The Ranger previously secured a CE Mark in 2014; Boston Scientific announced its plans to start the U.S. rollout of the device immediately. The agency approved the balloon dor treatment of peripheral artery disease in the femoral artery of the upper thigh and the popliteal artery that runs behind the knee, where narrowing vessels can hinder blood flow to the legs.
The green light given by the FDA was based on a randomized clinical trial, which compared the Ranger to standard percutaneous transluminal angioplasty performed in the same arteries.
After a year, fewer people saw severe side effects after the procedure, at 5.9% of those treated with the Ranger balloon when compared to 16.5% receiving the drugless intervention as the company said.
Fosun follows BioNTech in changing COVID-19 vaccine
Fosun Pharma has halted the development of BioNTech’s first COVID-19 vaccine, following the lead of its German partner by choosing BNT162b2 as the candidate to take up to the market.
BioNTech signed up to collaborate with Fosun to bring a COVID-19 vaccine to China in March. The settlement worth up to USD 135 million, led to Fosun registering a phase 1 trial of mRNA vaccine BNT162b1 with the Chinese authorities in July. Less than one week later, BioNTech and its global partner Pfizer selected BNT162b2 as the candidate to take forward into phase 2/3.
Now, Fosun Chief Medical Officer Aimin Hui has informed Reuters that BNT162b2 is also the preferred shot for the Chinese market. Fosun has opted against further development of BNT162b1, choosing instead to run a bridging study, which may allow it to use global BNT162b2 data to support approval in China.
The switch to BNT162b2 could provide benefits. BioNTech and Pfizer selected the vaccine as their phase 2/3 candidate, despite it entering the clinic second, after linking it to a lower rate of adverse events than BNT162b1.
Treating Multiple Sclerosis with an antigen-specific cell therapy
Existing multiple sclerosis therapies systematically change the immune system to depress its erroneous attack on the protective myelin sheaths around nerve cells, which is the hallmark of the autoimmune disease. However, this method puts patients at a higher risk of infection.
The scientists at Thomas Jefferson University stated that they had found a way to train the immune system to tolerate self-antigens, which trigger inflammatory responses in multiple sclerosis while leaving the rest of the immune system intact.
They secluded tiny sacs called extracellular vesicles from cells known as oligodendrocytes. The sacs contained myelin antigens, and when they injected those particles into mice, it suppressed multiple sclerosis as per a new study published in Science Translational Medicine.
Because existing multiple sclerosis therapeutics systemically depress the immune system, scientists have been trying to search alternative therapies, which target the disease in an antigen-specific way. This way needs comprehension of which myelin self-antigens are involved in the disease. The problem is that disease-causing antigens can differ among patients or change over time in the same patient.
BioMarin nabs FDA review for drug vosoritide
The FDA will notify on BioMarin’s rare disease drug vosoritide by next year, according to them, there is no need for an advisory committee.
The U.S. regulator has accepted BioMarin’s NDA for vosoritide, the biopharma’s investigational, once-daily injection analogue of C-type natriuretic peptide (CNP) for children with achondroplasia, the most common form of disproportionate short stature, also known as dwarfism, in humans.
This is the first time an application has been accepted for a treatment for achondroplasia in the United States; the European Medicines Agency in Europe has already validated its marketing application.
Though this can change, the FDA informed BioMarin that it does not presently intend to hold an advisory committee meeting for discussion of the application.”
The FDA reminded the company that two years back, it made a recommendation that these sorts of applications will require two-year controlled trials in different age groups, which it does not have.
BioMarin thinks it can make things easier with its “highly persuasive” results from the one-year randomized, double-blind, placebo-controlled phase 3 trial when coupled with data from a midstage program, which has up to five years of long-term follow-up that has been compared to natural history data on growth.
Its phase 3 study pitted vosoritide against placebo in 121 children aged 5 to 14 who have the genetic disorder and whose growth plates are still open.
