BioPharm International Editors

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

The companies entered a license agreement for the Trianni Mouse, a transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies (mAbs), to support MacroGenics’ discovery programs for mAb-based therapeutics.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer’s and Parkinson’s disease.

The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

The agency sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

A report from GlobalData, a data and analytics company, reveals the predicted role of immuno-oncology drug development and personalized medicine in the pharmaceutical industry in 2019.

The $2.1-billion acquisition strengthens Novartis’ position in nuclear medicine and radioligand therapy for treating cancer.

The proposed $12.7-billion deal includes the spinoff of GSK and Pfizer consumer brands to a new UK-listed company.

The STERIS ProKlenz ONE alkaline cleaner now has a label performance claim for biofilm removal, in addition to the product’s existing label as a disinfectant and virucide.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The use of artificial intelligence creates growth opportunities in novel therapeutics development by leveraging multi-sourced data, according to experts at research and consulting firm Frost & Sullivan.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

The UK Pharma Industry has emphasised the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.

The merged companies will provide histopathology services in the research and pre-clinical therapeutics markets.

According to research from staffing firm, Kelly Services, 14% of life science professionals based in the UK may move abroad if Brexit results in negative changes to economic conditions.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.