News

EquipNet India, a subsidiary of EquipNet, a laboratory equipment supplier, celebrated its 10th anniversary in the surplus asset management market.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

The new purification resin is expected to improve monoclonal antibody purification capacity by up to 40% due to its high binding capacity.

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

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.