News

Indena is completing the construction of a new GMP kilolab for highly potent APIs.

Lonza has announced plans to acquire a clinical-stage mammalian manufacturing facility in the United States from Shire.

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.

The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.

The iCON brand aims to offer flexible, rapidly deployable systems for biopharmaceutical manufacturing.

The Cell and Gene Therapy Catapult, one of UK’s centers of excellence, has partnered with Japan’s Forum for Innovative Regenerative Medicine to boost their respective stances in the global cell and gene therapy landscape.

GE Healthcare opened a 3D printing lab in Sweden that will speed the launch of products for bio/pharma manufacturing, such as a custom chromatography column.

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

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.

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 agency published four guidance documents regarding ANDAs and amendments to ANDAs.

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Die-cut strip packaging made with Romaco’s Siebler heat-sealing technology will be displayed at Constantia Flexibles’ booth (Stand 42H51) at CPhI Worldwide 2017.

The acquisition broadens the CDMO’s preclinical and clinical offering to include bioanalytical and drug discovery services.

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.

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

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.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

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.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

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.