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FDA Approves Pfizer “Gamma” Treatment

Daniel Chase

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Fortune favors the brave, but when the brave catches a cold, they may not fare too well. With flu season in full swing, a cacophony of coughs and sneezes can be heard from a mile away, and over-the-counter solutions just are just snot enough anymore. Though U.S. health officials haven’t reported many flu cases this season, it may be too soon to know if this year’s bugs will be as severe as years past. 

New Drugs On The Block

In preparation of a gnarly flu virus this year, biotech companies have been working tirelessly to create a drug strong enough to tackle this year’s flu. On Wednesday, the Food and Drug Administration (FDA) approved the first new antiviral flu medicine in twenty years. The drug, created by Japanese pharmaceutical company subsidiary, Genentech, is called Xofluza (or baloxavir marboxil). 

“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.” 

FDA Commissioner Scott Gottlieb, M.D.

Xofluza, for which I am unclear how to pronounce phonetically, stands out from previous flu drugs because it attacks the virus immediately through a single oral dose. According to the official FDA press release, if treatment is started within 48 hours of becoming sick with the flu, Xofluza alleviates the associated symptoms in a short amount of time. The new option for flu sufferers is already gaining respect in the medical field. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, told CBS News that he applauds Xofluza because of its unique ability to “inhibit replication of the flu virus in the first place, at a step much earlier than the current medications available.” Dr. Glatter raved about simplicity surrounding the regimen for treatment with Xofluza. The drug is “simpler to take — just one tablet, compared with other options, one of which requires twice-daily dosing for 5 days.” 

FDA Is Poppin’ Pill Approvals 

The FDA’s approval of Xofluza not only represents a huge advancement for flu drug development as well as increased accessibility of options for consumer treatment but even more so, Xofluza’s green light follows 46 other drugs approved by the agency just this year. The FDA claims that their reasons for approving so many novel medicines have to do with a drive to innovate and create “new drugs and therapeutic biological products.” 

The agency, through their Center for Drug Evaluation and Research (CDER), is determined to increase the “availability of new drugs, biological products, and treatment options for patients” to further the advancement of health care for the American public. As the FDA approves the distribution and regulation of new drugs, pharmaceutical and biotechnology companies are reaping the financial benefits alongside the medical benefits enjoyed by their patients. 

Biotech Stocks Respond Nicely To FDA-Approved Treatment 

Joining the ride for the FDA’s approval-happy tour is pharmaceutical giant and critically-acclaimed creator of Viagra, Pfizer Inc. (PFE). Last week, on Oct. 17, the FDA approved Pfizer’s (PFE) new drug, Talzenna, which treats patients with a “germline BRCA-mutated, HER2-negative breast cancer. 

“Patients with germline BRCA-positive breast cancer are typically diagnosed at a younger age than those with non-hereditary breast cancer, and there are no therapies specifically approved for them outside of the current standard of care.”

Jennifer Litton, lead investigator, and associate professor, University of Texas MD Anderson Cancer Center

Earlier this year, Pfizer (PFE) along with Eli Lilly and Company (LLY) announced that both were working on treatment options for osteoarthritis (OA) pain felt in the knee or hip. Recent data findings indicate that “more than half of the patients treated” with Tanezumab (drug both are working on) reported a “50% or greater reduction in osteoarthritis pain of the knee or hip.” For those not aware of the collaborate efforts of Pfizer (PFE) and Eli Lilly, the two pharmaceutical companies entered into a $1.23 billion agreement in 2013 to jointly develop the drug.  

As a result of Pfizer’s (PFE) collab with Eli Lilly (LLY), the company’s shares have soared 21.7% year to date, trading at $43.77 per share, reportedly outperforming the sector’s increase of 4.9%. 

Capitalizing on these impressive gains, Pfizer (PFE) announced this week that has plans in the works for a new biopharmaceutical company called Cerevel Therapeutics, LLC, in partnership with Bain Capital, LP.  Pfizer (PFE) hopes that this new joint venture will create new treatment options for patients suffering from the central nervous system (CNS) disorders including, but not limited to, Parkinson’s and Alzheimer’s disease, epilepsy, schizophrenia, and addiction. 

Pfizer will retain a 25% stake in this partnership agreement. Cerevel Therapeutics’ headquarter will be reportedly be housed somewhere in the Greater Boston Area. 

Closing Thoughts 

As the world’s population continues to grow older in developed markets, the demand for drugs and medical services will increase. This growing need presents a lucrative opportunity for pharmaceutical companies and investors involved in the industry. It’s interesting that as medical advancements continue, more diseases are coming out of the woodwork. People are getting sicker, obesity in the U.S. is at an all-time high, and people, the world over, need affordable and effective treatment. The FDA’s approving of nearly 50 drugs in one year is representative of this very real epidemic. 

My hope is that as more drugs become available, we see a decline in the need for treatment because of the effectiveness of new medicines, and ultimately, a healthier population.

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Stock Price Newsletter – November 15, 2019

Joe Samuel

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best biotech stocks to trade now

3 Biotech Stocks To Watch As The Sector Heats Up

When it comes to building a portfolio, money managers almost always ask their clients to diversify their portfolio. That’s in order to hedge against market risks. Hence, an investor needs to explore a wide range of sectors and choose stocks from those. One of the hottest sectors lately is the biotech sector.

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Comcast (CMCSA) Enters The Streaming Business: How Far Can It Go?

There had been a lot of anticipation with regard to the ‘streaming wars’ for most of the year. At least it’s here, with the launch of Apple TV+ (AAPL) and Disney Plus (DIS). However, those two launches simply signify the commencement of the streaming wars.

See For Yourself


3 Pharma Stocks to Watch As The Sector Gets Attention In November

It is often noticed that investment experts ask people to diversify their money across sectors. More often than not, it is recommended that some attention should be allocated towards biotech stocks. The simple reason behind this is the fact that biotech stocks have proven to be fruitful companies and the sector continues to churn out winners.

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Biotechnology

3 Biotech Stocks To Watch As The Sector Heats Up

A. Lawrence

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top biotech stocks to watch list

When it comes to building a portfolio, money managers almost always ask their clients to diversify their portfolio. That’s in order to hedge against market risks. Hence, an investor needs to explore a wide range of sectors and choose stocks from those. One of the hottest sectors lately is the biotech sector.

It has managed to generate impressive growth over the past decade and remains a potentially high growth space for investors. On that note, here is a quick look at two biotech stocks that should be tracked by investors.

Biotech Stocks To Watch #1: GT Biopharma (GTBP)

GT Biopharma (GTBP) is a clinical-stage, immuno-oncology biotech company focused on innovative treatments based on its patent-pending TriKE™ technology. GT Biopharma (GTBP) is in good company within this space. Obviously you have the biotech giants:Gilead Sciences, Inc. (NASDAQ:GILD), Incyte Corporation (NASDAQ:INCY), &Merck & Co. (NYSE:MRK). But according to a recent article that was published on The Motley Fool it may be time for investors to give their attention to the “little guys” aka the Small Cap Stocks.

Within this article, The Motley Fool talks about 3 “Out of favor” “Cancer Treatment Stocks.” One of the companies is a small-cap stock that, according to the article, “sports marquee oncology partnerships with Gilead Sciences, Incyte, as well as Merck.” 

top biotechnology stocks to watch today

Similarly, when investors look at GT Biopharma (GTBP) they will notice that the company is indeed a small-cap stock and like the company The Motley Fool mentioned, has ties to a large entity to help further its own corporate missions. GT Biopharma (GTBP) has deep ties to the University of Minnesota & its prestigious Masonic Cancer Center, a comprehensive cancer center designated by the National Cancer Institute. Thanks to this relationship, GT Biopharma has been able to capitalize on several key developments:

GT Biopharma (GTBP) announces that Tim Schacker, M.D., Jeffrey S. Miller, M.D., and their colleagues at the University of Minnesota presented data showing its HIV-TriKE™ was able to kill HIV infected cells in the reservoir

GT Biopharma (GTBP) Announces Solid Tumor Targeting TriKe™ Kills Non-small Cell Lung Cancer (NSCLC) Tumor Cells

Read more on GT Biopharma Here.

Biotech Stocks To Watch #2: Jaguar Health (JAGX)

The first biotech stock to consider is that of Jaguar Health Inc (NASDAQ:JAGX), which made a major announcement at the end of October. That has resulted in the major rally in the stock through November and so far, the stock has gained as much as 45%. The company had announced that its fully owned subsidiary Napo Pharmaceutical has agreed on a distribution agreement with TannerGAP.

TannerGAP is part of the larger Tanner Pharma Group and will distribute the product Mytesi in places at which it is not yet registered. At this point in time, Mytesi is registered in Israel, the United States and Canada. Recently Jaguar also appointed Ian Wendt as its Vice President of Commercial Strategy.

On November 14 the company announced that Georgetown University ‘s Data Safety Monitoring Committee (“DSMC”) has reviewed the interim analysis for futility for the third-party, investigator-initiated Phase 2 HALT-D study evaluating the effectiveness of Mytesi® (crofelemer) for symptomatic relief in HER2 positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel or trastuzumab, pertuzumab, carboplatin, and docetaxel (the “Study”). The DSMC has notified the Principal Investigator that the Study is allowed to enroll to completion. Enrollment in the Study now exceeds 85%, and the treatment period for each patient is 3 months.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

Biotech Stocks To Watch #3: Therapix Biosciences (TRPX)

The other biotech stock that warrants attention is that of Therapix Biosciences Ltd (NASDAQ:TRPX). The company is involved in developing treatments that are CBD based and today it announced top line results from the Phase 2A clinical study of its product THX-110. The study revealed that the product did, in fact, have a positive effect on patients who are afflicted with obstructive sleep apnea (OSA).

The study was conducted at the Assuta Hashalom Medical Center located in Israel and it represents a major positive for Therapix. After the news broke, the rocketed by as much as 19.45% and has emerged as one of the biotech stocks to watch for the rest of the week.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

best penny stocks Clovis Oncology (CLVS)

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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Entertainment

Comcast (CMCSA) Enters The Streaming Business: How Far Can It Go?

Joe Samuel

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stock market today

There had been a lot of anticipation with regard to the ‘streaming wars’ for most of the year. At least it’s here, with the launch of Apple TV+ (AAPL) and Disney Plus (DIS). However, those two launches simply signify the commencement of the streaming wars.

Comcast To Launch Own Streaming Service in 2020

comcast peacock

NBC Universal, owned by Comcast Corporation (NASDAQ:CMCSA), is all set to launch its own streaming service named Peacock in April next year and it is interesting to figure where it is going to stand with regards to the streaming wars. As everyone knows, content and pricing are the most important factors in this regard. Here is a closer look at Peacock.

According to reports, Peacock is apparently going to launch with as much as 15,000 hours worth of content for its users and it is also going to include such cult classic shows like ‘The Office’. More often than not, streaming services need a few ‘anchor shows’ in order to attract users and that seems to be in place at Peacock.

[MARKET PREVIEW] The $40 Billion Dollar Content Gold Rush

Content Providers Eager To Capitalize

Fearless Films Inc. (FERL) is a full-service production company with award-winning upper management. The company specializes in producing both short and feature films as well as scriptwriting and distribution.

Fearless Films has been developing its operations recently which has caught the interest of new investors. One development was a recent news press relating to an agreement with Victor Altomare, the Founder and President of Fearless. The company entered a Letter of Intent to acquire the rights of up to 12 movies from a library held by Mr. Altomare. The price of the acquisition is to be determined at a later date.

streaming cord cutting entertainment stocks

On October 31, Fearless Films (FERLannounced that further to its initial press release on the 16th, the Company has selected The Lunatic as the first film to be selected for appraisal and final negotiation. Fearless will engage an international accounting and advisory firm with a strong film industry practice to provide an independent valuation of the film, following which the company will enter into final negotiations on the purchase.

Companies like Fearless are looking to fill the content needs of companies streaming companies. Jeffrey Cole explained how Apple, for example, needs new content, “I think entertainment’s going to become a key element of Apple’s business. For them, spending $2 billion on [original content] is just dabbling. If they like what they see, I think they’ll have a $10 billion budget.” This is a massive market potential that Fearless Films is looking to capitalize on.

[MARKET PREVIEW] The $40 Billion Dollar Content Gold Rush

What’s In Store For Peacock?

However, it is highly interesting to note that Peacock is going to make an ad-supported free version of the platform available. Initially, it was supposed to be an option for Comcast cable or broadband customers only.

This pricing structure could throw the other companies into chaos, considering no one in the industry offers a free version at this point. Peacock expects to generate $5 per month per user from the free version. Apple TV+ is priced at $4.99 per month but it is free 12 months for users who have purchased a new Apple device. Disney Plus, on the other hand, is priced at $6.99 a month.

A yearly subscription will cost $69.99 a month. Another heavyweight that is going to join the arena in a few months is HBO Max and that is going to set back a customer $14.99 on a monthly basis. However, HBO Max will be available for free for AT&T customers. So, it is clear that the streaming space is heating up and Peacock has come up with a very interesting plan to make a mark.

movie stocks

Pursuant to an agreement between Midam Ventures LLC and Fearless Films Inc. (FERL), Midam has been paid $94,980 by Fearless Films Inc. (FERL) for a period from October 1, 2019 to November 17, 2019. We may buy or sell additional shares of Fearless Films Inc. (FERL) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Fearless Films Inc. (FERL). Click Here For Full Disclaimer.

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