According to the first annual report into clinical trials by the Association of the British Pharmaceutical Industry, the United Kingdom is leading the rest of Europe in early-stage clinical research into new medicines and vaccines. / read more /
If successful, the acquisition will boost Recipharm’s global position in the contract development and manufacturing organization (CDMO) market. / read more /
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The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention. / read more /
Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children. / read more /
Roche’s ADC, Kadcyla, has been recommended for approval in the EU for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. / read more /
Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy. / read more /
The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies. / read more /
The companies will work to discover and develop therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC RNAi platform technology. / read more /
GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities. / read more /
Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development. / read more /
Pharma companies must comply with the pharmacopoeia requirements for each country in which they plan to distribute drugs. Often, stakeholders do not have a sufficient understanding of these requirements. In the first article in a series, learn the legal and regulatory basis for pharmacopoeia compliance and the impact of pharmacopoeias throughout a drug’s lifecycle. / read more /
Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis. / read more /
The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development. / read more /
SMA MicroParticle ICS™ VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio. / read more /
Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.
