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Lonza and Asher Biotherapeutics to Collaborate on Manufacturing AB359
Lonza and Asher Biotherapeutics have entered a manufacturing agreement for a cis-targeted IL-2 fusion protein, AB359.
IAVI and Moderna Partner to Tackle Global Health Priorities Using mRNA for Vaccines and Antibodies
IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.
Evonetix Receives Patent for Thermally-Controlled DNA Synthesis Technology
Evonetix’s thermally controlled DNA synthesis technology is designed to enable highly parallel DNA synthesis in a benchtop platform.
FDA Grants Priority Review to Intravenous Treatment of COVID-19 in Hospitalized Adults
FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines
ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.
Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL
Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
WeylChem Inaugurates New Multi-Purpose Plant in Lamotte, France
WeylChem has put a new multi-purpose custom manufacturing plant at its French site in Lamotte into operation.
NIH Funds New Tuberculosis Research Advancement Centers
NIH has announced four new grant awards to fund new tuberculosis research advancement centers.
Early Access Issued for Eligible Patients in the UK for Radioligand Therapy in Advanced Prostate Cancer
UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.
INCOG Biopharma Completes Construction of Cleanroom Production Area
INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.
Catalent Acquires Vaccine Manufacturing Innovation Centre in Harwell, Oxford
Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.
PerkinElmer Introduces the HTRF and AlphaLISA Assay Kits
PerkinElmer’s HTRF and AlphaLISA assay kits are designed to detect and quantify CHO host cell protein impurities.
Thermo Fisher Scientific Launches User-Friendly Raman Spectroscopic Analyzer
The Thermo Scientific Ramina Process Analyzer is designed with user ease at the forefront.
Stanley Capital-Backed Portfolio Company DSS Acquires MyMeds&Me
Stanley Capital has announced the acquisition of MyMeds&Me by its portfolio company Drug Safety and Pharmacovigilance Services Solutions.
FDA Accepts Dupixent for Priority Review for Patients with Eosinophilic Esophagitis
FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.
ATMPS Ltd Wins US Patent for the Use of Blockchain in Advanced Medicinal Therapy Products
ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.
Merck Expands Manufacturing Facility in Elkton, Virginia
Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.
FDA Seeks Expanded Authorities, Along with More Funds
Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.
Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster
FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.
ten23 health Expands its Sterile Drug Product Manufacturing Site at Visp, Switzerland
ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.
Sterling Pharma Solutions Expands Capabilities and Laboratory Capacity
Sterling Pharma Solutions has unveiled a £1 million expansion project to increase its capabilities and laboratories capacity at its Deeside, UK site.
UK Government Awards £15.9 million grant to Chemical Producer Croda
UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.
Twisted Vibrations Enable Quality Control for Chiral Drugs and Supplements
Research from the University of Michigan showed that Terahertz light can be used to probe both the structures of molecular crystals and their twists.
Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products
Lonza has joined IPAC-RS, providing benefits to Lonza’s inhalation- related businesses due to IPAC-RS’ global voice of the orally inhaled and nasal drug products industry.
ViiV Healthcare Announces FDA Approval of Once-Daily Treatment for Children Living with HIV
ViiV Healthcare announced that FDA has approved Triumeq PD, a dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV.
A Future Investment
The AMR Action Fund has made its first investments, marking an important step forward for the partnership to achieve its goal of bringing new treatments to the market for priority pathogens.
Next Level Interrogation
3D cell cultures could provide key avenues to unlocking critical information.
Major League Moves
Advances in pharmaceutical neuroscience present an opportunity for pharmaceutical companies to stay ahead of the curve.
Rentschler Biopharma and Vetter Unveil Xpert Alliance
Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.
Symbiosis Successfully Completes UK Research and Innovation Project to Enhance Supply Chain for ATMPs
Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.