Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We are pleased by today's FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalaemia. Steven Fishbane, MD, Profess
LONDON- British drug major AstraZeneca announced Monday that the US Food and Drug Administration or FDA has approved Lokelma, formerly ZS-9, for the treatment of adults with hyperkalaemia. The European Commission granted marketing authorisation for Lokelma in the European Union on March 22, 2018. Sean Bohen, Chief Medical Officer at AstraZeneca, sa
By a News Reporter-Staff News Editor at Pharma Business Week The Janssen Pharmaceutical Companies of Johnson& Johnson announced that the U.S. Food and Drug Administration has approved DARZALEX in combination with VELCADE *, a proteasome inhibitor; melphalan, an alkylating agent; and prednisone- VMP- for the treatment of patients with newly d
By a News Reporter-Staff News Editor at Pharma Business Week Palladio Biosciences, Inc. http://palladiobio.com/, a privately held biopharmaceutical company founded to develop medicines that make a meaningful impact on the lives of patients with orphan diseases of the kidney, announces that the US Food and Drug Administration has granted Palladio.
By a News Reporter-Staff News Editor at Pharma Business Week Salix Pharmaceuticals, Ltd., one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., and its partner Norgine B.V. announced tha
The US Food and Drug Administration approved on Thursday a new drug for the preventive treatment of migraine in adults. "Aimovig", with generic name "erenumab-aooe", is the first FDA- approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Researchers detail new data in CDC and FDA. The results indicated that FDA decisions to approve the drug corresponded to risk to benefit ratios less than or equal to 0.136, and that decisions to withdraw the drug from the US market corresponded to risk to benefit ratios greate
The first in a new class of migraine treatments has just received approval from the FDA; Amgen and Novartis Aimovig is the first CGRP inhibitor to receive approval but wont be the last, as a number of competitors wait in the wings. Though that may seem odd for a treatment costing $6,900 per year, it is below the $10,000 price point that some analys
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Cepheid announced that it has received U.S. Food and Drug Administration 510 clearance and waiver under the Clinical Laboratory Improvement Amendments for the Xpert Xpress Strep A test. It also leverages the versatility of our platform to improve patient care, "said David
The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches. The list price will be $6,900 a year, and Amgen said the drug will be available to patients within a week.
Amgen today announced that the U.S. Food and Drug Administration has approved Aimovig for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA- approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor which is believed to play
The United States Food and Drugs Administration, in a statement this week, approved a new drug Lucemyra for the treatment and alleviation of opioid symptom withdrawal symptoms in adults in whom the drugs have been withdrawn abruptly. FDA Commissioner Scott Gottlieb, M.D. in his statement said, As part of our commitment to support patients strugglin
Aimovig, which was developed by Amgen of California and Novartis of Switzerland, is also known as Erenumab, and it offers new hope to people who suffer from chronic migraines. Aimovig has cleared all the requirements to go on sale, after receiving approval from the FDA. Eric Bastings from the Center for Drug Evaluation and Research of the FDA.
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Scientia Vascular, an early stage medical device company with patented and proprietary vascular access technology, recently received FDA clearance for a new product called the Aristotle 14 guidewire, which is used during ischemic and hemorrhagic strokes and other challenging.
Migraine sufferers unhappy with current treatments will soon have a new option to consider. Aimovig, a monthly shot, just received approval from the Food and Drug Administration and is now eligible for sale, CBS News reports. The shot is the first FDA- approved drug of its kind designed to stop migraines before they start and prevent them over the
Aimovig is the first in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks, the FDA said in a statement. "Aimovig provides patients with a novel option for reducing the number of days with migraine," said Eric Bastings, a deputy director in the FDA`s Center for Drug E
US WorldMeds has received approval from the US Food and Drug Administration for the use of Lucemyra to alleviate opioid withdrawal symptoms in adults. FDA commissioner Scott Gottlieb said: As part of our commitment to support patients struggling with addiction, were dedicated to encouraging innovative approaches to help mitigate the physiological..
FDA approved Aimovig erenumab from Amgen Inc. and Novartis AG late Thursday to prevent migraine in adults. The price is lower than the $8,500 placeholder annual WAC the Institute for Clinical and Economic Review used in its April cost-effectiveness analysis of Aimovig. At its annual WAC of $6,900, Aimovig compared with Botox exactly meets the $100,
BASEL- Amgen announced that the U.S. Food and Drug Administration has approved Aimovig or erenumab-aooe for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA- approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor- which i
The FDA approved the first non-opioid drug, lofexidine hydrochloride, to help treat symptoms of opioid withdrawal in adults. The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from opioids. "Today`s approval rep
The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. Scott Gottlieb said in a statement.
The opioid addiction market got a new player Wednesday with the FDA approval of Lucemyra, a pill that helps patients manage symptoms of withdrawal. The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY- based US WorldMeds. We know that the physical symptoms of opioid withdrawal can be one of th
The battle against opioid addiction in the United States got a new weapon Wednesday, in the form of a pill to help patients manage symptoms of withdrawal. The Food and Drug Administration said it gave its seal of approval to Lucemyra, a medication that has been used to treat opioid withdrawal in the United Kingdom for more than two decades. Lucemyr
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. Aimovig is the first FDA- approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. "Aimovig provides patient
The FDA approval comes after the review of a comprehensive data package submitted by Pfizer indicating high similarity between Retacrit and its reference products, Epogen and Procrit. Pfizer has already signed an agreement with Vifor Pharma for the commercialisation of the biosimilar in select channels across the US. Previously, the company secured