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Clinical Trial Diversity Advances in Regulatory Agenda
New guidance from FDA and legislation from Congress promote clinical trial diversity.
AmoyDX and AstraZeneca Enter Master Collaboration Agreement
AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.
Thermo Fisher Scientific Launches New GMP-manufactured Cas9 Protein
Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.
High Purity New England Launches Third Facility
High Purity New England has launched its third facility, focused on single-use assemblies.
GSK to Acquire Sierra Oncology for $1.9 Billion
GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9 billion.
Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
ReiThera and Exothera Collaborate on Manufacturing Vaccines for Low and Middle-income Countries
ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.
Achilles Therapeutics Announces Manufacturing Expansion in the UK and US
Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.
Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.
Tjoapack Announces Completion of Netherlands Packaging Facility
Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.
VectorBuilder to Expand with $500 Million Gene Delivery Research and Manufacturing Campus
VectorBuilder will expand with the construction of new $500 million Gene Delivery Research and Manufacturing Campus in Guangzhou, China.
FDA Revives Initiative to Identify and Reward Quality Drug Operations
FDA is reviving efforts to establish a Quality Management Maturity program.
University Hospital Hamburg-Eppendorf Leads Trial to Explore Personalized Medicine in COVID-19
Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.
Opus Enters Collaboration with Resilience for AAV-Based Gene Therapy Development and Manufacturing
Opus enters a strategic collaboration with Resilience for AAV-based gene therapy development and manufacturing for inherited retinal diseases.
Orchard Therapeutics Announces Reimbursement Agreement for Libmeldy
Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.
EC Approves Dupixent for Treatment of Severe Asthma in Young Children
Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.
Ymmunobio AG Signs Patent Purchase Agreement with LeukoCom GmbH
Ymmunobio AG has signed a patent purchase agreement with LeukoCom GmbH to expand its development of cancer therapies.
Legislation Targets High Cost of Clinical Trials
Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
Pfizer plans to acquire ReViral and its respiratory syncytial virus therapeutic candidates to strengthen Pfizer’s capabilities in infectious disease research.
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.
Evonetix Receives Patent for Thermally-Controlled DNA Synthesis Technology
Evonetix’s thermally controlled DNA synthesis technology is designed to enable highly parallel DNA synthesis in a benchtop platform.
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.
Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL
Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
WeylChem Inaugurates New Multi-Purpose Plant in Lamotte, France
WeylChem has put a new multi-purpose custom manufacturing plant at its French site in Lamotte into operation.
NIH Funds New Tuberculosis Research Advancement Centers
NIH has announced four new grant awards to fund new tuberculosis research advancement centers.
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.