Fampyra has been given the green light for use by the Health Service in Scotland to treat people with MS who have a walking disability. Approval was given by the Scottish Medicine Consortium) despite a known increased risk of seizures.
FDA
New MS drug approval delayed by three months
People with MS who have been looking forward to the long-awaited US Food and Drug Administration (FDA) approval of the MS drug Ocrevus (ocrelizumab) are disappointed now it has been delayed. This is because, although a decision had been promised for late December 2016, an 11th-hour decision means the approval hearing has now been put … Continue reading New MS drug approval delayed by three months
Homeopathy ‘treatments’ may have labels to warn they do not work
Homeopathic ‘medicines’, including those used by some people with MS, could soon bear labels saying that they may not work – by order of the US government. Homeopathic remedies are regulated as drugs under the Federal Food, Drug and Cosmetic Act (FDCA). Under current Agency policy, the Food and Drug Administration (FDA) does not evaluate the remedies for safety or … Continue reading Homeopathy ‘treatments’ may have labels to warn they do not work
Welcome or Not, FDA Focuses on Stem Cell Treatments
News that the US Food and Drug Administration (FDA) is to hold a public hearing next month to consider greater oversight of stem cell clinics operating in the country is as welcome as it is late. I say “late” because, while the regulators have been twiddling their fingers, the stem cell business has been booming … Continue reading Welcome or Not, FDA Focuses on Stem Cell Treatments
Drug ´breakthrough´ for primary progressive MS
Everyone living with primary progressive multiple sclerosis should be excited by the fact a drug being developed for treatment of that particular type of MS has been given ´breakthrough´ designation by the USA´s Food and Drug Administration (FDA). The special status means that the drug, called ocrelizumab, could be approved more quickly following positive phase … Continue reading Drug ´breakthrough´ for primary progressive MS
If GM creatures are ‘safe’, why worry about ‘negligible risk’ of escape?
Two stories in the news are currently giving me a few concerns. At first glance, they may appear unconnected but they are linked by the facts that they involve genetically modified creatures and that one has already been approved while a field test of the other is being supported by a parliamentary scientific committee. Now, … Continue reading If GM creatures are ‘safe’, why worry about ‘negligible risk’ of escape?