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Kindeva Drug Delivery Completes Acquisition of iPharma Labs
Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.
Aizon Launches GxP Compliant Data Processing Solution
Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.
FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation
FDA is at a pivotal moment because of important gains in medical treatment based on science.
Sustainable Medicines Packaging Award Winners to be Announced at Connect in Pharma
Connect in Pharma will host an awards ceremony to showcase innovations in sustainable pharmaceutical packaging.
EMA Starts Rolling Review of Adapted COVID-19 Vaccines
The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.
International Collaboration on Pharmaceutical Regulations
Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.
Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility
Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.
Orbit Discovery Awarded Innovate UK Grant
Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.
FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older
FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.
Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands
Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.
Aptamer Group Signs Deal with Flip Gene Therapeutics
Aptamer Group has signed a deal with Flip Gene Therapeutics to support the development of inducible gene therapies.
SCHOTT to Triple Vial Production Capacity in the US
SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.
Boehringer Ingelheim to Acquire Trutino Biosciences
Boehringer Ingelheim has signed an option to acquire Trutino Biosciences.
FDA User Fee Legislation Advances in Senate
Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.
Humanigen, PCI Pharma Services Enter Agreement for Lenzilumab Commercialization
Humanigen and PCI Pharma Servicesare partnering up for the commercialization of lenzilumab.
MHRA to Play Greater Role in International Medicines Regulation
MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
Icosapent Ethyl Gains Nod from NICE
NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.
Merck Collaborates with Agilent Technologies on PAT for Downstream Processing
Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.
Researchers Invent New Material that Can Capture and Release Biomolecules
A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.
Exothera, LogicBioTherapeutics, and Polyplus Collaborate on Industrial-Scale AAV Manufacturing
Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.
CPHI China Opens its International Partnering Program After China Goes Up in CPHI Index
CPHI China and P-MEC China has opened its online partnering platform after China experienced gains in the CPHI Pharma Index.
Pain Regulation Gene Discovery Leads to New Treatment Target
UK researchers have discovered a gene involved in chronic pain, which has created a new treatment target.
FDA Publishes Draft Quality Risk Management Guidance
The draft ICH Q9(R1) document details the importance of quality risk management principles.
FDA Publishes Guidance on Regenerative Medicine Therapies
The new draft guidance describes a standards recognition program for regenerative medicine therapies.
Yourway Announces New European Depot in Dublin
Yourway intends to construct a new manufacturing facility in the Dublin Airport Logistics Park.
Spectrum Chemical Strikes Buffers Distribution Deal with ANGUS Chemical Company
The deal will see Spectrum market and distribute ANGUS’ biologics grade buffers in the United States and Canada.
Precision BioSciences Releases Data on CAR T Therapy Candidates
Precision BioSciences has released clinical trial data on CAR T therapy candidates PBCAR0191, PBCAR19B, and PBCAR269A.
Moderna Bivalent Booster Candidate Demonstrates Superior Antibody Response Against Omicron
Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.
REGENXBIO Launches New Gene Therapy Manufacturing Facility in US
REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.
EMA Publishes 2021 Annual Report
In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.