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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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Enzyme replacement therapy for alpha-mannosidosis gets FDA approval
The first and only enzyme replacement therapy approved for alpha-mannosidosis in the US has been cleared for adult and paediatric patients.
Fusion to acquire radiologand therapy for prostate cancer
An investigational new drug application for an ongoing Phase II trial of an alpha-emitting radiopharmaceutical will be acquired by Fusion Pharmaceuticals.
Lonza completes bioconjugation facility expansion
The planned expansion of Lonza’s bioconjugation facility in Visp, Switzerland has been completed, the company has announced.
European Commission awards €7.7 million to mechanochemistry project
€7.7 million has been awarded to IMPACTIVE by the European Commission to study mechanochemistry as a sustainable method for synthesising active pharmaceutical ingredients (APIs).
Genentech to open new high-tech biologics facility
A new, high-tech, sustainable biologics manufacturing facility at Genentech’s US Oceanside campus will be operational in early 2025.
Neoadjuvant nivolumab improves long-term survival for lung cancer
Analysis of a Phase II trial for non-small cell lung cancer has suggested neoadjuvant nivolumab improved five-year recurrence-free survival compared with historical outcomes.
HPAPI global market to reach $34.04b in 2026
The global highly potent active pharmaceutical ingredient (HPAPI) market is expected to reach $34.04 billion in 2026, a report has predicted.
Johnson & Johnson appoints new Executive Vice President, Pharmaceuticals, R&D
An executive from Sanofi has been appointed as Johnson & Johnson’s new Executive Vice President of Pharmaceuticals, R&D.
Analytical platform could advance mRNA medicine QC
An innovative analytical platform based on liquid chromatography, mass spectrometry and software analysis can quantify the structure of mRNA-based medicines, researchers have found.
CAR T-cell therapy offers substantial remission rates in trial
In a Phase III study, a CAR T-cell therapy more than tripled progression-free survival compared with standard care for triple-class exposed multiple myeloma.
Pfizer and BioNTech mRNA shingles vaccine study begins
A Phase I/II trial for the first mRNA-based shingles vaccine programme has been initiated by Pfizer Inc. and BioNTech SE.
CGT Catapult to bolster new UK life sciences campus
The Cell and Gene Therapy Catapult (CGT Catapult) is set to be involved in the establishment of one of the largest life sciences campuses in Europe.
Astellas and Bayer announce management changes
Two Big Pharma companies have announced management changes in 2023: Astellas will have a new President and CEO and Bayer AG will be led by a new CEO.
Pierre Fabre to lead commercialisation of EBVALLO®
Following transfer of the European Commission marketing authorisation from Atara, Pierre Fabre will lead commercialisation of EBVALLO® in Europe.
Could oral difelikefalin be first FDA-approved drug for notalgia paresthetica?
A study by Icahn School of Medicine at Mount Sinai researchers showed oral difelikefalin could potentially relieve itching associated with notalgia paresthetica.
