Tag: Amgen (AMGN)

The FDA committee voted 19 to 1 in favor of approving Amgen’s & UCB’s new osteoporosis product Evenity

The FDA committee voted 19 to 1 in favor of approving Amgen’s & UCB’s new osteoporosis product Evenity

On January 8, 2019 the osteoporosis monoclonal antibody Evenity (romosozumab) developed by Amgen and UCB was granted approval by the Japanese Ministry of Health, Labor and Welfare for osteoporosis in patients at high risk of bone fracture. Yesterday, Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced that 19 out of 20 members of the  U.S. FDA, Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted YES for the approval of Evenity™ for osteoporosis …
Amgen, Rhythm Pharmaceuticals and an important story to know

Amgen, Rhythm Pharmaceuticals and an important story to know

Amgen Higher Dividends For those who invest in top-tier biotech firms for dividend payments, in addition to the firms’ continued growth, Amgen (AMGN) announced last Friday that its Board of Directors declared a $1.45 per share dividend for the first quarter of 2019. The dividend will be paid on March 8, 2019 to all stockholders of record as of the close of business on February 15, 2019. This represents …
Politics and the Market

Politics and the Market

The Week in Review #35 Politics and the Market The market tumbled today as Theresa May, the Prime Minister of England, delayed the Brexit vote!  The question becomes, what will be put forth next as a legitimate reason for bringing the market down and eroding investors’ gains? The weather? A war among gangs in a fourth-world country? Maybe the resignation of the chairman of a …
There are no reasons for the Market’s tumbling. The value of the Biotech Revolution.

There are no reasons for the Market’s tumbling. The value of the Biotech Revolution.

Today, the market took another beating as a result of either an intentional or an unintentional lack of clearance by professionals in describing correctly the standing of employment and other current economic realities. They pinpointed irrelevant reasons in an effort to justify the Stock Market's tumbling.  One big headline was that 150,000 added jobs did not meet expectations. They never explained whether those jobs were all …
Amgen and UCB product for bone fracture in susceptible postmenopausal women. What about the Market’s deep dips?

Amgen and UCB product for bone fracture in susceptible postmenopausal women. What about the Market’s deep dips?

Another reason was found to hit the market when the economy is good and sustained and expected to be of a long duration. Of a short duration are the causes presented as economy killers. They are almost all related to China. We believe that the negotiations between China and the United States on the tariffs and other subjects will end up in favor of both …
The molecule that enhanced the T Cells cancer treatment efficacy while preventing autoimmune diseases

The molecule that enhanced the T Cells cancer treatment efficacy while preventing autoimmune diseases

Yesterday, the Stock Market skyrocketed and with it a significant number of Prohost Picks that we keep reminding ourselves are undervalued. The outperformance unveiled the interred strength of firms such as: Illumina (ILMN), Amgen (AMGN) and Vertex (VRTX), the gene therapy firms: RegenxBio (RGNX) and Spark (ONCE), and the gene editing firms: Crispr (CRSP), Intellia (NTLA) and Editas (EDIT), as well as others in the Prohost Portfolio. The rebounding in the …
We call it the bad market

We call it the bad market

The Week in Review #33 WE CALL IT THE BAD MARKET The Federal Reserve’s raising of the interest rate does not and should not mean a demise of the companies trading on the NASDAQ and other stock exchanges. The biotech group of firms with strong scientific fundamentals will not stop innovating and bringing breakthroughs to millions of people who are desperate for them if an …
Amgen’s product Amgevita, a biosimilar to adalimumab, will be launched in the European market today.

Amgen’s product Amgevita, a biosimilar to adalimumab, will be launched in the European market today.

Amgen (AMGN) announced that AmgevitaTM, a biosimilar to adalimumab, will launch in markets across Europe beginning on October 16, 2018. According to Amgen’s press release, AmgevitaTM is the first adalimumab biosimilar to be approved by the European Commission (EC). The EC approval is based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 confirmatory studies of the product for moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The …
Outperformance, underperformance and volatility

Outperformance, underperformance and volatility

The Week in Review #31 IN THE DEPARTED WEEK NOVEL MIGRAINE DRUGS ARE APPROVED ELI LILLY AFTER AMGEN AND TEVA In less than five months, the FDA approved three products belonging to four drug developers – all targeting calcitonin gene-related peptide (CGRP) for the prevention of migraine headache. The latest for Eli Lilly (LLY) last week . . . This content is for paid subscribers. …
Amgen and AstraZeneca have in hand a very much needed Asthma drug

Amgen and AstraZeneca have in hand a very much needed Asthma drug

In the Week in Review posted yesterday on our website that is experiencing several attempts on its life, we wrote about some firms, including Amgen. In the Amgen’s article we tried to let the reader recognize the importance of Amgen’s (AMGN) asthma product tezepelumab and how it differs from all other asthma drugs on the market, including the conventional tablets, inhalers and infusions. The Novel …
What is looking good in the aggressive portfolio

What is looking good in the aggressive portfolio

The Week in Review #29 PROHOST AGGRESSIVE PORTFOLIO  - The aggressive portfolio hosts biotech firms with solid scientific fundamentals and prominent scientists whose stocks have plummeted following some setbacks. A setback could be a failure of an investigational product to meet the endpoints of its clinical trial or that the small biotech firm has taken long to achieve its goals . . . This content …
Amgen and UCB resubmit BLA to the FDA for the approval of Evenity™ to prevent or heal Osteoporosis bone fracture in post-menopausal women

Amgen and UCB resubmit BLA to the FDA for the approval of Evenity™ to prevent or heal Osteoporosis bone fracture in post-menopausal women

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) to the U.S. FDA for the approval of their osteoporosis investigational monoclonal antibody product Evenity™ (romosozumab). The product is indicated for osteoporosis in postmenopausal women at high risk for fracture.The drug increases bone formation and reduces bone resorption simultaneously to increase bone mineral …
Our outperforming firms and more

Our outperforming firms and more

The Week in Review #24 Biotech Stocks’ Performances, Products on the Move and Biotech Research Biotechnology stocks’ performance should be based on the firm’s intrinsic news that announces the power of their technologies and the successes or failures of their lead products and, to a lesser extent of their early-phase trials’ products. To be taken in consideration too are their financial statuses, especially of firms …
Amgen: The FDA approves Aimovig™. The first specific migraine drug

Amgen: The FDA approves Aimovig™. The first specific migraine drug

The U.S. Food and Drug Administration (FDA) approved Amgen’s (AMGN) new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in the occurrence of migraine. The drug will be marketed by Amgen and Novartis (NVS).  Aimovig 70 mg is …
Inspiring News from a Small Firm

Inspiring News from a Small Firm

Following the news announcing that Amgen’s (AMGN) drug KYPROLIS® (carfilzomib) extended the lives of patients with relapsed or refractory multiple myeloma in combination with lenalidomide + dexamethasone, we got news from a small company called Karyopharm Therapeutics (KPTI) announcing positive news from a trial with its product selinexor in multiple myeloma. The news announced that Karyopharm’s oral selective inhibitor of nuclear export (SINE) compound selinexor demonstrated positive results from the Phase 2b STORM study …
Amgen Has More Good News. What Is Going on with the CRISPR Gene Editing Firms?

Amgen Has More Good News. What Is Going on with the CRISPR Gene Editing Firms?

A couple of days following the news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on Amgen’s (AMGN) product Prolia® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy, the same Committee recommended a label variation for KYPROLIS® (carfilzomib) with an addition that includes the final overall survival (OS) data from the Phase 3 ASPIRE trial. In the ASPIRE trial, KYPROLIS …
AveXis Drug’s Data for Spinal Muscular Atrophy Highlights Gene Therapy

AveXis Drug’s Data for Spinal Muscular Atrophy Highlights Gene Therapy

The Week in Review #21 Part 2 THE  MARKET (2) - Our remarks in the past Week in Review included our confidence that the attempts by negative investors to drive the market crazy will not deprive the market from its innate capability to sense and react to the authentic factors it usually reacts to . . . This content is for paid subscribers. Please click here to …
The Biotech Revolution is Alive and Speeding

The Biotech Revolution is Alive and Speeding

The Week in Review #21 Part 1 THE MARKET - Like symphonic orchestras that bring to the listeners’ ears, minds and souls melodies composed by legendary authors, the stock market reflects what’s going on in the world, which would positively or negatively impact the lives and well being of the earth’s residents . . . This content is for paid subscribers. Please click here to subscribe or here to …
Observing Queer Stories

Observing Queer Stories

Prohost Letter #418 Observing Queer Stories  PORTOLA - Portola (PTLA) has been granted approval of an important factor Xa inhibitor Bevyxxa (betrixa-­ban for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for a life-­threatening VTE . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Amgen’s Migraine Drug Passes the Trial Tests with High Grades

Amgen’s Migraine Drug Passes the Trial Tests with High Grades

Amgen (AMGN): Phase 3b results from LIBERTY study assessing the safety and efficacy of Aimovig™(erenumab) 140 mg in patients with an episodic migraine who had experienced two to four previous preventive treatment failures demonstrate that the study met its primary and secondary endpoints.    With regard to meeting the primary endpoint, the results demonstrate that patients on Aimovig experienced at least a 50 percent reduction from baseline in …