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FDA's stem cells authority

The US District Court for the District of Columbia has ruled that FDA has the authority to regulate stem-cell treatments as drugs. The ruling paves the way for FDA to enforce oversight over the numerous stem-cell clinics that have come into existence over the past few years.

http://PharmTech.com/FDAStemCells

EMA follow-up measures

The EMA is phasing out follow-up measures to marketing authorisations in place of a new classification system that will be introduced in a stepwise manner. The EMA began reclassifying outstanding unclassified follow-up measures in August. Affected marketing-authorisation holders will receive an outcome fax about the new classification.

http://PharmTech.com/EMAFollowUp

Rising inspections

In the coming years, the global industry is expecting more improved consistency among regulatory inspections; inspections that are well-informed by global issues; and enhanced recognition and reliance upon inspections conducted by recognised health authorities, which may reduce the total number of regulatory inspections at any one site.

http://PharmTech.com/RisingInspections

EU–Japan cooperation

The EMA has reported on the benefits of its increased interaction and cooperation with Japanese medicines regulatory authorities. In particular, EMA says progress has been made in the are of orphan medicines and rare diseases. Paediatrics, advanced therapies, pharmacogenomics, and nanomedicines have also benefited from the collaboration.

http://PharmTech.com/EMAJapan

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News bites

UK invests in stem cells

The UK is investing €10.2 million in a centre that will be dedicated to stem-cell biology and medicine, with the aim of developing therapeutic approaches to illnesses that have no effective treatments. A facility is being purpose-built for the institute on the University of Cambridge's Biomedical Research Campus.

http://PharmTech.com/StemCellInstitute

Silk protein innovation

Research from Tufts University in the US shows that silk protein can be used to stabilise and maintain the potency of vaccines and other drugs without the need for refrigeration. Silk stabilisation preserved the efficacy of the measles, mumps and rubella (MMR) vaccine, as well as penicillin and tetracycline, significantly better than other options.

http://PharmTech.com/SilkProtein

Elan spins off discovery

Elan Corp. is spinning its discovery unit and Neotope Biosciences division, which is resposinble for the discovery of the monoclonal antibody therapy Tysabri. The new entity will be called Neotope Biosciences and will focus on identifying and translating targets into potential therapies for chronic degenerative and other related disease areas.

http://PharmTech.com/ElanSpinOff

Novartis in cancer deal

Novartis is collaborating with the US's University of Pennsylvania to research, develop and commercialise targeted cancer therapies. In particular, the two parties will focus on targeted chimeric antigen receptor (CAR) immunotherapies. As part of the collaboration, Novartis and the university intend to jointly establish a new R&D facility.

http://PharmTech.com/NovartisCancer

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
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View Results
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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology Europe,
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