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Health News Roundup: U.S. FDA approves Ferring Pharma’s first gene therapy for bladder cancer; EU regulator backs gene therapy to treat rare bleeding disorder and more

sonasmultimedia by sonasmultimedia
December 17, 2022
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Following is a summary of current health news briefs.

Maiden seeks to reopen plant after India govt lab says cough syrups were safe

Maiden Pharmaceuticals Ltd said on Friday it will seek to reopen its main factory after India’s main drugs officer said test samples of cough syrups that had been linked to deaths in Gambia showed they had not been contaminated and met government standards. The plant was closed after the World Health Organization said in October that its investigators had found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products. It linked the products to the deaths of 69 children.

U.S. FDA approves Ferring Pharma’s first gene therapy for bladder cancer

The U.S. Food and Drug Administration on Friday approved Swiss drugmaker Ferring Pharmaceuticals’ first gene therapy for treating patients with a type of bladder cancer. The therapy , Adstiladrin, was approved for adult patients. It has be to administered once every three months into the patient’s bladder via a urinary catheter.

We’ve run out of cholera vaccines, WHO official says as disease surges

The global stockpile of cholera vaccines the World Health Organization helps manage is “currently empty or extremely low”, a WHO official said on Friday amid a resurgence of the disease around the world. The U.N. health agency says global fatality rates are rising and there are around 30 countries around the world that have reported cholera outbreaks this year, about a third higher than in a typical year.

EU regulator backs gene therapy to treat rare bleeding disorder

The European Union’s health regulator on Friday said it had recommended granting a conditional marketing authorisation for a gene therapy by Australian drugmaker CSL Ltd and partner uniQure N.V., to treat haemophilia B, a rare bleeding disorder which is caused by genetic anomalies. About one in 40,000 people are affected by the inherited disorder, caused by a gene mutation that hampers the body’s ability to make clotting protein factor IX.

U.S. FDA advisers to weigh on updating initial COVID vaccine doses

The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants. While updated booster doses from Pfizer and Moderna are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread.

Chinese leaders vow to prop up COVID-battered economy as virus spreads

President Xi Jinping and his senior officials pledged to shore up China’s battered economy next year as the deaths of two veteran state journalists highlighted the worsening spread of COVID-19 in the capital Beijing. Xi and his leaders ended their two-day Central Economic Work Conference with a call, via state media, to step up policy adjustments and strengthen coordination to support an economy that analysts estimate grew just 3% this year – its worst performance in nearly half a century.

U.S. FDA flags shortage of Eli Lilly’s new diabetes drug Mounjaro

The U.S. health regulator has added Eli Lilly and Co’s Mounjaro to its list of drugs facing shortages, highlighting the company’s struggles to meet booming demand for the newly approved diabetes injection. Trulicity, another diabetes treatment in the company’s stable and its biggest-selling drug, was also added to the Food and Drug Administration’s shortage list on Thursday.

EU health regulator backs Amicus therapy for muscle disorder

The European Union’s health regulator said on Friday it had recommended granting marketing authorization for Amicus Therapeutics Inc’s experimental therapy to treat Pompe disease, a muscle disorder. Pompe disease is a rare genetic condition that leads to a buildup of the complex sugar glycogen, causing muscular impairment. The condition may also lead to heart failure in young patients.

Cancer researchers question antitrust arguments against Illumina-Grail deal

U.S. and European antitrust enforcers want to unwind gene sequencing leader Illumina Inc’s purchase of cancer test company Grail, saying the two would stifle competition in a critical area of medicine, but some cancer researchers say it’s far too early to make that assessment. Illumina is the leading maker of high-speed genomic sequencing systems that can examine fragments of DNA found in blood or other samples for use in everything from solving crimes to drug research.

Opposition to U.S. school vaccine mandates rose during pandemic -survey

Opposition to COVID-19 vaccine mandates that became increasing political during the pandemic appears to have spilled over to inoculations long required for school children in the United States, with many more adults now against them, according to a new survey. Nearly three in 10 adults (28%) said parents should be able to decide not to vaccinate their children for measles, mumps, and rubella (MMR) in a recent Kaiser Family Foundation (KFF) survey. That was up from 16% in a 2019 Pew Research Center poll conducted before the COVID-19 pandemic, KFF researchers said.

(With inputs from agencies.)



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