Novartis’ sickle cell drug wins FDA priority review
The governing body accepted the company’s Biologics License Application for prevention of vaso-occlusive crises.
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Tag: breakthrough
Milestone reached as HIV remission achieved in second patient
A patient treated with a stem cell transplant has been in remission from HIV for 18 months and is no longer taking HIV drugs.
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Breakthrough status for Roche’s autism drug
Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
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Shire’s cytomegalovirus therapy wins ‘Breakthrough’ status
An experimental drug being developed by Shire to treat cytomegalovirus (CMV) infection has been given a boost in the US with a ‘Breakthrough Therapy Designation’.
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US awards Novartis’ Kisqali ‘Breakthrough’ status
Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.
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‘Breakthrough’ tag for GSK’s multiple myeloma drug
An investigational antibody-drug conjugate being developed by GlaxoSmithKline for patients with multiple myeloma has been awarded Breakthrough Therapy Designation from the US Food and Drug Administration.
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AZ’ lung cancer drug Tagrisso bags breakthrough status
AstraZeneca’s Tagrisso has been awarded breakthrough status in the US as a first-line treatment for a specific type of non-small cell lung cancer (NSCLC), potentially speeding up its development and regulatory pathway.
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Second breakthrough badge for Janssen’s antidepressive
Janssen’s esketamine has picked up a breakthrough therapy designation in the US as a treatment for major depressive disorder with imminent risk for suicide, potentially speeding up development and review timelines.
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US breakthrough status for Novartis’ breast cancer drug
Novartis’ experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.
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BMS’ Opdivo gets ‘breakthrough’ badge for bladder cancer
US regulators have awarded Bristol-Myers Squibb’s immunotherapy Opdivo its sixth breakthrough therapy status, this time for its potential in treating bladder cancer.
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- Storm Therapeutics and AlidaBio launch collaboration to advance RNA‑targeting cancer therapies
- Excellence adventure
- MHRA approves Nucala for eosinophilic COPD in adults on triple therapy
- Bial launches new sublingual Parkinson’s treatment in UK
- Acesion Pharma launches phase 2 trial of AP31969 in atrial fibrillation
