FDA Policy/General

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The Medicines Company says the Phase 3 clinical trial, TANGO 1, evaluating its antibiotic Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections, met FDA pre-specified endpoints by showing an overall success rate of 98.4%. The trial randomized 550 adults, it says, to receive either Carbavance via a three-hour infusion every eight hours or piperacillin-tazobactam via 30-minute infusion every eight hours, each for up to 10 days. Also, after a minimum of five days of IV therapy, the company says patients who met protocol-defined criteria of improvement were transitioned to oral levofloxacin.

Agilis Biotherapeutics has been selected by the National Center for Accelerating Translational Sciences as an awardee of a Cooperative Research and Development Agreement under the National Institutes of Health’s Therapeutics for Rare and Neglected Diseases program. NCATS and the company have signed a letter of intent for the CRADA to facilitate development activities in support of registering Agilis’ gene-therapy candidate for treating Aromatic L-Amino Acid Decarboxylase deficiency, a rare-genetic disease that can result in profound developmental failure, frequent hospitalizations, life-long care, and premature death.

Sanofi and Boehringer Ingelheim signed contracts to secure the strategic transaction of an exchange of Sanofi’s animal health business (Merial) and Boehringer Ingelheim’s consumer healthcare (CHC) business. Sanofi would integrate Boehringer Ingelheim’s CHC business in all countries except China. Upon successful completion, Boehringer Ingelheim’s CHC business - with an enterprise value of $6.7 billion - would be transferred to Sanofi and Sanofi’s Merial, with an enterprise value of 11.4 billion, would be transferred to Boehringer Ingelheim with a cash payment to Sanofi of 4.7 billion to reflect the difference in value of the two businesses.

Pfizer has completed its acquisition of Anacor Pharmaceuticals, Inc. Pfizer Innovative Health group president Albert Bourla says that the company believes it is in a position to capitalize on the potential for a near-term U.S. product launch of crisaborole, with the potential to be a first-line treatment option for patients with mild-to-moderate atopic dermatitis.

Medtronic Plc plans to buy HeartWare International for about $1.1 billion. It says HeartWare’s HVAD System, is placed in the body through a less-invasive surgery and assists with blood flow when the heart is unable to pump blood efficiently. HeartWare is also developing the MVAD System, a next-generation heart pump 40 % percent smaller than the HVAD System, but the system has seen clotting-related side effects in trials, Medtronic adds.

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