BioSpace News Archive

Drug Development

Janssen R&D’s STELARA (ustekinumab) Shows Positive Results In Treatment of Systemic Lupus Erythematosus in Phase II Trial

The study met the primary endpoint, with a significantly higher proportion of patients in the STELARA group showing improvements in lupus disease activity as measured by the SLE Responder Index (SRI)-4 response at week 24, compared with patients receiving placebo.

November 6, 2017

·

14 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

·

3 min read

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

·

22 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

·

5 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

·

6 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

·

9 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

·

28 min read

Novocure Announces Six Clinical Presentations on Novocure’s Phase III Pivotal EF-14 Trial Data in Newly Diagnosed Glioblastoma at 22nd Annual Meeting of the Society for Neuro-Oncology

NovoCure announced today six clinical presentations on Novocure’s phase 3 pivotal EF-14 trial data in newly diagnosed glioblastoma (GBM) at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO), November 16 through November 19, in San Francisco

November 6, 2017

·

8 min read

Treatments Commence at Two Algerian Hospitals Equipped with Modern Varian Radiotherapy Systems

reatments delivered using linear accelerators including Algeria’s first TrueBeam systems are being delivered at Sidi-Bel-Abbes and Tlemcen Hospitals in the west of the country.

November 6, 2017

·

2 min read

Business

Rexahn Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Corporate Update

Rexahn’s cash and investments totaled approximately $23.2 million as of September 30, 2017, compared to approximately $20.3 million as of December 31, 2016.

November 6, 2017

·

9 min read