All Therapeutics articles – Page 6
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News
CDER director Richard Pazdur to retire from FDA
In the interim, Dr Tracy Beth Høeg will serve as acting director for FDA's Center for Drug Evaluation and Research.
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ArticleCould a simple handle change your cleanroom contamination risk?
MBV AG addresses challenges in air monitoring and aseptic handling with MAS-100 Sirius®: a next‑generation active microbial air sampler created in close collaboration with pharmaceutical manufacturers and cleanroom experts.
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News
Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
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NewsUK first country to secure zero-tariff US pharmaceuticals deal
New trade deal to “ignite economic growth” and help boost the UK’s position as a superpower in life sciences.
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ArticleEuropean Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
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NewsAbbVie’s atogepant illustrates migraine therapy label expansion potential
If approved in Europe, atogepant would provide patients with a new acute treatment option for migraine attacks.
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NewsBSI launches a world-first environmental standard for the pharma industry
New BSI standard PAS 2090 could reshape how the pharmaceutical industry reports and minimises its environmental footprint.
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NewsLife sciences responds to 2025 UK Autumn Budget
The modern Industrial Strategy is informing the UK government’s decisions in the Budget.
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NewsNovartis adjusts manufacturing strategy in Switzerland to secure competitiveness
Swiss pharma company to trim production of oral medicines and packaging in Stein, while boosting productivity in Schweizerhalle.
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Chiesi gains pace on climate target with new carbon minimal inhaler data
Findings presented at the British Thoracic Society (BTS) Winter Meeting back biopharma’s Net Zero commitment.
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NewsDupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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AstraZeneca furthers US manufacturing commitment with $2bn Maryland investment
The move is part of biopharma's $50 billion pledge to US medicines manufacturing and R&D.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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NewsMedicines manufacturing in the UK to receive £54m sustainability boost
R&D projects supported by the Centre for Process Innovation (CPI) aim to shape a sustainable, resilient and competitive future for pharma manufacturing.
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NewsInsmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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NewsModerna strengthens US mRNA manufacturing capabilities with over $140m investment
The expansion places the pharma company’s full manufacturing loop in the US under one roof.
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Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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News
Johnson & Johnson targets oncology portfolio with $3bn Halda acquisition
Acquisition of the US biotech gives Johnson & Johnson rights to clinical-stage precision treatments for solid tumours.
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NewsFDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.