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Why do some FDA-approved drugs get a Black Box Warning (BBW)?

Last Friday, the U.S. Food and Drug Administration (FDA) approved two gene therapies for sickle cell disease. This marks a significant milestone as one of these therapies is the first treatment in the United States that utilizes the CRISPR gene editing technology. Sickle cell disease is an inherited blood disorder where the body produces abnormal, sickle-shaped hemoglobin, causing red blood cells to have difficulty carrying oxygen to the body's tissues. Lyfgenia and Casgevy are two different approaches. Lyfgenia delivers modified genes into the body by disabled viruses, while Casgevy uses molecular "scissors" to remove faulty gene parts and either disable or replace them with normal DNA strands. Even though both drugs were approved on the same day, Lyfgenia was given a Black Box Warning (BBW). A BBW is the highest warning that can be issued for a drug by the FDA, indicating a severe risk to patient health linked to the drug. This is highlighted in a black box on the medic

New medication “clears up” Psoriasis almost completely

Researchers at Northwestern University, USA, have succeeded in finding a drug that can clear psoriasis in the body, almost completely and   the great majority of the responses persist at least 60 weeks . The new drug called ixekizumab, tradename Taltz ® , is  a monoclonal antibody, prescribed to those with moderate to severe psoriasis. Research published in the prestigious journal, New England Journal of Medicine ; reports the results of 3 large, long-term clinical trials which saw 80% of patients psoriasis completely or almost completely cleared.  Psoriasis affects 3% of the world population. It is an immune-mediated inflammatory disease and its most significant symptom is itchy, dry and red skin. Accompanying those uncomfortable symptoms, psoriasis is also associated with an increased risk of depression, heart disease, and diabetes. What are Phase 3 trials? ( Understanding the Drug Discovery Process- Compound Interest ) "Usually 1000-3000 people, gauge

Two is Better than One, Cancer Drug Could Cure HBV

A promising cure has been found which uses an anti-cancer drug along with an anti-viral drug to treat hepatitis b, and within phase 1/2a trials and has achieved 100% success. Hepatitis-B is a chronic viral disease that is currently incurable.  Over two billion people worldwide are infected with hepatitis B and approximately 400 million have a chronic HBV infection, unimaginable numbers. The virus infects liver cells and can lead to complications including cirrhosis and liver cancer, resulting in more than 780,000 deaths annually. Hepatitis B patients in Australia are the first people who will have access to the potential treatment. The scientists from Melbourne's Walter and Eliza Hall Institute researched the combination of the anti-viral drug and the anti-cancer drug (developed by a US company-TetraLogic pharmaceuticals). Dr Marc Pellegrini and Dr Greg Ebert and their colleagues at the institute utilised their research on the behaviour of Hep-B in infected cells as

Exam Drug Fails to Live up to its Expectations

Exam season is always a stressful time for students and every time it comes around everyone prepares in their own to make sure they can perform their best, even if it means taking performance enhancing drugs. There’s a prescription drug called Modafinil that can enhance your concentration. Personally I've never heard of anything like this till yesterday, the only drug I heard of at exam season is caffeine pills. Loads of students would take caffeine pills at exam season to try and stay up and revise or pull an all-nighter the day before the exam to cram in as much information as possible.  But sometimes that didn’t end up well because some students would end up taking too much caffeine pills and faint during the exam and subsequently need to be hospitalised for overdose.

Manipulation of Anthrax to Deliver Cancer Drugs to Tumours

Cancer is acknowledged as one of the most dangerous biological diseases and there are many ongoing research studies to try and find suitable drugs to cure the uncontrollable cell replication. Cancer is caused when cells replicate unusually and rapidly to form tumours, this is because the cell does not undergo apoptosis (the normal programmed cell death) and these tumours need to be treated so that the disease does not further spread to the rest of the body and so that the tumours do not cause pressure on other parts of the body. [1] In 2008 breast cancer was responsible for the death of about 153 women in every 100,000 women in the population [1] and about 76 cases of lung cancer per 100,000 men. [1] These statistics have led to an escalation in the development of new treatments in an attempt to impede the uncontrolled cell replication typical of cancer cells.

Sugar is more addictive than cocaine... – what?!

“Everything is a poison, nothing is a poison. It is the dose that makes the poison.” Last week the statement “sugar is more addictive than cocaine” was spreading in the science news. I personally found this really strange and hard to believe, so I was directed to an article about a study conducted by the University of Edinburgh.