Thursday , May 25 2017
Home / 2015 / April

Monthly Archives: April 2015

The Buzz of Caffeine

Coffee brings a variety of health benefits. For the sake of your liver, it’s not just coffee but any form of caffeine that provides a “perk,” so to speak. Readers might recall several of my past blogs touching on the benefits of coffee for those with hepatitis C. Past research …

Read More »

Study Finds Adaptive Biotechnologies’ Next-Generation Sequencing-Based Technology Can Detect Hodgkin Lymphoma Disease Recurrence

Adaptive Biotechnologies’ next-generation genetic diagnostic technology has demonstrated the potential to detect trace amounts of classical Hodgkin’s lymphoma (CHL) that remains in the body after treatment. Researchers at The University of Texas MD Anderson Cancer Center conducted a study showing that Adaptive Biotechnologies’ next-generation sequencing-based approach to identification and quantification …

Read More »

FDA Issues Three Final Guidance Documents on Biosimilars

The US Food and Drug Administration (FDA) has issued three long-awaited documents with final guidance on biosimilars. In 2010, the agency passed the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act. In 2012, the FDA released the first guidance documents in draft form. …

Read More »

Genzyme’s Fabry Disease Drug Granted FDA Fast Track Status

US health regulators have granted a speedy review for Genzyme’s investigational drug for treatment of a rare lysosomal storage disorder. Genzyme, a Sanofi company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy …

Read More »

Celgene Inks Cancer Deals with Agios Pharmaceuticals and Northern Biologics

Celgene is enhancing its oncology pipeline, striking separate cancer-focused deals with Agios Pharmaceuticals and startup Northern Biologics. Agios announced it is expanding its partnership with cancer metabolism partner Celgene. The companies have entered into a new joint worldwide development and profit share collaboration for AG-881, a small molecule that has …

Read More »

Hospira Highlights the Importance of Extrapolation for Successful Development of Biosimilars Market

Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week. The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration …

Read More »

Genmab and Novartis Announce Arzerra Meets Primary Endpoint in Late-Stage Study

Novartis and partner Genmab announced that Arzerra (ofatumumab) met its primary endpoint in a late-stage leukemia study. In separate announcements, the companies said that top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra in combination with fludarabine and cyclophosphamide met the primary endpoint of improvement …

Read More »

Big Data’s Importance on Decision Making for Cancer Treatment Detailed by Cancer Experts

Big data plays a critical role in improving clinical decision making for patients with cancer, says cancer experts. Cancer experts have reported how a Varian Medical Systems supported project in the area of distributed learning is helping to harness the power of big data to benefit patients. Speakers at a …

Read More »

Mylan Stays Committed to Acquiring Perrigo, Rejecting Teva’s $40 Billion Takeover Bid

Today, Mylan NV announced that its board of directors unanimously rejected Teva Pharmaceutical Industries’ $40.1 billion takeover bid. The company stated that its board determined that the offer from Teva “grossly undervalues Mylan.” On April 21, 2015, Teva announced the unsolicited acquisition bid of Mylan NV, offering the company a …

Read More »