News

The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Leistritz’s Twin Screw Extrusion Workshop will take place on Nov. 29–30, 2017 in both Clifton, NJ and the NJ Leistritz facility, and will feature classroom sessions and equipment demonstrations.

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

Lonza and Portola Pharmaceuticals have entered into a supply agreement for AndexXa (andexanet alfa), a recombinant protein used in patients on FXa inhibitors who experience a major bleed or need urgent surgery.

The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.

Shingrix represents a new, possibly better alternative to existing treatments.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

Kancera’s drug candidate KAND567 will be developed as a capsule formulation for oral administration. Work will be performed at Recipharm’s development facility in Solna, Sweden.

The new building is protected by special construction against vibration to ensure accurate calibration of laboratory balances.

The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.

The agency is looking for industry input on best practices for continuous manufacturing.

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.

The company has extended its presence in the US market to support its growing business in the region.

Piramal Pharma Solutions (PPS), part of Piramal Enterprises, has appointed John Fowler as its COO.

AAPS has announced the five graduate students awarded with a $10,000 fellowship for their research efforts in global health solutions.

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.

HTG, a company that provides molecular profiling services, expects to complete submission of its premarket approval application to FDA for an in vitro gene assay by 2018.

J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.

The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.

Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.

The biopharmaceutical company broke ground on what will be a new 3000-ft2 addition to its Kansas biomanufacturing facility.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.