Bio/Pharma News

FDA Issues Warning Letter to India Facility

February 23, 2015

The agency cites Apotex’s Bangalore facility with quality system failures.

Valeant Acquires Salix for $14.5 Billion

February 23, 2015

Valeant announced that it acquired Salix Pharmaceuticals for approximately $14.5 billion, which could result in annual cost savings of $500 million.

Johnson & Johnson’s Remicade Patent Invalidated

February 20, 2015

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

NIST Partners with MedImmune on Protein Characterization Venture

February 20, 2015

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Sanofi Appoints Bayer's Brandicourt as New CEO

February 20, 2015

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Cell Medica Begins Commercial Manufacturing of Cell Therapies

February 19, 2015

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

First Hospira Biosimilar mAb Approved in West Europe

February 17, 2015

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Genzyme Announces $845-Million Gene Therapy Deal

February 12, 2015

Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar

February 11, 2015

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen Announces Humira Biosimilar Clinical Studies Success

February 06, 2015

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.