Tag: Amgen (AMGN)

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 log …
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 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 …
Acorda’s Attempted Rally. See Also: Amgen, Merck and AstraZeneca

Acorda’s Attempted Rally. See Also: Amgen, Merck and AstraZeneca

Acorda (ACOR) stock was up around 10% reaching over $28 in premarket trading. The stock is trading now around $27 with its gains oscillating between $2 – $2.20. The enthusiasm for ACOR seems to be about rumors that Biogen (BIIB) or possibly other Asian drug makers might have demonstrated the interest in Acorda. What’s going on with Acorda? In June 2017, the stock rallied on news about positive clinical trial …
The Year in Review Part 1

The Year in Review Part 1

Prohost Letter #416 Part 1 The Year In Review - 2017 Unheard of Programs - AN AWESOME YEAR for the biotech sector regarding its accomplishments. Many of the accomplished programs were unheard of regarding the degree of their positive impact on medical practice. Unfortunately, many of these accomplishments, which included the making of new discoveries, the creation of novel advanced technologies and the design of …
Prohost Letter #415

Prohost Letter #415

Prohost Letter #415 New Promising Technologies PROTAC - A Technology That Offers a Superior Class of Drugs PROTAC is an approach that created a new class of drugs described as superior and far less toxic than targeted drugs known to block disease-­causing proteins. The technology belongs to a private Company called Arvinas . . . This content is for paid subscribers. Please click here to subscribe …
Must Read News. See Also: A New Immunotherapy Combination by Incyte and AstraZeneca

Must Read News. See Also: A New Immunotherapy Combination by Incyte and AstraZeneca

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of …
The Week in Review #9

The Week in Review #9

The Week in Review #9 KNOCKING DOWN THE BIOTECH STOCKS - Knocking down the biotech companies’ stocks during the announcement of the quarterly reports is no news. Most investors in the stock market, especially those who invest in the biotech sector have become familiar with this pattern . . . This content is for paid subscribers. Please click here to subscribe or log in.
New Breakthrough Immuno-Oncology Products

New Breakthrough Immuno-Oncology Products

The Week in Review #7 A lot more happened in the past week regarding improving the treatment of cancer and of other devastating diseases. This issue contains discoveries that aim at improving breakthrough immuno-­oncology treatment outcomes. Here are some of the breakthrough technologies and treatments that might improve, by-­far, the management of cancer . . . This content is for paid subscribers. Please click here to …
Why Our Increased Enthusiasm for Incyte’s Product Baricitinib

Why Our Increased Enthusiasm for Incyte’s Product Baricitinib

Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the …
Some Good and Bad Stories

Some Good and Bad Stories

The Week in Review #2 The Fairest Upgrades of the Week - Some analysts gave a generous and well measured dose of fairness evaluating biotech firms’ accomplishments. Credit Swiss upgrades Portola Pharmaceuticals (PTLA) from neutral to outperform while maintaining its $70 target . . . This content is for paid subscribers. Please click here to subscribe or log in.
Prohost Letter #412 Part 3

Prohost Letter #412 Part 3

Prohost Letter #412 Part 3 GLIOBLASTOMA - Is There Hope? Senator John McCain was diagnosed with a malignant brain tumor, glioblastoma – the most common and aggressive form of brain cancer. The cancer is so aggressive that most surgeries did not provide survival. This brain cancer affects around 3 people out of 100,000 in the U.S., with men more than women and whites more than other …