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...
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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...
Pancreatic cancer treatment market to grow to $2.9b by 2021
17 December 2015 | By Victoria White
GBI Research says the treatment market for pancreatic cancer is set to grow from its current level of $1.9 billion to an impressive $2.9 billion by 2021, driven primarily by an increased prevalence of the disease...
Stem cell therapy does not provide significant improvement in Crohn’s disease
17 December 2015 | By Victoria White
A clinical trial to test the effectiveness of a stem cell therapy among adults with difficult to treat Crohn's disease has found it is not significantly better than conventional treatment in producing sustained disease remission after one year...
Rainin TerraRack™ wins Green Apple Environment Award
17 December 2015 | By METTLER TOLEDO
METTLER TOLEDO is proud to announce that its Rainin TerraRack™ line of pipette tip racks has achieved success in this year’s Green Apple Awards...
Adcetris leads the Hodgkin’s lymphoma treatment market
17 December 2015 | By Victoria White
Adcetris will continue to lead the Hodgkin’s lymphoma treatment market in the US and is likely to gain swift popularity following its anticipated label extension in Europe from early 2016, according to an analyst with GlobalData...
Novo Nordisk announces results for SUSTAIN2 trial of semaglutide
17 December 2015 | By Victoria White
The trial investigated the efficacy and safety of semaglutide compared with sitagliptin after 56 weeks of treatment in people with type 2 diabetes...
FDA approves Basaglar, a long-acting insulin treatment
17 December 2015 | By Victoria White
The FDA has approved Basaglar for the treatment of adult and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus...
