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Astellas 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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First 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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New 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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Next-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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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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New 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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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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CDKL5 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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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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Paper 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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Novel 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).
