Drug Development

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

Shashank Upadhye, Esq., managing partner at Amin Talati Upadhye, will discuss intellectual property/patent issues for active pharmaceutical ingredients and abbreviated new drug applications at CPhI North America in Philadelphia, PA, on Tuesday, April 24, 2018.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Nik Leist’s keynote address will explore the manufacturing of digital medicines at the CPhI North America 2018 conference in Philadelphia, PA, on Wednesday, April 25, 2018.

The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges.

Formulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.

Researchers at MIT have discovered a new set of compounds that do not elicit a foreign body response when implanted. These biomaterials permit the development of a new category of treatment with the ability to deliver therapeutics either at a constant rate or under programmable conditions by using implantable cells as protein factories.

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.

Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.