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FDA Sweeps Websites with Warning Letters
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Ajinomoto Althea Adds High Potency Capabilities
Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.
Spectrum Chemical in Distribution Deal with Cole-Parmer
Spectrum Chemical announced an agreement with Cole-Parmer for the distribution of Spectrum’s USP fine chemicals.
J&J and HHS Team Up on Flu Vaccine and Drug R&D
Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.
Recipharm in Manufacturing Pact with Roche
Recipharm has announced a long-term manufacturing pact with Roche, which includes the acquisition of Roche’s solid-dose manufacturing facility in Leganés, Spain.
Catalent to Acquire Cook Pharmica for $950 Million
The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
Molecular Devices and Cytena Collaborate on Single-Cell Printer
The single-cell printer system helps isolate single cells and provide visual documentation to ensure monoclonality for cell line development.
Gates Foundation Invests $40 Million in Immunotherapy Collaboration
The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.
Aplagon and Cadila Collaborate on Anti-Thrombotic Biologics
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.
Wuxi Medical Instrument Factory Receives FDA Warning Letter
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Leistritz to Host Annual Twin Screw Extrusion Workshop
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.
Manufacturers Seek Strategies for Ensuring Quality of Innovative Therapies
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
FDA Approves Amgen’s Avastin Biosimilar
The approval marks the first biosimilar approved in the United States for treating cancers.
EMA Recommends Approval of Herceptin Biosimilar
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.
Glass Vials for Biologic Injectables
Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.
Fujifilm Opens New $9-Million Cell Culture Labs in UK
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, Portola Pharmaceuticals Sign Manufacturing Agreement
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.
FDA to Fund Manufacturing Research Programs at NIPTE
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.
FDA Panel Votes Unanimously to Approve GSK Shingles Vaccine
Shingrix represents a new, possibly better alternative to existing treatments.
Experts Set a 10-Year Roadmap for Optimizing Lyophilization
Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.
Recipharm and Kancera Collaborate on Development and Manufacture of Cancer Drug
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.
Sartorius Opens New Manufacturing Facility for Lab Instruments
The new building is protected by special construction against vibration to ensure accurate calibration of laboratory balances.
EMA Hosts Antimicrobial Resistance Meeting
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 Partners with Berkeley Lights on Automated Biological Workflow
Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.
FDA to Promote Continuous Manufacturing
The agency is looking for industry input on best practices for continuous manufacturing.
Alexion Restructures, Moves Headquarters, Closes Facilities, Cuts Jobs
Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.
Oxford Genetics Opens First US Office
The company has extended its presence in the US market to support its growing business in the region.
PPS Appoints New COO
Piramal Pharma Solutions (PPS), part of Piramal Enterprises, has appointed John Fowler as its COO.
AAPS Announces 2017 Foundation Fellowship Winners
AAPS has announced the five graduate students awarded with a $10,000 fellowship for their research efforts in global health solutions.
FDA Issues Warning Letter to EpiPen Manufacturer
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.
