Drug Development

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.

The API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

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investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.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

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

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.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Piramal is investing $55 million into the expansion of its API manufacturing capabilities and capacities across sites in North America and Asia.

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

West will be showcasing its range of packaging components and drug delivery solutions, including NovaPure components, LyoSeal caps, and the SmartDose platform.

Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

Investments include the installation of development and analytical equipment to support the development of highly potent APIs as well as a new 2800-liter hydrogenator and 1500-mm diameter centrifuge for increased flexibility and capacity within the manufacturing plant.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

Europe updates the guideline on excipients information in labeling and packaging.