News

The company’s Krios G3i cryo-electron microscope is a finalist in the 2018 Edison Awards.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.

Takeda is considering approaching Shire with a possible offer.

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.

Natoli acquired Carlisle Precision Machining, which supplies replacement parts for encapsulation equipment.

Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.

MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.

AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.