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KALYDECO in Cystic Fibrosis receives positive CHMP opinion by EMA
- October 21, 2018
- Posted by: Pharmascroll
No CommentsVertex Pharmaceuticals (Europe) Limited announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis
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Positive results from new triple combinations in Cystic Fibrosis, displayed by Vertex
- October 21, 2018
- Posted by: Pharmascroll
Phase 2 results of VX-659 and VX-445 triple combination regimens concurrently published in The New England Journal of Medicine Vertex Pharmaceuticals at the 32ndNorth American Cystic Fibrosis Conference presented Phase 2 data evaluating clinical safety and efficacy as well as in vitro data of two triple combination regimens (VX-659, tezacaftor and ivacaftor; VX-445, tezacaftor and
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Dupixent® (Dupilumab) approved by FDA for Asthma indication
- October 21, 2018
- Posted by: Pharmascroll
Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype Only asthma biologic that offers patient self-administration at home Only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13
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Synspira’s drug receives FDA Orphan Designation for Cystic Fibrosis treatment
- October 16, 2018
- Posted by: Pharmascroll
Synspira,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