication of Nucala to include paediatric patients between 6 and 11 years old.

Elis Biomed has been announced as the winner of the Start-Up of the Year Category for the 2018 Cambridge Independent Science and Technology Awards.

The vaccine producer announced an expansion to its Holly Springs, NC, manufacturing facility where it will increase production of its cell-based quadrivalent influenza vaccine.

The new collaborative center aims to serve as a hub for innovations in drug development and manufacturing.

With the $252-million acquisition of contract development, manufacturing, and testing organization Avista Pharma Solutions, Cambrex will enter the market for early stage small-molecule development and testing services.

During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.

Under the new long-term agreement, Sartorius Stedim Biotech will continue to offer Lonza media and buffer products under non-exclusive terms.

AstraZeneca is set to divest United States rights to Synagis (palivizumab) to Swedish Orphan Biovitrum (Sobi), a biopharmaceutical company focused on rare diseases, for $1.5 billion.

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.

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.

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.

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.