Bikash Chatterjee, president and chief science officer at Pharmtech Associates and Girish Malhotra, president of EPCOT International, touch upon how manufacturing could be revolutionized by new technologies if regulators evolve to prevent hindering future innovation.
The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.
Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.
The winners will be announced on Nov. 5, 2019 on the first day of CPhI Worldwide.
On Tuesday Nov. 5, 2019, Dr. Meinolf Brackhagen from DuPont Nutrition & Biosciences will discuss the current and future roles of excipient suppliers
During day two of CPhI Worldwide in Frankfurt, Germany, Informa Pharma Intelligence will host a roundtable discussion regarding recent and future mergers and acquisitions.
The agency announced it has approved 1171 generic drugs in fiscal year 2019.
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.
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.