FDA Policy/General

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GliaCure has begun dosing Alzheimer’s patients in a Phase 1b clinical trial of its GC021109 to evaluate safety and tolerability. The company says its approach promotes the clearance of amyloid and stimulates anti-inflammatory actions through a single target.

Bayer HealthCare has entered into an exclusive license agreement with Isis Pharmaceuticals under which Bayer will further develop and commercialize ISIS-FXIRx, an antisense investigational drug in development for preventing thrombosis in areas of high unmet medical need. Bayer says it will evaluate the therapeutic profile of the product in an appropriate patient community.

Biotherapeutics company Oncobiologics has completed construction of a GMP commercial launch manufacturing facility at its headquarters in Cranbury, New Jersey. The company says the new 2000-L facility has already been deployed to manufacture ONS-3010, a biosimilar candidate to Humira(adalimumab) for use in an upcoming Phase 3 clinical trial.

CytRx Corp. reported on an interim analysis from two Phase 1b combination studies of standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. It says the combinations appear to be well-tolerated and the lowest dose level of aldoxorubicin (170 mg/m2) demonstrated impressive tumor responses in patients with bone cancer and a variety of soft tissue sarcomas.

Traverse Biosciences says it has executed a $250,000 cooperative research and development agreement with Aratana Therapeutics to advance the development of TRB-N0224 , a chemically-modified curcumin, for treating and controlling periodontal disease in companion animals. It says the funds provided by Aratana will be used by Traverse to conduct a proof-of-concept efficacy study to evaluate TRB-N0224 in an accepted animal model of canine periodontal disease.

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

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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