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Yposkesi Launches Project SKY for its Second Commercial Bioproduction Site
Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.
Optima Teams Up with Clinics to Develop Production Unit for CAR-T Cell Therapies
Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.
Process Development Improvements Post-Pandemic
What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?
Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.
EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
DFE Pharma Becomes Newest Partner in MMIC Collaboration
CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.
Immodulon Gains Allowability of Claims for Key European Patent Application
Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.
CGT Catapult Forms Consortium to Accelerate Manufacturing Technology Development
The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.
Novel Automated Process May Speed Up Development of New Medicines
Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.
Roambee Expands Cold Chain Visibility Offering Through Modum Acquisition
Roambee has acquired Modum, a Swiss pharma last mile-focused cold chain monitoring player, expanding its cold chain visibility capabilities.
Brinter Successfully Closes Seed Funding Round Led by Innovestor
Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor.
Boehringer Ingelheim Joins QUTAC as Founding Member
Boehringer Ingelheim has joined the Quantum Technology and Application Consortium (QUTAC) as a founding member.
New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
FDA Approves ANDA for Albuterol Sulfate
An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.
Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
VIVEbiotech Launches Lentiviral Vector Manufacturing Plant for Cell and Gene Therapies
VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.
FDA Publishes Guidance Documents to Enhance Supply Chain Security
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
AGC Biologics to Supply More Plasmid DNA for Pfizer-BioNTech COVID-19 Vaccine
AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.
Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment
FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.
FDA Approves Treatment for Plasminogen Deficiency Type 1
FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.
Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb
FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.
FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
Biden Budget “Wish List” Maps FDA and Health Care Priorities
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.
Emerson Integrates MTP Process Automation Standard into Control Systems
The Module Type Package standard is now supported in Emerson’s DCS and PLCs.
MedPharm Opens Manufacturing Facility for Topical and Transdermal Drug Products
MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.
Hovione to Re-Join iBet
Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in new therapeutic fields.
Aceto to Acquire Cascade Chemistry
Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.
Recro to Expand its Clinical Trial Services Offerings
The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.
