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The collaboration will evaluate the combination of BMS’ Opdivo immunotherapy with an investigational antibody drug conjugate in development by AbbVie.

Keynote speakers for ISPE’s 2017 Annual Meeting & Expo include representatives from AstraZeneca and GSK.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 24, 2017.

Eurofins Scientific has announced an agreement to acquire EAG Laboratories to expand its reach in North America.

MilliporeSigma announced the opening of its first end-to-end biodevelopment center in the Asia Pacific (APAC) region.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Spectrum Chemical announced an agreement with Cole-Parmer for the distribution of Spectrum’s USP fine chemicals.

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

Recipharm has announced a long-term manufacturing pact with Roche, which includes the acquisition of Roche’s solid-dose manufacturing facility in Leganés, Spain.

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

The single-cell printer system helps isolate single cells and provide visual documentation to ensure monoclonality for cell line development.

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.

Lonza and Portola Pharmaceuticals have entered into a supply agreement for AndexXa (andexanet alfa), a recombinant protein used in patients on FXa inhibitors who experience a major bleed or need urgent surgery.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

Shingrix represents a new, possibly better alternative to existing treatments.

The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.

The German biotech company can now supply its proprietary ligand on a GMP industrial-scale for clinical applications in immune-oncology.

The agency is looking for industry input on best practices for continuous manufacturing.

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.