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Pfizer Invests $500 Million into Its Gene Therapy Facility
Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.
FDA Approves Regeneron’s Eylea for Eye Disease
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.
USP Proposes Change to Reporting Thresholds
The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.
FDA Approves Pneumonia Treatment
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
ACG Capsules Introduces New Line of HPMC Capsules
The ACGcaps H+ capsules work to meet pharmaceutical and nutraceutical needs while remaining gelatin-free.
Generics: Getting Beyond “File First, Figure it Out Later”
A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues
Sarepta Therapeutics Receives Complete Response Letter for Golodirsen NDA
FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.
FDA Agrees to Accelerated Approval of Small Cell Lung Cancer Treatment
The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.
FDA Grants Accelerated Approval to Janssen’s Tuberculosis Drug
The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.
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.
