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AbbVie 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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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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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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Will ESR1-mutated breast cancer treatment gain approval?
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
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Efficacy of novel drug proven in MDD study
Significant results from a Phase II study in major depressive disorder (MDD) for a novel kappa opioid receptor (KOR) antagonist has prompted initiation of a Phase III programme.
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European Commission extends approval of cystic fibrosis medicine
For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
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Novel oral therapy shows potential in plaque psoriasis
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
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Could small molecule medicine treat rare liver disease?
A novel PPAR alpha/delta agonist “could provide an important new therapeutic option for long-term treatment [of primary biliary cholangitis (PBC)].
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First AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
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First-in-class oral small molecule trial data presented at 2023 ERA Congress
At the 2023 ERA Congress, Chinook Therapeutics revealed Phase I data for its first-in-class oral small molecule LDHA inhibitor.
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NICE recommends oral migraine treatment for first time
An oral small molecule CGRP antagonist has been recommended for episodic migraines in National Institute for Health and Care Excellence (NICE) final draft guidance.
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$1.7b acquisition to develop rare haematology therapy
When CTI BioPharma is acquired by Swedish Orphan Biovitrum AB (Sobi), the companies intend to advance an oral kinase inhibitor treatment for a rare haematological disease.
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Oral drug reduces treatment-resistant migraine frequency
Initial data from study results being presented at the 75th American Academy of Neurology Annual Meeting indicate that an oral CGRP inhibitor reduced episodic migraine frequency.
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Oral PCSK9 inhibitor substantially reduces cholesterol, study finds
One of the first oral PCSK9 inhibitors tested in clinical trials significantly reduced low-density lipoprotein (LDL) cholesterol levels in patients with high cholesterol and/or heart disease.
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Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
