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The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

GE’s new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

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.

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.

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

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.

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.

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.

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.

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.

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

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