News

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

The new company, Immatics US, will develop autologous and allogeneic adoptive cellular therapies for various types of tumors based on novel immunotherapy targets.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

The acquisition will give IDT Biologika access to the veterinary vaccines market.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

The acquisition occurs one day after FDA approval of Sprout’s Addyi, the first medication to treat hypoactive sexual desire disorder in women.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

WuXi said its biologics manufacturing business will be one of the company’s key growth drivers over the next several years.

  Juno Therapeutics shared some of its business strategies related to process development and manufacturing in a second-quarter earnings call on Aug. 12, 2015. According to CEO Hans Bishop, the company believes its progress in the manufacture of chimeric antigen receptor (CAR or CAR-T) T-cell products will drive the company’s success for all of its product candidates and will be especially important for JCAR015, its investigational treatment for acute lymphoblastic leukemia (ALL). FDA cleared the investigational new drug application for JCAR015 on July 30, 2015.

The partnership will help divert 840 tons of waste related to single-use products from landfills or incineration during the next year alone.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

The company closed its Zebulon-based plant after routine testing of a cooling tower revealed the presence of the bacterium responsible for Legionnaire’s disease.

FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.

The platform detects the virus through silver nanoparticles attached to antibodies.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.