Boehringer Ingelheim to open new biopharmaceutical facility in Vienna
22 December 2015 | By Victoria White
The facility will produce ingredients manufactured using cell cultures and will create more than 400 new jobs in the Austrian capital...
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Merck KGaA and Pfizer advance avelumab clinical development programme
22 December 2015 | By
Merck KGaA and Pfizer have announced the opening of trial sites for an international Phase III study of avelumab in patients with ovarian cancer...
Pharmaceutical industry to pay £550 million in 2016 as part of the PPRS
22 December 2015 | By Victoria White
The PPRS is a unique scheme where pharmaceutical companies agreed to contribute towards the cost of medicines, with the aim of making the latest treatments affordable for the NHS...
PsiOxus initiates study of Keytruda and enadenotucirev in carcinomas
22 December 2015 | By Victoria White
Enadenotucirev is an oncolytic virus that has been shown in Phase I clinical trials to reach and selectively infect cancer cells when administered by intravenous infusion...
Adynovate meets endpoint in paediatric Haemophilia A study
21 December 2015 | By Victoria White
The study enrolled 73 previously-treated patients with severe haemophilia A younger than 12 years of age and assessed the treatment's haemostatic efficacy in prophylaxis and treatment of bleeding episodes...
Pembrolizumab improves survival in PD-L1 expressing NSCLC
21 December 2015 | By Victoria White
MSD has announced results from the Phase 2/3 KEYNOTE-010 study of Keytruda (pembrolizumab) in patients with previously treated non-small cell lung cancer (NSCLC)...
FDA grants Breakthrough designation for BI 1482694 in lung cancer
21 December 2015 | By Victoria White
BI 1482694 is Boehringer Ingelheim’s 3rd-generation, epidermal growth factor receptor mutation-specific tyrosine kinase inhibitor...
FDA authorises Phase III IND for Celyad’s C-Cure and C-Cathez
21 December 2015 | By Victoria White
The FDA has authorised Celyad’s IND application to proceed, thus allowing for the clinical testing of C-Cure cardiopioetic cells delivered via C-Cathez in a Phase III heart failure trial...
CHMP issues positive opinion for Tagrisso (osimertinib)
18 December 2015 | By Victoria White
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of AstraZeneca’s Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small…
Isis Pharmaceuticals becomes Ionis Pharmaceuticals
18 December 2015 | By Victoria White
Explaining his reasoning behind the company name change, Stanley Crooke, CEO of Ionis, told Forbes: “My underlying concern was that the name was a distraction"...
Adaptimmune initiates Phase I/II T-cell therapy study in NSCLC
18 December 2015 | By Victoria White
This will be the first study of Adaptimmune’s unpartnered affinity enhanced T-cell therapy targeting MAGE-A10, a highly immunogenic member of the MAGE-A family of cancer testis antigens...
CHMP issues positive opinion for AstraZeneca’s lesinurad
18 December 2015 | By Victoria White
The CHMP has adopted a positive opinion recommending the marketing authorisation of lesinurad 200mg tablets for the adjunctive treatment of hyperuricaemia in adult gout patients...
EC approves Imlygic as Europe’s first oncolytic immunotherapy
18 December 2015 | By Victoria White
The European Commission has approved the use of Amgen’s Imlygic (talimogen laherparepvec) for the treatment of adults with unresectable melanoma...
CPhI Worldwide reviews the Spanish pharma market
18 December 2015 | By Victoria White
CPhI Worldwide has announced the findings from a comprehensive review of the Spanish pharma market following the closing of its most successful ever CPhI Worldwide to date in Madrid last month...
BMS divests its HIV R&D assets to ViiV Healthcare
18 December 2015 | By Victoria White
ViiV will pay to Bristol-Myers Squibb upfront payments totaling $350 million with potential development and regulatory milestone payments of up to $518 million for the clinical assets and up to $587 million for the discovery and preclinical programmes...
