FDA Policy/General

Since Our Last Issue ...

Nortech Systems has reached an agreement to acquire Devicix a medical product design and engineering firm. The company says the addition of Devicix will enhance and broaden Nortech’s capabilities for complete design, manufacturing and service, particularly for regulated medical devices.

The Second Circuit Court of Appeals has affirmed a district court’s dismissal of a product liability suit involving Medtronic’s Infuse spinal fusion device. In Otis-Wisher vs. Medtronic, the appellate judges supported the company’s contention that all claims are preempted. “Common law claims, such as these, challenging the safety of an FDA-approved medical device may survive preemption only if they constitute so-called ‘parallel’ claims, such as claims ‘premised on a violation of FDA regulations’ where state law provides a damages remedy for such violations,” the judges wrote.

Heron Therapeutics has begun a Phase 2 clinical trial of HTX-011, for preventing post-operative pain, after IND clearance from FDA. The company says HTX-011 uses its Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.

A U.S. district judge in San Francisco judge dismissed a whistleblower lawsuit against Gilead Sciences, which had accused the company of distributing its HIV/AIDS drugs for about three years after switching manufacturers without government approval. The judge said the company’s failure to get FDA approval did not give rise to a whistleblower claim.

Boston Scientific has begun a worldwide study of the rate and causes of shocks for patients implanted with the Emblem Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death in the setting of severely reduced cardiac function (left ventricular ejection fraction </= 35%). According to the company, the UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria derived from the MADIT-RIT study, which evaluated shock rates in 1,500 patients implanted with TV-ICD devices.

Benitec Biopharma is launching an exploratory cellular therapy program including exosome-based delivery using its ddRNAi technology and will collaborate with UK-based stem cell therapeutics company, ReNeuron. The companies say they have completed a series of in vitro experiments that demonstrate that stem cells transduced with ddRNAi-expression constructs produce exosomes that are effective at delivering expressed shRNAs to target (cancer) cells and to knock down a specific gene in those cells. They add that the data also indicated that ReNeuron’s stem cells could be more effective than mesenchymal stem cells for this purpose.

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