The FDA says it will hold a meeting on September 24 to re-examine the safety of Essure, a birth-control method that was approved in 2002. Essure is marketed as the only permanent birth control method that does not require surgery. While Bayer has acknowledged side effects including pelvic pain, migration of the device or rash, women have said they have experienced other unlisted side effects.
Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement. We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.
Bayer says it appreciates the opportunity to discuss the matter with the FDA.
While there are risks with all medical devices and procedures, our highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.
ZMapp is granted fast track approval in America. LeafBio says the grant is an “important milestone” which brings them closer to eventually gaining approval. The drug has been administered under emergency use authorization to nine infected patients in Africa in addition to two infected missionaries in Europe during its first clinical trial. LeafBio CEO Whaley:
We are gratified to receive this designation for ZMapp. We are hopeful that this step will accelerate its access once safety and efficacy are demonstrated to satisfaction by FDA in ongoing clinical trials.
FDA approves H. Lundbeck A/S and Otsuka Pharmaceutical Co Ltd’s anti-psychotic drug Rexulti for the treatment of schizophrenia. The approval follows the results of seven clinical trials, three of which examines its effects on schizophrenia and four of which examines its effects on major depressive disorder (MDD).
The FDA announces the approval of Neupro, the first skin patch designed to treat symptoms of early Parkinson’s disease. Neupro patches, which are changed daily, deliver rotigotine through the skin. Rotigotine is a member of a class of drugs called dopamine agonists, which mimic dopamine’s effects.
The FDA approves Neupro, the first skin patch designed to treat symptoms of early Parkinson’s disease. Neupro patches, which are changed daily, deliver a drug called rotigotine through the skin. Rotigotine is a member of a class of drugs called dopamine agonists, which mimic dopamine’s effects.
The FDA approves Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson’s disease. The drug is a monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination. Dr. Steven Galson, Director of the Center for Drug Evaluation and Research, says:
This is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson’s disease. Parkinson’s is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians’ treatment options.
Novartis announces that the FDA has approved Stalevo (carbidopa, levodopa and entacapone) tablets for patients with idiopathic Parkinson’s disease (PD) who experience signs and symptoms of end-of-dose “wearing off.” Stalevo contains levodopa, the most widely used agent for Parkinson’s disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone extends its benefits, permitting Parkinson’s disease patients to have an improved ability to perform everyday tasks and a reduction in symptoms associated with the disease.
Levodopa is recognized as the cornerstone of Parkinson’s disease therapy, but its long-term use is limited by its reduced ability to fully control Parkinson’s disease symptoms. By blocking the enzymatic breakdown of levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include more “on” time during which Parkinson’s symptoms are well-controlled and daily activities are improved, and simpler, more convenient dosing.
The Federal Food and Drug Administration approves deep brain stimulation (DBS) for Parkinson’s disease (PD). According to NIH National Institute of Neurological Disorders and Stroke:
DBS is a surgical procedure used to treat disabling motor symptoms of PD, such as tremor, rigidity, stiffness, slowed movement and walking problems. The DBS system consists of the lead, the extension, and the IPG. The lead—a thin, insulated wire also called an electrode—is inserted through a small opening in the skull and implanted in the brain. The tip of the electrode is positioned within a specific brain area. The implantable pulse generator (IPG)—similar to a heart pacemaker—delivers electrical stimulation to specific areas in the brain that control movement. Once the system is in place, electrical impulses are sent from the IPG up along the extension wire and the lead and into the brain. These impulses block abnormal electrical signals and alleviate PD motor symptoms.