Category: News & Comments

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 …
Exelixis initiates phase 3 trial with Cabometyx in radioiodine-refractory differentiated thyroid cancer (DTC) patients

Exelixis initiates phase 3 trial with Cabometyx in radioiodine-refractory differentiated thyroid cancer (DTC) patients

Exelixis (EXEL) announced its initiation of a phase 3 pivotal trial (COSMIC-311) of Cabometyx (cabozantinib) in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. The co-primary endpoints for the trial are progression-free (PFS) survival and objective response rate (ORR). Why conducting trial on patients with radioiodine-refractory differentiated thyroid cancer.    Differentiated thyroid tumors make up …
The FDA granted Paratek two important product approvals. One is for acne

The FDA granted Paratek two important product approvals. One is for acne

The U.S. Food and Drug Administration (FDA) has approved Paratek Pharmaceuticals’ (PRTK) product Seysara™ (sarecycline) for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for acne to Allergan PLC, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world. Seysara (sarecycline) …
Antisense investigational product demonstrates successful results treating a life-threatening disease with no current treatment

Antisense investigational product demonstrates successful results treating a life-threatening disease with no current treatment

The high risk of premature death from cardiovascular disease is believed to be caused by an elevated level of lipoprotein (a) {Lp(a)}. Elevated Lp(a) is described as an independent, hereditary risk factor for cardiovascular disease (CVD). Diet and exercise, or even currently prescribed cholesterol-lowering treatments do not help the devastating outcome of this condition. Around 8 to 10 million people are living with established cardiovascular …
The medical news of the year comes at the hands of Abott

The medical news of the year comes at the hands of Abott

While preparing The Week in Review issue from Prohost, our attention  shifted towards historical news about a procedure that improved the heart function in severe heart failure patients. For cardiologists and their patients, the positive results were surprising, stunning and beyond anticipation. Current treatments of severe heart failure are only symptomatic and do not stop the heart muscle deterioration that results in imminent death. Data …
Exelixis: Health Canada approves Cabometyx in advanced renal cell carcinoma

Exelixis: Health Canada approves Cabometyx in advanced renal cell carcinoma

Exelixis’ (EXEL) partner Ipsen Biopharmaceuticals Canada Inc. received approval of Cabometyx®(cabozantinib) tablets from Health Canada for adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada had granted Cabometyx priority review status, which resulted in the accelerated review of Ipsen’s new drug submission. Explaining the importance of Cabometyx’s additional approval, Michael M. Morrissey, Ph.D., President and Chief Executive Officer …
Viking Therapeutics: VK2809 scores impressive results in non-alcoholic fatty liver disease

Viking Therapeutics: VK2809 scores impressive results in non-alcoholic fatty liver disease

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol – The Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in LDL-C in Patients Receiving VK2809  – 57% to 60% Median Liver Fat Reduction Observed in VK2809-Treated Patients  – 77% to 91% of VK2809-Treated Patients Experienced ≥ 30% Reduction in Liver Fat …
Argenx’s product, Efgartigimod, demonstrates positive results in primary immune thrombocytopenia

Argenx’s product, Efgartigimod, demonstrates positive results in primary immune thrombocytopenia

Phase 2 clinical trial data of argenx’s (ARGX) product Efgartigimod (ARGX-113) in adult patients with primary immune thrombocytopenia (ITP)  showed a favorable safety and tolerability profile. The results also demonstrated that efgartigimod caused meaningful platelet count improvements across doses and ITP patient classifications, including newly diagnosed, persistent and chronic, and correlated with a consistent reduction in IgG levels. Commenting on the news, Nicolas Leupin, Chief Medical …
Gilead Sciences: In pursuit of cures for intractable diseases

Gilead Sciences: In pursuit of cures for intractable diseases

Gilead Sciences (GILD) has news that we felt good about it for a company that saved millions of lives from the minute, but monster viruses HIV and HCV. Curing millions of patients with HCV, has led Gilead to decide that the time has come for bringing cures to many horrible diseases. Yesterday, September 12, the news announced that Gilead and Precision BioSciences have entered into …
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 …
Gilead and Galapagos have good news for patients with severely active Ankylosing Spondylitis

Gilead and Galapagos have good news for patients with severely active Ankylosing Spondylitis

Gilead Sciences’ (GILD) and Galapagos’ (GLPG) product filgotinib – a highly selective JAK1 inhibitor has met the primary efficacy endpoint in Phase 2 TORTUGA trial in adults with moderately to severely active ankylosing spondylitis (AS). Patients treated with filgotinib achieved significantly greater improvements compared to those who took a placebo. The results came from the Phase 2 of the TORTUGA – a multi-center, randomized, double-blind, …
RegenxBio has good news

RegenxBio has good news

We reiterate that undeniably outstanding news about gene therapy is taking time to penetrate investors’ ears. They are still falling victim to bad rules of thumb and critics’ magnifications of the negative impact of some stocks’ dilution when companies with superior programs try to finance through a public offering. The stocks’ punishments following financing is not a rule to apply to all firms, especially those …
PTC Therapeutics now with a wealthier pipeline

PTC Therapeutics now with a wealthier pipeline

Before we sell PTC Therapeutics (PTCT), after the stock had reached and surpassed our latest and highest 2018 target, the firm did the right thing that we expected was good enough to encourage investment in this firm.  The good thing is acquiring Agilis Biotherapeutics – a small firm that succeeded in creating innovative gene therapy programs for rare genetic disorders that affect the central nervous …
When all the prophets are taken by surprise

When all the prophets are taken by surprise

When the Goal is Reaching into the Future, Pessimists Have No Place on the Ship The revolution in the biotech sector has proven to be moving fast towards reaching goals that were impossible to imagine a couple of years ago that they could be attainable. This is not true only regarding lay investors, or desperate patients, but also regarding the most professional clinicians, researchers and …
Why Celyad’s stock gained $2.30 today

Why Celyad’s stock gained $2.30 today

Celyad (CYAD) is an immuno-oncology firm, which created CAR T CELL treatments for cancers, including  solid tumors. Celyad announced its consolidated financial results for the six-month period ending 30 June 2018. Celyad’s report is endorsed by Europe. Dr. Christian Homsy, Celyad’s CEO started by expressing the firm’s great enthusiasm towards the progress it has made in the first half of 2018, which include a significant advancement of …
Aerie’s successful new confirmatory study for Rhopressa® was a necessity

Aerie’s successful new confirmatory study for Rhopressa® was a necessity

Aerie Pharmaceuticals (AERI) announced results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of its glaucoma product Rhopressa® (netarsudil ophthalmic solution) 0.02% on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension. This study is the first performed on glaucoma patients to confirm that Rhopressa® lowers intraocular pressure (IOP) primarily through trabecular meshwork outflow facility.  In the trials, the enrolled patients …
Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron Pharmaceuticals (REGN) and bluebird bio, Inc. (BLUE) announced a collaboration to apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery of human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and …
A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

The Future is Starting Now Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main topic the Prohost Letter that we are working diligently working on posting at any time now. This is extremely important to know before the hype …
The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion recommending marketing authorization of Alnylam’s (ALNY) RNAi product Onpattro™ (patisiran). The product is designed to treat hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The CHMP opinion is based on conclusive positive results from APOLLO Phase 3 study on patients with hATTR amyloidosis. The results were published in The New England Journal …
Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis’ (NVS) financials results exceeded analysts’ expectations. The firm’s research institutions’ strategy, well-designed structure, plans for innovation and accurate execution led to a wealthy and competitive pipeline with more than 200 projects in clinical development. Novartis is flying into the future finding its way to more effective treatments and possible cures. As a matter of fact, Novartis is at the end of the road towards …