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UK becomes first country to approve oral pill treating COVID-19

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UK becomes first country to approve oral pill treating COVID-19

The UK’s medical regulator approved on Thursday the first oral pill treating COVID-19 developed by U.S.-based pharmaceutical companies Merck, Sharp and Dohme, and Ridgeback Biotherapeutics, with the government ordering 480,000 courses due for delivery in November.

The pill, called Molnupiravir, will be administered to those recently diagnosed with the virus twice a day. The pill is the first antiviral medication for COVID-19 that could be taken orally rather than through injection or intravenously.

“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID,” British Health Secretary Sajid Javid in a statement, labelling the approval as a “gamechanger,” for vulnerable people.

According to the UK Government, the pill will be administered to both vaccinated and unvaccinated people following a national study meant to gather further data determining its level of effectiveness before making it publicly available.

It is worth noting, that for the drug to be most effective, it needs to be taken within five days of developing symptoms.

The distribution process by the NHS remains unclear moving forward, with analysts noting that a handful of care homes will be the first to receive the drug, while elderly or vulnerable patients may need to receive a prescription from their doctors after testing positive.

“Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission,” Merck said in a statement.

The Medicines and Healthcare Products Regulatory Agency (MHRA) categorized the drug as safe and effective at reducing hospitalization and death in people experiencing mild to moderate COVID-19 symptoms but are still likely of developing severe illness.

The watchdog’s head June Raine hailed the pill as “another therapeutic to add to our armory against COVID-19.”

“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage,” she said in a separate statement.

The trial phase evaluated data from 775 patients initially enrolled in the third phase of testing and had recently been diagnosed with the disease.

“Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry,” Merck highlighted in it’s clinical trials.

According to the report, 7.3 percent of those who took the drug were hospitalized that compares with 14.1 percent of patients who were given a placebo. “There were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of COVID,” it added.

In its approval document, the MHRA recommends the drug is used “as soon as possible” following a positive COVID test and within five days of symptoms onset.

It is worth mentioning that the British government has failed to disclose the cost of the 480,000 courses of molnupiravir; however, the U.S. has already ordered an advance purchase of 1.7 million courses for a fee of roughly $1.2 billion, allowing for roughly $700 for each patient.

Other countries including Australia, Singapore and South Korea have also made purchase agreements.

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MedTech

Why BioTech is important

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Biotechnology has many advantages including helping improve food quality, quantity, and processing, as well as also has having functions in manufacturing, where simple cells and proteins can be manipulated to produce chemicals.

The source of biotechnology comes from the fact that technology aims to create tools to empower humans, aiming to change humans themselves to better fit them to the world. Also, Biotechnology is the application of advances made in the biological sciences, especially involving the science of genetics and its application.

Its implications in health and medicine gives the importance of Biotechnology, by having scientists being able through genetic engineering, which is the controlled alteration of genetic material, to create new medicines, including interferon for cancer patients, synthetic human growth hormone and synthetic insulin, among others.

As such, the significance of biotechnology is shown by having scientists use the tools of biotechnology to manipulate cells with increasing control, from precision editing of DNA to synthesizing entire genomes from their basic chemical building blocks. These cells could go on to become bomb-sniffing plants, miracle cancer drugs, or ‘de-extinct’ wooly mammoths, and biotechnology may be a crucial ally in the fight against climate change according to the Future of Life Institute.

“The impact of biotech is huge on people’s lives, having the majority of the food we eat coming from engineered plants, which are modified – either via modern technology or by more traditional artificial selection – to grow without pesticides, to require fewer nutrients, or to withstand the rapidly changing climate,” the institute added.

“Manufacturers have substituted petroleum-based ingredients with biomaterials in many consumer goods, such as plastics, cosmetics, and fuels. Your laundry detergent? It almost certainly contains biotechnology. So do nearly all of your cotton clothes,” it noted.

Even so, biotech is present in our detailed lives, helping us in every way possible, such as the assistance to prenatal screening and home pregnancy test, in addition to immunizations and antibiotics, which improved life expectancy. Also, biotechnology is the main reason for many drugs that heal diseases such as cancer and heart disease.

On the other hand, biotechnology has its own disadvantages and consequences for the fact that microbes are tiny and difficult to detect, however the dangers are enormous. Further, engineered cells could divide on their own and spread in the wild, with the possibility of far-reaching consequences.

The unintended consequences of benign research or the purposeful manipulation of biology to cause harm, are factors that prove that biotechnology can be harmful.

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iSTAR gains European approval for implant for glaucoma surgery

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While glaucoma is the leading cause of irreversible blindness affecting around 100 million people worldwide, iSTAR Medical, a Belgium-based medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), announced Wednesday, that its breakthrough MIGS device, MINIject™, has been approved in Europe for open-angle glaucoma patients.

As such, MINIject enables more patients to be effectively treated with MIGS because of its powerful and sustained performance combined with an excellent safety profile.

In addition, it represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Studies by iSTAR Medical across four trials in over 150 patients, show that MINIject demonstrates a balance of powerful and sustained intra-ocular pressure (IOP) reduction with a positive safety profile.

“With today’s European approval, MINIject becomes the only commercially available MIGS device targeting the supraciliary space as a natural outflow pathway for IOP reduction,” Michel Vanbrabant, CEO of iSTAR Medical, said.

“This is a major milestone for iSTAR Medical and our mission to bring truly next-generation MIGS devices to the glaucoma community,” he noted. “I want to thank our team, our investors, and our medical partners for their continued belief in a safer and better way to manage glaucoma by targeting the supraciliary space, with an implant powered by our proprietary STAR material,” the CEO added.

Professor Dr. Burkhard Dick, head of the Department of Ophthalmology at University Eye Hospital Bochum, Germany, and one of the MINIject STAR-II trial investigators, treated the first patient with MINIject after European approval.

 Moreover, MINIject is being investigated in iSTAR Medical’s pivotal STAR-V study, which was approved by the United States Food and Drug Administration (FDA) in July 2021, the results of which will be instrumental to gain commercial access for MINIject in the U.S. market.

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EU regulator authorizes Pfizer’s COVID vaccine for kids 5-11

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The European Union’s drug regulator on Thursday authorized Pfizer’s coronavirus vaccine for use on children from 5 to 11 years old, clearing the way for shots to be administered to millions of elementary school pupils amid a new wave of infections sweeping across the continent.

It is the first time the European Medicines Agency has cleared a COVID-19 vaccine for use in young children.

The agency said it “recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11.”

After evaluating a study of the vaccine in more than 2,000 children, the EMA estimated that the vaccine was about 90% effective in preventing symptomatic COVID-19 in young children and said the most common side effects were pain at the injection site, headaches, muscle pain and chills. The agency said the two-dose regimen should be given to children three weeks apart.

At least one country facing spiking infections didn’t wait for the EMA approval. Authorities in the Austrian capital, Vienna, already have begun vaccinating the 5 to 11 age group. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned the continent could see deaths top 2 million by the spring unless urgent measures are taken.

The EMA green light for the vaccine developed by Pfizer and German company BioNTech has to be rubber-stamped by the EU’s executive branch, the European Commission, before health authorities in member states can begin administering shots.

Earlier this week, Germany’s health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on Dec. 20.

The United States signed off on Pfizer’s kids-sized shots earlier this month, followed by other countries including Canada.

Pfizer tested a dose that is a third of the amount given to adults for elementary school-age children. Even with the smaller shot, children who are 5 to 11 years old developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press in September.

But the studies done on Pfizer’s vaccine in children haven’t been big enough to detect any rare side effects from the second dose, like the chest and heart inflammation that has been seen in mostly male older teens and young adults.

American officials noted that COVID-19 has caused more deaths in children in the 5 to 11 age group than some other diseases, such as chickenpox, did before children were routinely vaccinated.

Earlier this month, the EMA said it began evaluating the use of Moderna Inc.’s COVID-19 vaccine for children ages 6 to 11; it estimated that a decision would be made within two months.

Although children mostly only get mild symptoms of COVID-19, some public health experts believe immunizing them should be a priority to reduce the virus’ continued spread, which could theoretically lead to the emergence of a dangerous new variant.

Researchers disagree on how much kids have influenced the course of the pandemic. Early research suggested they didn’t contribute much to viral spread. But some experts say children played a significant role this year spreading contagious variants such as alpha and delta.

In a statement this week, WHO said that because children and teens tend to have milder COVID-19 disease than adults, “it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.”

It has appealed to rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries who have yet to give a first vaccine dose to their health workers and vulnerable populations.

Still, WHO acknowledged that there are benefits to vaccinating children and adolescents that go beyond the immediate health benefits.

“Vaccination that decreases COVID transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools,” WHO said.


THE HAGUE, Netherlands (AP)

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