LIVE: ISPE 2016 Europe Conference on Biotechnology
24 October 2016 | By Niamh Louise Marriott, Digital Content Producer
We're live at ISPE 2016 Europe Conference on Biotechnology! Check this stream for live updates of the event...
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News
FDA approves Roche’s blood screening assay for donor screening
24 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The cobas MPX assay enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood...
NICE recommends ‘breakthrough’ drug nivolumab for advanced renal cell cancer
21 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Nivolumab is an intravenous drug, a form of immunotherapy that works by harnessing the power of the patient’s own immune system to destroy the cancer cells...
Sanifit launches Phase II calciphylaxis study
20 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Calciphylaxis is a serious and rare condition characterised by vascular calcification and thrombosis leading to necrosis of the skin and fatty tissue...
MicuRx’S Phase III MRSA antibiotic trial to support Chinese NDA filing
20 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The recent $55M Series C financing will allow MicuRx to complete this Phase 3 study, and at a vital time with antibiotic resistance at an all time high...
Lonza to hold free webinar on LIMS and MODA-EM™ solution
Lonza will hold a free 60-minute webinar on 2 November 2016 titled “LIMS and MODA-EM™ Solution – A Comprehensive Solution for Pharmaceutical Manufacturing Quality Control.”
Wickham Laboratories Announces Renewal of FDA Accreditation
20 October 2016 | By Wickham Laboratories
Wickham Laboratories reports a successful completion of the FDA auditing process with renewal of GMP accreditation....
EU approval for Abeona’s gene therapy to treat Sanfilippo Syndrome Type A
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Gene therapy program ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA), a rare autosomal recessive disease...
NICE to tackle ‘underdiagnosed’ coeliac disease sufferers with new quality standards of treatment
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Coeliac UK welcomes NICE quality standards but is concerned that many CCG's in England will not reverse blanket bans on gluten-free prescribing...
Antibiotic-resistant ‘superbug’ bacteria found at NHS-funded factories
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Out of 34 sites tested, 16 were found to be harbouring bacteria resistant to antibiotics, according to the report. Resistance to three major antibiotics...
Ferring receives positive CHMP opinion for IVF aid Rekovelle
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for Rekovelle...
FDA to re-review application for AstraZeneca’s hyperkalaemia treatment
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Hyperkalaemia (potassium levels > 5.0 mEq/L in the blood serum) occurs in patients with advanced chronic kidney disease and chronic heart failure...
Apitope regains global rights to its multiple sclerosis treatment from Merck
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
In 2009, Apitope granted exclusive worldwide rights to Merck to develop and commercialise ATX-MS-1467 but now have successfully regained...
TiGenix’s Crohn’s disease drug granted Swiss orphan drug designation
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Cx601 is a suspension of allogeneic adipose-derived stem cells for the treatment of complex perianal fistulas in patients with Crohn's disease that have...
Success for Clementia’s Phase II Fibrodysplasia Ossificans Progressiva trial
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Palovarotene was well-tolerated, with all subjects completing the 12-week trial and enrolling into the open-label extension trial...
