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Guidance on the Harmonization of Compendial Standards Published
FDA released draft guidance on using the USP pending monograph process in the drug application process.
Amicus Partners with Catalent on Lysosomal Disease Gene Therapy Programs
Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.
FDA Publishes Guidance on Instructions for Use in Patient Labeling
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
Amicus Therapeutics Enters Strategic Manufacturing Collaboration with Thermo
Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.
Proposed Rule Designed to Open Biosimilar Competition
FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.
Industry Continues to Invest Significantly in UK R&D
New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
Lonza Announces Acquisition of Novartis Drug Product Facility
Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.
Pfizer Completes Acquisition of Clinical-Stage Biotech
Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.
Fujifilm Irvine Scientific Plans to Open New Manufacturing Site in Europe
Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.
Source of Nucleic-Acid Asymmetry May Advance Gene Therapy
Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.
Gilead, Carna Biosciences in R&D Collaboration
The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.
FDA Announces Draft Guidance for Bioanalytical Method Validation
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
Bristol-Myers Squibb, Draper to Develop Liver Tissue Model
The companies will work to develop a liver tissue model for screening the toxicity of drugs.
Catalent Biologics Acquires Vaccine Manufacturing Facilities
Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.
Gottlieb Elected to Pfizer’s Board
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.
International Survey Uncovers Challenges in Laboratory Workflows
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
Sartorius’ New Flow Cytometer Offers Fully Automated Cell Processing
The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.
FDA Challenges USP Standards for Biologics
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
AbbVie Announces $63 Billion Allergan Acquisition
In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.
FDA Approves Amgen and Allergan's Biosimilar to Herceptin
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability
The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
Partnership Forms to Standardize Cell and Gene Therapy Supply Chain Solutions
Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.
IVERIC bio, Catalent Partner on Gene Therapy for Orphan Inherited Retinal Diseases
IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.
Genmab, Janssen Partner for Next-Generation mAb Antibody
Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.
Lonza, Gamida Cell Form Commercial Cell-Therapy Manufacturing Pact
The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.
Sanofi, Google to Develop New Healthcare Innovation Lab
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.
Catalent to Purchase BMS Manufacturing Site in Anagni, Italy
Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.
LSNE Expands to Europe with Acquisition of Facility in Spain
Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.
CPI to Showcase Results of Biologic Drug Development Collaboration
Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.
Will Congress Enact Curbs on Drug Pricing?
Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
