Pharmaceutical Technology Editors

A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.

With this acquisition, Oncurious, a Belgium-based biotechnology company, will gain a pipeline of immune-oncology drug candidates.

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

Avista Pharma has appointed Eric Evans as CFO.

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.

FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.

Lonza is expanding parenteral dosage development capability and capacity in its Drug Product Services (DPS) sector at the company’s Basel, Switzerland facility.

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.

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.2 analytical laboratory.

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).

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.

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

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.

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.

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.

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.

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.

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.

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