Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.
Orgenesis has signed a co-development agreement with Accelix to integrate advanced optic technologies, cartridges, and software onto POCare platform.
Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.
Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.
On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.
A recently published European Medicines Agency (EMA) report has demonstrated that there are continued efforts being made across Europe to reduce the amount of antibiotics used in animals.
GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.
Enterprise Therapeutics is the recipient of funding worth up to £5.7 million (US $7 million) from the Cystic Fibrosis Foundation.
Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.
The companies will present the SV model a semi-automatic machine for the inspection of liquid, lyophilized, or powder products in ampoules, vials, cartridges, and pre-filled syringes.
The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.
The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.
The transaction gives Alexion access to Achillion’s portfolio of oral small-molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases.
Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.
The Italy-based pharmaceutical glass and plastic packaging manufacturer, announced it will be showcasing its prototypes for usability, sustainability, connectivity, and traceability.
The new Flexi-Cap Prime will be presented at CPhI Worldwide in Frankfurt, Germany, on Nov. 5–7.
The companies will be presenting Push Packs at CPhI Worldwide on Nov. 5–7 in Frankfurt, Germany.
As the world awaits the outcome of Brexit, a presentation taking place at CPhI Worldwide in Frankfurt, Germany will delve deeper into the implications of each potential scenario on the pharma industry.
During the first day of CPhI Worldwide in Frankfurt, Germany, a panel of experts will be discussing the evolution of CDMOs in the shifting therapeutic landscape.
On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
The transaction is set to be completed at the end of the first quarter of 2020.
AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.
The collaboration aims to reduce “vein-to-vein” time for patients and to optimize manufacturing and supply operations.
The new location will handle logistics, development, data, service support, FAT, and project management.
CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.
In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.