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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.
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.
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.
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.
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.
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.
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.
Thermo Fisher Introduces New Electroporation System for Large-Scale Cell Therapy Development and Manufacturing
Thermo Fisher Scientific’s new Gibco CTS Xenon Electroporation System aims to provide easier scale up for cell therapies, from clinical development to commercial manufacturing.
NCI Awards ATCC Task Order to Provide Cancer Epidemiology Services to Research Community
Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.
Research Shows that Junk DNA Encodes Essential Immune and Metabolism Instructions
Researchers from the Telomere-to-Telomere Consortium have discovered new properties about junk DNA that could have wide-reaching implications.
KeyPlants Ships First-of-its-Kind Vaccine Manufacturing Facility to Africa
KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.
Sanofi and IGM Biosciences Announce Collaboration Agreement
Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.
Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On
Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.
Pfizer Issues Voluntary Recall of Blood Pressure Tablets Due to High Levels of Nitrosamine
Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.
Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in India
Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.
Orion to Refocus R&D to Cancer and Pain
Orion is planning to refocus its R&D efforts on the development of new proprietary products focused on cancer and pain.
Novartis’ Pluvicto Approved by FDA for Treatment of Advanced Prostate Cancer
FDA has approved Novartis’ targeted radioligand therapy Pluvicto for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.
EMA Recommends EU Approval of Roche’s Polivy Combination for Diffuse Large B-Cell Lymphoma
EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.
Huma and AstraZeneca Partner to Accelerate Innovation for Digital-First Patient Care
Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.
FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate
Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.
EMA Grants Recommendation for New Gene Therapy to Treat Adult Patients with Multiple Myeloma
EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.
FDA and Congress Re-Examine Accelerated Approval Program
Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.