European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
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Perfusion offers significant advantages in bioproduction of therapeutic enzyme
Research comparing intensified bioprocesses to fed-batch shows high cell density perfusion significantly advances productivity while maintaining quality and costs.
Pfizer and MPP to expand COVID-19 oral antiviral treatment access
The license agreement between Pfizer and the Medicines Patent Pool (MPP) will enable access to Pfizer's antiviral candidate in 95 countries.
NICE does not recommend elosulfase alfa for Morquio A syndrome
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
Protein catenation to advance development of therapeutic proteins
Higher order protein catenation enables the development of artificial antibodies with improved binding affinity and prolonged serum half-life, shows study.
Drug combination an alternative leukaemia treatment to chemotherapy
A clinical trial found that all-trans retinoic acid and arsenic trioxide is an effective treatment for acute promyelocytic leukaemia.
EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
GCD enables product traceability and batch definition in continuous biomanufacturing
Research shows using the greatest common divisor (GCD) to define batches in continuous biomanufacturing enhances process control and raw material traceability.
Intranasal anti-depressant drug successfully delivered to the brain
A new pre-clinical study succeeded in the intranasal delivery of an anti-depressant peptide-based drug to the brain in mouse models.
Cosentyx®displays a 72 percent reduced arthritis flare risk
Cosentyx® resulted in a 72 percent reduced flare risk for enthesitis-related arthritis and juvenile psoriatic arthritis in a Phase III study.
Depression drug shows positive results in groundbreaking Phase IIb study
COMP360 25mg versus 1mg comparator dose demonstrated a -6.6 point difference on the Montgomery-Åsberg Depression Rating Scale by week 3.
Aimovig®displays superiority over topiramate in migraine study
Amgen announces positive results from the first and only randomised, double-blind, head-to-head study comparing Aimovig® to topiramate.
Rinvoq® shows positive results in rheumatoid arthritis post-hoc analysis
In the analysis, 34 percent of rheumatoid arthritis patients receiving Rinvoq® achieved Clinical Disease Activity Index (CDAI) remission.
Wegovy™ demonstrates sustained weight loss in two-year obesity study
Novo Nordisk's Wegovy™ reduced body weight by 15.2 percent versus 2.6 percent with placebo in Phase IIIb study.
