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Adalimumab biosimilars shaping market, research states
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
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Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
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MHRA authorises new COVID-19 vaccine
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
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Accelerating biomanufacturing with automated PAT systems
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
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New immuno-oncology treatment approved for endometrial cancer
The first new treatment option approved for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in decades has been authorised by the US Food and Drug Administration (FDA).
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Innovation passport designation awarded to Pfizer and Arvinas
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
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Biogen to acquire rare disease drugmaker for $7.3b
As part of its acquisition of Reata Pharmaceuticals, Biogen will add the first US Food and Drug Administration (FDA)-approved treatment for Friedreich’s ataxia to its portfolio.
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AstraZeneca appoints new EVP of BioPharmaceuticals R&D
Former Senior Vice President, Head of Research and Product Development of Alexion, will succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.
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ADC demonstrates meaningful survival data for HER2 cancers
Topline data from a Phase II trial signify a significant step forward for ENHERTU® (trastuzumab deruxtecan) in its potential to provide a new option in HER2 expressing cancers.
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Finnish manufacturing facility to get €50m expansion
The planned €50 million investment at the Finland-based CDMO facility will enable advanced technologies to be used for development and manufacture of advanced therapy medicinal products (ATMPs).
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New CKD treatment option approved in EU
The first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in chronic kidney disease (CKD) patients versus placebo has been approved in the EU.
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Novel antibody therapeutic demonstrates potential in GVHD
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
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Small molecule API market to value $284.7 billion by 2032
Key opportunities within the small molecule active pharmaceutical ingredient (API) market include adopting continuous manufacturing and delving into niche disease areas, research has indicated.
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EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
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Roche to co-develop hypertension RNAi therapeutic
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
