News

PCI Pharma Services, a pharmaceutical outsourcing services provider, will acquire Millmount Healthcare, a pharmaceutical and healthcare contract packaging services provider, to expand its European services.

The alliance gives Celgene an option to acquire programs run by Nimbus Therapeutics for developing therapeutics to treat autoimmune disorders.

Virgin Atlantic Cargo and Delta Cargo have opened a new Pharma Zone at their joint facility at London Heathrow Airport for the handling and storage of pharmaceutical shipments.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Kraig Biocraft Laboratories, a developer of spider silk-based fibers, will open a new facility in Michigan to combine its research and production efforts.

A grant from the Bill & Melinda Gates Foundation will advance PnuVax’s pneumonia vaccine’s clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.

The US Department of Justice reports that AmerisourceBergen has pled guilty to illegally distributing misbranded oncology drugs and will pay a $260-million penalty.

DoKaSch Temperature Solutions, a Germany-based provider of climate-controlled air cargo containers, announced that its Opticooler air cargo containers are now available in the United States.

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company’s product and water testing businesses in the UK.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

The agency will require training for healthcare providers who prescribe immediate-release opioids.

The International Society for Pharmaceutical Engineering (ISPE) has revealed the results of its 2017–2018 International Board of Directors election.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

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.

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.