BioSpace News Archive

Policy

First U.S. FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical’s SensePatch Drug Delivery Technology

Under the Prescription Drug User Fee Act, the FDA has set an action date of June 23, 2018.

November 6, 2017

·

2 min read

Policy

Compugen to Initiate Manufacturing of COM902, its Lead Anti-TIGIT Monoclonal Antibody

Compugen today announced that it is advancing COM902, its lead anti-TIGIT antibody, into manufacturing in anticipation of filing an IND in 2019.

November 6, 2017

·

4 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

·

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

·

7 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

Business

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

November 6, 2017

·

10 min read

Drug Development

The Medicines Company and Alnylam Pharmaceuticals Announce Initiation of Phase III Clinical Trials of Inclisiran

The Medicines Company today announced the initiation of the Phase III clinical program for inclisiran, with the commencement of patient dosing on November 1, 2017 in the ORION-11 trial.

November 6, 2017

·

16 min read