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The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

According to Alexion, the acquisition will help rebuild its clinical pipeline.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

A new report gives an overview of the work of the International API Inspection Program.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

Thermo Fisher Scientific and the University of Pittsburgh have established a new pharmacogenomics center of excellence to support translational research that demonstrates the value of PGx in precision medicine.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

ReForm Biologics and KBI Biopharma will collaborate to improve biopharmaceutical formulations and development.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

A new study by the Business Research Company reveals prominent contract research organization outsourcing trends.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

David Weingarten, PhD, and Mark Feldstein, PhD, will present ways to optimize pharma patent protection to avoid generic competition and increase return on investment at CPhI North America 2018.

Serialization technology and implementation expert Rick Seibert will present an insight briefing on recent serialization challenges at CPhI North America in Philadelphia, PA.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Pharma event announces plans to alternate locations between Indonesia and Thailand to open new market opportunities.

The acquisition is expected to accelerate progress towards personalized cancer healthcare.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

CPhI North America 2018 is hosting a forum for female pharmaceutical professionals to network, collaborate, and share their perspectives at this year’s conference.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.