FDA Policy/General

Since Our Last Issue ...

BioLineRx Ltd. will collaborate with Merck to support a Phase 2 study of its BL-8040 in combination with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic pancreatic cancer. According to the companies, the multi-center study is designed to evaluate the safety and efficacy of this combination in patients with metastatic pancreatic adenocarcinoma. BioLineRx says BL-8040 is a CXCR4 antagonist that has been shown in several trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death.

Shire has agreed to buy Bannockburn, IL-based biopharmaceutical firm Baxalta Inc. in a $32 billion deal. The company will pay $18 in cash plus 0.1482 of its American depository shares for each Baxalta share. Baxalta was separated from parent Baxter International Inc. in July.

The California Institute for Biomedical Research and Scripps Research Institute have announced publication of two papers in the Proceedings of the National Academy of Sciences on the development of a switchable chimeric antigen receptor (sCAR)-T cell system that provides control over the activation, targeting, and anti-tumor activity of CAR-T cells. According to the two groups, the approach uses recombinant antibody-based molecular switches to mediate the interaction between the switchable CAR-T cell and target cell. They add that this holds promise for a safer and more versatile alternative to conventional CAR-T cells because the switchable CAR-T cells can be turned on, turned off, and retargeted with high precision-based on the dosing regimen of the antibody-based switch.

The National Institute of Health’s National Human Genome Research Institute has awarded $40 million over four years to the New York Genome Center to create a Center for Common Disease Genomics to establish a collaborative large-scale genome sequencing program. According to the center, it will explore the genomic contributions to common diseases such as autism, heart disease, diabetes, and stroke.

Albany Molecular Research (AMRI) has signed a collaboration agreement with the New York Center for Nanomedicine Research (NYCNMR) to co-market their nanotechnology services to global pharmaceutical and biotechnology clients. AMRI says it will gain access to NYCNMR’s nanoscale therapeutic and formulation services and NYCNMR’s customers will benefit from AMRI’s integrated drug discovery solutions including expertise in assay method development and computer-aided drug discovery.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome