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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.
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.
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.
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.
Empagliflozin Trial Stopped Early Due to Clear Positive Efficacy in People with Chronic Kidney Disease
Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.
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.
Will Decentralized Clinical Trials Become Mainstream?
Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity
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.
DFE Pharma, Harro Höfliger, and Sterling Partner to Provide Formulation Services for Respiratory Products
DFE Pharma, Harro Höfliger, and Sterling have announced a partnership called Inhalation Together to provide formulation services for respiratory products.
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.
Recro Announces Name Change to Societal CDMO to Reflect Corporate Expansion and Transformation
Recro Pharma changed its name to Societal CDMO to reflect the company’s expansion as a result of the acquisition of IriSys.
Teva Reaches Agreement with Rhode Island to Settle Opioid-Related Claims
Teva has reached an agreement with the Attorney General of Rhode Island to settle opioid-related claims.
RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments.
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.
Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products
Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.
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.
physIQ and CellCarta Collaborate on Personalized Approach to Vaccine Development
physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.
