Pharmaceutical Technology Editors

The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.

FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.

The company will display its expanded supply chain product portfolio at CPhI North America 2017.

The Women’s Leadership Forum includes a panel of female executives from the pharmaceutical and specialty chemicals market.

More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.

The Dara SX-310-PP/D aseptic filling, stoppering, and capping machine for vials features full servo-driven automation and a compact footprint.

The company will be releasing its Titan continuous process scale-up system at CPhI North America/InformEx 2017.

The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.

Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.

Industry experts forecast the changes to the pharma industry for 2017.

The new DoseGuard design is compatible with standard 20-mm containers.

CPhI Worldwide announced new additions to its 2017 advisory board.

The company is expanding their April 2017 voluntary recall of phenobarbital tablets.

The agency released its report on pilot project to involve patients in the assessment of medicines.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.

CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

The pharmaceutical market in Spain is showing signs of stability according to a report by GlobalData.

New incubators, instrumentation, and staff will increase cell bioassay capabilities for EAG Laboratories.

The drug is approved to treat postmenopausal women with osteoporosis and is the first anabolic bone building agent approved in the US in approximately 15 years.

With two acquisitions, German company Fresenius Kabi enters biosimilars market and expands in US.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.