BioPharm International Editors

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

The International Society of Automation (ISA) and Siemens entered a global partnership to increase awareness of industrial cybersecurity needs and standards.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

Genentech’s Actemra (tocilizumab), a rheumatoid arthritis drug, has been approved for a new indication, treating CAR T cell-induced cytokine release syndrome (CRS), a side effect of CAR T cell therapy.

Thermo Fisher Scientific has completed the previously announced acquisition of Patheon for approximately $7.2 billion.

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

Circa Group, a biotechnology company, has announced a collaboration with formulation science consultancy iFormulate to launch Cyrene, a biosolvent.

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

MilliporeSigma, the life-science subsidiary of Merck KGaA, announced an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.

An industry workgroup made up of pharmaceutical companies, toxicologists, and data experts plans to unveil the early results of a data sharing project designed to enhance the safety of drug substances and aid compliance with quality guidelines, such as ICH M7.

FDA’S CDER and ORA have entered into a concept of operations agreement to integrate facility evaluations and inspections for human drugs.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

The KBF 1020 constant climate chamber from Binder offers storage for large quantities of test specimens or large samples.