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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.
Gamma Biosciences and Mirus Bio to Develop Lipid-Polymer Nanocomplexes
Gamma Biosciences has announced an initiative through its subsidiary, Mirus Bio, to develop lipid-polymer nanocomplexes for improve mRNA delivery solutions.
Roquette Invests €25 million for Polyols at its Site in Lestrem, France
Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.
FDA Approves Opdualag for Unresectable or Metastatic Melanoma
FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
Marinus Pharmaceuticals Announces FDA Approval of ZTALMY for CDKL5 Deficiency Disorder
FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).
AstraZeneca’s Antibody Combination Authorized for Use in Great Britain for Prevention of COVID-19
AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.
Moderna and the Japanese Government Reach an Agreement to Supply Japan with Additional 70 Million Doses of Moderna’s COVID-19 Booster Vaccine
Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.
COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.
USP Medicine Supply Map Reviews Global API Manufacturing
New report released by USP offers a look into API supply-chain vulnerabilities.
Sanofi Announces €300 Million Collaboration with Blackstone Life Sciences to Advance a Treatment for Multiple Myeloma
Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.
Sanofi and Seagen Announce ADC Development Collaboration
Sanofi and Seagen have entered an agreement to investigate three cancer targets.
Catalent Completes $30 Million Project for Biopharmaceutical Development and Manufacturing in Limoges, France
Catalent has announced the completion of a $30 million project at its facility in Limoges, France focused on biopharmaceutical development and drug product manufacturing.
BioMed X Institute and Merck KGaA Start Second Research Project in Immunology
BioMed X and Merck KGaA, Darmstadt, Germany announced their collaboration on a research project to study T-cells and autoimmunity.
EMA Recommends Updated Product Information for Moderna and Janssen COVID-19 Vaccines
EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.
