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Synspira’s drug receives FDA Orphan Designation for Cystic Fibrosis treatment
- October 16, 2018
- Posted by: Pharmascroll
No CommentsSynspira,a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic fibrosis. Synspira is developing PAAG15A as SNSP113, a potential
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Samumed And United Therapeutics enter Agreement For Ph I IPF Drug
- September 17, 2018
- Posted by: Pharmascroll
Samumed LLC has entered an exclusive license agreement with United Therapeutics Corporation for North American rights to Samumed’s SM04646, being developed for the treatment of idiopathic pulmonary fibrosis (IPF). Deal terms include $10 million up-front, plus up to $340 million in developmental milestones and up to low double-digit royalties. “We are excited to partner with
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Roivant acquires therapy to treat Chronic Cough in IPF patients
- September 6, 2018
- Posted by: Pharmascroll
Roivant Sciences announced that it has completed a transaction with Patara Pharma to acquire global rights to PA101 (now called RVT-1601), a novel formulation of inhaled cromolyn sodium delivered through a proprietary nebulizer device designed to yield high lung deposition and distribution, as well as related assets owned by Patara Pharma. In a completed Phase
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Esbriet dose modifications do not alter treatment effect in IPF, study finds
- August 29, 2018
- Posted by: Pharmascroll
A recent study conducted and published in BMJ Journals states that dose reductions and interruptions in Esbriet, an approved therapy used to manage the IPF symptoms, does not compromise its treatment effect on patients. Researchers involved in the study understood that temporary dose modifications, such as reductions or interruptions, may allow patients to better manage
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Preclinical Study Results presented for IPF drug BBT-877, by Bridge Biotherapeutics
- August 23, 2018
- Posted by: Pharmascroll
BBT-877 demonstrated the best-in-class potential at the preclinical experiments in comparison with competing compounds US IND will be submitted by year end Bridge Biotherapeutics presented the results of the preclinical study on ‘BBT-877’, an investigational drug candidate for IPF (Idiopathic Pulmonary Fibrosis) treatment, at the IPF Summit 2018 held in San Francisco, California. BBT-877 was
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FDA Approves ORKAMBI in Cystic Fibrosis for Children Ages 2-5 Years
- August 13, 2018
- Posted by: Pharmascroll
Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. ORKAMBI oral granules
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Boehringer Ingelheim to Develop novel Gene Therapy for Cystic Fibrosis
- August 7, 2018
- Posted by: Pharmascroll
Boehringer Ingelheim steps into the field of gene therapy, a focus area of its Research Beyond Borders initiative, with experienced partners, in an effort to bring to cystic fibrosis patients a long-term treatment aimed at correcting the underlying genetic causes of this devastating disease. Boehringer Ingelheim will collaborate with the UK Cystic Fibrosis Gene Therapy
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Genkyotex announces Ph 2 trial for GKT831 in Patients with IPF
- August 3, 2018
- Posted by: Pharmascroll
Trial to be fully funded via a grant from the United States National Institutes of Health to a consortium of leading academic institutions Genkyotex announced that the United States National Institutes of Health (NIH) has awarded an $8.9 million grant to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a
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NICE advises restricted use of antibiotics for COPD
- July 10, 2018
- Posted by: Pharmascroll
These draft recommendations come as NICE publishes draft antimicrobial prescribing guidance and a separate update to its 2010 clinical guideline on diagnosing and managing COPD in over 16s. The draft antimicrobial guidance recommends that antibiotics should be offered to people who have a severe flare up of symptoms, also known as a severe acute exacerbation. However other factors should
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Spiriva Respimat gets UK license for young asthma patients
- June 7, 2018
- Posted by: Pharmascroll
Boehringer Ingelheim today announced an expanded UK indication for Spiriva (tiotropium) Respimat as add-on maintenance bronchodilator treatment in patients aged six years and older with severe asthma who experienced one or more severe asthma exacerbations in the past year, following the European Union regulatory acceptance in March 2018. The US Food and Drug Administration expanded