HEALTHONLINEUS

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“Did the European Parliament Overlook an Opportunity to Accelerate Orphan Drug Development?”

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals […]

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The Future of Psychedelic Reform: How Soon Could Changes Occur?

The conversation on psychedelics around the world continues to evolve, with more and more emerging clinical data highlighting their potential to treat mental health disorders. Last year’s developments – see our previous blog post here – led us to anticipate an upcoming change but yet the legal landscape remains unchanged. In the UK, the independent […]

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Regulatory Collaboration: FDA, UK MHRA, and Health Canada Promote Transparency in Machine Learning Medical Devices

In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are […]

The post Machine Learning Medical Devices – FDA, UK MHRA and Health Canada Join Forces (Again) in Promoting Transparency appeared first on Healthcare & Life Sciences Blog.

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Key Priorities and Challenges of Hungary’s Upcoming EU Presidency

Hungary has taken over the EU Council’s rotating presidency as of 1 July 2024. Hungary’s EU presidency comes at a time when the European Parliament (EP) has already adopted its position on the EU pharma reform, and the file is now in the Council’s hands. In this article, we review Hungary’s EU presidency program and […]

The post What to Expect From Hungary’s EU Presidency? appeared first on Healthcare & Life Sciences Blog.

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EU Imposes Stricter Sanctions on Russia and Belarus, Affecting the Healthcare Sector

Alongside its allies, the EU has implemented a vast volume of sanctions on Russia and Belarus following Russia’s invasion of Ukraine in February 2022.  The EU sanctions against both Russia and Belarus are at the core of the EU’s response to Russia’s military aggression and aim to diminish Russian resources and curb Russia’s capacity to […]

The post Further EU Sanctions Tighten on Russia and Belarus – Impacting the Healthcare Sector appeared first on Healthcare & Life Sciences Blog.

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Step-by-Step Guide to Preparing Perfect Hard-Boiled Eggs

# Step-by-Step Guide to Preparing Perfect Hard-Boiled Eggs

Hard-boiled eggs are a versatile and nutritious food that can be enjoyed on their own, added to salads, or used in various recipes. However, achieving the perfect hard-boiled egg — one with a tender white and a creamy yolk — can be tricky. Overcooking can result in a greenish ring around the yolk and a rubbery texture, while undercooking leaves the yolk runny. This step-by-step guide will help you master the art of preparing perfect hard-boiled eggs every time.

## Step 1: Choose Fresh Eggs (But Not Too Fresh)

While fresh eggs are generally preferred for most cooking purposes, slightly older eggs (about 7-10 days old) are easier to peel after boiling. As eggs age, the pH level of the egg white increases, which helps the membrane separate more easily from the shell. If you’re using farm-fresh eggs, consider letting them sit in the refrigerator for a few days before boiling.

## Step 2: Gather Your Equipment

Before you start, make sure you have the following:
– Eggs (as many as you need)
– A large saucepan or pot
– Water
– A slotted spoon or tongs
– A bowl of ice water (for cooling the eggs)
– A timer

## Step 3: Place Eggs in a Single Layer in the Pot

Place your eggs in a single layer at the bottom of the saucepan. This ensures even cooking. Avoid stacking eggs on top of each other, as this can lead to uneven results. If you’re boiling a large batch, use a bigger pot to accommodate all the eggs comfortably.

## Step 4: Add Cold Water

Fill the saucepan with cold water until the eggs are fully submerged. The water should cover the eggs by about 1 inch (2.5 cm). Starting with cold water helps the eggs cook more evenly and prevents cracking due to sudden temperature changes.

## Step 5: Bring the Water to a Boil

Place the pot on the stove over medium-high heat. Allow the water to come to a rolling boil. This may take a few minutes, depending on the size of your pot and the number of eggs you’re boiling. Keep an eye on the pot to prevent it from boiling over.

## Step 6: Turn Off the Heat and Cover the Pot

Once the water reaches a rolling boil, turn off the heat and immediately cover the pot with a lid. This method, known as “off-heat cooking,” ensures that the eggs cook gently and evenly without becoming overcooked or rubbery.

## Step 7: Set a Timer

The cooking time will depend on how you like your eggs. For hard-boiled eggs with fully set yolks, follow these guidelines:
– **Soft-boiled eggs (slightly runny yolk):** 6-7 minutes
– **Medium-boiled eggs (partially set yolk):** 8-9 minutes
– **Hard-boiled eggs (fully set yolk):** 10-12 minutes

For perfect hard-boiled eggs, aim for 10-12 minutes. If you’re unsure, you can always test one egg after 10 minutes and adjust the time accordingly.

## Step 8: Prepare an Ice Bath

While the eggs are cooking, prepare a bowl of ice water. Simply fill a large bowl with cold water and add ice cubes. The ice bath will stop the cooking process immediately and help prevent the yolks from turning green or gray, which can happen if the eggs are overcooked.

## Step 9: Transfer the Eggs to the Ice Bath

Once the timer goes off, use a slotted spoon or tongs to carefully transfer the eggs from the hot water to the ice bath. Let the eggs sit in the ice water for at least 5 minutes. This cooling step not only stops the cooking process but also makes the eggs easier to peel.

## Step 10: Peel the Eggs

After the eggs have cooled, gently tap them on a hard surface to crack the shell. Roll the egg between your hands to loosen the shell, then peel it off. If you’re having trouble peeling the eggs, try peeling them under running water — the water can help separate the shell from the egg white.

## Step 11: Store or Serve

If you’re not eating the eggs right away, store them in the refrigerator. Hard-boiled eggs can be stored in their shells for up to one week. If you’ve already peeled them, place them in an airtight container with a damp paper towel to keep them fresh.

## Bonus Tips for Perfect Hard-Boiled Eggs

– **Add a pinch of salt or vinegar to the water:** This can help prevent the eggs from cracking during cooking.
– **Use a spoon to crack the shell:** If you’re struggling to peel the eggs, gently tap the egg with the back of a spoon to

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“India Pharma Industry: 4 Key Developments to Watch”

The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from […]

The post Guest Feature: India Pharma Focus – 4 Key Industry Developments to Track appeared first on Healthcare & Life Sciences Blog.

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Step-by-Step Guide to Creating a Delicious Vegetarian Poke Bowl

# Step-by-Step Guide to Creating a Delicious Vegetarian Poke Bowl

Poke bowls have become a popular dish worldwide, originating from Hawaii and traditionally featuring raw fish, rice, and a variety of fresh toppings. However, with the growing demand for plant-based meals, vegetarian poke bowls have emerged as a delicious and nutritious alternative. They are packed with vibrant vegetables, plant-based proteins, and flavorful sauces, making them a perfect meal for vegetarians and anyone looking for a healthy, satisfying dish.

In this step-by-step guide, we’ll walk you through how to create a delicious vegetarian poke bowl that’s both easy to make and customizable to your taste preferences.

## Ingredients for a Vegetarian Poke Bowl

Before we dive into the steps, here’s a list of common ingredients you’ll need to create a vegetarian poke bowl. Feel free to mix and match based on your preferences:

### Base:
– **Rice** (Sushi rice, brown rice, or jasmine rice)
– **Quinoa** (for a protein-packed alternative)
– **Mixed greens** (for a lighter, low-carb option)

### Plant-Based Protein:
– **Tofu** (firm or extra-firm, marinated or plain)
– **Tempeh** (for a nutty flavor and texture)
– **Edamame** (young soybeans, rich in protein)
– **Chickpeas** (roasted or boiled)
– **Seitan** (for a meaty texture)

### Vegetables:
– **Cucumber** (thinly sliced or spiralized)
– **Carrots** (shredded or julienned)
– **Avocado** (sliced or cubed)
– **Radishes** (thinly sliced)
– **Seaweed** (nori strips or wakame)
– **Red cabbage** (shredded)
– **Bell peppers** (thinly sliced)
– **Mango** (for a touch of sweetness)
– **Pickled ginger** (for a tangy kick)

### Toppings:
– **Sesame seeds** (black or white)
– **Green onions** (chopped)
– **Crispy fried onions** (for crunch)
– **Nori strips** (dried seaweed)
– **Crushed peanuts or cashews** (for added texture)

### Sauces:
– **Soy sauce** (or tamari for a gluten-free option)
– **Ponzu sauce** (a citrusy soy-based sauce)
– **Sriracha mayo** (for a spicy, creamy kick)
– **Miso dressing** (for a rich umami flavor)
– **Sesame oil** (for a nutty aroma)
– **Spicy peanut sauce** (for a Thai-inspired twist)

## Step-by-Step Guide to Building Your Vegetarian Poke Bowl

### Step 1: Prepare the Base
The foundation of your poke bowl is the base. You can choose from a variety of options depending on your preference for grains or greens.

– **Rice**: If you’re using rice, rinse it thoroughly under cold water to remove excess starch. Cook it according to the package instructions. Sushi rice is a popular choice for poke bowls because of its sticky texture, but you can also use brown rice or jasmine rice for a healthier or more fragrant option. Once cooked, let the rice cool slightly before assembling your bowl.

– **Quinoa**: If you prefer quinoa, cook it according to the package instructions. Quinoa is a great alternative for those seeking a gluten-free or higher-protein base.

– **Mixed Greens**: For a lighter option, use a bed of mixed greens like spinach, arugula, or kale. This is ideal if you’re looking for a low-carb or refreshing poke bowl.

### Step 2: Prepare the Plant-Based Protein
To make your poke bowl filling and nutritious, you’ll need a good source of plant-based protein. Here are some options:

– **Tofu**: Press the tofu to remove excess moisture, then cut it into cubes. You can either marinate the tofu in soy sauce, sesame oil, and a bit of rice vinegar for extra flavor, or pan-fry it until golden and crispy.

– **Tempeh**: Slice tempeh into thin strips and marinate it in a mixture of soy sauce, garlic, and ginger. Pan-fry or bake it until crispy and caramelized.

– **Edamame**: If you’re using edamame, simply boil or steam the beans for a few minutes until tender. You can season them with a pinch of sea salt for extra flavor.

– **Chickpeas**: Roasted chickpeas add a crunchy texture to your poke bowl. Toss them in olive oil, salt, and spices (such as paprika or cumin), then roast them in the oven at 400°F (200°C) for 20-30 minutes.

### Step

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Key Dates and Deadlines Announced in the Published EU AI Act

In Brief The long-awaited EU AI Act was published in the Official Journal of the European Union today, 12 July 2024. The Act regulates activities across the AI lifecycle, as covered in more detail in our previous post, and the countdown for implementation has now started for companies developing or deploying AI technologies, with the Act […]

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Medtronic Announces Voluntary Recall of MiniMed Insulin Pumps Due to Safety Concerns

**Medtronic Announces Voluntary Recall of MiniMed Insulin Pumps Due to Safety Concerns**

*October 2023*

Medtronic, a global leader in medical technology, has announced a voluntary recall of certain models of its MiniMed insulin pumps due to safety concerns. This recall affects thousands of users who rely on these devices to manage their diabetes. The company has taken this step after identifying potential risks that could compromise patient safety.

### Overview of the MiniMed Insulin Pump

The MiniMed insulin pump is a small, portable device that delivers insulin to patients with diabetes. It is designed to help individuals maintain better control of their blood sugar levels by providing continuous insulin delivery throughout the day. The device is particularly popular among people with Type 1 diabetes, who require regular insulin administration to manage their condition.

Insulin pumps like the MiniMed offer an alternative to multiple daily injections, allowing users to program the device to deliver precise doses of insulin based on their needs. The pump is typically worn on the body and connected to a small catheter inserted under the skin.

### Reason for the Recall

Medtronic’s decision to recall certain MiniMed insulin pump models comes after reports of potential safety issues. According to the company, the affected devices may have a malfunction in their delivery mechanism, which could lead to either over-delivery or under-delivery of insulin. Both scenarios pose significant risks to users.

– **Over-delivery of insulin** can result in hypoglycemia (low blood sugar), a condition that can cause symptoms such as dizziness, confusion, seizures, and in severe cases, loss of consciousness or death.

– **Under-delivery of insulin** can lead to hyperglycemia (high blood sugar), which, if left untreated, can result in diabetic ketoacidosis (DKA), a life-threatening condition that requires emergency medical attention.

The recall specifically affects certain models of the MiniMed 600 and 700 series pumps, which have been identified as having a higher likelihood of malfunctioning. Medtronic has urged users to check their device model and serial number to determine if their pump is part of the recall.

### Medtronic’s Response and Recommendations

In a statement, Medtronic emphasized its commitment to patient safety and the importance of addressing the issue promptly. The company is working closely with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to ensure that affected users are informed and provided with appropriate guidance.

Medtronic has advised users of the recalled pumps to take the following steps:

1. **Check the Model and Serial Number**: Patients should verify whether their pump is part of the recall by checking the model and serial number, which can be found on the back of the device or in the pump’s settings menu.

2. **Contact Medtronic**: If the pump is part of the recall, users are encouraged to contact Medtronic’s customer support for further instructions. The company is offering replacement pumps to affected users at no additional cost.

3. **Monitor Blood Sugar Levels Closely**: Until a replacement is provided, patients should closely monitor their blood sugar levels and be vigilant for any signs of hypoglycemia or hyperglycemia. If any unusual symptoms occur, they should seek medical attention immediately.

4. **Consult Healthcare Providers**: Users are also encouraged to consult their healthcare providers to discuss alternative insulin delivery methods or adjustments to their diabetes management plan during this transition period.

### Impact on Patients

For many individuals with diabetes, insulin pumps are a critical tool in managing their condition. The recall has understandably caused concern among users, particularly those who have relied on the MiniMed pump for years. However, Medtronic has reassured patients that the recall is a precautionary measure to prevent potential harm and that the company is committed to resolving the issue as quickly as possible.

In the meantime, healthcare professionals are advising patients to remain calm and follow Medtronic’s instructions. While the recall may be inconvenient, it is essential to prioritize safety and ensure that insulin delivery devices are functioning properly.

### Regulatory Oversight and Future Steps

The FDA has classified this recall as a **Class I recall**, the most serious type of recall, indicating that the use of the affected devices may cause serious injury or death. The agency is working closely with Medtronic to monitor the situation and ensure that corrective actions are taken.

Medtronic has also committed to conducting a thorough investigation to determine the root cause of the malfunction and to prevent similar issues from occurring in the future. The company has a long history of innovation in diabetes care, and it is expected that they will take the necessary steps to restore confidence in their products.

### Conclusion

Medtronic’s voluntary recall of certain MiniMed insulin pumps underscores the importance of patient safety in the medical device industry. While the recall may cause temporary disruptions for users, it is a necessary step to prevent potential harm. Patients are encouraged to stay informed, follow the company’s guidance,

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