The US Food and Drug Administration has approved TNKase or Tenecteplase, which is a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.

Ischemic strokes happen when a blood clot blocks a blood vessel in your brain. It can cause permanent brain damage and death. If enough brain cells die, you can also lose the abilities or body functions those cells control. They are also the most common types of stroke, with 80% of all strokes being ischemic strokes.

How is TNKase administered?

It is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion. The manufacturer of TNKase, Genetech said a new 25-mg vial configuration will also be available in the coming months.

How Was TNKase approved?

The approval came at the backdrop of a study that compared TNKase to Activase in patients with acute ischemic stroke. These patients also presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.

How Common Are These Strokes?

In the United States it self, it affects more than 795,000 people each year and is the leading cause of long-term disability. It is also the fifth leading cause of death. Since brain damage can happen if this progresses rapidly, one needs an immediate, fast-acting medical care.

TNKase thus provide a faster and simpler administration which can be critical for anyone. The chief medical officer and head of global product development at Genetech, Levi Garraway, MD., PhD., said, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients."

What Are The Symptoms Of Ischemic Strokes?

Some of the most common symptoms include weakness or paralysis on one side of your face and body. You may also feel trouble speaking or have loss of speech, also known as aphasia. You may faced slurred or garbled speaking, also known as dysarthria. Other symptoms include loss of muscle control on one side of your face, or sudden worsening or loss of your senses, including vision, hearing, smell, taste, and touch.

Other symptoms include:

• Loss of coordination or clumsiness
• Blurry vision or double vision
• Dizziness or vertigo
• Nausea and vomiting
• Neck stiffness
• Mood swings or sudden personality changes
• Confusion or agitation
• Seizures
• Memory loss (amnesia)
• Headaches which are sudden and severe
• Passing out or fainting
• Coma

Are There Any Warning Signs?

While these are symptoms one has who is prone to this condition. However, often, many may confuse it with other illnesses. It is best to keep an eye out for warning signs. These could be looking out for yourself or your loved one. Note if there is a sudden loss of balance. Look out for sudden vision loss or changes in one or both eyes. Look for a droop on one or both sides of your face, especially when you smile. Raise both arms and see if one arm sags or drops in a way it usually does not. Note for your speech. Are you as fluent? Are you have trouble speaking? If you see any of such signs, start tracking it and talk to your healthcare provider.

American drugmaker Eli Lilly has sued six companies in the US over the alleged illegal sale of its experimental weight-loss drug retatrutide.

In a statement, Lilly said that the lawsuits target US entities allegedly selling illegal retatrutide products, claiming that their products are for “research use only” while allegedly marketing them for human use. These include

• compounding pharmacies,
• medical spas
• online sellers.

“Retatrutide is being rigorously studied as part of a comprehensive clinical trial development program,” said David A. Hyman, Lilly’s chief medical officer.

“We take the responsibility of evaluating the safety and efficacy of our investigational medicines seriously. What is being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk,” he added.

Which Six Companies Is Lilly Suing?

Lilly has filed lawsuits against:

• Aesthetic Envy Cosmetic Centers LLC, doing business as Aesthetic Envy
• Astra LLC, doing business as Astra Peptides
• Legendary Peptides, LLC
• Striker Pharmacy, LLC
• Texas Peptides Inc
• Lone Star Peptide Co

Black-Market Retatrutide

Lilly said it has referred more than 200 individuals and entities to the US Food and Drug Administration (FDA), the US Department of Justice, state attorneys general, law enforcement agencies and professional licensing boards.

The company is also working with regulators, law enforcement and customs authorities worldwide to address the illegal market.

Lilly urged social media and e-commerce platforms, credit card companies, payment processors, and shipping and logistics companies used by sellers to help protect patients and tackle the illicit activity.

The drugmaker noted that it has reported more than 14,000 websites, advertisements, social media posts and product listings that allegedly market retatrutide unlawfully across more than 100 countries to internet service providers, social media platforms and e-commerce companies.

FDA Says Unapproved Retatrutide Is Illegal

The US FDA has made clear that selling unapproved retatrutide directly to consumers is illegal. Retatrutide also cannot be lawfully compounded.

The FDA has warned that so-called “research-use only” products are of unknown quality and may pose risks to consumers’ health.

Black-market sellers and businesses posing as legitimate medical providers have openly marketed retatrutide as a weight-loss “hack.”

According to Lilly, such products are frequently made by unregulated foreign manufacturers. Regulators, customs agencies and law enforcement authorities worldwide have warned about these products and have taken actions including raiding clandestine manufacturing sites, seizing shipments and making arrests.

What Is Retatrutide?

Retatrutide is one of Eli Lilly’s next-generation obesity treatments and is currently under development. Unlike Lilly’s currently approved GLP-1 drugs, retatrutide activates three hormone receptors: GLP-1, GIP and glucagon.

Researchers believe this triple-action approach could help people lose excess weight by reducing appetite while also increasing energy expenditure.

Retatrutide Shows Promise in Trials

Retatrutide has attracted significant interest after late-stage clinical trials showed some of the highest weight-loss outcomes reported with an obesity medication. In Phase 3 studies, adults without diabetes who received the highest dose lost more than 28% of their body weight over 80 weeks.

Lilly plans to submit retatrutide for approval to the US FDA in the first quarter of 2027.

President Donald Trump on Monday signed an executive order calling for fewer routine childhood vaccinations and directing the Justice Department to challenge state vaccine laws, a move swiftly rejected by physicians and vaccine makers.

The order, signed on August 10, calls for childhood vaccines to be administered at separate medical visits whenever possible and narrows federal recommendations to vaccines against 11 core diseases.

"For too long, America recommended more childhood vaccines than any peer nation. No longer," the White House share in a post on X.

It also directs federal health agencies to develop a plan for separate measles, mumps and rubella vaccines, which are currently not available as individual shots in the US.

What Does the Executive Order Say?

The executive order, titled “Delivering Gold Standard Childhood Vaccine Recommendations for Americans,” cuts the number of vaccines recommended for all children from 18 to 11.

• Immunizations recommended for all children: Measles, mumps, rubella, diphtheria, tetanus, pertussis (whooping cough), polio, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV), and varicella (chickenpox).

• Immunizations recommended for certain high-risk groups or populations: Respiratory syncytial virus (RSV) monoclonal antibodies, hepatitis A, hepatitis B, meningococcal B, meningococcal ACWY, and dengue for children with certain underlying conditions or specific exposure risks.

• Immunizations based on shared clinical decision-making: Hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza, and COVID-19 are to be considered in consultation with a doctor based on the child’s individual circumstances.

Splitting the MMR Vaccine

Also read: Donald Trump Signs Order To Split MMR Vaccine: Is It Safe For Children?

The order calls for the combined MMR vaccine to be replaced by separate measles, mumps, and rubella shots.

The MMR vaccine currently protects children against all three diseases with a combination shot. Under existing CDC guidance, children receive two doses, generally at 12 to 15 months and again at 4 to 6 years.

Trump claimed that “there could be a possibility” the MMR vaccine is “quite lethal,” but said that when separated, the vaccines are “not at all lethal, but just very effective.”

Trump also suggested that vaccines cause autism, despite a lack of scientific evidence showing a link.

The CDC and many major medical groups have long recommended the combined vaccine because it reduces the number of injections and lowers the risk that children will miss protection against one of the three diseases.

When Will the Order Be Implemented?

The new executive order does not immediately replace the current CDC childhood immunization schedule. It, instead, directs the HHS Task Force on Safer Childhood Vaccines to develop plans within 90 days to assess vaccine timing and sequencing and adjust the federal schedule as appropriate and consistent with applicable law.

There are also logistical hurdles. Individual measles, mumps and rubella vaccines are not currently licensed in the US. The combined MMR vaccine is manufactured by Merck and GSK for the US market. Merck stopped making single-disease shots for measles, mumps and rubella in 2008, and such vaccines are not routinely used in most other countries.

Merck and GSK said there is no published scientific evidence supporting separation of the vaccines and that decades of evidence support the safety of the combined MMR vaccine.

“Even under current expedited review pathways, it could take years — potentially as many as 10 — to meet the safety and efficacy requirements to obtain FDA approval and then begin manufacturing and commercialization” of single-disease shots, Merck said.

Dr. Andrew Racine, president of the American Academy of Pediatrics, said that although it is possible to separate the MMR vaccine into its individual components, each component would need to be manufactured and tested.

“They wouldn't be able to do that probably for another 10 years, and there's no indication that they have any interest in doing that,” Racine was quoted by Reuters as saying.

Read More: Amid Cyclospora, Salmonella Outbreaks, US FDA Issues Guidance on Ready-to-Eat Produce

WHO expresses Concern

Taking to social media platform X, WHO Director-General Dr. Tedros Adhanom Ghebreyesus said that “vaccines are among the most powerful tools” for keeping children safe and “making deadly diseases preventable.”

Expressing concern about the changes to US immunization policy, the WHO said they “are not aligned with decades of evidence that show when children are most vulnerable to disease, when vaccines provide the strongest protection, how many doses are needed, and which vaccines can be given together safely.”

“The current evidence is unequivocal: vaccines — including the MMR vaccine — are safe and do not cause autism,” he said, adding that “delaying vaccines or separating doses unnecessarily does not make vaccination safer and can leave children unprotected.”

Dr. Andrew Racine, president of the American Academy of Pediatrics, said the announcement could create unnecessary uncertainty for families.

“Science about vaccines and their efficacy has not changed,” Racine said.

People working night shifts were nearly twice as likely to develop long COVID, according to a new study.

Researchers at Spain’s ISGlobal said no previous study had examined whether disruption of the body’s biological clock could increase the risk of developing long COVID.

“Our findings suggest that circadian disruption plays a role in the transition from acute infection to persistent symptoms,” said Manolis Kogevinas, an ISGlobal researcher.

Published in the Scandinavian Journal of Work, Environment and Health, the study also found that chronic insomnia further increased the risk, highlighting the potential importance of healthy sleep habits in preventing long COVID and other post-acute infectious syndromes.

Night Shift Raises Long COVID Risk

Also read: Long COVID Patients May Face Brain Fog & Fatigue Due To Reduction In Dopamine? New Study Explains

The research team followed 2,941 adults in Catalonia between 2021 and 2023. Among the 1,899 participants who became infected with SARS-CoV-2, 284 developed long COVID during the two-year follow-up.

Long COVID was defined as persistent symptoms lasting more than three months after infection.

Compared with day workers, people who worked night shifts had an 88% higher risk of developing long COVID. This was after accounting for other factors, including vaccination history and chronic diseases.

The association was stronger among night workers with obesity.

Importantly, the increased risk was seen in both current and former night workers, suggesting that it may reflect longer-term effects of circadian disruption rather than short-term changes.

However, night-shift work was not associated with a higher risk of infection. This suggests that disruption of the biological clock may influence how the body recovers from infection rather than the likelihood of catching the virus.

Chronic Insomnia Further Raises Risk

Read More: Amid Cyclospora, Salmonella Outbreaks, US FDA Issues Guidance on Ready-to-Eat Produce

The researchers found that chronic insomnia independently increased the risk of long COVID by 42%, regardless of night shift work.

The two factors also appeared to have a synergistic effect. Night shift workers with chronic insomnia were 2.7 times more likely to develop long COVID than day workers without insomnia.

The biological mechanisms behind the association are not yet fully understood. Researchers noted that the time of day when the body encounters a pathogen may influence the immune response. Disruption of the biological clock may also impair the immune system’s ability to clear an infection.

Could Better Sleep Help Prevent Long COVID?

With insomnia becoming increasingly common, the researchers highlighted the need to better understand the short- and long-term effects of disturbed sleep on infection-related outcomes.

The findings suggest that sleep may be a potentially modifiable factor in reducing the risk of long COVID and other post-infectious conditions.

“Promoting healthy sleep habits and minimizing circadian disruption could represent simple, low-cost strategies to reduce the long-term consequences of viral infections, particularly among people who work night shifts,” Kogevinas said.

What is Long COVID?

Long COVID is a debilitating condition that can persist for months or even years after a SARS-CoV-2 infection. Long COVID is an infection-associated chronic condition marked by fatigue, cognitive impairment, exercise intolerance, and multisystem dysfunction.

It has affected an estimated 400 million people worldwide and continues to have significant health, social, and economic consequences. Despite the ongoing risk, prevention strategies have received relatively little attention.