BioSpace News Archive

Drug Development

Magenta’s Expanded Stem Cell Product, MGTA-456, Engrafts in 100% of Patients, Leading to Robust Neutrophil and Immune Recovery in Two Phase II Clinical Studies

Data show rapid and durable engraftment with MGTA-456, an expanded cord blood stem cell product, in all 18 patients with hematologic malignancies across all conditioning regimens tested.

December 11, 2017

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5 min read

Drug Development

Aptevo Therapeutics’ Novel Bispecific Antibody Therapeutic APVO436 Shows Broad Activity in Primary Human AML Samples

Aptevo is developing APVO436 for the treatment of acute myeloid leukemia (AML), a form of blood and bone marrow cancer that is characterized by rapid disease progression.

December 11, 2017

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8 min read

Drug Development

Novartis Drug Crizanlizumab Shown to Prolong Time to Patients’ First Sickle Cell Pain Crisis in Subgroup Analysis Of SUSTAIN Study

The data from a subgroup analysis of the Phase II SUSTAIN study showed that crizanlizumab, at 5.0 mg/kg per month increased the time to SCPC in patients on treatment, including those in high-risk subpopulations and with hydroxyurea use1

December 11, 2017

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9 min read

Policy

LabCorp Supports American Clinical Laboratory Association Lawsuit on PAMA Final Rule

LabCorp today issued the following statement regarding the lawsuit filed by the American Clinical Laboratory Association (ACLA) against the Acting Secretary of the U.S. Department of Health and Human Services (HHS) in the U.S. District Court for the District of Columbia.

December 11, 2017

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4 min read

Drug Development

MorphoSys Presents Clinical Data on MOR208 plus Lenalidomide in Aggressive Lymphoma (R/R DLBCL) at ASH 2017 Conference

MorphoSys today presented clinical data from the ongoing phase 2 clinical trial evaluating MOR208 in combination with lenalidomide in patients with relapsed or R/R DLBCL.

December 11, 2017

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8 min read

Policy

Quest Diagnostics Supports Suit Against HHS Charging That CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System

The lawsuit by ACLA asserts that CMS, operating under the purview of HHS, ignored congressional intent and instituted a highly flawed data reporting process in advance of setting market rates under the PAMA.

December 11, 2017

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2 min read

Policy

Teva Dismisses Litigation After Mylan Wins U.S. Court Ruling Related to Teva’s Cold Filtration Patents for Copaxone 40 mg/mL

Mylan today announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan’s Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL.

December 11, 2017

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5 min read

Business

Bioinformatics Solutions Chooses Science Exchange as the Primary Online Channel to Offer Protein de novo Sequencing Services to Scientists

Science Exchange announced the partnership with Bioinformatics Solutions to offer online access to its protein de novo sequencing services to scientists around the globe.

December 11, 2017

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3 min read

Drug Development

Spark Therapeutics Presents Preliminary Data on Investigational SPK-8011 Phase I/II Dose-Escalation Clinical Trial in Hemophilia A at 59th American Society of Hematology (ASH) Annual Meeting and Exposition

Preliminary data as of Dec. 6, 2017, show a 100-percent reduction in annualized bleeding rate (ABR) and 98-percent reduction in annualized infusion rate (AIR) in first four participants.

December 11, 2017

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6 min read

Pharm Country

Envigo Implements First-in-Class Surgical Model Tracking System

The system, which tracks both animals and surgeons, works by implanting RFID microchips in each surgically-modified animal model allowing Envigo to record real-time, accurate data on animals in surgery.

December 11, 2017

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2 min read