Formulation and Drug Delivery

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

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.

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

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

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.

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.

The pharmaceutical packaging and drug delivery conference has announced its event program taking place on Feb. 7–8, 2018 at Paris Expo Porte de Versailles in France.

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

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

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

Inovio has reported results from a study with non-human primates that showed 100% effectiveness with a DNA vaccine the company is developing with the US Army.

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

The agency has published educational material for physicians promoting the benefits of biosimilars.

The biopharmaceutical company has received a $4.2-million grant from the Bill & Melinda Gates Foundation to invest in the development of new treatments for Enterotoxigenic Escherichia coli infections, a bacterial cause of diarrhea in the developing world.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

The two companies announced their collaboration for the production and development of cancer vaccines.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.