Drug Development

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

The company has officially opened a local brand office in South Korean to support its existing business in the region.

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Ralph Gosden, head of product development at Catalent’s Swindon, United Kingdom site, explains the opportunities of orally disintegrating tablets as a patient-centric dosage form.

Pharmaceutical companies are increasingly adopting patient-centric formulation development to ensure that drug products adequately meet the needs of end-users in all target patient populations.

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.

Industry experts were honored for business, scientific, and social contributions.

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.

Model-based formulation and technology selection methodologies facilitate rapid product development.

CDMOs sharpen skills for identifying API potency risks and establishing safety and handling procedures.

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

The contract research organization (CRO) has acquired Xenometrics, a non-clinical CRO specializing in preclinical assessment of new drug candidates.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

Wyatt Technology has added the DynaPro Plate Reader III to its macromolecular and nanoparticle characterization product offerings.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

Innovator companies are exploring new avenues to keep generic drugs at bay, says CPhI expert, but competition authorities and drug regulators will play a key role in preventing such abusive anti-competitive practices.

The CDMO is investing £6 million into a new facility at its United Kingdom site to expand its milling, micronization, and solid form capabilities.