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First treatment for myelofibrosis with anaemia approved
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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Clinical Trials
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CPHI Pharma Awards 2023 finalists announced
The finalists for CPHI’s Pharma Awards 2023 across twelve categories for innovation, manufacturing, sustainability, best start-up initiative and breakthrough digital technologies have been announced.
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Small molecule drug shows promise in rare disease
In a Phase II trial, the small-molecule drug CBL-514 demonstrated significant reduction in lipoma size and pain improvement in Dercum's disease, a rare disorder.
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Pfizer’s migraine medicine recommended by NICE
The National Institute for Health and Care Excellence (NICE) has published final draft guidance on Pfizer’s Rimegepant, recommending it for the first time as a treatment for acute migraines.
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Novel vaccine delivers significant survival in lung cancer trial
The most advanced therapeutic cancer vaccine in clinical development has demonstrated a 41 percent reduction of the risk of death for non-small cell lung cancer (NSCLC) in a Phase III trial.
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Sandoz to commercialise mAb biosimilar candidate
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
whitepaper
Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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MHRA releases its CTA application performance metrics
Recent data reveals how many clinical trial authorisation (CTA) applications and substantial amendments the Medicines and Healthcare products Regulatory Agency (MHRA) received and assessed in the past year, including statistics for novel trial designs.
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NICE recommends new type 2 diabetes treatment
A safer alternative to current first line therapies has been recommended by the National Institute for Health and Care Excellence (NICE) as a new treatment option for type 2 diabetes.
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Alzheimer’s senescent cell combination therapy presents promise
Evidence from a Phase I trial suggests that the tyrosine kinase inhibitor dasatinib in combination with quercetin clears amyloid from the brain and lowers inflammation in the blood.
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Guidance recommending BMS cardiac myosin inhibitor published
NICE’s final guidance recommending Bristol Myers Squibb’s first-in-class obstructive hypertrophic cardiomyopathy (oHCM) drug on the NHS, is now published.
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New medicines manufacturing centre to enhance UK talent
Part of the £650 million ‘Life Sci for Growth’ funding package announced in May 2023, £5.5 million is set to deliver a new UK Medicines Manufacturing Skills Centre of Excellence to boost the skills of talent in the life sciences sector.
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NICE recommends new Fabry disease treatment
Recommendation of Elfabrio® (pegunigalsidase alfa) means patients with Fabry disease in England will be able to access a new treatment option.
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European Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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Trial-first for Roche lung cancer ALK inhibitor
Roche has provided the first evidence that its oral anaplastic lymphoma kinase (ALK) inhibitor for non-small cell lung cancer (NSCLC) could be key in treating the early-stage disease.
