All articles by CE – Page 54
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NewsFirst oral medicine for postpartum depression approved
The first approved oral treatment that provides rapid symptomatic improvement in postpartum depression (PPD) is expected to be commercially available in the fourth quarter of 2023.
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NewsAntibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
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NewsNew HIV drug formulation could transform paediatric administration
The first fixed dose combination (FDC) formulation containing dolutegravir that is suitable for certain paediatric HIV patients globally, has been deemed safe and effective by US researchers.
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NewsNext-gen sustainable inhalers on the horizon
Global development and manufacture of the next generation of green inhalers is positioned to be accelerated by a new joint £33 million government-industry investment.
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NewsAdalimumab 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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NewsNew European monograph for Cannabis flower adopted
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
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NewsHarnessing continuous improvement in the CAPA process
In a risk-based framework for implementing a corrective and preventive action (CAPA) process, a continuous improvement approach is proposed as a way to drive higher product quality and improve patient safety.
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NewsMHRA 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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NewsAccelerating 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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NewsNew 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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NewsInnovation 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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NewsCDKL5 deficiency-associated seizure treatment approved in EU
The European Commission (EC) has approved the first treatment for paediatric patients in the EU to treat seizures associated with CDKL5 deficiency disorder.
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NewsBiogen 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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NewsPaper reports on QbD in bilayer tablet development
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
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NewsNovel pill could aid postpartum depression symptoms
If approved, the treatment could provide the first oral, at-home, neuroactive steroid therapy to treat postpartum depression (PPD).
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NewsAstraZeneca 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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NewsApproval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
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NewsInnovative solid-state storage for biologics developed
A new method enabling biological materials to be stored in a solid-state means medicines such as insulin could be administered orally in the future.
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NewsADC 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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NewsFinnish 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).