Pharmaceutical Technology Editors

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

This year, experts took on topics ranging from innovation to market access and the impact of mega trade pacts.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

AstraZeneca and Lilly will evaluate the safety and efficacy of a range of additional combinations for solid tumors across both companies’ complementary portfolios.

Impax Laboratories announced that FDA has approved its generic version of guanfacine extended-release tablets 1 mg, 2 mg, 3 mg, and 4 mg.

Wetteny Joseph has been appointed as president of Catalent’s Clinical Supply Services.

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.

The agency gives an update on the regulation of combination medical products.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

The site is expected to become fully operational in 2017 and will produce approximately 40 million packs and 850 million tablets of some 30 innovative medicines every year.

Under the terms of the agreement, Hikma will have the exclusive rights to register, distribute and market Zevtera in the Middle East and North America.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

The company celebrates the 10th anniversary of its filler-binder excipient at CPhI Worldwide.

The two companies will combine life-sciences marketing and a consulting firm to create a life sciences-centered consulting service.

FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Merck relaunches brand identity to reflect transformation into a science and technology company.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

Catalent Pharma Solutions won the “Innovation in Process and Formulation Development” category at the annual CPhI Pharma Awards, for its OptiShell softgel technology platform.

CDMO Aesica Pharmaceuticals introduced a new service approach in which the company will taks on the management of other CDMOs, while serving as the single, central point of customer contact, the company announced in an Oct. 14, 2015 press release.

Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.

The joint marketing agreement allows the companies to expand dedicated blister feed system technologies.

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

The company presented a portfolio of new products during the meeting in Madrid.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

In the past, contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) have been focused most on achieving scale, reaching new clients in new geographic regions, and adding services that were previously unavailable, according to Gil Y. Roth, president of the Pharma and Biopharma Outsourcing Association. In a new report from CPhI, Roth explicates how consolidation has changed how CMOs position their services to clients and how CMOs add value to their businesses.

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.