Category: News & Comments

What the Aimmune and Nestlé Health Science agreement tells us

What the Aimmune and Nestlé Health Science agreement tells us

Aimmune Therapeutics (AIMT) has news. A lot of it is from a successful phase 3 trial for its peanut allergy drug as well as other news that boosts our conviction that this product is, indeed, important and has a good chance for approval in the U.S. and overseas.   Aimmune is a biopharmaceutical company developing treatments for potentially life-threatening food allergies. The firm’s Characterized Oral …
Jazz Pharmaceuticals has good, not bad news

Jazz Pharmaceuticals has good, not bad news

In today’s news Jazz Pharmaceuticals (JAZZ) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for the approval of solriamfetol.  Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive daytime sleepiness in adult patients with narcolepsy, obstructive sleep apnea, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. The aim of the …
RegenxBio: Another licensing agreement providing additional validation of its NAV platform

RegenxBio: Another licensing agreement providing additional validation of its NAV platform

RegenxBio (RGNX) has granted Abeona Therapeutics (ABEO) an exclusive worldwide license to its NAV AAV9 viral vector (subject to certain non-exclusive rights previously granted for MPS IIIA) for the treatment of four diseases: Sanfilippo syndrome type A (MPS IIIA) and type B (MPS IIIB), Infantile Batten Disease, also known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease) and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis type 3 …
About Illumina’s acquisition

About Illumina’s acquisition

Illumina (ILMN) and Pacific Biosciences (PACB) announced they have signed an agreement for Illumina to acquire Pacific Biosciences at a price of $8.00 per Pacific Biosciences share, in an all-cash transaction. The agreement has already been approved by the board of directors of both firms. The acquisition complements Illumina’s sequencing solutions with accurate long-read sequencing capabilities to answer complex genomic questions. Why the acquisition? While Illumina’s accurate and economic short-read sequencing platforms address the …
Observing Array Biopharma

Observing Array Biopharma

A number of biotech or biopharmaceutical companies have succeeded in the past couple of years in changing their statuses from clinical stage to revenues-generating firms. A number of these firms reside in the Prohost Portfolio, picked up before they generated revenues from their newly approved products’ sales. We are following up on these firms’ news as they come out of their new journeys towards marketing …
Alleviating osteoarthritis pain without the need for opioid drugs

Alleviating osteoarthritis pain without the need for opioid drugs

Tanezumab, an investigational humanized monoclonal antibody developed by Pfizer (PFE) and Eli Lilly (LLY), met all three co-primary endpoints in patients with osteoarthritis (OA). The 16-week Phase 3 study, which evaluated subcutaneous administration of tanezumab in patients with OA, demonstrated that the patients who received two doses of tanezumab, separated by eight weeks, experienced a statistically significant improvement in pain, physical function and patients’ overall assessment …
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 …