FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.
FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.
On November 15, health regulators in the
United States flagged concerns that Merck's chronic
cough drug, gefapixant, may not have a meaningful benefit.
On November 15, health regulators in the
United States flagged concerns that Merck's chronic
cough drug, gefapixant, may not have a meaningful benefit.
Reuters reports that the concerns
were listed in documents released ahead
of a meeting of independent experts.
In afternoon trading, Merck shares
were down almost 1%, coming in at $101.2. .
Concerns were raised after additional efficacy
data was submitted by the company to the
U.S. Food and Drug Administration (FDA).
Concerns were raised after additional efficacy
data was submitted by the company to the
U.S. Food and Drug Administration (FDA).
In January of last year, the FDA
declined to approve the drug.
The FDA's expert panel of advisers is set to meet
on November 17 to discuss the data provided by
Merck and determine the efficacy of gefapixant.
Reuters reports that the panel will determine whether the
small reduction in cough frequency that comes with the
drug is clinically meaningful enough to be approved.
Reuters reports that the panel will determine whether the
small reduction in cough frequency that comes with the
drug is clinically meaningful enough to be approved.
Chronic cough impacts about 10% of the world's adult
population, with about half of those individuals not having
an identifiable cause for the cough despite testing. .
Merck's gefapixant blocks receptors that
stimulate nerves which trigger a cough.
In the European Union and Japan, the drug
has been approved to treat chronic coughing
and is sold under the brand name Lyfnua
Credit: Wibbitz Top Stories Duration: 01:30Published
Gene-Editing, Sickle Cell Treatment , Gets UK Approval .
Regulators in the United Kingdom have
authorized the world's first gene therapy
treatment for people with sickle cell disease.
Regulators in the United Kingdom have
authorized the world's first gene therapy
treatment for people with sickle cell disease.
'Time' reports that the decision could offer
relief for thousands of people in the U.K.
who suffer from the crippling disease.
On November 16, the Medicines and Healthcare
Regulatory Agency said it approved Casgevy,
which uses the gene-editing tool CRISPR.
The U.K. regulator approved Casgevy for the
treatment of patients over the age of 12
with sickle cell disease and thalassemia. .
The future of life-changing
cures resides in CRISPR-based
(gene-editing) technology, Dr. Helen O'Neill, University College London, via 'Time'.
The use of the word ‘cure’
in relation to sickle cell disease
or thalassemia has, up until
now, been incompatible. , Dr. Helen O'Neill, University College London, via 'Time'.
Dr. Helen O'Neill, of University College
London, called the MHRA's approval of Casgevy , “a positive moment in history.”.
'Time' reports that sickle cell disease can block blood
flow and result in excruciating pain, organ damage,
strokes and other serious health problems.
The new treatment is currently under review by
the United States Food and Drug Administration,
which is expected to deliver a decision next month.
High costs have caused experts to express
concerns that gene therapy treatments could be
financially out of reach for most people.
Credit: Wibbitz Top Stories Duration: 01:31Published
Cantaloupes Recalled , Over Possible Salmonella Contamination.
On Nov. 9, the FDA announced that
Sofia Produce LLC is recalling all fresh cantaloupes.
The company "operates under the
name Trufresh," 'USA Today' reports. .
The cantaloupes that may be contaminated with salmonella were distributed to Arizona, California, Florida, Illinois, Maryland, Michigan, New Jersey, Texas, Tennessee and Wisconsin.
They were also distributed to Canada.
The cantaloupes were sold between
Oct. 16-Oct. 23 and contain a "Malichita" label.
The cantaloupes were sold between
Oct. 16-Oct. 23 and contain a "Malichita" label.
The words "Product of Mexico/Produit
du Mexique" also appear on the fruit.
Consumers who bought the recalled products should throw them away or return them to the store.
There haven't been any illnesses
reported so far, according to 'USA Today.'.
Symptoms of a salmonella infection include
stomach pain, fever, nausea, vomiting and diarrhea.
If you think you may have been affected,
contact your health care provider.
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Orders Recall and Issues , Warning Over Eyedrops, From CVS, Rite Aid and Others.
'The Independent' reports that health regulators
in the United States have warned consumers
not to use a number of over-the-counter eyedrops.
The Food and Drug Administration issued an advisory
on over two dozen lubricating eyedrops due to a risk
of infections that could result in blindness.
Six companies, including CVS Health and Target, were ordered
to recall the products after FDA inspectors reported
unsanitary conditions and bacteria at production facilities.
Six companies, including CVS Health and Target, were ordered
to recall the products after FDA inspectors reported
unsanitary conditions and bacteria at production facilities.
In an October 27 statement, the FDA warned
consumers to stop using the products and avoid
purchasing any that can still be found in stores. .
'The Independent' reports that the FDA
did not disclose which factory was involved
or when the agency conducted its inspection.
While no infections had been reported at the time of the
FDA's announcement, the agency directed consumers and
doctors to submit cases on its online reporting system. .
While no infections had been reported at the time of the
FDA's announcement, the agency directed consumers and
doctors to submit cases on its online reporting system. .
Earlier in 2023, federal officials connected an outbreak
of a drug-resistant bacteria to eyedrop products produced
by two companies, EzriCare and Delsam Pharma.
According to the Centers for Disease Control and
Prevention, over 80 people have tested positive for
eye-infections caused by this rare strain of bacteria. .
At the time, the companies' products were
recalled after inspectors visited the factory
in India that produced the eyedrops.
Inspectors discovered problems, including
inadequate sterility measures with how the
eyedrops were both produced and tested.
Credit: Wibbitz Top Stories Duration: 01:31Published
Fairbridge Capital (Mauritius) Limited (FCML) on Monday said it has completed an offer for sale (OFS) of four crore equity shares of Thomas Cook (India) Ltd.. IndiaTimes
India on Sunday recorded 76 fresh Covid-19 cases while the number of active cases stood at 442, according to Union health ministry data. India's Covid-19 tally.. IndiaTimes
Former Health Secretary Matt Hancock has given evidence at the Covid Inquiry saying he had in mind the impact Covid would have on children, the economy, and other health conditions.
Report by Ajagbef. Like us on Facebook at http://www.facebook.com/itn and follow us on Twitter at http://twitter.com/itn
FDA Authorizes , Pfizer’s COVID-19 Vaccine, for Kids Ages 5 to 11.
On October 29, the Food and Drug Administration gave authorization for Pfizer-BioNTech's
COVID-19 vaccine for children ages 5 to..
Credit: Wibbitz Top Stories Duration: 01:30Published
CNN’s Nick Watt reports.
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