BioPharm International Editors

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

WuXi's new US facility will manufacture CAR T-cell therapies and other cancer immunotherapies.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

The upgrades will offer the opportunity for higher product yields and higher purity levels.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.