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FDA Gives Guidance on Development of Breast Cancer Drugs
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
Exscientia Enters Binding Agreement to Acquire Allcyte
Exscientia has entered into a binding agreement to acquire the artificial intelligence precision-based medicines company, Allcyte.
Regeneron’s Antibody Combination Therapy Reduces COVID-19 Mortality Risk
RECOVERY trial results have shown that Regeneron’s investigational antibody combination therapy reduces the mortality risk for seronegative hospitalized patients with severe COVID-19.
CureVac Releases Interim Results from COVID-19 Vaccine Candidate Trial
CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.
Biden Administration Invests in Antiviral Medicines
The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.
GSK and iTeos Therapeutics Enter mAb Collaboration
GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.
PHE Analysis Demonstrates Efficacy of COVID Vaccines Against Delta Variant
Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.
Survey Reveals Attitudes of Public Toward Rare Diseases and Medicines Access
BIA has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases.
Horiba Joins CGT Catapult Consortium to Accelerate Development of PAT
Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing
Sanofi Facility for Flu Vaccine Licensed by FDA
Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.
Evonik and Stanford University Partner to Develop mRNA Drug Delivery Technology
Evonik and Stanford University have signed a research collaboration to develop and market a new drug delivery platform for mRNA and gene therapy.
Yposkesi Launches Project SKY for its Second Commercial Bioproduction Site
Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.
Optima Teams Up with Clinics to Develop Production Unit for CAR-T Cell Therapies
Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.
Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.
EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
DFE Pharma Becomes Newest Partner in MMIC Collaboration
CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.
Immodulon Gains Allowability of Claims for Key European Patent Application
Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.
CGT Catapult Forms Consortium to Accelerate Manufacturing Technology Development
The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.
Novel Automated Process May Speed Up Development of New Medicines
Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.
Roambee Expands Cold Chain Visibility Offering Through Modum Acquisition
Roambee has acquired Modum, a Swiss pharma last mile-focused cold chain monitoring player, expanding its cold chain visibility capabilities.
Brinter Successfully Closes Seed Funding Round Led by Innovestor
Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor.
Boehringer Ingelheim Joins QUTAC as Founding Member
Boehringer Ingelheim has joined the Quantum Technology and Application Consortium (QUTAC) as a founding member.
New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
FDA Approves ANDA for Albuterol Sulfate
An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.
Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
VIVEbiotech Launches Lentiviral Vector Manufacturing Plant for Cell and Gene Therapies
VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.
FDA Publishes Guidance Documents to Enhance Supply Chain Security
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
AGC Biologics to Supply More Plasmid DNA for Pfizer-BioNTech COVID-19 Vaccine
AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.
