All news articles – Page 54
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NewsCHMP to review MAA for geographic atrophy treatment
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
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NewsImmunotherapy combo could overcome melanoma anti-PD-1 resistance
A “practice-changing” immunotherapy drug combination demonstrated inhibition of two main immune checkpoints in a trial assessing efficacy in metastatic melanoma.
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NewsCDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
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NewsAbbVie gains EU migraine treatment approval
The first once-per-day oral CGRP receptor antagonist gepant treatment has been approved in the EU as a preventative treatment for both chronic and episodic migraines.
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NewsSandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
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NewsUK approval for Pompe Disease therapy
The MHRA has granted marketing authorisation for a two-component therapy for adults with late-onset Pompe Disease, a rare disorder.
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NewsCPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
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NewsBuccal drug delivery market to reach $7.1b by 2030
Growth of the buccal drug delivery market is driven by the high bioavailability of buccal formulations as well as the ageing population, smoking addiction and increased R&D.
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NewsLilly completes biopharma acquisitions
Lilly expands its portfolio of treatments for cardiometabolic diseases with acquisition of Versanis Bio and Sigilon Therapeutics.
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NewsFDA approval for Janssen’s prostate cancer treatment
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
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NewsEuropean Commission revokes marketing authorisation for Novartis’ crizanlizumab
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
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NewsCDMO expands CGT manufacturing site in Italy
The expansion of the CGT manufacturing site in Milan, Italy, will support viral vector development and manufacturing for late-stage clinical and commercial projects.
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NewsMultiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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NewsFDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
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NewsNovo Nordisk makes $1 billion acquisition agreement
Under a $1 billion acquisition agreement, Novo Nordisk A/S will investigate a potential first-in-class small molecule CB1 receptor blocker as a treatment for obesity.
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NewsWill Novartis provide new oral option for chronic hives?
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
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NewsADC oncology therapy market to value over $36b by 2029
With antibody-drug conjugates (ADCs) gaining favour as oncology treatments, research shows Daiichi Sankyo, Seagen and Roche are currently three of the market's most important players.
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NewsSemaglutide demonstrates cardiovascular benefit
In Novo Nordisk’s landmark trial for cardiovascular outcomes, semaglutide 2.4mg has potential to change how obesity is regarded and treated, headline data suggests.
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NewsAstraZeneca’s tezepelumab and dapagliflozin accepted for use in Scotland
The Scottish Medicines Consortium (SMC)’s acceptance means eligible patients across the UK can now benefit from AstraZeneca's Tezspire (tezepelumab) for severe asthma and Forxiga (dapagliflozin) for chronic heart failure.
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NewsNew vaccine development centre to strength UK's capabilities
The UK’s new vaccine development and evaluation centre will target pathogens for which a vaccine does not exist or could be improved, supporting pandemic preparedness.