All Clinical Development articles – Page 25
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NewsNICE recommends Eli Lilly ulcerative colitis biologic
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
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ArticleGene therapy: a radical pharmaceutical revolution
Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring provides an overview of past and present gene therapy development, plus the progress of clinical trials and key challenges in the sector.
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Newssa-mRNA vaccine facilitates durable COVID-19 immunisation
A novel sa-mRNA vaccine has demonstrated the ability to provide prolonged protection against COVID-19 at lower doses, Phase I/II data shows.
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NewsEuropean Commission approves long-acting HIV drug option
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
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NewsCAR T therapy exhibits encouraging proficiency in R/R LBCL
The first study assessing Yescarta® as second-line therapy for transplant ineligible relapsed/refractory (R/R) large B-cell lymphoma (LBCL) demonstrated durable remission rate in a Phase II trial.
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NewsFirst 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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NewsAdvanced therapy collaboration network launched in Scotland
Advanced therapy (ATMP) manufacturers and developers in Scotland are set to be supported through a new collaboration initiative from the Cell and Gene Therapy Catapult (CGT Catapult).
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NewsCHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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NewsCPHI 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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NewsSmall 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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NewsPfizer’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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ArticleHow breakthrough CAR-T cancer therapies could be made more widely accessible
The development and regulatory approval of the first autologous CAR T-cell therapies is a huge advance for modern medicine and has been greeted with justifiable excitement. But applications of this technology are still limited, and given the time and cost constraints, more must be done to broaden access to this ...
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ArticleImplementing the future of mRNA therapeutics
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
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NewsNovel 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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NewsSandoz 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.
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NewsMHRA 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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NewsNICE 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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NewsAlzheimer’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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NewsGuidance 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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NewsRaman spectroscopy market expected to value $875m by 2028
A report has shown that growing demand for accurate identification of pharmaceutical raw materials is anticipated to boost the global Raman spectroscopy market.