All Therapeutics articles – Page 52
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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.
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NewsAstellas to advance oncology CAR-T therapy
An investment of $50 million by Astellas Pharma in Poseida Therapeutics’ Phase I allogeneic CAR-T product candidate for solid tumour indications is set to advance the cancer immunotherapy field.
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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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ArticleTreating 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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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.