Drug Development

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

The method developed by Cambrex uses standard plant equipment and requires only two synthetic steps and one recrystallization, minimizing waste and use of solvents.

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.

The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.

Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.

Modified-release lipid-based formulations in softgel capsules can address physiochemical and pharmacokinetic challenges posed by drug compounds.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

Is pharma up to the task of developing knowledgeable, motivated employees?

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

The joint venture will focus on the discovery, development, and commercialization of potential new drugs for the global market as well as speed delivery of new medicines to China.

Pharma trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.