Mezzion Pharma Co, a well-known biotech company announced the positive results from phase 3 FUEL trial. It was designed to access the safety and efficacy of udenafil for treating certain adolescents with congenital single ventricle heart disease (SVHD).

Novartis announced the global phase III PARAGON-HF study results; examining the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients. The trial merely missed statistical significance for its composite primary endpoint for death reduction due to cardiovascular (CV) issues and total heart failure hospitalizations. Safety and tolerability were constant with earlier reported sacubitril/valsartan data.

A novel experimental drug is demonstrating encouraging results through its final phase of human clinical trials. Filgotinib is a JAK inhibitor selectively targeting the JAK1 enzyme. It is chiefly being investigated for the rheumatoid arthritis treatment, but initial clinical trials have encouraged for treatment of ulcerative colitis and Crohn's disease.

New research suggested that a network of brain associated with experiencing pain could be a significant target for antidepressant medications. The Trial study, published in The Lancet Psychiatry, revealed that the use of serotonin and norepinephrine reuptake inhibitors (SNRIs) led to alterations in functional architecture of the pain network of brain.

The New Drugs and Clinical Trial Rules 2019 have been lauded by the regulatory experts. The new regulations have laid the pathway to patient-science-centric human studies bringing in clarity, transparency, time predictability and harmonized it as per the ICH guidelines.

Phase Ⅲ trials will be initiated by Janssen Vaccines & Prevention, a Johnson & Johnson unit, along with the partners to evaluate an investigational preventive vaccine for HIV-1 infection.

For the early identification of gastric cancer, the scientists at Okayama University have developed an artificial intelligence (AI)-based endoscopic diagnosis system.

Novartis, Amgen and Banner Alzheimer’s Institute has announced that they are stopping two pivotal Phase Ⅱ/Ⅲ clinical trials in the Alzheimer’s Prevention Initiative Generation Program.

The Scion announced that results from a randomized, controlled trial of Parkinson’s disease (PD) subjects who used company’s non-invasive neuromodulation device TNM™ has been published.

The largest trial of nicotinamide riboside was published validating the efficacy and safety of Chroma Dex’s proprietary form of NR, Niagen. This is first clinical trial study measuring both kinetics and dose-dependent effects of chronic Niagen supplementation.

Pierre Fabre revealed the data of phase 3 trial known as BEACON. This study used encorfenib (BRAF inhibitor), binimetinib (MEK inhibitor) and cetuximab (anti-EGFR antibody) for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC), in subjects who have already received one or two line of therapy as per the inclusion criteria of the study protocol.

The combination of Lenalidomide and Rituximab is successful and administered to treat patients with relapsed or refractory follicular lymphoma. Obinutuzumab has demonstrated to increase antibody-dependent cellular cytotoxicity, phagocytosis, and B-cell direct killing better than rituximab. The objective of the study was to determine the activity and safety of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma.

An announcement was made from Boston Biomedical Inc., regarding CanStemIIIP study for accessing the safety and efficacy of an investigational agent. Napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine study in patients with metastatic pancreatic ductal adenocarcinoma will be stopped due to futility.

Reports emerged that Genentech, a Roche company reached primary endpoint of its Phase III clinical trial called MINISTONE-2, demonstrating that Xofluza (balaxavir marboxil) was comparable to Tamiflu (oseltamivir). Tamiflu has been prevalent in the market from last two decades. Xofluza is broadly approved in the markets of Japan for people older than 12 years. The objective of the company behind this trial is to market Xofluza as an alternative to Tamiflu.

The top European regulatory bodies like European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) released a letter to clinical trial sponsors last month. This step was taken to remind them to publish the results of all clinical trials conducted in the EU in EudraCT database.

Teva Pharmaceutical Industries Ltd. announced the FOCUS (Phase IIIb Study of Fremanezumab) exploratory endpoints results at the 5th Congress of the European Academy of Neurology.

The leading therapeutic company known as Alnylum Pharmaceuticals, Inc., announced the marketing authorization application submission to European Medicines Agency for Givosiran. Givosirn is an investigational RNAi therapeutic drug which targets Aminolevulinic Acid Synthase 1 (ALAS1) in development for acute hepatic porphyria treatment. Givosiran is administered subcutaneously.

When the pulmonary arteries become narrower or obstructed, then the condition is known as Pulmonary Hypertension. Due to this condition, right ventricle of the heart is in lot of pressure to work hardly to pump blood leading to weakening and organ enlargement. When it is present in newborn babies, it is called as Persistent Pulmonary Hypertension of Newborn or neonatal pulmonary hypertension.

Reports emerged from the large-scale European trial showed that the frozen embryo transfers fail to boost in vitro fertilization (IVF) process over the fresh transfers.

In May 2019, the ICH E8(R1) draft guideline on General Considerations for Clinical Trials reached Step 2b of the ICH process and entered the period of public consultation. ICH E8’s modernization is the first step towards the GCP Renovation initiated in 2017.

The agency, Health Canada, issued guidance to study the off-label uses of different drugs in clinical trials.

Many diseases are caused due to aging and targeting that process can be handy in treating those diseases and improving quality of daily life. EPFL researcher’s have reported that a pomegranate derived compound shows promising signs towards achieving this goal. In human clinical trials, the fruit-derived compound showed that it can slow mitochondrial aging in elderly patients without any side effects.

The correlation between BioCell Collagen® effects with associated changes to skin aging were represented by BioCell Technology during the clinical trial. 128-female subjects were studied for 12 weeks with placebo to some and twice daily 500mg BioCell Collagen® orally to some. Results of placebo and BioCell Collagen® were compared in 113 participants completing the study.

Rheumatology and immune-dermatology leader, Novartis announced new clinical data from MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA).

TrialAssure’s new online portal “TrialResults.com” comes as a boon when the industry faces mounting pressure to be more transparent than ever. It enables sponsors to publicly share clinical trial summaries in simple language and provide a platform for participants to access summaries in their native language.

In recently issued human clinical study, Arjuna Natural Ltd.’s patented, high-potency curcumin formulation BCM-95 (Curcugreen) demonstrated the possibilities for efficiently managing Osteoarthritis symptoms. Pain is the key symptom of Osteoarthritis in which individuals seek medical care.

Draft guidance has been released by the USFDA regarding the ways to enhance the participation of population diversity in clinical trials. Sponsors must consider the USFDA recommendations while designing and conducting clinical trials in order to eliminate avoidable exclusions and to get effective safety data.

CLL trial data for Venclyxto (venetoclax) plus Gazyvaro (obinutuzumab) is shared by Roche and AbbVie in the New England Journal of Medicine. The trial was done in patients who had untreated chronic lymphocytic leukemia.

Positive results pertaining to RC48 Phase II clinical trials were announced by RemeGen Ltd. The company had evaluated a potential new medicine for patients who have HER2-positive metastatic or unresectable urothelial cancer. These patients had undergone chemotherapy treatment earlier and had visceral metastasis.

Turkish Ministry of Health has given approval to Vanessa Research for conducting Phase II Clinical Trial of Shylicine. It is the first-ever investigational oral solution for the treatment of lethal and rare microvillus inclusion disorder. The efficacy and safety of Shylicine will be studied during twelve-weeks of Phase II clinical trials.

An open-label Phase III study for FIGHT-302 using pemigatinib (INCB54828) is announced by Incyte. It is a selective fibroblast growth factor receptor inhibitor in comparison to cisplatin with gemcitabine chemotherapy, which is the current treatment for patients with surgically unresectable or metastatic cholangiocarcinoma.

Novartis is developing the new combination for asthma treatment which will be given once daily. It involves the combination of indacaterol acetate /glycopyrronium bromide, which imparts bronchodilation effect along with momentasone furoate through dose controlling Breezhaler.

A novel drug to treat Alzheimer’s disorder has effectively passed the first phase of clinical trials. It will be now tested on patients through Priavoid during Phase two clinical trials.

The approval process duration of effectively developed cancer therapies in other countries such as the United States has been reduced in China after the recent regulatory changes. This can help in bringing the lifesaving cancer treatment to patients at a much faster rate. Memorial Sloan Kettering (MSK) has collaborated with the Chinese Thoracic Oncology Group (CTONG) followed by this regulation. CTONG has more than 20 cancer centers in China, where subjects from China and the United States can enroll themselves for clinical trials. The primary goal for this collaboration is to conduct clinical trials for lung cancer, which is the major cause of death in both countries. Telemedicine is the other distinctive aspect of this collaboration. To gain policy advisory support, MSK and CTONG have taken the assistance from leaders of US FDA, China National Medical Products Administration, Australian Lung Cancer Trials Group and New York based Asia Society Policy Institute.

Biogen and Eisai were running a clinical trial for Alzheimer’s disorder. They lost billion dollars after the failure of this trial. Mind and memory of an individual in Alzheimer gets deteriorated to an extent where they are not able to perform their function. Four drugs related to Alzheimer’s disorder were approved by FDA. However, all of them were just helping systems, none of them is slowing or reversing the disease.

Newer challenges related with recruitment planning and study design will be set to the industries involved in clinical trials with the expansion of inclusion policy.

A non-inferiority phase 3 trials has been done in 424 subjects having rifampin-resistant tuberculosis and are susceptible to aminoglycosides and fluoroquinolones. Random selection of subjects was done to impart either a long regimen of 20 months or short regimen of 9-11 months in line with WHO guidelines. It was concluded from the trial that short regimen was alike the long regimen in safety terms.

The study at University of Glasgow was initiated with the purpose to match more effective and targeted treatment with patients. University of Glasgow’s clinical trials project along with a research program by Precision-Panc had initiated the trial to bring a patient-specific pancreatic cancer treatment approach. Cancer Research UK has given the major funding for the project. The project has recently recruited 100th patient for their study which is a remarkable success.

A novel Bi-specific antibody, APVO210 developed by Aptevo Therapeutics has been developed to treat Inflammatory and Autoimmune disorders. As per the officials of the firm, the Phase 1 clinical trials for the bi-specific antibody have been initiated. The major aim of the biotechnology company, Aptevo Therapeutics Inc. is to develop novel hematology, autoimmune and oncology therapeutics.

There will be guideline update by FDA regarding how to conduct trails by clinical investigators. The update will be done to in line the approval standards with updated science and technology. As per the FDA official, they will also update the review process at each stage of innovative products.

The number of common cancer types is reducing and an increase in uncommon cancer type is observed in the study conducted at National Cancer Center Hospital, Japan.

Macrogenics, Inc. is a biopharmaceutical company at the clinical stage, it is targeting for discovering and developing a monoclonal antibody-based therapeutic system for cancer treatment. This organization made an announcement on December 6th stipulating that they have received a letter from USFDA in which they have put some kind of restriction on Mono-therapy study of MGD009 Phase 1, which is a B7-H3 x CD3 bispecific DART ^® molecule along with MGD009 and MGA012 (anti-PD-1) combination study.

A draft guidance to conduct first in human (FIH) clinical trials for cancer drugs has been released by USFDA which will help sponsors in designing clinical trials to speed up the development of cancer drugs through multiple expansion cohort study designs.

A Phase 2 safety and efficacy study (B5161002) and an open label extension study (B5161004) evaluating Domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy has been terminated by Pfizer. Duchenne muscular dystrophy (DMD) is a rare, serious, debilitating childhood genetic disease characterized by progressive muscle degeneration and weakness and significantly shortened life expectancy.

USFDA has launched a pilot program to support the use of complex innovative trial designs in the development of drugs and biologics. The launch of pilot program was decided after discussion held during a public meeting held in March although certain concerns were raised by stakeholders such as Genetech and Biogen regarding flexibility and scope of such trials.

Orphan Drug Designation has been granted to ASLAN003 which is a product of ASLAN Pharmaceuticals by USFDA for the treatment of acute myeloid leukemia (AML). ASLAN003 is an orally active potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which depletes the intracellular pool of pyrimidines thereby lowering the levels of adenosine triphosphate and induction of the tumor suppressor p53 which at high levels can trigger apoptosis (programmed cell death).

TrialAssure is a global clinical trial disclosure and transparency reporting company which helps clients to meet regulatory compliance goals through a flexible, scalable and streamlined platform that gets regularly updated with respect to ever-changing clinical trial disclosure requirements. Otsuka Pharmaceutical Development and commercialization, Inc. is a global healthcare company based in Tokyo, Japan.