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....
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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...
AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) to treat chronic lymphocytic leukaemia
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The CHMP recommends approval of venetoclax monotherapy in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have...
New Colombia Resources collaborate with AiP seeking FDA approval for medical cannabis product
17 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The Ministry has publicly expressed interest in bringing Cannabis research to Colombia and the Company feels their project is in line with this aspiration...
NICE does not recommend Janssen’s Waldenstrom’s macroglobulinaemia candidate
17 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The National Institute of Health and Care Excellence (NICE) has published draft guidance that does not recommend Janssen’s Imbruvica (ibrutinib) for treating some people with Waldenstrom’s macroglobulinaemia – a rare type of slow growing non-Hodgkin’s lymphoma.
Daiichi Sankyo enrols first patient in Phase III acute myeloid leukaemia trial
17 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Daiichi Sankyo has enrolled their first patient in the global phase 3 QuANTUM-First study evaluating the oral FLT3-ITD inhibitor quizartinib in patients...
‘Fast track’ cost effective treatments for patients following NICE changes
17 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Proposed changes to the way NICE appraises new treatments could see patients benefiting from the most cost effective treatments nearly three months faster...
Aeterna Zentaris’ Zoptrex granted licensing agreement for Australia and New Zealand
14 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Zoptrex, a novel synthetic peptide carrier linked to doxorubicin, is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer...
