Pharmaceuticals – Digital Tech Blog https://digitaltechblog.com Explore Digital Ideas Mon, 17 Jun 2024 23:02:51 +0000 en-US hourly 1 https://wordpress.org/?v=6.2.6 https://i0.wp.com/digitaltechblog.com/wp-content/uploads/2023/03/cropped-apple-touch-icon-2.png?fit=32%2C32&ssl=1 Pharmaceuticals – Digital Tech Blog https://digitaltechblog.com 32 32 196063536 FDA approves Merck vaccine designed to protect adults from bacteria that can cause pneumonia, serious infections https://digitaltechblog.com/fda-approves-merck-vaccine-designed-to-protect-adults-from-bacteria-that-can-cause-pneumonia-serious-infections/ https://digitaltechblog.com/fda-approves-merck-vaccine-designed-to-protect-adults-from-bacteria-that-can-cause-pneumonia-serious-infections/#respond Mon, 17 Jun 2024 23:02:51 +0000 https://digitaltechblog.com/fda-approves-merck-vaccine-designed-to-protect-adults-from-bacteria-that-can-cause-pneumonia-serious-infections/

Merck’s new pneumococcal vaccine.

Courtesy: Merck

The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form. 

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia. 

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer. 

Merck’s competitive edge

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028. 

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. 

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said. 

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers. 

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021. 

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data. 

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

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Ozempic, Wegovy may curb drinking, smoking and other addictive behaviors – here’s what we know https://digitaltechblog.com/ozempic-wegovy-may-curb-drinking-smoking-and-other-addictive-behaviors-heres-what-we-know/ https://digitaltechblog.com/ozempic-wegovy-may-curb-drinking-smoking-and-other-addictive-behaviors-heres-what-we-know/#respond Sun, 10 Sep 2023 15:41:51 +0000 https://digitaltechblog.com/ozempic-wegovy-may-curb-drinking-smoking-and-other-addictive-behaviors-heres-what-we-know/

An Ozempic (semaglutide) injection pen is seen on a kitchen table in Riga, Latvia on 06 August, 2023. 

Jaap Arriens | Nurphoto | Getty Images

Heather Le Biller shed 9 pounds within the first week of taking Novo Nordisk‘s blockbuster diabetes drug Ozempic – and then even more as she continued treatment. 

Le Biller, a flight attendant who lives in France, noticed her appetite quiet down while taking the weekly injection. But so did her cravings for wine, a drink she called “almost customary to pair with every dinner” in France. 

“When I was on Ozempic, it made me not want that as much anymore,” Le Biller told CNBC. “I could have a few sips of wine and just be satisfied and move on. I didn’t need multiple glasses a night, so it definitely seems to help with that.” 

Le Biller is among several patients who took diabetes and weight loss drugs and also noticed an effect on their cravings for alcohol, nicotine, opioids or even some compulsive behaviors, such as online shopping and gambling.

Those drugs – including Ozempic and its weight loss counterpart from Novo Nordisk, Wegovy – are called GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person’s appetite. 

These anecdotal reports add to the growing list of potential benefits of GLP-1s beyond shedding unwanted pounds. Dramatic weight loss is the primary reason why those drugs have skyrocketed in popularity in the U.S., despite the fact that they can cost around $1,000 a month and some health insurers have stopped covering them altogether. 

“We’re prescribing these drugs and seeing this effect as a secondary benefit in patients. One of my patients even said they’re not doing as much online shopping, which is helping their wallet,” said Dr. Angela Fitch, an obesity medicine physician and president of the Obesity Medicine Association. That group is the largest organization of physicians, nurse practitioners and other health-care providers dedicated to treating obesity. 

A customer drinks a glass of wine at the It’s Italian Cucina restaurant on April 05, 2023 in Austin, Texas. A new analysis of more than 40 years of accumulated research has found that moderate drinking has no health benefits. 

Brandon Bell | Getty Images

This striking effect of GLP-1s isn’t a new idea. Several studies have demonstrated that certain GLP-1s curb alcohol intake in rodents and monkeys. 

More research needs to be done, particularly on humans, to prove that the drugs have that effect. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. 

Novo Nordisk told CNBC in a statement that they aren’t pursuing that research.

“Pharma has this general lack of interest in investing in the addiction field” due to a perfect storm of factors, including the high stigma around addiction disorders among doctors, physicians and even patients, according to Dr. Lorenzo Leggio, clinical director of the National Institute on Drug Abuse, or NIDA.

Leggio and other scientists are working to fill the gap – and have already made strides toward confirming the potential of GLP-1s as addiction treatments.

What do we know so far?

Scientists have published nearly a dozen studies showing how GLP-1s stop binge drinking in rats and mice, reduce their desire for alcohol, prevent relapse in addicted animals and decrease alcohol consumption overall. 

Earlier studies have examined older, less potent GLP-1s such as exenatide, a drug approved for diabetes under the names Byetta and Bydureon. 

But more recent studies on semaglutide – the generic name for Ozempic and Wegovy – and another drug from Eli Lilly called dulaglutide “are the most promising” because they reduced alcohol intake in animals by 60% to 80%, according to pharmacologist Elisabet Jerlhag. 

Studies have also shown that rats that stop taking dulaglutide, which is approved for diabetes under the name Trulicity, “take weeks before they start drinking again,” she said.

Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. 

Boxes of the drug trulicity, made by Eli Lilly and Company, sit on a counter at a pharmacy in Provo, Utah, January 9, 2020.

George Frey | Reuters

Other studies on animals have also found that GLP-1 drugs reduce the consumption of nicotine, cocaine, heroin and amphetamines. 

Few studies have been done on humans, but six clinical trials are now underway investigating how semaglutide may alter people’s drinking and smoking habits. 

The reason behind this anti-addiction effect of GLP-1s is that those drugs also affect the brain, not just the gut, according to NIDA’s Leggio. 

“The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well,” Leggio told CNBC. “There is a clear shared overlap. So it’s possible that the medications may help people with addiction by acting on that specific mechanism.”

GLP-1s specifically decrease the amount of dopamine the brain releases after people indulge in behaviors like drinking, smoking or even eating a sweet dessert, according to Dr. Steven Batash, a gastroenterologist who provides nonsurgical weight loss procedures in Queens, New York. 

Batash said dopamine is a neurotransmitter that “reinforces the pleasure” of doing those activities. When GLP-1s take away that pleasure, they also eliminate the motivation to do those activities. 

What needs more research?

Still, NIDA’s Leggio advises against using GLP-1s off-label to reduce addictive behaviors, “simply because there’s not enough evidence in humans that they work.” 

“The animal studies are very promising and what people are reporting is very, very important, but as a scientist, I will also tell you that that’s not enough,” he told CNBC. 

Leggio said scientists need to conduct more double-blind, randomized, placebo-controlled studies on humans – or trials where both participants and researchers don’t know who is getting randomly selected to receive a placebo or an actual drug. Those types of studies are “the gold standard” for proving whether a treatment achieves a certain effect or not, he added

But even if those trials confirm that GLP-1s can reduce addictive behaviors in humans, “it will most likely work for some patients and not others,” according to Leggio. 

“We already know, as a matter of fact, that these medications and any drug overall do not work for everybody,” he said. 

The Good Brigade | Digitalvision | Getty Images

For example, the only clinical study in this area investigated whether exenatide could treat alcohol use disorder in people, as compared with cognitive behavioral therapy.

But a subgroup analysis of that 2022 study found that exenatide reduced drinking in a subgroup of participants who had obesity, while the drug actually increased drinking in people who didn’t. 

The reason may be that “leaner patients” treated with exenatide experienced a larger decrease in blood sugar, which might be associated with increased cravings for alcohol, the researchers wrote in the study.

But even that hypothesis needs to be confirmed with further research. 

It’s also unclear how long the anti-addiction effect of GLP-1s will last. That’s already one complaint patients have when it comes to weight loss: People who lose weight after taking Ozempic or Wegovy tend to gain most of it – or even more – back within a few years. 

“It’s possible that some people will relapse and go back to heavy drinking if they stopped taking the medication,” Leggio said. He added that some patients will need constant treatment because addiction is a chronic disease. 

However, Leggio said there’s “nothing wrong” with a patient seeking GLP-1s to treat diabetes or obesity, in addition to an addiction disorder. 

“If you want to see whether Ozempic will help you better control the sugar in your blood but also help you with your drinking, that’s wonderful. Killing two birds with one stone,” Leggio said. “But if the only reason you want to take the drug is because of your alcohol or smoking, then you should wait for more evidence.” 

It may take years, but scientists and other health experts hope that a new class of treatments for alcohol use disorder, smoking and other addictive behaviors is on the horizon. 

“It may be that three, four or five years from now, you and I are going to say that GLP-1 agonists are wonderful for treating mild diabetes, wonderful for weight loss, and perhaps we will also say that they are wonderful for curbing addictive behaviors,” Batash told CNBC.

But even if GLP-1s get approved to treat addiction, it’s unclear how many people would take them. Uptake of existing medications for addiction is already low.

About 14 million American adults had alcohol use disorder – a disease associated with uncontrolled drinking – in the past year as of 2019. But only 1.6% used any of the three FDA-approved drugs for the condition. 

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Why startups are investing millions to make drugs and semiconductors in space https://digitaltechblog.com/why-startups-are-investing-millions-to-make-drugs-and-semiconductors-in-space/ https://digitaltechblog.com/why-startups-are-investing-millions-to-make-drugs-and-semiconductors-in-space/#respond Sun, 20 Aug 2023 18:53:50 +0000 https://digitaltechblog.com/why-startups-are-investing-millions-to-make-drugs-and-semiconductors-in-space/

In-space manufacturing may sound like science fiction but it’s happening already, albeit on a very small scale. It’s a fledgling market that analysts and several startups are projecting will take off. 

“If you look at pharma, semiconductors, beauty and health products and potentially food in the sense of like new crops, we estimated the market to be above $10 billion at some point in 2030, depending on the speed of maturation,” said Ilan Rozenkopf, a partner at McKinsey.

Space offers a unique environment for research and development because its higher levels of radiation, microgravity and near vacuumless state allows companies to come up with new manufacturing methods or materials that are not possible on Earth.

The practice is not entirely new. The International Space Station has hosted several experiments from academics, government agencies and commercial customers for things such as growing human tissue, making purer semiconductors and developing new or better drugs. In the 2024 fiscal-year budget, President Joe Biden even set aside $5 million for NASA to pursue cancer-related research on the ISS.

But access to the ISS has always been competitive and interest continues to grow. Now, several space startups see an opportunity to satisfy in-space manufacturing demand using compact space factories. One company is Varda Space Industries in Southern California. Varda’s mission is to help pharmaceutical companies improve their drugs or come up with new drug therapies by taking advantage of the unique properties of space, and then return those materials back to Earth.

Varda Space Industries’ first pharmaceutical manufacturing satellite and reentry vehicle attached to a Rocket Lab Photon bus.

Rocket Lab

Key to Varda’s business proposition is a phenomenon known as protein crystallization. 

This occurs when super-saturated protein solutions are essentially evaporated to form a solid so scientists can study a protein’s structure. Understanding the crystal structure of a protein can help scientists get a better idea of disease mechanisms, identify drug targets and optimize drug design. Think drugs that have less side effects, are more effective or can withstand a greater array of conditions such as not needing to be refrigerated.

Years of research have shown that protein crystals grown in space are much higher quality than those grown on Earth. The plan is not to make the entire drug in outer space, just what is known as the primary active pharmaceutical ingredient, or the portion responsible for the therapeutic effects of a drug.

“You’re not going to see us making penicillin or ibuprofen or these types of very generic mass consumption targets, given the amount of crystalline you need to create is far beyond our current capabilities,” said Delian Asparouhov, co-founder and president of Varda Space Industries. “But there is a wide set of drugs that do billions and billions of dollars a year of revenue that actively fit within the manufacturing size that we can do even on our current manufacturing facility.”

Asparouhov said that in the U.S. in 2021 and 2022, of the hundreds and millions of doses of the Pfizer Covid vaccine administered, “the actual total amount of consumable primary pharmaceutical ingredient of the actual crystalline mRNA, it effectively was less than two milk gallon jugs.”

Across the Atlantic in Cardiff, Wales, Space Forge is working on designing its own in-space factory to manufacture next-generation semiconductors. Space Forge’s goal is to make semiconductor substrates using materials other than silicon to manufacture more efficient, higher performing chips. 

“This next generation of materials is going to allow us to create an efficiency that we’ve never seen before,” said Andrew Parlock, managing director of Space Forge’s U.S. operations. “We’re talking about 10 to 100 X improvement in semiconductor performance.”

A rendering of Space Forge’s ForgeStar manufacturing satellite.

Space Forge

Just like with pharmaceuticals, the secret sauce to achieving this type of performance improvement in semiconductors lies in creating the perfect crystals in space. These types of advanced chips are important for industries such as 5G and electric vehicles. Similar to Varda, Space Forge plans to manufacture only part of the chips in space.

“Once we’ve created these crystals in space, we can bring them back down to the ground and we can effectively replicate that growth on Earth,” said Josh Western, CEO and co-founder of Space Forge. “So we don’t need to go to space countless times to build up pretty good scale operating with our FAB partners and customers on the ground.”

To learn more about in-space manufacturing as well as Varda and Space Forge’s plans to make the practice a viable business, watch the video.

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