news
Boosting the safety of bulk drug substances is aim of FDA measures
Boosting the safety of compounded drugs is the aim of new plan from the US Food and Drug Administration (FDA), which has unveiled a series of measures.
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Drug Manufacturing
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UK-US post-Brexit trade deal risks increased drug prices
A trade deal between the UK and USA could risk increasing drug prices in the UK, which could diminish the affordability and accessibility of the NHS...
news
FDA approves Aristada Inito for the initiation of Aristada for schizophrenia
Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one...
product
Product Hub: Introducing ENDOZYME® II GO, endotoxin testing made faster, easier and more consistent
The rapid ENDOZYME® II GO assay is the latest member of bioMérieux’s ENDONEXT™ range of endotoxin detection assays based on sustainable recombinant horseshoe crab Factor C (rFC). The new assay caters to two important needs: efficiency and consistency...
news
bioMérieux launches ENDOZYME® II GO, an innovative test for the detection of endotoxins in pharmaceutical microbiology control
bioMérieux, a world leader in the field of industrial microbiological control, announces the launch of ENDOZYME® II GO, a new endotoxin test in the bioMérieux ENDONEXT™ range of recombinant horseshoe crab Factor C (rFC) assays.
news
FDA approves Palynziq for PKU, a rare and serious genetic disease
Novel enzyme therapy for adults with PKU who have uncontrolled blood phenylalanine concentrations with current treatment...
news
FDA expands approval of Gilenya to treat multiple sclerosis in paediatric patients
The FDA has approved Gilenya to treat relapsing multiple sclerosis in children and adolescents age 10 years and older...
news
ACG exhibits a wide range of Capsules solutions at CPhI USA
ACG’s Capsules business will showcase their range of capsules solutions at CPhI North America, an international platform that brings together Pharma industry’s leaders from drug development, drug manufacturing and bio-manufacturing...
news
FDA accepts NDA for ALKS 5461 for major depressive disorder
The FDA has accepted for review the New Drug Application for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder ...
news
EC approves Alofisel for complex perianal fistulae in Crohn’s disease
The EC has approved Alofisel for the treatment of complex perianal fistulae in adult patients with nonactive/mildly active luminal Crohn’s disease...
news
Crystallographic method accelerates drug development
Researchers have developed a novel method that speeds up the process of determining crystal structures of organic salts and significantly reduces the effort required to do so...
news
FDA expands approval of Adcetris for Stage III or IV classical Hodgkin lymphoma
The FDA has approved Adcetris to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy...
news
ACG GROUP: ‘World’s only market-ready track & TR solutions provider’ for EUFMD – Inspections business launches groundbreaking Track & Trace capabilities.
ACG is the ‘world’s only market ready Track & Trace solutions provider', in accordance with the EU Falsified Medicines Directive (EUFMD) - which comes into effect in February 2019...
whitepaper
Application Note: Identification of counterfeit phosphodiesterase inhibitors using NIR spectroscopy and chemometrics
The counterfeiting of pharmaceuticals for economic gain is a growing problem in a modern society within which medicines play a major role...
news
FDA approves Glatopa a generic option for relapsing forms of multiple sclerosis
Sandoz has announced that the FDA has approved and launch of Glatopa as a fully-substitutable, AP-rated generic version of Copaxone for relapsing forms of MS...
