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ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir DTG 50mg film-coated tablet (FCT) in paediatric HIV patients

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ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir DTG 50mg film-coated tablet (FCT) in paediatric HIV patients

Dec 13, 2019: ViiV Healthcare announced that it has made regulatory submissions to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in quest of approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir (DTG), as well as a simplified dosing regimen in order to optimise the use of the existing DTG 50mg film-coated tablet (FCT) in paediatric HIV patients.

Paediatric HIV remains a global issue, with children suspiciously affected by the HIV epidemic. Latest statistics show that there are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first five years of life.

 Major obstacles keep on for the children, such as the availability of HIV testing, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals.

These submissions to the EMA and FDA are based on the data from ongoing P10934 and ODYSSEY (PENTA20) studies.

Data to hold the submissions was generated from ViiV Healthcare’s collaborations by means of the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY.

In order to maintain broad and more affordable access to optimised antiretroviral (ARV) formulations, ViiV Healthcare enables generic companies to manufacture and sell generic versions of paediatric DTG royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan African countries and also in some upper-middle-income countries through its voluntary licensing policy.

https://viivhealthcare.com/en-gb/media/press-releases/2019/december/viiv-healthcare-files-submissions-to-the-fda-and-ema-for-the-fir/

FDA Approved Amarin’s Vascepa For the cardiovascular problems, Shares Up 5%

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FDA Approved Amarin’s Vascepa For the cardiovascular problems, Shares Up 5%

Dec 13, 2019: Shares of Amarin Corp. jumped 5% on the extended trading session after the company said, it received approval to market its drug Vascepa for. U.S. Food and Drug Administration has approved Amarin’s new indication and label expansion for Vascepa capsules.

Now, it is the first and only drug approved by the FDA as an addition to maximally tolerated statin therapy in order to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with the elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for the cardiovascular disease. https://fda.einnews.com/article/504835618?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D

Trastuzumab deruxtecan (DS-8201), accomplished the tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

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Trastuzumab deruxtecan (DS-8201), accomplished the tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

Dec 11, 2019: AstraZeneca and Daiichi Sankyo presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody-drug conjugate (ADC) and potential new medicine for the patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. The primary endpoint of objective response rate (ORR) which was confirmed by independent central review found to be 60.9% with trastuzumab deruxtecan monotherapy (5.4mg/kg). About one out of five breast cancers are HER2-positive. Despite recent improvements and approvals of new medicines and there remains significant unmet needs for patients with advanced HER2-positive metastatic breast cancer. This disease remains inoperable with patients eventually progressing after currently available treatments.

HER2 (tyrosine kinase receptor growth-promoting protein) which is found on the surface of some cancer cells that are associated with aggressive disease and poor prognosis in breast cancer patients. https://www.astrazeneca.com/media-centre/press-releases/2019/trastuzumab-deruxtecan-achieved-a-tumour-response-rate-of-60-in-pivotal-phase-ii-her2-positive-metastatic-breast-cancer-trial-11122019.html

First Ever Randomized Phase 3 Clinical Trial (LIBRETTO-431) for the Treatment of Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

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First Ever Randomized Phase 3 Clinical Trial (LIBRETTO-431) for the Treatment of Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

Dec. 11, 2019: Eli Lilly and Company today announced the opening of the LIBRETTO-431 clinical trial for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients.

Trial participants will be randomized in order to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC.

“This is an significant milestone in order to further demonstrate the benefit of selpercatinib and also the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care”.

Selpercatinib (LOXO-292), is a highly selective and potent, oral investigational new medicine in the clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase.  https://investor.lilly.com/news-releases/news-release-details/lilly-opens-first-ever-randomized-phase-3-clinical-trial

EVENITY® (romosozumab) approved by European Commission (EC) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture

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EVENITY® (romosozumab) approved by European Commission (EC) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture

Dec. 11, 2019: Amgen and UCB announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

EVENITY is a novel bone-builder with a dual effect that can increase bone formation and to a slighter extent reduces bone resorption (or bone loss).

EVENITY is an important step in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months.

The approval received in October 2019 follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The first launches of EVENITY in the European Economic Area (EEA) are planned for the first half of 2020.

EVENITY (romosozumab) is a bone-forming monoclonal antibody, designed to work by inhibiting the activity of sclerostin, which concurrently results in increased bone formation and to a lesser extent decreased bone resorption. https://www.amgen.com/media/news-releases/2019/12/european-commission-approves-evenity-romosozumab-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture/

U.S. FDA OKs for Pfizer’s XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

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U.S. FDA OKs for Pfizer’s XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

Dec 12, 2019: U.S. Food and Drug Administration (FDA) has approved Pfizer’s  XELJANZ ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers.

Ulcerative colitis is a chronic inflammatory disease  that can significantly affect a patient’s quality of life and be emotionally oppressive due to symptoms, flares and complications.

XELJANZ/XELJANZ XR, indicated for the treatment of adult patients suffering with moderate to severe active UC, who have had an inadequate response or who are intolerant to TNF blockers.

XELJANZ ® (tofacitinib) is approved for adult patients with three indications: moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure and moderate to severe  active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure. https://www.oaoa.com/news/business/article_0f2d0780-5ba9-5766-b3ff-7a4b0317b5bd.html

The U.S. Food and Drug Administration granted accelerated approval for the first targeted treatment, Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy

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The U.S. Food and Drug Administration granted accelerated approval for the first targeted treatment, Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy

December 12, 2019: The U.S. Food and Drug Administration granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) for the patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping.

It is estimated that approximately 8 per cent of patients with DMD have this mutation. This is the new medical treatments for serious neurological disorders for the treatments for rare diseases.

DMD is a rare genetic disorder that is characterized by progressive muscle deterioration and weakness. It is caused by the absence of dystrophin, a protein that helps keep muscle cells intact.

Patients  with DMD progressively lose the ability to perform activities separately and often require a wheelchair by their early teens.

Vyondys 53 approved under the accelerated approval pathway that provides for the approval of drugs, treat serious or life-threatening diseases and generally offer a meaningful advantage over existing treatments. https://fda.einnews.com/pr_news/504734147/fda-grants-accelerated-approval-to-first-targeted-treatment-for-rare-duchenne-muscular-dystrophy-mutation

Innovative diabetes management solution (Accu-Chek SugarView app) announced by Roche

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Innovative diabetes management solution (Accu-Chek SugarView app) announced by Roche

Dec 10, 2019: Roche announced that it has obtained the CE Mark for its Accu-Chek SugarView app, innovative diabetes management solution in Europe and further countries around the world requiring the CE Mark.

Officially classified as in-vitro diagnostics (IVD) software, this app will be made extensively accessible by Roche first for certain smartphone models via the Google Play Store and thus enabling broader access to therapy relevant information for the non-insulin dependent people with type 2 diabetes or pre-diabetes.

This App determines the blood glucose range using the Accu-Chek Active test strip and two phot os taken off the strip with a smartphone camera and follow step-by-step guide leads the user through the testing process.

A dedicated algorithm on the blood glucose result on the test strip to one of the categories varing from “low” to “very high”.

Also, based on the testing result, it can combine the blood glucose range with basic information on how to take action, such as exercise or eating. https://www.roche.com/media/releases/med-cor-2019-12-10.htm

Daiichi Sankyo Initiates Pivotal Phase 2 Trial in Japan with Valemetostat to treat patients with adult T-cell leukemia-lymphoma

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Daiichi Sankyo Initiates Pivotal Phase 2 Trial in Japan with Valemetostat to treat patients with adult T-cell leukemia-lymphoma

Dec 10, 2019: Daiichi Sankyo Company, Limited announced  that the first patient has been dosed in a pivotal phase 2 study in Japan evaluating  valemetostat (DS-3201), an investigational EZH1/2 dual inhibitor, in patients with relapsed/refractory adult T-cell leukemia-lymphoma (ATL). (non-Hodgkin’s lymphoma).

Patients often face a difficult prognosis, especially for relapsed disease while treatment with ATL. Valemetostat is a novel targeted therapy that has demonstrated initial potential in several types of NHL including ATL, which represents one of the greatest areas of need among lymphoma patients, mainly in Japan.

The pivotal, open-label, multi-center, single-arm phase 2 study will evaluate efficacy and safety of valemetostat as monotherapy in patients with relapsed/refractory ATL.

It is an investigational and potential first-in-class EZH1/2 dual inhibitor that targets epigenetic regulation by inhibiting both the EZH1 (enhancer of zeste homolog 1) and EZH2 (enhancer of zeste homolog 2) enzymes, which act through histone methylation to regulate gene expression.  https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/007080.html

Healx collaborates with Boehringer Ingelheim to discover new treatment approaches for rare neurological diseases

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Healx collaborates with Boehringer Ingelheim to discover new treatment approaches for rare neurological diseases

Dec 09, 2019: Healx the AI-powered biotechnology company, announces that it has entered into an agreement with Boehringer Ingelheim to identify indications related to rare neurological diseases.

This project will influence Healx’s comprehensive AI-based drug discovery platform, Healnet and expertise in rare diseases and pharmacology, in order to identify potential new indications for assets from Boehringer Ingelheim’s pipeline.

Healx will use their data analysis and technological capabilities in order to support Boehringer Ingelheim’s efforts in prioritising selected indications for advance research.

Healx has remarkable experience in the area of numerous rare neurological disorders, such as fragile X syndrome as well as Pitt-Hopkins syndrome.

Healnet successfully used to investigate, predict and progress new treatment options for the ultra-rare neuro developmental disorder Pitt-Hopkins syndrome.

The project with Boehringer Ingelheim adds to Healx’s portfolio of agreements and collaborations with the Pharmaceutical and Biotechnology companies, academia, Clinical Institutes and rare disease charities while its foundation in 2014. https://healx.io/news/healx-joins-forces-with-boehringer-ingelheim-to-discover-new-treatment-approaches-for-rare-neurological-diseases/

GenesisCare launched UK’s first MRIdian radiotherapy machine: a new radiotherapy treatment to reduce treatment time

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GenesisCare launched UK’s first MRIdian radiotherapy machine: a new radiotherapy treatment to reduce treatment time

Dec. 10, 2019: Cancer patients can begin from today potential access to the UK’s first MRIdian machine, a new radiotherapy treatment to reduce treatment time and cause fewer side effects.

This technology combines magnetic resonance imaging (MRI) techniques with high precision radiotherapy beams that allow clinicians to adapt treatment to take account of tumour movement in real time, which reduces the amount of healthy tissue hit by radiotherapy, thereby lowering the risk of side effects.

Although, machine enables higher doses to certain tumours than would be possible using conventional radiotherapy treatment time can be shortened.

the MRIdian early stage prostate cancer patients typically require five treatments while with conventional radiotherapy, it require at least 20 treatments.                         https://www.icr.ac.uk/news-archive/first-patient-in-the-uk-receives-pioneering-new-form-of-radiotherapy

FDA OKs to Navigen for its IND Application to Initiate First-in-Human Studies for CPT31, a Novel, D-peptide HIV Entry Inhibitor

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FDA OKs to Navigen for its IND Application to Initiate First-in-Human Studies for CPT31, a Novel, D-peptide HIV Entry Inhibitor

Dec. 10, 2019: Navigen, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug application (“IND”) for the initiation of a Phase I study in healthy volunteers in order to test the safety, tolerability, and pharmacokinetics of its D-Peptide HIV entry inhibitor, CPT31.

To enter human cells and replicate, HIV must fuse its membrane with that of a host cell, then CPT31 prevents membrane fusion and consequently blocks HIV from infecting cells.  

The Results from the non-human primate studies conducted by Dr. Malcolm Martin’s group at the National Institute of Allergy and Infectious Diseases (NIAID), confirmed that CPT31 may be effective for both HIV prevention and treatment. 

According to Dr. Michael Kay, professor of biochemistry at the University of Utah and an inventor of CPT31. In pre-clinical testing, CPT31 demonstrated a well-built barrier to resistance resulting from an extremely high binding affinity to a highly conserved region of HIV.

Also, it is active in vitro against all major clades of HIV and suggesting that the  CPT31 may be a good alternative for many HIV patients. Moreover, there are plans to formulate CPT31 as a long-acting injectable. 

Recent surveys of HIV patients and clinicians reveal there is a first choice among both groups for long-acting formulations, including injections, over daily oral dosing.  https://fda.einnews.com/pr_news/504488459/navigen-announces-fda-clearance-of-its-ind-application-to-initiate-first-in-human-studies-for-cpt31-a-novel-d-peptide-hiv-entry-inhibitor

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