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Parker Bioscience Filtration Expands Single-Use System Facility in UK
The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.
FDA Approves New Rheumatoid Arthritis Drug
RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA
Olympus to Present Light Microscopy Award
Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.
FDA Approves Roche’s New Cancer Drug
FDA has approved Roche’s new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.
India Facility Receives Warning Letter
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
Cytena Owners Agree to Sell All Shares to Cellink
A strategic agreement has been announced that will see all shares of Cytena be sold to Cellink for a purchase price of EUR30.25 million (US$33.79 million).
ACG Acquires German Pharma Processing Equipment Provider
ACG Engineering, which is a part of the ACG Group, has announced its acquisition of a German-based pharma processing equipment provider, Xertecs.
Sanofi to Advance Innovative Bispecific Small-Molecule Project
Exscientia has revealed that Sanofi will be advancing an innovative bispecific small-molecule project that was discovered through the companies’ modality collaboration.
Majority of High-Containment CMO Facilities Located in 5EU and Switzerland, Notes GlobalData
The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.
Nemera Acquires Chicago Consulting Firm
Nemera has acquired a healthcare focused design and innovation consulting firm in Chicago, IL, Insight Product Development, strengthening its presence in North America.
Industry Responds to UK Government Immigration Rules Proposals
Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.
GNA Biosolutions Closes Latest Financing Round Backed by US/EU Consortium
GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.
European Commission Extends Use of Dupixent to Include Adolescents
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
Pfizer Recalls Two Lots of Relpax
The company is recalling the product because of potential microbiological contamination.
Optima Pharma Inaugurates Center for Building Turnkey Plants
Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.
Nephron and Clemson to Develop Robotics for Syringe Filling
Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.
Caladrius Biosciences, Cognate BioServices in Clinical Manufacturing Pact
The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.
FDA Wants Companies to Update Drug Listing Information
The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.
New Jersey Facility Receives FDA Warning Letter
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
Amgen Wins Enbrel Patent Case, Sandoz to Appeal Ruling
A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).
AskBio Plans to Improve Gene Therapeutics with Synpromics Acquisition
AskBio’s acquisition of Synpromics will improve the efficacy of its adeno-associated virus gene therapy vectors.
Samsung Demonstrates Full-Scale ATF Perfusion at Songdo Facility
Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%
BioLife Solutions Completes Acquisition of SAVSU Technologies
The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.
HALIX Completes New cGMP Manufacturing Facility; Startup Slated for Q4 2019
The new facility will manufacture biopharmaceutical products under cGMP conditions.
Eurofins Genomics Acquires Blue Heron Biotech, Expands Gene Synthesis Capabilities
The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.
Topical Products Recalled
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.
GSK US Pharma Head Steps Down
Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
Keystone Biologicals Acquired by BioIVT for Portfolio Expansion
The acquisition will expand BioIVT’s disease-state portfolio by volume and product range.
Avomeen Analytical Services Introduces New Project Director Role
The new position will expand the company’s large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.
Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
