BioSpace News Archive

Policy

Biohaven Announces FDA Clearance of IND Application for Sublingual BHV-0223 in Patients With ALS

Biohaven and its wholly owned subsidiary, Biohaven Pharma, today announced that the FDA has notified the Company that it may proceed with its clinical investigation of sublingual BHV-0223 as a potential treatment for patients with ALS.

November 1, 2017

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6 min read

Drug Development

Meta-Analysis Using Real-World Data Evaluates Safety Profile of Takeda’s Entyvio (vedolizumab) in Patients With Moderate to Severe Ulcerative Colitis or Crohn’s Disease

New meta-analysis provides a comprehensive view of real-world data and furthers understanding of Entyvio as an important treatment option for patients with ulcerative colitis or Crohn’s disease.

November 1, 2017

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12 min read

Business

Vedanta Biosciences to Advance Cancer Immunotherapy Candidates Based on Microbiome-Derived Live Biotherapeutics that Induce CD8+ T Cells

Vedanta Biosciences announced that it has exclusively sub-licensed key intellectual property from JSR Corporation to develop and commercialize microbiome-derived cancer immunotherapies based on live biotherapeutics.

November 1, 2017

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5 min read

Drug Development

TWi Biotech Presents Positive Results From AC-201 CR Phase II Proof-of-Concept Study in Gout Patients in 2017 ACR/ARPH Annual Meeting

The trial demonstrated taking 100mg AC-201CR twice a day in combination with 40mg febuxostat significantly increased the treatment success rate from 55% to 64% and from 27% to 39% defined as reaching serum uric acid concentration below 6mg/dL and 5mg/dL in 4 weeks, respectively.

November 1, 2017

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5 min read

Genetown

Insulet Corporation Raises Awareness for Diabetes Community During National Diabetes Awareness Month

Earlier this year, Insulet announced that it will be establishing a direct local presence in Europe on July 1, 2018.

November 1, 2017

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5 min read

Biotech Bay

Global Availability of Varian Halcyon Treatments Expands with First Cancer Patient Treated in Australia

Varian Medical Systems announced a 71-year-old male with prostate cancer became the first patient in Australia to be treated on the Halcyon system at ROC in Toowoomba by Brisbane-based Icon Group.

November 1, 2017

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2 min read

Policy

Lannett Comments on Amended Civil Complaint

Lannett today responded to the allegations in the amended civil complaint by a number of states’ attorneys general pending in the U.S. District Court for the Eastern District of Pennsylvania against a number of sellers of generic pharmaceuticals involving a number of products.

November 1, 2017

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2 min read

LivaNova Recognizes Epilepsy Awareness Month This November

The need for awareness, treatment options and education is at an all-time high.

November 1, 2017

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4 min read

Business

Intercept Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Business Update

Intercept recorded $40.9 million of worldwide net Ocaliva sales, including a change in estimate related to deferred revenue with a net effect of a one-time increase of $4.1 million in net revenue for the quarter.

November 1, 2017

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20 min read

Policy

RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT for Migraines

RIZAPORT is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines.

November 1, 2017

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10 min read