I can extract side effects

Eagle Country Biogen is a world-leading biopharmaceutical company for the treatment of neurological diseases such as Alzheimer's disease, with annual sales exceeding US$10 billion. It ranked 20th among the top 50 global prescription drug companies last year.

Aduhelm is one of Biogen's flagship drugs.

The drug selectively binds to amyloid beta in the brain, and then activates the immune system to remove amyloid plaques from the brain.

However, the road to the market of this flagship drug was very bumpy, with twists and turns, and there were many controversies after it was launched.

When the drug was first applied to the FDA for marketing, it was rejected due to the unknown effect. Originally, Biogen had planned to give up this drug, but in the follow-up clinical trials, after expanding the sample and increasing the dosage, it was found that it had a positive effect on patients. highlighted.

So Biogen continued to invest in research and development, reapplied for FDA approval, and obtained accelerated approval for marketing.

The approval was highly controversial within the industry amid strong opposition from FDA advisory committee members to the drug approval. When regulators decided to approve the drug, ten members of the panel resigned.

Adulhemo's safety has been the reason for the drug's ill-fated life, when a woman who took it died of cerebral edema. It has not been confirmed that the cause of her death was caused by this drug, but this has a great impact on the confidence of doctors to prescribe to patients.

Biogen continues to generate data supporting the drug's safety and efficacy in demonstrating its efficacy in Alzheimer's disease. At the subsequent Alzheimer's disease clinical trial meeting, Biogen announced the data of two phase III trials, the results showed that after treatment, the patients' amyloid plaques were reduced, and p-tau181 in plasma (Alzheimer's disease tau marker) was significantly reduced.

It is generally believed that the FDA approved the drug on the grounds that the benefits of the drug to patients with Alzheimer's disease outweigh its risks, which mainly expresses an attitude of encouraging AD drug research.

After all, the current research on new drugs for the treatment of AD has basically been wiped out. In the past ten years or so, no new drugs have been approved, which really discourages the enthusiasm of pharmaceutical companies for research and development. With the aging of society, the research and development of AD drugs is very urgent.

The FDA's accelerated approval provides patients with an earlier opportunity for treatment. At the same time, the FDA also requires Biogen to continue a new randomized controlled clinical trial to further verify the clinical benefits for patients. If follow-up trials are unfavorable, the FDA may withdraw approval of the drug.

Patients and their families are still looking forward to this. After all, they have been waiting for too long. The last time the FDA approved the Alzheimer’s disease drug Namenda (the domestic name is “Memantine”) occurred in 2003.

However, after the new drug was launched, due to the high price, the annual treatment cost was as high as 60,000 US dollars, resulting in bleak sales, and Eagle Country officials soon announced that it would be included in the country's medical insurance, and Biogen took advantage of the momentum to reduce the price to 30,000 US dollars per year. It was finally possible to save a little bit of the situation in the market.

However, in addition to Eagle Country, the drug was also rejected by Europa and Sakura Country drug regulators at the end of last year. Both said that there is not enough data to support their approval of the drug.

In short, Biogen's stock price often enjoys a roller-coaster ride because of the news of this drug, which also makes Biogen's CEO very sensitive to any related news.

When he saw the news that his own medicine was pulled out to compare with Sanqing's special AD medicine, his eyes suddenly went dark, and an ominous premonition instantly enveloped him.

At this time, in a hut somewhere in Eagle Country.

Amy Jones is watching the news on TV intently, which shows the detailed clinical data of Sanqing and Bojian's AD specific drugs.

She has brown hair and deep eyes, tall and tall, with deep crow's feet at the corners of her eyes. She looks to be in her early forties, with a very calm face.

Looking at it, her eyes suddenly fluctuated, she got up and walked to the computer, and began to search the Internet for news about this specific drug.

As a familial Alzheimer's patient, her grandmother and mother both suffered from the disease, and she knows the disease very well.

About 1%-5% of AD patients in the world have a family history, and most of them develop symptoms before the age of 60, and many people even begin to show symptoms in their 40s.

This also led to their greater suffering, because most of the common patients did not start to get sick until they were 60 years old.

Amy is forty-two years old. According to her mother's two generations of experience, she knows that she has not much time left.

After working hard to take care of her grandmother for many years, the mother found that she had symptoms of illness again, so she resolutely swallowed the gun and committed suicide, and she was unwilling to drag her daughter down. This gave her great mental stimulation.

Since then, she has lived alone in a hut in the suburbs, quietly waiting for that day to come.

Under her pillow was the gun that took her mother away. If nothing happened, this gun would also take her life away.

Before the illness completely devoured her brain, she was ready to meet her mother and grandmother at any time.

There is also a Bible under the pillow. Before going to bed every day, she will silently recite this book, and then recall the details of a day's life to confirm whether her memory is intact.

This disease, like the sword of Dalymos hanging above her head, could fall at any time and harvest her life.

And now, some people in the news say that there is already a special medicine that can cure this disease.

At first, she sniffed it. After all, she also met some patients through this disease, but they took various medicines on the market, but the feedback they gave was not very good.

This includes Biogen's special medicine. A patient had a splitting headache after taking this medicine and had to stop taking it to protect himself.

However, this specific medicine of Sanqing seemed a little different, and the more she searched for relevant information, the more frightened she became.

Similarly, she also saw the paper in the journal "Nature", and the treatment effect shown on it made her heart flutter.

A longing for life slowly surfaced in her heart again.

Can this disease really be cured?

The paper emphasizes that the drug is only effective for early stage patients, which is enough for her.

She hasn't gotten sick yet. If she keeps taking this medicine, won't she be able to delay the onset of the disease?

Amy immediately lifted her spirits and began to pay attention to the special reports of Fox News.

"The results of the clinical phase II trial show that the patient's condition is improving every week. Positron emission tomography (PET) imaging shows that after one month of treatment, 80% of the patients have a negative PET test, which means that they have amyloid in their brains. The level of deposition is not significantly different from that of healthy people."

"At the same time, compared with the placebo group, the combined index iADRS, which evaluates the patient's cognitive ability and daily living ability, decreased by 89%."

"Patients had an average reduction in amyloid plaque levels of 84 units, compared to a baseline value of 108 (a value of less than 25 indicates a negative amyloid scan)."

"1% of the subjects experienced mild dizziness, nausea, palpitations, allergic reactions and other reactions, and follow-up clinical observation is still needed."

The more she looked at it, the more excited she became. The data of the Phase II clinical trial all showed the strong curative effect of Sanqing AD special drug, with few side effects, which is nothing compared to the harm of cerebral edema.

So I immediately contacted other AD patients, and everyone shared the good news.

All the patients in Yingguo cheered: "God, thank you for allowing Sanqing to produce such a miraculous drug, we are finally saved!"

They are ready to take action to make Sanqing, a special drug, available in Yingguo as soon as possible.

At this time, Blanche of Fox News also faced a huge embarrassment.

The clinical data of Sanqing’s special drug for AD is really good, so good that it is beyond anyone’s expectation, causing all the authoritative experts to be dumbfounded. Opponents are left far behind.

Dementia is finally cured!

This miraculous effect led to a surge in traffic, and even passers-by who had never heard of the disease were attracted by the gimmick.

But the more people read it, the more famous the name of Sanqing Special Effect Medicine became. More and more experts were persuaded and began to praise this medicine.

This is not the effect that Blanche wants at all. He wants experts to criticize this medicine severely, thus tarnishing Sanqing's reputation.

How did that happen? Sanqing did not falsify, and the curative effect of this medicine is actually true?

Blanche tugged at her hair, trying to figure it out.

Suddenly, the phone rang, and it turned out to be Boss Mo from Fox News.

He quickly picked up the phone, ready to meet Boss Mo's wrath.

Who knew that the voice on the other side of the phone was very satisfied with him.

"Blanche, you did a great job. This news feature is very good. We have gained countless traffic, and now we are the most popular media on the entire network."

Blanche faltered and said, "But, boss, we said that Sanqing stole Pfizer's technology in order to tarnish their reputation. Now it seems to be counterproductive."

"Hehe, how could it be? Why do we want to make Sanqing smelly? This is a pharmaceutical company, or a pharmaceutical company in the far east. Does his reputation have anything to do with us? No. Everything we do, no Is it all for traffic, to attract attention?"

Blanche suddenly realized: "So the process is not important, but the result is important. As long as there is popularity and traffic, it doesn't matter what we do among us."

"Yes, you have learned this before you can be a real journalist. The audience is not important, but their attention is important. Work hard and keep this topic hot. You will benefit a lot."