The U.S. FDA announced that the administration had approved a blood test that can be administered on babies, in order to identify and diagnose mental disabilities. The identification process occurs after a matching gene associated with mental disabilities is found in the baby’s genetic code. This is the first blood test of it’s kind to gain approval by the FDA.
The FDA announced this month that the Cerena Transcranial Magnetic Stimulator by eNeura, a device used to alleviate migraine pain, has warranted their seal of approval and is now allowed to be marketed in the U.S. The device is the first of its kind to receive approval for this indication and is meant to be used on patients 18 years or older. Christy Foreman, Director of the Office of Device Evaluations, Center for Devices and Radiological Health of the FDA, stated “Millions of people suffer from migraines and this new device represents a new treatment option for some patients.”
The FDA recently approved ReSure Sealant, a product of Ocular Therapeutix, which can now be commercially sold in the United States to prevent the leakage of postoperative fluids after patients undergo cataract surgery.
The research of an international team led by Dr. Robert Plenge, formerly of Harvard Medical School, and Yukinori Okada, RIKEN Center for Integrative Medical Sciences in Japan, recently discovered42 previously unidentified areas within the human genome which are directly associated with Rheumatoid Arthritis. According to the findings, these areas are currently being targeted by medications with approval to treat other conditions not related to this type of arthritis.
Rheumatoid Arthritis is an autoimmune disease and one of over 100 different types of arthritis. Unlike Osteoarthritis, the most common version of the disease, in Rheumatoid Arthritis the immune system mistakenly attacks body tissue. Rheumatoid Arthritis affects the hands and any other joint membranes with the exception of the lower back.
Mallinckrodt announced a business venture with Medtronic to further both pre-clinical and clinical development of intrathecal therapeutics, as well as commercial advancement of the therapy. Both companies aim to make this type of treatment more widely available in the United States for patients suffering from chronic pain and severe spasticity.
Genzyme was denied approval from the FDA for Lemtrada (Alemtuzumab), a drug used to treat multiple sclerosis. According to the statement made by Sanofi, the current owner of Genzyme, the FDA stated that the drug lacks the necessary amount of clinical trials needed to deem it a safe and effective treatment for MS. However, the drug has been approved in Europe since September 2013.
The Avillion Group announced it is venturing into a collaborative business agreement with Pfizer, with the intention of conducting a collaborative phase 3 clinical trial of BOSULIF. The trial will be centered upon a global setting including locations in the United States as well as Asia and Europe. The trial will commence with a starting dosage level of 400 mg a day, and will be administered as a first-line treatment for patients suffering from Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).
OraSure Technologies recently sent a letter to the FDA in response to a warning letter their subsidiary, DNA Genotek, received in December 2013. After an inspection conducted at the company’s facilities located in Ottawa, Canada in September 2013, the FDA issued a Form 483 to DNA Genotek in response to non-satisfactory observations. DNA Genotek is OraSure’s molecular collection subsidiary.
The newly released Kinsa smart thermometer received FDA approval after its successful crowd funding campaign on Indiegogo. The thermometer can be connected to the user’s smartphone and is listed at a retail price of $15.00, its corresponding app, is free. Kinsa’s application includes free health map tracking, directions to the closest urgent care facility and a one-touch call to a nurse who will answer questions for you.
Pharmaceutical companies are now looking into testing drugs on animals other than rats and mice. Amgen is one of the first companies to venture into this phase of drug testing, bringing 12 grizzly bears into their laboratories to test obesity drugs. The intent is to find a more suitable drug that can tackle the nation’s obesity problem, as most drugs designed for this purpose have not been successful.