Medika Life has covered the halls of JPMorgan in San Francisco, ViVE in Nashville, and the Digital Health Summit in Boston. But the outreach received before BIO—from stakeholders in Austin, Belfast, Milan, Riyadh, and Tulsa—suggested something seismic was shifting. At BIO 2025, that story came into focus: a world where health innovation is no longer limited by geography but defined by vision, investment and intention.

The Biotechnology Innovation Organization isn’t just where technologies are launched and global biotech identities are shaped. What we witnessed in Boston this year wasn’t just presence, but purpose. From Riyadh to Milan, leaders arrived not merely to exhibit, but to engage. They came to say, ‘We are here. We are investing. We are innovating.’ BIO 2025 stood out for its sheer scale and energy—a mosaic of emerging voices ready to help steer the next wave of life science breakthroughs.

Global Trends: Infrastructure, Incentives and Inclusion Drive Expansion

A common thread across these rising biotech regions is the power of public-sector catalysts. Investment in R&D tax credits, translational research centers, and workforce training has de-risked innovation for early-stage companies. Regions like Oklahoma and Northern Ireland exemplify how government partnerships with academia and industry can create a vibrant life sciences pipeline.

In parallel, digital innovation is enabling smaller regions to leapfrog traditional limitations. AI-led discovery, digital twins, and virtual trial platforms are reducing costs and increasing speed-to-data. This convergence of science and software is helping new hubs like Austin and Riyadh accelerate globally competitive capabilities in diagnostics, personalized medicine, and regulatory science.

“We’re not competing with Boston—we’re complementing it,” said a delegate from Invest Northern Ireland. “In a connected world, biotech ecosystems aren’t isolated—they’re collaborative nodes on a global grid.”

Meanwhile, leaders from Italy’s Ministry for Foreign Affairs and Saudi Arabia’s SFDA emphasized the importance of regulatory agility. Their message was clear: modern biotech requires modern policy. Whether through centralized ethics boards, digital review platforms, or alignment with international standards, regulatory transformation is essential to scale innovation.

These developments signal a broader inflection point—biotech is no longer about place. It’s about purpose, policy, and partnerships.

Austin: Where Tech Meets Translational Medicine

Austin is no longer just the city of live music and digital startups. With more than 300 life science companies and a 74% employment boom in biotech over the past five years, it’s transforming into a powerhouse of translational medicine.

Heavyweights like Thermo Fisher, Natera, and Luminex now call Austin home, joined by trailblazers such as Paradromics, Elligo Health Research, and Prophase Biostudios. These companies blend biotech, medtech, and AI in ways that are shaping the next frontier in diagnostics, therapeutics, and digital health.

“As one of the country’s fastest-growing emerging life sciences hubs, the Austin region is responsible for a significant portion of the biotechnology sector’s growth in Texas,” said Ed Latson, CEO of Opportunity Austin. “Our tech talent, VC ecosystem, and institutions like UT Austin are driving an uptick in innovations, with over 350 life science patents issued to Austin companies in the past five years.”

Austin’s 4.4 million square feet of science innovation space—plus another 1.1 million square feet under construction—signals that this rise is more than momentum. It’s movement.

Italy: From Scientific Legacy to Global Scale

Italy’s BIO 2025 pavilion was both a showcase and a statement: this country is stepping into biotech leadership. Long known for its academic excellence, Italy is now connecting its research infrastructure to industrial manufacturing and global markets.

With 770 production sites and the largest Contract Development and Manufacturing Organization output in Europe (€3.6B), Italy is scaling up innovation across oncology, AI diagnostics, and organ-on-chip development. Companies like BiomimX, Math Biology, Genenta Science, and InSilicoTrials are bridging cutting-edge science with clinical utility.

“Italy’s presence at BIO Boston reflects years of work by the Italian Trade Agency to promote an integrated system of scientific expertise, high-tech supply chains, and a talent-rich ecosystem,” shared Erica Di Giovancarlo, Director of the ITA New York Office.

Initiatives like the Montalcini Global Biotech Tour and policy instruments from the Ministry for Foreign Affairs support this ambition.

“Pharma is one of Italy’s top global exports,” noted Mauro Battocchi, Director General. “That would be unthinkable without a strong base in R&D, regulation, and manufacturing.”

Northern Ireland: Precision Science with Global Reach

With 250+ companies and $2.5 billion in revenue, Northern Ireland’s life sciences sector has grown 75% in just three years. The delegation to BIO was led by Invest Northern Ireland and featured companies from drug discovery (AMPLY), CRO services (Almac, Celerion), and diagnostics (Randox).

Queen’s University Belfast and Ulster University deeply anchored the region’s ecosystem. Global companies are noting that Celerion recently relocated its UK Phase I operations to Belfast’s new iREACH facility, betting on local talent and translational research capacity.

From scientific rigor to export capability—145+ countries and counting—Northern Ireland proves that locale doesn’t limit global vision.

Oklahoma: Equity-Focused Innovation with Local Roots

Oklahoma’s biotech renaissance is rooted in intentionality—it is focused on equity, local workforce development, and community-based innovation. Biosciences now contributes more than $16 billion to the state’s economic impact, with more than 750 companies and 42,000 jobs.

The Oklahoma delegation at BIO emphasized sustainability, manufacturing, and health equity, with standout organizations including Wheeler Bio, BioTC, ParaNano, and Utopia Plastix.

“We’re not here to be a branch office,” one delegate told me. “We’re here to bring Oklahoma’s soul to the bioscience table.”

With significant support from the Oklahoma Center for the Advancement of Science & Technology (OCAST), OKBioStart, and the University of Oklahoma, this state is redefining what it means to be an innovation hub.

Saudi Arabia: A New Powerhouse for Biotech Partnerships

Saudi Arabia came to BIO with a clear strategy and global ambitions. Led by His Excellency Prof. Dr. Hisham Saad Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), the Kingdom made its voice heard across two key sessions.

At “Global Biotechnology at a Crossroads,” Dr. Aljadhey discussed Saudi Arabia’s modernization of clinical trials and regulatory frameworks, aligning with international standards. At “Partnering for Progress,” he showcased the Kingdom’s integrated biotech ecosystem, spanning R&D, data, manufacturing, and patient care.

Beyond BIO, the SFDA delegation engaged with Harvard University and global pharmaceutical leaders and joined a private sector roundtable hosted by BIO and the U.S. Chamber of Commerce. These engagements reflect Saudi Arabia’s commitment to cross-border collaboration, secure supply chains, and sustainable innovation infrastructure.

With leaders from the Saudi Ministry of Health, King Faisal Specialist Hospital, and the National Institute of Health also in attendance, the message was clear: Saudi Arabia is ready to be a regional biotech hub with global reach.

The New Map of Global Innovation

This isn’t just a reshuffling of zip codes. It’s a redrawing of the innovation map—pushed forward by ecosystems committed to inclusion, science, sustainability, and scale.

These five rising regions aren’t simply showing up. They’re standing up—challenging legacy thinking, collapsing silos, and reminding the world that leadership in life sciences doesn’t require a familiar address. It requires ambition, alignment, and action.

At BIO 2025, the message was unmistakable: where you innovate matters less than why you innovate—and for whom.

From Austin’s AI-powered translational medicine to Saudi Arabia’s regulatory reinvention, the next wave of breakthroughs will be shaped not by old borders but bold commitments.

Expectations are high. Patients in Milan and Muskogee, Belfast and Boston, Riyadh and Rochester are not waiting for innovation to trickle down. They are looking globally—for the fastest path to solutions that sustain and save lives.

The future of biotech is already in motion. It’s inclusive. It’s intentional. And it’s unstoppable.

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Perhaps all we heard from the title and the take away is “I want it now.” When it comes to science and public health, that’s a mega problem. When do I want it? Now!

Clinical Trials Usually Take Years.  Enter Operation Warp Speed

How long do or should clinical trials take – well, it depends – but often years. Science takes time. It demands rigor and objectivity. It’s not a “now” pursuit. It’s why so many potential medicines fail to advance through clinical stages to our medicine chests as physicians and patients work diligently to evaluate their safety, effectiveness and long-term risks in observational studies. 

For example, the research into drugs to reduce life-threatening high cholesterol spans decades.  Many think of the incredible drugs now available as generic, which fueled continued research. Few think of the game-changing Framingham Heart Study or the groundbreaking and Nobel Prize-level work of scientists Drs. Michael Brown and Joseph Goldstein. There is beauty to science.  In the famed Academy Award-winning movie The Agony and the Ecstasy with Charlton Heston, as Michelangelo and Rex Harrison playing Pope Julius II, Heston’s character is constantly asked by Harrison, when will the Sistine Chapel ceiling be completed.  The artist replies: “When it’s done.”  That’s science!

It’s possible that COVID threw science – the purity of the art of discovery to improve humanity’s lot – out with the peer-review bathwater.  Everyone is at fault in some way. Government agencies, elected officials, public health champions, media, and, yes, the public are all part of the now movement.  We all wanted a biomedical elixir to ward off the virus NOW! We have been conditioned to get what we want quickly.  We order online at Grub Hub or Amazon, and within hours – a day tops – a vehicle pulls up to our doorstep.  NOW!

Now, how about COVID? We expected salvation at warp speed.  Companies no longer wait to share data at peer-review forums or in top-notch journals.  When the public cries out, we send out a press release. We expect answers from pharma, the White House and CDC immediately. We moved to evaluate, approve and move to rally people to access the COVID vaccines a mere 13 months after trial initiation. The mRNA vaccine became the first FDA-approved COVID-19 vaccine on August 23, 2021.  That’s the equivalent of now when it comes to drug development.

It Takes Years to Develop a Vaccine – NOW?

In comparison, the usual vaccine development timeline is five to 10 years and sometimes longer to determine if a product is safe and efficacious in clinical trials, completes the required regulatory approval processes, and a manufacturer has a sufficient quantity of vaccine doses for public access.  COVID broke the previous record of four years set by the development of a mumps vaccine in the 1960s.

But there are reasons we were able to go fast. The infectious disease community is collaborative. There are previous models of engagement, We have technologies that enable us to screen options that didn’t exist in the 1960s. It’s impossible to compare apples to apples or oranges. The times have changed. Science can move faster; however, objectivity and peer review remain musts.

Don’t point the finger of blame at any one institution or segment of the process.  Everyone created and bought into this urge for now!  We were frightened for our survival, mental health and economies.  The White House was responding to public pressure.  Events changed rapidly, and so did the news flow.  Media leaped into the fray to bring out their wagons of consulting experts aboard, with varied opinions to keep eyes glued to screens. Researchers slept at lab benches to sustain the world – to ward off the – then-deadly pandemic. 

We cannot forget that while we criticize the scientific process and unknown long-term effects of these vaccines, the “power of now” drives decisions and actions.  We cannot forget that the ERs were filling up, and people were dying at the start of the pandemic.  We were scared, and fear ignited non-reflective action. Countless public health challenges were pressing – addiction, poverty, isolation and more. We needed a response. Sometimes the process is imperfect. Let’s not forget to evaluate how all this impacted science and apply the learnings in the future.

Tech as a Scientific Accelerator

Technology has become the gas pedal for science.  AI, AR, machine learning, and big data are all variations of the same concept, but technology does enable scientists to move rapidly. The urgency to offer hope tips the hat to companies being permitted to update the public via news releases and later share detailed information in a peer-review setting. Industry scientists yearn to help sustain lives. Everyone had good intentions. However, we need to find better balance and return to a culture that encourages objective reflection and third-party (even uncensored) pushback,

The Power of Now was geared to get us to think beyond the moment.  To consider who we are and our purpose in the world.  However, like most things, we commercialize good ideas. COVID left too many casualties – most important among them precious people and, yes – scientific exchange.  Now is a competitive advantage – often a first-to-market must.  However, science is a reflective task accelerated by technology. 

Let’s Open the Door to the Power of Options

The Power of Now has given way to the Power of Options, a concept shared by David Noble and Carol Kauffman in the recent issue of HBR. Scientists remain societal leaders.  Scientists are curious and explorers.  We must encourage scientists to create their life-saving magic in coordination with the checks and balances of their peer-review culture.

The post How COVID and the Power of Now Killed Scientific Peer Review appeared first on Medika Life.

I rarely write articles if I am pissed off for the simple reason logic tends to fall by the wayside, but in this instance, I forgo that rule as I am roundly and soundly pissed off. To be absolutely clear, in case you’ve been under a rock for the last two years, Pfizer, Moderna, J&J and every company capable of producing treatments have been developing and manufacturing Covid therapies classified by government regulatory agencies as vaccines.

They are not! Full stop, end of sentence, end of debate. These medicines they have developed are a million miles away from a vaccine. They mitigate symptoms, a significant contribution to public health and an amazing response to SARS-COV2. In other words, if you have been immunized, you are far less likely to die from developing Covid after being infected with the SARS-COV2 virus. Vaccines, as best accepted by the public, prevent you from contracting or developing a disease like, for instance, polio. These “so-called” – as a popularized term Covid “vaccines” don’t do that. You still get sick.

Vaccinate, inoculate and immunize are three words that describe the “jab” people get to guard them against serious infectious illnesses. Harmonious – yes – but each offers a different consumer expectation. Did we select the right word to describe these breakthrough medicines? We did not.

Two years into the pandemic, the fallacy continues and has a foreseen side effect, an effect that anyone with sufficient intelligence could easily have and did foresee. By incorrectly calling and labeling these treatments vaccines, people have now associated everything attached to the Covid treatments with other vaccines. In the short span of two years, we may have undone a level of trust in vaccines that took generations to establish.

The public was led to believe by a cascade of voices that the vaccine would likely prevent infection and contagion. When people “fully vaccinated” fell ill, tested Covid positive, and passed the virus along, the belief bar in vaccines as preventive approaches to other deadly and debilitating viral illnesses began to fall. What was lost as the power public health message was that far fewer people who received a “shot” became seriously ill and hospitalized.

Fewer People Trust Vaccines Thanks to Mislabeled Covid Vaccines

In the UK, doctors are encouraging polio boosters as polio makes a reemergence for the first time in two generations. Measles and mumps are on the upsurge as parents shy away from basic, trusted vaccines with a long-established safety history. Thanks to the misconception that Covid treatments as designed to fully prevent viral contagion and fall short of that mark, too many parents have put a knee down on all vaccines. I cannot blame them as I have empathy for their rationale – but not for their action.

World’s Largest Clinical Trial Still Underway

We are engaged in the largest clinical trial the world has ever seen! There are problems with the Covid treatments, not the least of which is the fact that we are still generating long-term data for their safety. These were an urgent effort by governments, economists, public health officials and drug developers to answer the call to action and the needs of a population willing to lower the bar on longer-term standard safety protocols in favor of a quick-fix “I don’t want to die” solution. Billions of people have been jabbed, millions experienced side effects, and we continue with the madness while positioning and selling these incredible disease mitigators – treatments – as vaccines.

Risk versus risk has to be returned to medicine. There are risks associated with drugs and risks associated with not taking a medication. Make no mistake, these treatments have a place in the Covid world, for instance, for those at risk of death from comorbidities. But, we must come to terms that the risk may outweigh treatment benefits for some – PARTICULARLY IN CHILDREN.

And now, ironically, it is the children paying the price. As they again fall prey to diseases once eradicated, we have no one else to blame by abandoning good scientific processes – that includes taking sufficient time to study the data. Hopefully, this will work out for the best. If it doesn’t, let’s remember, we did this to ourselves.

The post Real-World Repercussions of Mislabeling Treatments as Vaccines appeared first on Medika Life.

We Americans have a long and glorious history of snake oil salesmen. There is always someone peddling useless — and sometimes harmful — concoctions when there’s sickness and suffering. John D. Rockefeller’s father was just such an itinerant quack. What finer pedigree could you ask for?

It should be no surprise then that here in the US of A, we’ve taken the most dubious claims of hydroxychloroquine’s effects on COVID-19 and hyped them from the highest podium in the land: “What do you have to lose?”.

Aside from the shame of snake oil salesmen being encoded into the DNA of our country is the fact that Americans always seem eager to buy what the shameless hucksters are selling.

And then, there’s the question of the snake oil itself. The stuff in the bottle. What is it anyway?

What is hydroxychloroquine, and where does it come from?

The short answer is that hydroxychloroquine is a modification of an earlier drug called chloroquine, which in turn is a synthetic version of a natural drug derived from tree bark that many of us have heard of, called quinine. Quinine has a veeery long history as an antimalarial drug. Still, it is also commonly known as an additive in tonic water (as in gin and tonic), giving it its characteristic bitter taste. Quinine is a plant alkaloid. Alkaloids can be toxic and are known for their bitterness. Think of caffeine — a classic alkaloid.

With some very smart commentators blogging on current issues with these drugs (Derek Lowe on the Science Magazine website is particularly good).

Despite the fun of digging into that black hole of technical information, I thought the back story was even more interesting.

Countess Ana de Osorio

It all starts with Ana de Osorio, wife of Luis Jeronimo de Cabrera, Count of Chinchon and importantly, Viceroy of Peru from 1629 to 1639.

I love the names and titles.

Ana de Osorio, Countess of Chinchon…

In 1638, the story goes, Ana de Osorio became very sick from malaria. The governor of Loxa wrote to the viceroy claiming to have been cured by the bark of the quinaquina tree. The governor was summoned, the medicine administered, and Ana was cured. Ana returned soon after to Spain bringing this miraculous bark of the tree eventually named after her as the Cinchona tree.

It turns out that this story, documented in 1663 by an Italian, Sebastiano Bado, was wrong on most counts and was disproved by the discovery in 1930 of the Viceroy’s official diary.

It turns out, for example, that Ana, the first Countess of Chinchon, died three years before Luis even went to Peru as viceroy. The second Countess of Chinchon, who did accompany Luis, was the picture of health the whole time but died on the journey from Peru back to Spain. But the (mis)story of Ana de Osorio persists to this day, like a virus that has become integrated into the DNA of our culture.

The Cinchona Tree

The bark of the Cinchona tree nonetheless bent the curve of medical and human history. It was brought by Jesuit priests to Europe, where the Spanish apparently knew of the bark’s medicinal value as early as the 1570s and was first used to treat malaria in Rome in 1631 (long before the mythical Ana even fell ill).

This bark, also called Jesuit’s bark or Peruvian bark at the time, became one of the most valuable exports from Peru when it became clear that it successfully treated malaria patients in Rome. Rome was once surrounded by marshes, and the name malaria comes from the medieval Italian words mala (bad) and aria (air). Malaria was associated with “bad air” emanating from Roman swamps.

Today we know that the cause of the disease is a single-celled parasite, Plasmodium falciparum, carried by mosquitoes that are endemic to marshlands.

Bad Air

Bad air was typically what Western medieval people blamed for any kind of disease. This was consistent with the ‘miasmic theory,’ passed down almost unchanged from ancient Greece a couple of millennia before. Microscopic organisms were not even known until Robert Hooke published his findings on them in 1665, followed soon after by Anton van Leeuwenhoek’s observations with his famous homemade microscopes. The role played by some of these microorganisms in human disease was still not recognized until Louis Pasteur’s experiments in the 1860s and Lister’s treatise on antisepsis which was published in 1867. Too late to mitigate the savagery of the American Civil War, which killed 2% of the population, most from disease (like malaria) and infection (doctors did not wash their hands or otherwise use aseptic technique while sawing off soldier’s mangled limbs).

But back to Rome, where malaria killed indiscriminately. Popes, cardinals, priests, and many other Romans — rich and poor — died miserably from the disease. The Jesuit’s knowledge of this bark’s curative abilities eventually led to its explosive rise in value and demand throughout 17th and 18th century Europe.

The Peruvian quinaquina tree eventually yielded a purified drug, the active ingredient called quinine, in 1820. Pierre Joseph Pelletier and Joseph Bienaime Caventou, French chemists who discovered caffeine and strychnine, among many other alkaloid plant compounds, found quinine was the active ingredient in the Peruvian tree bark.

Colonial Drugs

Quinine used as a drug enabled Europeans to colonize Africa. Native Africans had evolved certain traits associated with sickle-cell anemia and other genetic diseases, which gave them some resistance to malaria. Europeans did not have these genetic characteristics and were much more susceptible to the parasite. Africa became known as the White Man’s Grave. Quinine rectified that genetic deficiency and led to Europe rapidly colonizing and chopping up Africa in a global game of Risk.

The European’s colonial drive took them around the world, and quinine clearly enabled their global competition for territory, resources, and subjects, especially in equatorial and malaria-infested regions of the world. Although quinine is credited with saving many millions of lives over the centuries, one of the unintended consequences was that it enabled the Western powers’ colonial ambitions and conflicts, thus setting the stage for the slaughterhouse of World War I and its domino effect of WWII.

Quinine’s bitterness spurred British officials in various early 19th century colonial outposts to mix their medicine with soda and sugar — which marked the origin of tonic water. The British in colonial India mixed their tonic water with gin, creating a classic cocktail that is still embedded in our culture to this day.

The value of quinine rose rapidly, causing Jesuit’s bark to focus on global games of Risk and Monopoly. Peru and the neighboring countries tried to corner the market for their native Cinchona trees, but the Dutch managed to smuggle seeds out of South America. Eventually, Dutch plantations in Indonesia became the dominant world suppliers. The wily Dutch outplayed the South Americans and ended up with 97% of the global market and set up a quinine cartel in 1913 to control global supply and prices.

The 20th Century Drug

Quinine played a key role in one of the biggest successes and engineering marvels of the 20th century — the Panama Canal, built between 1904–1914 — driven by the big stick policies and willfulness of Teddy Roosevelt. There were many reasons for the failure of the early French efforts to build a canal across Central America. Still, the immense casualty rate among the engineering and labor forces certainly played a key role in France abandoning the project to the Americans.

Tropical diseases such as malaria were a major if not top contributor to French casualties. Central to the success of the American project was the groundbreaking public health initiatives driven by Dr. William Gorgas and his team — and their application of a new scientific understanding of malaria and other tropical diseases being transmitted by mosquitos. Mosquito control and prophylactic administration of quinine were among the cornerstones of their efforts.

Malaria also played an outsized role in the number of casualties during the First World War (disease — not the enemy — was usually the main killer of soldiers in wars throughout history). Before WWI, scientists and public health experts successfully controlled malaria in parts of Europe like Italy and Greece. However, these public health measures lapsed during the war, and also afterward: malaria became a global scourge again, well into the 20th century. Prophylactic use of quinine was studied and implemented by some countries during the Great War.

The late 19th and early 20th century were a sort of golden age of synthetic and organic chemistry, and quinine played a Muse’s role in this. Chemists tried to synthesize quinine since it was an expensive natural product (remember the Dutch cartel). Their efforts often failed miserably — but in a classic example of experimental serendipity — the failures sometimes bore fruit. William Perkin’s attempt in 1856 to make quinine resulted in abject failure and a mess, but the mess yielded a brilliant purple dye which made him a fortune. He was 18 years old.

The Age of Synthetics

Synthetic organic dyes, triggered by Perkin’s success, were one of the economic foundations of the German economy. Starting in the late 1860s, well-known companies formed that exists to this day: Bayer, BASF, Hoechst, etc.

A number of dyes were proposed as treatments for malaria, including methylene blue developed by Paul Ehrlich in 1890 and first used by him to treat malaria patients in 1891. Aside from not being as effective as naturally derived quinine, the dye-based malaria drugs had the unfortunate side effect of turning patients into various unnatural colors.

Finally, Hans Andersag, a researcher at Bayer AG in Germany, discovered a synthetic version of quinine in 1934 which eventually became known as chloroquine. Bayer ran clinical trials of these drugs in North Africa in the early 1940s during WWII, and this information fell into Allied hands around 1943. US doctors eventually recognized the efficacy of chloroquine, and it was approved for clinical use in the US in 1947.

During WWII, millions of US soldiers were given prophylactic antimalarial regimens, which resulted in a very unexpected and positive side effect. Clinicians noted reduced symptoms in those suffering inflammatory disorders such as skin rashes and some forms of arthritis after taking the drug. Clinical trials subsequently demonstrated the efficacy of antimalarials for a range of inflammatory diseases, starting with systemic lupus erythematosus in 1951. Today chloroquine analogs are administered off-label (i.e., not approved by the FDA) for a wide range of autoimmune diseases since they are among the few effective treatments that reduce symptoms. However, we still do not know exactly how chloroquine-based drugs blunt inflammation.

Another positive outcome of WWII was more organizational. The Office of Malaria Control in War Areas, established in 1942, was the immediate predecessor of the CDC, which was first known as the Communicable Disease Center when it kicked off on July 1, 1946. Malaria was the first target on its project roster, with the National Malaria Eradication Program starting a year after the CDC’s founding. Success was declared by 1951. Spraying DDT was one of the cornerstones of the CDC’s efforts to eradicate the mosquito vector of malaria, while chloroquine was the cornerstone of prophylaxis and treatment of the disease.

Where We Are Today

Hydroxychloroquine is a modification of chloroquine where a hydroxyl group (-OH) was appended to the side chain to reduce toxicity and was approved for medical use in the US in 1955.

In the years since chloroquine and hydroxychloroquine were approved in the US, we’ve learned a few things about these antimalarial drugs. We know now that these drugs accumulate in lysosomes and inhibit their acidification, which has subsequent effects on a range of cellular processes, including antigen presentation. We know these drugs reduce cytokine production by macrophages and inhibit toll-like receptor signaling and a variety of other immune pathways. But we remain far from causally linking the drugs to these disparate biological effects or ultimately to their clinical efficacy (against malaria or various inflammatory diseases).

Our long history of using these drugs has given us some insights into their limitations, side effects, and adverse drug interactions. One of the more severe side effects includes QT prolongation, an electrical disturbance of the heart that can lead to a fatal arrhythmia. Another is a 30% mortality among patients administered hydroxychloroquine who also took metformin, an important anti-diabetic drug.

In the US, malaria is no longer a significant clinical problem. But hydroxychloroquine and its analogs are prescribed for a wide range of debilitating autoimmune diseases, and many patients have come to rely on these drugs.

Then in 2020, dubious and poorly executed clinical studies hyped the effects of hydroxychloroquine and falsely claimed this drug had beneficial effects on COVID-19 patients. Didier Raoult, who masterminded these efforts, has since been censured and his papers retracted.

No placebo-controlled, double-blinded, sufficiently-powered clinical studies show hydroxychloroquine works against COVID-19.

Diabetics have a worse outcome with COVID-19, and these patients likely take metformin which is known to have lethal interactions with hydroxychloroquine.

In the rest of the world, over a million people per year, mostly pregnant women and young children, still die from malaria. But in a typical display of poorly allocated healthcare capital, we spend more on baldness treatments than for antimalarial treatments. Drug resistance has become a significant problem in many parts of the world so the need to invest in more antimalarial drug development is acute — but we still mostly use drugs that are almost a century old.

We’re gradually learning more and more molecular details of the intricate and complex life cycle of Plasmodium falciparum, the malaria parasite. Here are a couple of beautiful animations that show how malaria moves through the human host in one video and in the mosquito host in the other.

Molecule Allows Malaria Parasite to Commandeer Red Blood Cells
Two groups of HHMI scientists working independently have identified a critical enzyme that allows a malaria-causing…www.hhmi.org.

I don’t think there is anyone left who believes hydroxychloroquine works against COVID-19. If there are, if it is you, don’t be the last sucker buying snake oil. Instead, get vaccinated against COVID-19. Today.

The post The Evolution of Quinine to Hydroxychloroquine, Covid’s Snake Oil appeared first on Medika Life.

More than 6 million Americans currently live with Alzheimer’s disease. The FDA recognized the urgency in providing a treatment option now instead of waiting years for further clinical trial data. Alzheimer’s is the 6th leading cause of death in the United States, and cases will increase as our population ages.

Alzheimer’s is a progressive neurological disease affecting memory and causing dementia. Alzheimer’s is the most common cause of detention, accounting for 60-80% of cases. While most people who develop the disease are over age 65, early-onset Alzheimer’s affects approximately 200,000 younger Americans.

Alzheimer’s causes microscopic changes in the brain that destroy our ability to form memories. As the disease progresses, patients lose their ability to interact with others, speak, or care for themselves. The Alzheimer’s patient lifespan varies widely, but on average, people die within eight years of the diagnosis.

The Alzheimer’s Association explains the two main brain abnormalities that cause the disease: plaques and tangles.

1. Plaques: Deposits of a protein fragment called beta-amyloid that build up in the spaces between nerve cells.
2. Tangles: Twisted fibers of another protein called tau that build up inside cells.

The FDA approval of Aduhelm gives families hope as this drug is the first treatment specifically targeting the underlying cause of Alzheimer’s. In addition, Aduhelm helps prevent the development of the amyloid-beta plaques in the brain.

In the Aduhelm clinical trials, patients showed a reduction in the amyloid-beta plaques. Reducing plaque formation should slow the progress of Alzheimer’s dementia. Aduhelm is intended to help patients with mild cognitive impairment and slow the disease progression. The drug does not treat severe dementia.

The FDA acknowledged the controversy surrounding the Aduhelm clinical trials. Last year, Biogen pharmaceuticals applied for approval. The FDA did not approve the new drug because one study did not meet the primary endpoint of a reduced cognitive decline. However, a further review of the Biogen data revealed that the high-dose, time-dependent protocol successfully reduced plaque formation.

The FDA approved Aduhelm using the Accelerated Approval pathway to meet an unmet need and to provide early access to a treatment option for those with early-stage Alzheimer’s. The Accelerated Approval pathway allows the FDA to approve a medication for a serious disease when the data shows promise, even if there is some uncertainty regarding the clinical benefit.

The FDA concluded, “the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

The FDA requires pharmaceutical companies to conduct Phase 4 confirmatory post-approval studies when a drug is approved under the Accelerated Approval pathway. Phase 4 studies must show the medication has clinical benefit to patients, or the FDA can remove the drug from the market.

Many people are concerned about the cost of this new medication. Patients receive Aduhelm through an IV infusion once a month. Each treatment costs $4,312, making the annual treatment price $56,000 per year.

The Biogen instructions for use package insert for Aduhelm list the side effects seen in the clinical trials. As with any medication, allergic reactions or hypersensitivity reactions can occur.

Some patients experienced headaches, confusion, dizziness, vision changes, or nausea. A temporary swelling causes these symptoms in the brain called Amyloid Related Imaging Abnormalities or ARIA. In addition, small areas of bleeding around the surface of the brain can occur. Fortunately, the clinical trials showed these side effects resolve on their own.

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1. We cannot vaccinate the entire planet quickly enough. Some 30 countries have yet to administer their first vaccine. Continued outbreaks in these areas allow opportunity and time for the virus to mutate.
2. Vaccines are going to have to be fine-tuned and re-administered at some point to address new variants, effectively meaning we have to start all over again.

Clearly, vaccines on their own aren’t going to rid us of Covid and the coronavirus. Our approach needs to be multi-faceted and an Israeli company, SaNOtize, may just have brought a winning hand to the table. They have developed a product, pre-pandemic, designed to reduce the impact of influenza and other viruses, a broad-scale antiviral that would do for the body what hand sanitizers do for the hands. Kill off the virus.

It’s the ideal treatment, destroying the virus before it gains a foothold, where other medications and treatments focus on countering the effects of the virus once it has entered our body and begins infecting our cells. This product focuses on killing it before it can pose a threat, and to achieve this, SaNOtize created a nasal spray.

SaNOtize Nitric Oxide Nasal Spray (NONS)

We first came across the spray in an article from the Royal Holloway, University of London website, published in early January of this year, entitled “New nasal spray proven to kill 99.9% of the coronavirus that causes Covid-19 is being trialed in the UK”. The intriguing subtitle suggests;

An academic from Royal Holloway is playing an instrumental part in the first UK clinical trials of a nasal spray proven to kill 99.9% of the coronavirus that causes Covid-19.

The article continues to explain the process of the innovative product, with the trial to take place at Ashford and St Peter’s Hospitals NHS Foundation Trust, in Surrey.

The SaNOtize Nitric Oxide Nasal Spray (NONS) is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs and Professor Pankaj Sharma, from the Department of Biological Sciences is playing his part as the director of the Institute of Cardiovascular Research at Royal Holloway.

The treatment, developed by SaNOtize Research and Development Corp. based in Vancouver, Canada, proved 99.9% effective in killing the coronavirus in independent lab tests at Utah State University’s Antiviral Research Institute. The SaNOtize treatment is based on nitric oxide, a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes Covid-19. The treatment can be delivered by nasal spray, throat gargle or nasal lavage.

The importance of nitric oxide within the human body and its healing properties was first discovered by Professor Ferid Murad of Stanford University, among others, for which he shared the Nobel Prize in Medicine in 1998. Prof Murad is a member of the board of SaNOtize. The strategy is to use the Nitric Oxide spray as a multi-stage defense against infection and to provide an effective treatment for mild and moderate cases with the goal of preventing severe inflammatory response and infection of the lungs.

Scientists believe the coronavirus is transmitted via airborne droplets to the mucous membranes in the nose, where it is replicated during a three-day incubation period, damaging the nasal mucosa cells, and is then carried in nasal secretions to the lower respiratory tract, leading to the danger of fatal viral pneumonia.

Branded as Enovid, production commences

An update was recently announced on the Times of Israel website. indicting the Israeli company SaNOtize has begun commercial production of the product, now labeled as Enovid. The Israeli Health Ministry-approved labeling says the antiviral is effective within 2 minutes and its inventor says the product can save many lives in countries without access to vaccines. Dr. Gilly Regev, the inventor, told The Times of Israel,

“We are hoping that our nasal spray will now save many lives of people in countries that are waiting for the vaccine,” said Regev, an Israeli-raised biochemist who co-founded the company SaNOtize and developed the spray in Canada. “This will be affordable and can be used for prevention, to protect from any respiratory viral infection.”

She continued to explain that it has been shown to be effective in the lab against a wide range of viruses, and said that new variants of the coronavirus won’t interfere with its effectiveness, emphasizing: 

“It contains a broad spectrum antiviral which kills all viruses and all variants.”

Israel will become the first country where the spray is sold. The Health Ministry has given interim approval for its sale as a medical device suitable for people age 12 and up — meaning it could be used by many who aren’t yet approved for coronavirus vaccines — with packaging stating: “Scientifically tested to kill 99.9% of viruses within 2 minutes.”. It has also been approved for sale in New Zealand, and approval is being sought in other countries, including the UK. Regev said that the factory, in Ness Ziona near Tel Aviv, is working to produce a stock of 200,000 to 500,000 bottles by May. 

The claim on the packaging is based on testing in labs, during which a range of live viruses, including influenza and SARS-CoV-2, were subjected to the spray. She acknowledged that the experiments took place outside the human body, in test tubes, and do not provide definitive proof of how effective the spray will prove in nasal passages — though she said they are very encouraging.

What about the suggestion that the spray can lessen the impact of COVID-19 among those who are infected? In early March, SaNOtize and Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, UK, announced results of the clinical trials we referred to earlier in the article. The results indicated that the spray could prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms and damage in those already infected. The study has been submitted to a leading medical journal for review and publication.

When will Enovid be available OTC?

Not soon enough, if the product lives up to its promise, and research and data suggest it will. It will be a massively welcome addition to our covid arsenal to do battle with the virus. Its method of action could also mean huge reductions in hospitalization if it proves effective.

Each bottle of Enovid contains a month’s supply for one person to spray twice a day for protection, which is suggested as adequate protection to kill any potential invading virus. The fact the product kills a broad range of viruses also offers protection against influenza and any potential variants that will develop over time. We’re excited to see this product on pharmacy shelves across the US and hopefully, the FDA will assess Enovid with the same vigor that was applied to the vaccines.

You can visit the SaNOtize website for detailed information on the product.

The post Killing The Coronavirus. A New Treatment Shows 99.9 Percent Efficacy appeared first on Medika Life.

What are statins?

Statins are medications that are used to control one’s cholesterol levels. They increase HDL and decrease LDL², the so-called good and bad cholesterol (refer to Points of Curiosity for more information).

What are they prescribed for?

Clinical trials have demonstrated that statins decrease one’s risk of having a heart attack or stroke². High total cholesterol or too much LDL cholesterol is problematic because they contribute to blood vessels’ blockage. Statins decrease the amount of cholesterol typically made in the body to better manage the excess deposits in less than ideal places.

What are the side effects of statins?

The vast majority of individuals who take statins have no adverse effects from the medication². The most common adverse effect is the muscles being sore². This adverse effect has a greater chance of occurring with higher doses of the medication². If you are experiencing such symptoms, you can talk with your doctor to discuss what to do next. Decreasing the dose may resolve the symptoms while continuing to protect against stroke and heart attack.

Rarely, those with affected muscles can develop rhabdomyolysis, where muscle cells die and release their contents into the blood². This can cause an acute kidney injury that may require hospitalization. It is best if statins are not taken with other medications that can cause muscle pathology as it increases the risk of this complication². Individuals may also rarely have evidence of liver injury². This is typically temporary and goes away without complications.

When should individuals not take statins?

Ultimately, this is often a question that requires consideration of an individual’s determined benefit of the medication compared to risk, as determined by their personal doctor. It is advised to avoid taking statins when one has active liver disease². They should also not be taken during pregnancy or while breast feeding².

What are the names of some statins?

The most commonly prescribed statins are atorvastatin, lovastatin, pravastatin, and simvastatin. Note how the end of the names of each of these medications is a statin.

Points of Curiosity

While HDL and LDL are known as good and bad cholesterol, it is more complicated than that. LDL plays a role in routine body maintenance. It can also cause problems if there is too much of it.

References

1. https://www.cdc.gov/nchs/fastats/older-american-health.htm
2. https://www.ncbi.nlm.nih.gov/books/NBK430940/

The post What Are Statins? appeared first on Medika Life.

A note from the Medika Editors

The importance of this partnership cannot be overstressed. We are facing a looming global medical crisis as antimicrobial resistance grows. The development of new antibiotics has not been prioritized and therefore this novel approach that seeks rather to restore the efficacy of existing drugs is hugely important. This will be one to watch closely.

Date of Release: Dec. 21, 2020

MELBOURNE, Australia /PRNewswire/ — Alterity Therapeutics (ASX: ATH,NASDAQ: ATHE) (“Alterity” or “the Company”) has today announced it has been granted a licence by UniQuest, the commercialisation company of The University of Queensland (UQ), to novel zinc ionophore technology to combat antimicrobial resistance in superbugs.

Under the licence, Alterity has secured the worldwide exclusive right to patented technology to develop and commercialise therapies that re-sensitise bacteria to antibiotics. The licensed technology combines Alterity’s PBT2 and other zinc ionophores with commonly used antibiotics to treat infections caused by multidrug resistant bacteria. This is an opportunity for Alterity to further leverage its investment in PBT2.

PBT2, Alterity’s most advanced zinc ionophore, breaks the resistance of many important superbugs to available antibiotics, and is covered for this use by patents until 2038. Importantly, PBT2 has previously completed long term preclinical safety studies and phase 2 clinical trial testing in other indications and has been shown to have a favourable safety profile in those trials.

A recently published article in the high-impact journal Science Translational Medicine^[1], showed that PBT2 could reverse antibiotic resistance to critical superbugs and demonstrate efficacy in an animal model of sepsis.

Professor Mark Walker of The University of Queensland said: “The results from our paper demonstrate that by breaking the resistance of superbugs, PBT2 and other zinc ionophores have the potential to restore the efficacy of several widely available antibiotics.”

The authors also noted that superbugs exposed to a combination of PBT2 and antibiotics had a very low propensity to develop further resistance, making the emergence of cross-resistance to the novel treatment unlikely. Thus, PBT2 may help address the issue of antimicrobial resistance without becoming part of the problem.

Geoffrey Kempler, Alterity’s Chairman and CEO said: “Even without the effects Covid-19, antibiotic resistant pathogens kill more than 700,000 people each year and represent a major threat to global public health”.

“The approach developed by our collaborators is novel and potentially revolutionary. Existing antibiotics are losing the battle against these infections and science is struggling to keep up as pathogens continually adapt. Because we can combine PBT2 with existing antibiotics, many of which are generic, this approach has strong commercial value to Alterity.”

The World Health Organisation has declared antibiotic resistant bacteria a serious threat to global health that requires novel strategies to overcome the problem. PBT2 can break the resistance of the most important resistant pathogens designated by the WHO.^[1],[2]

“The critical and urgent importance of this work is amplified in the current context of Covid-19, because secondary bacterial infections associated with viral pandemics are an important cause of mortality^[3]. The need for effective antimicrobial regimens is very high,” added Mr Kempler.

UniQuest CEO Dr Dean Moss said the technology had the potential to be a catalyst for change in what was a significant and growing public health problem. “This partnership has significant potential to help combat a growing and complex global problem,” he said.

In exchange for the grant of exclusive worldwide rights, once Alterity generates commercialization revenue, UniQuest is entitled to receive certain payments including milestone and royalty payments commensurate with academic licenses.

Alterity intends to direct new resources to the project with no impact on its lead commercialisation program for ATH434, which is advancing to Phase 2 in Multiple System Atrophy, a Parkinsonian disorder with no approved therapy.

Authorization & Additional information

This announcement was authorized by Geoffrey Kempler, Chairman and CEO of Alterity Therapeutics Limited.

SOURCE Alterity Therapeutics Limited

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She looked at options like uterine myomectomy and uterine fibroid embolization, but she wanted kids one day. She feared the potential impact on her future fertility. She searched for an effective medication to treat her fibroids and reduce her heavy menstrual bleeding. She wanted to get her life back. 

For many years, women with fibroids have sought out menstrual cycle control options beyond oral contraceptives, Depo-Provera injections, and Progesterone IUDs. In May 2020, the U.S. Food and Drug Administration approved Oriahnn™ for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

What is Oriahnn™?

Oriahnn™ is the only FDA-approved oral medication designed to improve and lighten heavy periods caused by uterine fibroids. Fibroids, also called leiomyomas, are benign uterine tumors that grow in the uterus. Up to 80% of women will develop one or more uterine fibroids during their lifetime. 

Oriahnn™ is a combination product containing elagolix, estradiol, and a type of progesterone called norethindrone acetate. Elagolix is a gonadotropin-releasing hormone antagonist. This term means it suppresses the ovarian sex hormones estrogen and progesterone, both of which stimulate fibroid growth.

The addition of estradiol and norethindrone acetate adds back some of the female hormones to prevent side effects and help thin out the endometrial lining. 

Oriahnn™ is approved for use in premenopausal women to reduce the amount of bleeding caused by uterine fibroids.

Why would a woman want to try Oriahnn™?

Many women suffering from the effects of fibroids seek a non-surgical treatment to control heavy periods. Medial options allow her to reduce her symptoms without impacting her future fertility. An effective medication will enable her to keep her options open.

Older medications, such as Depo-Lupron (leuprolide acetate), are administered as an injection. This type of medication is costly, poorly covered by insurance companies, and often triggers menopausal symptoms such as hot flashes. 

Oriahnn™ comes packaged as a daily oral medication giving women the options to avoid surgery, procedure, or a birth control method. This pill is clinically proven to reduce heavy menstrual bleeding due to uterine fibroids within one month of taking it. 

Oriahnn™ is not birth control. Patients using this medication who do not want to get pregnant may want to consider a nonhormonal contraceptive option such as condoms, Phexxy, spermicide, copper IUDs, or a diaphragm. 

Does Oriahnn™ work? 

Oriahnn™ was studied in two 6-month clinical trials used for FDA approval. These studies included 591 premenopausal women aged 26–53 with heavy periods due to sonographically-confirmed uterine fibroids.

The participants measured menstrual blood loss (MBL) for two cycles before starting Oriahnn™ or a placebo. Only those with greater than 80 ml of MBL qualified for the study.

In the first study, 68.5% of patients who received Oriahnn showed a reduction in menstrual bleeding compared to 8.7% of patients who received a placebo. 

In the second study, 76.5% of patients who received Oriahnn showed an improvement in blood loss compared to 10.5% of patients who received a placebo.

Oriahnn™ was proven to lighten heavy periods in 70% of women with a 50% reduction in menstrual blood loss. During the 6-month clinical trials, only three women required surgery for their uterine fibroids.

What side effects for Oriahnn™?  

During the clinical trials, about 10% of patients stopped treatment because of any side effects. Of note,7% of women taking the placebo also stopped treatment due to side effects.

The most common reported side effects were hot flashes, headache, fatigue, and irregular uterine bleeding.

All products containing estrogen and progestin combinations increase the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction. A doctor must evaluate a patient’s medical history to determine if these medications are an appropriate option. 

Oriahnn™ may increase the risk of bone loss so the FDA approval recommends limited its use to 24 months. 

A new medical option for fibroids

Gynecologists now have a new option to help women with fibroids. Women with fibroids who want to avoid surgery or birth control may want to consider Oriahnn™. 

This novel medication, back up by clinical evidence, gives women more choices to reduce menstrual bleeding caused by fibroids. 

The post Oriahnn; A Drug to Stop Heavy Periods for Women With Fibroids appeared first on Medika Life.

SILVER SPRING, Md., Oct. 2, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.

“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” 

said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”

Malignant pleural mesothelioma (MPM) is a life-threatening cancer of the lungs’ lining caused by inhaling asbestos fibers that about 20,000 Americans are diagnosed with each year. MPM accounts for most mesothelioma diagnoses, and most patients have an unresectable (unable to be removed with surgery) tumor at time of diagnosis. With currently available therapy, overall survival is generally poor. Opdivo and Yervoy are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function.

This combination therapy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients received intravenous infusions of Opdivo every two weeks with intravenous infusions of Yervoy every six weeks for up to two years, or platinum-doublet chemotherapy for up to six cycles. Treatment continued until disease progression, unacceptable toxicity or completion of two years. The objective was to determine if Opdivo in combination with Yervoy improved overall survival compared to chemotherapy. At the time of the analysis, patients who received Opdivo in combination with Yervoy survived a median of 18.1 months while patients who underwent chemotherapy survived a median of 14.1 months.

The most common side effects of Opdivo in combination with Yervoy in patients with MPM include: fatigue, musculoskeletal pain, rash, diarrhea, dyspnea (difficulty breathing), nausea, decreased appetite, cough and pruritis (itching). Yervoy can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs, such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Patients should tell their healthcare providers if they have immune system problems, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant or plan to become pregnant before starting treatment. 

The FDA granted approval to Bristol-Myers Squibb Company.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies. FDA approval occurred approximately 5 months ahead of the goal date.

Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer Inquiries: Email or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Related Links

http://www.fda.gov

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