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Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada
Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.
Evotec Opens Integrated Biologics Manufacturing Facility
The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.
European Commission Approves AstraZeneca’s Forxiga for Treatment of Chronic Kidney Disease
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
Nobelpharma Signs License Agreement for ProBioGen’s Vaccine Manufacturing Platform
Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.
GW Pharmaceuticals’ Epidiolex Approved by MHRA for Seizure Treatment
The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
Packaging Components for Parenteral Drug Development
Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.
EMA Endorses Track-and-Trace Recommendations
The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.
Kyowa and Bora Partner to Produce Generic Product
Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.
Emergent Approved to Export Vaccines in Latest COVID-19 Update
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
Atovaquone Oral Suspension Recalled
KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.
FDA Approves New Treatment for Pompe Disease
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
AGC Biologics Acquires Cell and Gene Therapy Commercial Manufacturing Facility
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
FDA Issues NIR Guidance
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
FDA Issues Warning Letter to Syntec Pharma Corp
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
BeiGene to Build New Manufacturing and Clinical R&D Facility in New Jersey
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Novavax and European Commission Finalize COVID-19 Vaccine Purchase Agreement
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
Metrics Contract Services Expands Greenville, North Carolina Facilities
Metrics Contract Services announces the completion of a $10 million expansion to their Greenville, NC facilities.
Catalent Finalizes RheinCell Therapeutics Acquisition
Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.
Syngene Announces Senior Level Appointments
Syngene International appoints two US-based executives to senior level positions.
TriRx Completes Acquisition of Elanco Animal Health Facility in Shawnee, Kansas
TriRx continues to expand its manufacturing capabilities with the acquisition of the Elanco Animal Health Facility in Shawnee, Kansas.
Nasal Spray and Mouth Rinse Demonstrate Efficiency in Preventing COVID-19 and Other Infections
BMG Pharma's clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.
Evonik Expands Biomaterials Portfolio through JeNaCell Acquisition
Evonik has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio.
Nanoform, Boehringer Ingelheim Collaborate on Pre-Clinical Development Projects
Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.
Imugene and Celularity to Develop Solid Tumor Treatment
A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.
EC Confirms Go-Live Date for Clinical Trials Information System
EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
WuXi STA Finalizes Acquisition of BMS’ Swiss Manufacturing Facility
WuXi STA has finalized its acquisition of Bristol Myers Squibb’s drug product manufacturing facility based in Couvet, Switzerland.
BMS Gains European Approval for Opdivo
Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment
CHMP Approves Manufacturing Scale-Up for Spikevax
EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.