Biopharma News
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.
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.
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.
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.
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.
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.
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.
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.
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.
