2. • 10 biggest Advances in Medicine in 2016Courtesy
:Www.pharmacovigilance123.blogspot.com.1. Teixobactin –
The First New Antibiotic in 30 Years Brings Hope Against
Antibacterial Resistance2016 saw the breakthrough
discovery of the resistance-fighting antibiotic teixobactin
from soil bacteria. This first-in-its-class antibiotic has
activity against Gram-positive organisms including MRSA
and all mycobacteria, and a novel mode of action inhibiting
peptidoglycan biosynthesis. Thanks to its quick bactericidal
action and inhibition of cell-wall synthesis, it prevents the
development of antimicrobial resistance. The drug is yet to
be tested on humans.2. The world's First Artificial Pancreas
Another one of the most exciting advances of 2016 was the
FDA's approval of Medtronic's
3. • MiniMed 670G, a hybrid closed-loop insulin delivery
system - the first device that automatically monitors
blood glucose and administers appropriate basal
insulin doses. This “Artificial Pancreas” is approved for
patients aged 14 years and older with type 1 diabetes.
This setup could dramatically reduce instances of
hypoglycemia and greatly improve the quality of life of
diabetics, who no longer have to constantly check their
blood sugar throughout the day.3. Nobel Prize in
Medicine Goes to Yoshinori Ohsumi for his Work on
AutophagyYoshinori Ohsumi of Japan
4. • won the 2016 Nobel Prize in Medicine and Physiology
for his discoveries of mechanisms for autophagy.
Disruptions in autophagy have been linked to cancer as
well as disorders such as Parkinson's disease and type 2
diabetes. Dr. Ohsumi's research pointed to possible
therapies for these conditions by identifying the genes
that code for autophagy. This knowledge gives
researchers clues on how to manipulate the process
through drugs and gene therapy.4. Exondys 51 Brings
Hope to Duchenne Muscular Dystrophy PatientsSelect
sufferers of Duchenne muscular dystrophy (DMD) also
got great news in 2016. In September, the FDA
approved Exondys 51,
5. • a therapy designed to treat exon 51-skipping DMD, which affects about 1 in 8 DMD patients. This is
the first drug ever approved by the FDA to treat DMD.5. FDA Bans Powdered GlovesThe FDA issued
a final rule banning powdered medical gloves beginning on 19 January 2017. The proposed ban
applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable
powder for lubricating a surgeon’s glove. It does not apply to not apply to powdered radiographic
protection gloves. Non-powdered surgeon gloves and non-powdered patient examination gloves
will also not be included in the ban and will remain Class I medical devices.6. The World’s First
Malaria Vaccine Set for RolloutThe Vaccine, known as RTS,S, acts globally against the deadly malaria
parasite P. falciparum. Based on the results from clinical trials, the new vaccine will provide partial
protection against malaria in young children. It will be given in four doses, and will be particularly
efficient in preventing complications. Having secured funding, the vaccine is set to begin pilot
studies in Africa.7. A pan-genotypic Hepatitis C Drug approvalIn June a unique HCV drug, Epclusa,
was approved. However, Epclusa isn't your typical genotype-specific drug. Epclusa is the first pan-
genotypic-approved drug, meaning it's capable of treating all six genotypes of hepatitis. It led to
95% to 99% virologic clearance 12 weeks after finishing treatment for patients with no or mild
cirrhosis of the liver, while for those with moderate to severe cirrhosis, Epclusa in combination with
a ribavirin led to 94% virologic clearance amt the 12-week
6. • post-treatment mark.8. New Statin GuidelinesThe United States Preventive Services Task Force
(USPSTF) updated its statin guidance in November. It gave a primary prevention recommendation
based on strong evidence that:All adults over the age of 40 with a 10-year CVD risk of more than 10
percent be offered statins at a low to moderate dose if they have one or more of dyslipidemia,
diabetes, hypertension, or if they smoke.If the 10-year risk was lower - between 7.5 percent and 10
percent - and there was at least one of these risk factors, the recommendation that the statin
regime be offered was not as strong.There was insufficient evidence to include any statin
recommendation for adults aged 76 years and older.9. Limit Fluoroquinolone Use in the Light of
Risks, FDA SaysPatients with uncomplicated infections should no longer receive fluoroquinolones,
given the risk for disabling and potentially permanent adverse events, the FDA said in May. Labels
for these antibiotics already warn about the risks for tendonitis, tendon rupture, central nervous
system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and
torsades de pointes, phototoxicity, and hypersensitivity. The FDA has updated the labels to state
that the serious risks posed by fluoroquinolones generally outweigh their benefits for patients with
sinusitis, bronchitis, and uncomplicated urinary tract infections that are treatable by other
means.10. Empagliflozin Wins Approval for Cardiovascular Disease PreventionThis December, FDA
approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death
in adult patients with type 2 diabetes mellitus and cardiovascular disease. In approving the new
indication, the FDA pointed out that cardiovascular disease is 70% higher in adults with diabetes
and is often the cause of premature death for people with the condition. In an outcomes trial,
Jardiance showed that it could cut the risk of cardiovascular death by 38%.