BioSpace News Archive

FDA

UCB’s VIMPAT (lacosamide) Now Approved by FDA to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

This new approval provides clinicians with the option to prescribe VIMPAT to their pediatric patients either as an oral solution or a convenient tablet.

November 6, 2017

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22 min read

Drug Development

Samumed Announces Results of Phase II Trial of SM04690 Demonstrating Evidence of Cartilage Regeneration in Patients With Knee Osteoarthritis

Data support potential of SM04690 as a disease modifying drug for knee osteoarthritis.

November 6, 2017

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3 min read

Drug Development

Boehringer Ingelheim Release: Efficacy and Safety Maintained in Patients Who Switched From Humira to Biosimilar Cyltezo

Boehringer Ingelheim today announced one-year data from VOLTAIRE-RA, a pivotal Phase III clinical trial comparing Cyltezo and reference product Humira.

November 6, 2017

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13 min read

Pharm Country

Alexion Receives New Japanese Patent for Soliris (Eculizumab), Extending Patent Protection Into 2027 and Strengthening Global Patent Portfolio

Alexion announced today that the Japanese Patent Office (JPO) has issued patent No. 6224059, directed to the composition of matter of eculizumab (Soliris) and pharmaceutical formulations of eculizumab, which will expire in 2027.

November 6, 2017

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7 min read

Business

RedHill Biopharma to Host Third Quarter 2017 Financial Results Conference Call on November 13, 2017

The Company will host a conference call on Monday, November 13, 2017, at 9:00 am EST to review the financial results and business highlights.

November 6, 2017

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5 min read

Drug Development

Stealth BioTherapeutics Initiates Phase III Study of Elamipretide in Patients with Primary Mitochondrial Myopathy

Pivotal trial to evaluate treatment for disease with no FDA-approved treatment options

November 6, 2017

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3 min read

Drug Development

Hypophosphatemia Data From AMAG Phase III Trial Presented at the American Society of Nephrology

This study was comprised of approximately 2,000 adult patients with iron deficiency anemia regardless of the cause who had failed or could not tolerate oral iron therapy

November 6, 2017

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6 min read

Drug Development

Bristol-Myers’ Opdivo Demonstrates Superior Three-Year Survival Benefit for Patients With Previously Treated Advanced Renal Cell Carcinoma

No new safety signals were identified and the data showed a safety profile consistent with two-year results.

November 6, 2017

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28 min read

Policy

Sarepta Therapeutics and Nationwide Children’s Hospital Announce FDA Clearance of IND for Micro-Dystrophin Gene Therapy Program for the Treatment of Duchenne Muscular Dystrophy

The Phase 1/2a clinical trial, now open to enrollment and scheduled for initiation by mid-November, is designed to assess the safety and tolerability of AAVrh74.MHCK7.micro-Dystrophin in individuals with Duchenne muscular dystrophy (DMD).

November 6, 2017

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9 min read

BioMidwest

Moleculera Labs Issued Key U.S. Patent Covering the Company’s Diagnostic Panel for Infection-Induced Autoimmune Neuropsychiatric Disorders

Moleculera Labs, today announced that a key patent has issued covering the company’s Cunningham Panel and its use in helping physicians identify whether an individual’s neurologic and/or psychiatric symptoms could be caused by an autoimmune dysfunction.

November 6, 2017

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2 min read