List view / Grid view
4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
18 November 2015 | By Victoria White
Survey results released by the ECDC show that the situation continues to worsen with regard to the spread of CPE in the EU, with 3 countries reporting an endemic situation...
18 November 2015 | By Cherwell Laboratories
Cherwell publishes case study discussing key considerations when purchasing an active air sampler...
13 November 2015 | By Victoria White
Ahead of the European Antibiotic Awareness Day, ESCMID has highlighted two of its more recent projects in the fight against antimicrobial resistance...
Sartorius Stedim Biotech (SSB) BioOutsource today announced its expert technical staff will be speaking at and/or attending BIOLATAM, Biosimilars LATAM and Biosimilars and Biobetters conferences from November 16-19. This will provide developers of biosimilars with an excellent opportunity to discuss the optimum assay design for rapid and accurate biosimilar characterisation…
12 November 2015 | By Victoria White
The data reveals antibiotic prescribing hotspots and interesting correlations against areas of deprivation. It also shows seasonal variation in antibiotic prescribing...
10 November 2015 | By Victoria White
CHS-0214 met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis...
10 November 2015 | By Victoria White
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases...
3 November 2015 | By Coulter Partners
Coulter Partners was delighted to partner with German diagnostics company Curetis AG on two strategic supervisory board appointments and congratulates them on their recent IPO launch...
3 November 2015 | By Wickham Laboratories
Introducing the MALDI Biotyper® for rapid microbial identification....
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
In this RMM In-Depth Focus: Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable...
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz
Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…
