Clinical Research Newsletter


USFDA holds back plasma therapy for treatment of COVID- 19


The USFDA disapproves plasma therapy as an emergent weapon for treating COVID -19 as reported on 19 August, 2020. However, currently the plasma therapy is being tested globally


The US-based firm, Advanced Penetration Technology, LLC. found a USFDA approved OTC ointment useful in treating viral infections including Covid-19


FDA registered a non- prescription over the counter ointment possessing virucidal activity has the potential to kill and treat viral infections including SARS-CoV-2, the virus respon


Bharat Biotech all set to conduct the Phase I and II clinical trials for its COVID-19 vaccine ‘Covaxin’, receives green signal from CDSCO


The Drug Controller General of India gave approval to Bharat Biotech to test its first Covid-19 vaccine via the skin through intradermal delivery.  The company would now conduct


ICMR collaborates with Serum Institute of India to develop a promising experimental corona virus vaccine to combat COVID-19 scenario


Clinical trials are the research-based studies conducted on human volunteers to evaluate a medical and therapeutical intervention by determining its effects in human health outc


Marinomed Biotech obtains promising outcomes in preclinical studies for further areas of application with its Marinosolv technology platform


A globally active biopharmaceutical company known as Marinomed Biotech AG, located in Vienna, has obtained promising outcomes in preclinical studies for further areas of ap


Improving of resuscitation outcomes in emergency departments by First-ever analysis of video recorded CPR


Less than 8% of people who experience from cardiac arrest outside of the hospital survive the incident, as per the American Heart Association.

To enhance


Immunosuppressive therapy does not enhance risk of vulvar or vaginal cancer in women with IBD


In a novel retrospective study, researchers discovered that the utilization of immunosuppressive therapy does not enhance the occurrence or recurrence of vulvar or vaginal


Exposure to Air pollution takes a heavy toll on gut bacteria, touting risk of chronic illnesses


Breathing impure air takes a huge toll on gut bacteria, enhancing risk of diabetes, obesity, gastrointestinal disorders and other chronic illnesses, new University of Color


Effective Treatment Option of Gabapentin for Alcohol Utilization Disorder, as per JAMA


About 30 million people in the U.S. attain criteria for alcohol use disorder, yet less than 1 million get medication that may be useful.

A randomized clin


Being Overweight in Middle Age enhances the risk of Prostate Cancer


Advanced prostate cancer etiology is understood very poorly. Few have evaluated the role of early adulthood BMI and adult BMI changes on risk of advanced forms of prostate


Artificial Intelligence may enahnce Management of Sleep Disorders, as per AASM


The potential utilization of Artificial Intelligence in the field of sleep medicine, leading to advance diagnosis and treatment is administered by a position statement from


EC approves marketing authorization of AbbVie shortening Maviret treatment duration to 8 weeks for treatment of naïve chronic HCV patients with GT 3 infection


A research-based global biopharmaceutical company, AbbVie, declared that the European Commission has granted a change to the marketing authorization for Maviret (glecaprevi


Phase 3 clinical trial of AstraZeneca for DANUBE for Imfinzi and tremelimumab for treatment of bladder cancer does not meets primary end point


AstraZeneca has Declared that the phase 3 DANUBE clinical trial for Imfinzi plus tremelimumab and Imfinzi (durvalumab) is unblockable, Stage IV (metastatic) bladder cancer


New manganese-zinc ferrite nanoparticles can potentially be utilized in cancer treatment


A team of Russian scientists has made chemically manganese-zinc ferrite nanoparticles that can potentially be utilized in cancer treatment. Due to their advance and unique


Dynacure initiates patient dosage in phase I/II study of DYN101 for treatment of CNM and myotubular


A clinical stage drug development company known as Dynacure is committed on enhancing the lives of patients with rare and orphan disorders declared that the first patient h


Phenelzine May have regeneration to combat Recurrent Prostate Cancer


Monoamine oxidase A (MAOA) stimulates prostate cancer growth and metastasis in pre-clinical models. They evaluated the impacts of phenelzine (a monoamine oxidase inhibitor)


Electrical Stimulation aids in Treatment of Chronic Constipation in Females, as per Clinical Trial


Management of chronic constipation is frustrating as patients frequently remain dissatisfied with laxative treatments. Chronic constipation impacts about 15 percent of the


EMA furnishes positive opinion for acelarin of NuCana in combination with cisplatin for treatment of biliary tract cancer


A clinical-stage biopharmaceutical company known as NuCana declared that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has furn


1st patient treatment in phase I trial initiated by Actinium Pharmaceuticals of Actimab-A CLAG-M to treat AML


A clinical-stage biopharmaceutical company, Actinium Pharmaceuticals, declared that the 1st patient has initiated treatment in the third and final cohort of the Actimab-A C


Study offers new proof about optimal way for treatment of BRCA carriers with breast cancer


The BRCA gene family which is generally known as the breast cancer genes acts in the repairing of damaged DNA. Inherited mutations in the genes BRCA1 or BRCA2 elevate the r


Newly recognized genetic signatures in common pediatric cancer make way for precision medicine


Nemours Children's Health System researchers used Next Generation Sequencing (NGS) to more accurate identification of genomic characteristics of leukemias in children, the


During pregnancy, stress can cause lifetime of immune system deficiencies


Mice under exposure to stress in the womb and soon after birth can anticipate a lifetime of immune system deficiencies that interferes the ability to ward off infections an


As per the Study, Distraction by technology during mealtimes may lower food intake


Distraction by technology during mealtimes may lower the amount of food a person eats, nutrition scientists recommended in a new study.

When 119 young adu


Liver fibrosis linked with one type of heart failure, despite of HIV or hepatitis C status


While there is a linkage between heart failure and liver fibrosis, the mechanisms for this linkage are presently unclear but may be of particular significance for people li


Researchers create new coating to lower pain and risk of infection for users of catheter


Researchers from the School of Pharmacy at Queen’s University Belfast (QUB) have created a new antimicrobial coating which can be used to urinary catheters and other medic


Researchers discover automated CT biomarkers which predict precise CV events and mortality


Researchers at the National Institutes of Health (NIH) and the University of Wisconsin have showed that using artificial intelligence (AI) to study CT scans can make more accura


Capability to deliver high-fidelity images by Seismic imaging of the human brain


UCL and the Imperial College London researchers stated that their proof-of-concept study, advertised today in npj Digital Medicine, makes the way for the development of hig


Binaural On-the-spot beats and mindfulness lowers negative impacts of mental fatigue


A psychobiological state known as mental fatigue caused due to extended periods of demanding cognitive activity which leads to slower reaction times and attention deficienc


Tramadol consumption associated to enhanced risk of Hip Fracture`

Tramadol has been suggested as one of the first‐line or second‐line therapies for patients with chronic non-cancer pain by several professional organizations. These involve fibromyal


Innovent Biologics starts patient recruitment in pivotal trial of Pemigatinib for treatment of advanced cholangiocarcinoma in Chinaq


A world-class biopharmaceutical company known as Innovent Biologics Inc, that develops and commercializes high quality medicines for the treatment of autoimmune, cancer, metabolic an


PureTech commences clinical trial of LYT-100 for treatment of lymphoedema and fibrotic conditions


A clinical stage biotherapeutics company, PureTech Health, focussed on developing, discovering and commercializing highly distinguished medicines for devastating diseases, declared t


Novel NGS technique provides quick, precise diagnosis of sepsis


In the Journal of Molecular Diagnostics a report appeared by Elsevier detailing a new technique that uses real-time next-generation sequencing (NGS) to analyze tiny amounts of microb


MRI-Targeted Biopsy enhances Diagnosis of Aggressive Prostate Cancer


Researchers have discovered that MRI-targeted biopsy can greatly enhance prostate cancer diagnosis and lower the chances of patients being either over treated or undertreat


Consumption of antibiotics during Infancy may enhance Childhood Obesity Risk


Antibiotic consumption during the second trimester and infancy could enhance the risk of childhood overweight or obesity, a current meta-analysis advertised in the Journal


New insight offered by study into neurofibromin-deficient ER+ breast cancer


An international team of researchers headed by scientists at Baylor College of Medicine has new information into the function of neurofibromin, a tumor suppressor geenrated


Researchers Develop minimum Invasive, Cost-Effective Blood Test for Detection of Deposits of Alzheimer Proteins in Brain


A minimal invasive as well as cost-effective blood test has been created by the researches from the National Institute of Ageing here which can diagnose Alzheimer's disease


Light Therapy may aid in Elevating Mood in People with A Concussion


Researchers have discovered that exposure of people with mild traumatic brain injury to early morning blue light therapy may lower depression and other concussion symptoms.


New Drug May effectively Reduce lethal Brain Swelling after Stroke


Stroke is typically caused due to blood clot in the brain and can result in death within minutes. In the UK alone, more than 100,000 strokes occur annually, on an average o


Hyper somnolence among Elderly May enhance Risk for Cancer, Diabetes and High BP


Hyper somnolence is described as excessive daytime sleepiness even after having seven or more hours of sleep. It can be deteriorating for some people, impacting the way tha


Phase III study of AbbVie for Venclexta in combo with low-dose cytarabine for treatment of acute myeloid leukemia fails to reach primary endpoint


A research-based global biopharmaceutical company known as AbbVie has declared the VIALE-C (M16-043) trial of Venclexta (venetoclax) in combination with low-dose cytarabine


IO Biotech declares positive results from phase II trial of lead cancer therapeutic vaccine, IO102


A clinical-stage biopharmaceutical company known as IO Biotech is developing novel, immune modulating anti-cancer therapies grounded on its proprietary T-win technology, de


Pre-hospital Treatment in Mobile Units lowers the Disability in Stroke Patients


Mobile stroke units well-equipped with CT for prehospital thrombolysis not only lowers the time of treatment, but had higher rates of thrombolysis and decreased risk for di


Intracranial Stents Safely lowers the Recurrence Risk of Ischemic Stroke as per the WOVEN Trial


Intracranial stents safely lowers the risk of recurrence is the observation of WOVEN trial which is one of the largest on-label, intracranial stenting trial to-date with lo


Tele-monitoring along with phone counseling enhances blood pressure control among minority stroke survivors


Inserting phone-based lifestyle counseling to home blood pressure tele-monitoring is an impactful strategy to enhance long-term blood pressure control among minority stroke


2 out of 3 young mothers suffers from mental health problems, as demonstrated in a study


New research from McMaster Hospital of Children demonstrates that 2 out of 3 young mothers have at least one mental associated health problem.



Advancement in surgical care for patients suffering from pancreatic cancer


Priorly this year, researchers and doctors celebrated the news that the 5-year survival rate for pancreatic cancer had surpassed into double digits for the first time up fr


Addendum ICH E9 accepted


The ICH E9(R1) Addendum to describing the proper Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process. The topic was sponsored by the ICH


Advice by FDA for financers of Adaptive Design Clinical Trials


The FDA advertised a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics. The document offers guidance to sponsors on the appropriate usage of adaptive


NIH study demonstrates maternal obesity associated to ADHD and behavioral problems in children


Maternal obesity may enhance the risk of a child for attention-deficit hyperactivity disorder (ADHD), as per the analysis by researchers from Human Development (NICHD), par


Prevention of Postanesthetic Shivering without Severe Side Effects using Ketamine


Postanesthetic shivering without severe side effects can be prevented by using ketamine, as per the recent study in the journal BMC Anesthesiology. The study further discov


Symptomatic or Radiographic Knee OA elevates Risk of Mortality


People with radiographic or symptomatic knee osteoarthritis (OA) are at elevated risk of all‐cause mortality, as per the recent study advertised in the journal Arthritis


Vitamin E impactful, Safe Treatment for NASH in HIV Patients


HIV-infected patients are at enhanced risk of non-alcoholic steatohepatitis (NASH). Vitamin E is suggested for the treatment of NASH in the general population. However, its


ICU Patients benefitted by Vitamin C, lowers Duration of Mechanical Ventilation


Critically ill patients may benefit from the uptake of vitamin C, a current meta-analysis in the Journal of Intensive Care has indicated. As per the study, vitamin C shorte


Air Pollution by Emissions from Automobile associated to Neonatal Heart Attack


Myocardial infarction is a vital form of cardiovascular disease worldwide. Researchers at Yale University have discovered that even a few hours' exposures to ambient ultraf


As per Lancet, Early Administration of Dexamethasone impactful For ARDS Treatment


Early administration of dexamethasone could lower the span of mechanical ventilation and overall death in patients with established moderate-to-severe acute respiratory distress synd


Span of Antibiotic Treatment not linked with UTI Recurrence in Children


Persistent with antimicrobial stewardship efforts, a current study has discovered that the span of antibiotic treatment for uncomplexed urinary tract infection (UTI) is not


Few Drops of Blood May provide assistance in Diagnosis of Autism Spectrum Disorder


Throughout the United States few drops of blood are accumulated from every newborn which are then preserved on filter paper and analyzed for dozens of genetic and congenita


Early commencement Of Treatment in Schizophrenia May Not Slow down the Progression of Disease


Overall mental health initiates to decline in Individuals with schizophrenia once the onset of symptoms. This gradual fall often continues for many decades, regardless of w


Enhanced Estradiol Levels May result in Impotence as per the Study


Erectile dysfunction is a consistent inability to acquire an erection sufficient to allow satisfactory sexual intercourse and is on the elevation globally. It has a negativ


IDMA requests DCGI to continue with Rs15,000 registration fee for 83 FDCs granted prior to New Drugs & Clinical Trials Rules


The Indian Drug Manufacturers Association (IDMA) has requested the Drugs Controller General of India (DCGI) seeking registration fees of Rs15,000 to continue instead of Rs.


As per JAMA, Prophylactic Treatment of Migraine not impactful in Pediatric Age Group


Researchers from the University of Basel have come to a conclusion that in pediatric age group preventive pharmacological treatment of migraine is no more impactful than pl


Childbearing and Breastfeeding May Prevent Early Menopause


Early prevention of menopause can be done by childbearing and breastfeeding as per the finding of one of the largest studies. Description of the study has advertised in the


Researchers in Canada discovered traces of Vitamin C deficiency disease Scurvy


In a current study, researchers have discovered traces of a disease called as Scurvy in Canada. The deteriorating condition is remembered as a disease of pirates.


Kala Pharmaceuticals declares Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease


A biopharmaceutical company, Kala Pharmaceuticals, Inc., committed on the development and commercialization of therapeutics utilizing its proprietary AMPPLIFY™ mucus-


Novel Head-to-Head Phase III Data Show SKYRIZI™ (risankizumab) Superior to Cosentyx® (secukinumab) across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psorias


A research-based global biopharmaceutical company, AbbVie, today declared that SKYRIZI™ attained both primary and all ranked secondary endpoints, involving superiorit


Data Missing on demonstrates Failure of Research Culture


2 years ago the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) enacted a “final rule” clarifying how and when universities, comp


Anti-dementia Drug 'crisdesalazine' of GNT Pharma shows Efficacy in Phase 3 Clinical Study with Companion Dogs with Dementia


GNT Pharma has successfully done Phase 3 clinical trial for crisdesalazine, a novel drug to treat canine cognitive dysfunction syndrome or Alzheimer’s disease.



Phase 2 clinical study of respiratory drug to treat Parkinson’s disease unveils promising results


The Cure Parkinson’s Trust (CPT) is enthusiastic to declare the publication of the outcomes of a Phase 2 clinical trial examining ambroxol as a potential treatment to decrease


As per study, risk of colorectal cancer remains despite modern treatment for ulcerative colitis


Patients suffering from the inflammatory bowel disease ulcerative colitis have a increased risk of dying from colorectal cancer, despite modern therapeutics, even though the ris


Root of fatal malaria infection claimed to be found in new study


As per the professor Ian Cheeseman from Texas Biomedical Research Institute that they don't know what is inside malaria infections, or how many different genetically distinct st


Women experiencing repeat miscarriages could be treated with diabetes drug



Targeted ultrasound kills cancerous cells while leaving healthy ones


Ultrasound waves of scaled intensity and frequency have demonstrated hope in breaking apart different types of cancerous cells without harming healthy blood cells.

The w


Phase III KEYNOTE-604 trial of Merck for Keytruda in combo with chemotherapy attains one of its dual primary endpoints of PFS for treatment of patients with ES-SSCLC


Merck declared that the phase III KEYNOTE-604 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy attained one of its dual primary endpo


New blood test to enhance triage for elderly concussion patients


The blood test, though, was not precise at quantifying patients who did have brain tissue.
A new blood test could precisely quantify elderly concussion patients without brain ti


As per JAMA, Shorter sleep duration in children may elevate risk of psychiatric disorders later


Sleep duration in children can help in anticipating the future occurrence of psychiatric disorder, a recent study has indicated. Targeting sleep duration thus could be useful fo


Pain caused by ureteral stenting could be eased by Local administration of vasodilators


Each year, more than half a million Americans go to the emergency room for kidney stone related problems. Ureteral stents and Kidney stones can cause ureteral colic and pain.


Phase II trial of Spectrum Pharma of poziotinib in priorly treated NSCLC patients with EGFR exon 20 insertion mutations fails


A biopharmaceutical company known as Spectrum Pharmaceuticals, Inc. committed on new and innovative and targeted oncology therapies, has reported that its pre-specified primary&


An easy and better testing method for patients with Parkinson’s disease


Parkinson’s disease is a neurodegenerative disorder that demonstrates symptoms such as tremor, limb rigidity, slow movements and gait, and balance problems. It impacts about 10


As per JAMA, Single dose of HPV vaccine gives similar protection as multiple doses


Launched first in 2006, the multi-dose human papillomavirus (HPV) vaccine can prohibit most anal and cervical cancers among children and young adults which came in contact to the vir


Lumasiran RNAi Therapeutic obtained Primary and Secondary Endpoints


A Phase 3 study examining the lumasiran RNAi therapeutic has reached its primary and secondary endpoints. Alnylam Pharmaceuticals, which manufactures the drug, reports that the


Reduction in cumulative exposure to obesity may substantially reduce risk of diabetes


As found in the recent study in EASD


Overdose deaths by Opioid on the elevation curve among children


Opioid epidemic in developed countries is harmful for both adults and children, and is constricting the respective health care systems. Researchers performed research to illustr


Pain relieving can be done by Acupuncture which helps in reduction of usage of opioids in Cancer


Acupuncture and/or acupressure may lead to vital reductions in the cancer pain intensity, reduction of requirements for opioids for the said purpose, indicates a recent study ad


Phase III study of GSK of Benlysta in patients with lupus nephritis obtains primary endpoint


GSK declared positive headline outcomes for intravenous (IV) Benlysta (belimumab) in the largest controlled phase III study in active lupus nephritis (LN), an inflammation of the kid


Adamas declared Results from Phase III Trial of ADS-5102


A company committed to developing and delivering medicines known as Adamas Pharmaceuticals, Inc., which are involved in making a clinically meaningful difference to people impac


Positive results from phase III study declared by BioMarin for vosoritide in children with achondroplasia


A worldwidel biotechnology company known as BioMarin Pharmaceutical has announced positive final outcomes from its randomized, double-blinded, placebo-controlled phase III 


LUSTER phase 3 studies of Novartis in patients with uncontrolled GINA 4/5 asthma fails to attain endpoint


Topline outcomes were declared by Novartis from its pivotal global phase 3 LUSTER-1 and LUSTER-2 studies traversing the efficacy and safety of the investigational oral, once-dai


New standards required for enhancing the design of clinical trials for MS patients


The group of working people of Akda,


Lilly and Boehringer Ingelheim declared EMPERIAL studies outcomes of empagliflozin in chronic heart failure


Eli Lilly and and Boehringer Ingelheim Company declared outcomes from the EMPERIAL- Reduced and EMPERIAL-Preserved studies associated to functional endpoints with empaglifl


Positive results announced by Reprieve Cardiovascular from first-in- human trial with PVM System for AHF


A pioneering medical device company known as Reprieve Cardiovascular is committed on enhancing results for patients suffering from acute decompensated heart failure (ADHF), 


Pivotal Phase III study declared by FerGene for nadofaragene firadenovec attained its primary endpoint obtaining a complete response at three months


Fergene  declared positive results from the pivotal Phase III clinical trial
accessing nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, to treat hi


Phase 3 of Roche IMspire150 trial of Tecentriq plus Cotellic; Zelboraf for priorly untreated BRAF V600 mutation-positive advanced melanoma attains primary endpoint


Phase 3 IMspire150 study was declared by Roche, in people with priorly untreated BRAF V600 mutation-positive advanced melanoma, attained its primary endpoint of progression-free su


Kisqali data of Novartis demonstrate superior overall survival in comparison to fulvestrant and constant efficacy across advanced breast cancer patient subgroups in MONALEESA-III


MONALEESA-III data demonstrates Kisqali (ribociclib) plus fulvestrant showed a statistically vital enhancement in overall survival, with an almost 30% reduction in risk of death in


Positive Tucatinib HER2CLIMB Trial outcomes by Seattle Genetics in Locally Advanced or Metastatic HER2-Positive Breast Cancer


Seattle Genetics, Inc. has made an announcement regarding the positive pivotal data from the HER2CLIMB trial examining tucatinib in patients with HER2-positive metastatic brea


Gracell declares progressive results from Multiple Human clinical trials to


xamine FasTCAR and dual CAR cell platform technologies

A clinical-stage immune cell therapy company known as Gracell Biotechnologies Co, Ltd has


Sage Therapeutics declares Planned Progression of SAGE-718 to Phase II in Huntington's Disease


Sage Therapeutics has made declaration that it plans to advance SAGE-718, a new, 1st-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMD


Forty Seven, Inc. declares Up-to-date Data from Ongoing Clinical study of Magrolimab in Patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia


Forty Seven, Inc. which is a clinical-stage and immuno-oncology company comitted on creating therapies to start off macrophages in the fight against cancer has made the declaration


Topline Data showed by Astex Pharmaceuticals from the ASCERTAIN Phase III Study of New, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML


A fully owned subsidiary of Otsuka Pharmaceutical Co. Ltd., known as Astex Pharmaceuticals, Inc., based in Tokyo, Japan has showed topline data from the ASCERTAIN phase III tria


Phase 3 data by Novartis on new inhaled dual combination QMF149 show vital improvement across key asthma outcomes in comparison to monotherapy


Novartis, declared data from the 52-week pivotal phase 3 PALLADIUM clinical trial which showed that QMF149 is a once-daily fixed-dose combination of indacaterol acetate and mometason


Positive phase III ACHIEVE I trial results by Allergan for ubrogepant


Positive phase III ACHIEVE I trial results were declared by Allergan for ubrogepant (UBR-MD-01), a robust phase III clinical trial examining the safety, efficacy and tolerability of


Clinical Trials Results on Curecode with Neuromide Skin Care Brand declared by Dr. Raymond Labs


K-Beauty’s leading skincare company, Dr. Raymond Labs which is committed for development and marketing innovative, affordable clinic-level skincare at home, declared the releas


Pfizer and Sangamo declare Updated Phase I/II Results demonstrating Sustained Increased Factor VIII Activity Through 44 Weeks followed up by SB-525 Gene Therapy Treatment


Together, Pfizer, Inc. and a genomic medicine company, Sangamo Therapeutics, Inc., declared updated follow-up results from the Phase I/II Alta study examining investigational SB-525


Positive Top-line Results by ACADIA Pharmaceuticals from Pivotal Phase III HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis


Positive top-line results were presented by ACADIA Pharmaceuticals from its Phase III HARMONY study. HARMONY was a phase III study which was
double-blinded, placebo-controlled,


Phase III trial Positive results for Toujeo in children and adolescents with type 1 diabetes


As per the reports submitted at the International Society for Pediatric and Adolescent Diabetes (ISPAD) 45th Annual Conference in Boston, children and adolescents aged between 6 to 1


Positive data were reported by OSE Immunotherapeutics from phase I clinical trial of anti-IL-7 receptor antagonist OSE-127


A clinical-stage biotechnology company known as OSE Immunotherapeutics, declared completion and positive results from the phase I study of OSE-127, a humanized monoclonal antibody wi


Positive results by Biogen from phase II LILAC study of BIIB059 for treatment of lupus patients


Positive results from the phase II LILAC study were declared by Biogen Inc for examining the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targetin


Roche decalred positive results from SAkuraSky study of satralizumab for treatment of neuromyelitis optica spectrum disorder


Roche declared the positive data from SAkuraSky, a pivotal phase 3 study of the investigational medicine satralizumab to treat neuromyelitis optica spectrum disorder (NMOSD).


Positive Results demonstrated by TauRx's Alzheimer's Drug in Large Clinical Trials


An unexpected result was published by TauRx which is based in Aberdeen, Scotland and Singapore for the pharmacokinetic analysis of the drug hydromethylthionine (LMTM) in Alzheimer&rs


42-month Positive DSMB Recommendation for Continuation of Phase III RESOLVE-IT Study of Elafibranor in NASH for GENFIT


A late-stage biopharmaceutical company known as GENFIT is committed to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver regar


Phase 3 ALTA-1L Trial demonstrate Promise for Patients with Non-Small Cell Lung Cancer


The ongoing phase 3 ALTA-1L trial of brigatinib (Alunbrig) in comparison to crizotinib (Xalkori) indicated that brigatinib reduced the risk of disease progression or death in adults


Promising Efficacy in Phase IIb MDNA55 Clinical Trial reported by Medicenna


A clinical stage immuno-oncology company, known as Medicenna Therapeutics Corp., has submitted updated clinical results from its Phase IIb trial of MDNA55 in patients with recurrent


FDA approval to Medtronic for IN.PACT AV DCB


The US Food and Drug Administration has granted approval to Medtronic for its IN.PACT AV Drug-coated Balloon (DCB) which is a paclitaxel-coated balloon for the treatment of failing A


Mylan pulled up by USFDA for manufacturing violations at Andhra plant


Mylan Laboratories has been pulled up by the USFDA for violating good manufacturing norms, involving lapses in handling raw materials and issues regarding cleaning of equipment, at i


Phase II ELEVATE study by VistaGen AV-101 as an adjunctive treatment of MDD fails to meet endpoint


VistaGen Therapeutics, declared topline results from the ELEVATE study, a phase II study of AV-101, its NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an ancillary


Novartis Phase III PREVENT trial of Cosentyx in patients with nr-axSpA meets primary endpoint


A leader in rheumatology and immuno-dermatology, Novartis, proclaimed elaborated results from the phase 3 PREVENT trial, examining the efficacy and safety of Cosentyx (secukinumab) i


Positive phase III TULIP 2 trial by AstraZeneca for anifrolumab to treat SLE


AstraZeneca presents elaborated results from the positive phase 3 TULIP 2 trial for anifrolumab, a possible new drug for the treatment of moderate to severe Systemic Lupus Erythemato


Positive Topline Results declared by Therapix Biosciences regarding Phase IIa Clinical Trial of THX-110 for Obstructive Sleep Apnea Program


Therapix Biosciences Ltd. declared topline results from its Phase IIa clinical study at Assuta Hashalom Medical Center in Israel, recommending that THX- 110, a combination of dronabi


DURECT Corporation declares Positive Results from the Phase IIa Clinical Trial of DUR-928 in Alcoholic Hepatitis Patients


DURECT Corporation, declared the results from its Phase IIa clinical trial of DUR-928 in Alcoholic Hepatitis (AH).

As stated by the principal investigator in the trial, Dr. T


Results presented by Indalo Therapeutics of Phase I Clinical Trial study for Lead Antifibrotic Drug Candidate IDL-2965


Indalo Therapeutics is involved in discovering and developing integrin antagonists for patients plagued by serious fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and n


Novartis Cosentyx demonstrates uplifting results in comparison to Humira from EXCEED head-to-head trial for treatment of psoriatic arthritis


Novartis, declared results from the EXCEED head-to-head trial Cosentyx (secukinumab) comparing to Humira (adalimumab) in patients with active psoriatic arthritis (PsA). While Cosenty


Phase III study of AbbVie SELECT-PsA 2 of Rinvoq for treatment in psoriatic arthritis met primary and all ranked secondary endpoints


AbbVie, proclaimed positive top-line data from the SELECT-PsA 2 phase III study. In the trial, both the doses of Rinvoq met the primary endpoint of ACR20 response at week 12 in compa


Positive results reported by Paratek Pharma for phase II studies of omadacycline in urinary tract infections


A commercial-stage biopharmaceutical company, Paratek Pharmaceuticals shared the outcome of its two exploratory phase II clinical studies examining the safety and efficacy in patient


Promentis Pharma declares positive results for phase IIA study of SXC-2023 targeting new glutamatergic mechanism and completion of enrollment for phase II trichotillomania study


Promentis Pharmaceuticals is developing technologically advanced therapies for neuropsychiatric disorders. It has successfully completed a behavioral biomarker study for its lead com


TGA Australia approval to Mallinckrodt’s Uvadex for use with Therakos Cellex photopheresis system


The Therapeutic Goods Administration (TGA),Australia has given the approval to Mallinckrodt Pharmaceuticals, for Uvadex (methoxsalen). The approval is given for extracorporeal admini


Positive results from phase I/IIa trial reported by ORYX with oncolytic virus ParvOryx in metastatic, inoperable pancreatic cancer


A translational medicine company named ORYX focusses on oncolytic virotherapy and cancer vaccines, reported positive clinical trial results from a dose-escalating phase I/IIa trial w


IPC directs pharmacy institutes for mandate use of PvPI-ADR mobile app for reporting ADRs for promotion of patient safety


The Indian Pharmacopoeia Commission (IPC) has suggested to pharmacy institutes to mandate use of PvPI-ADR mobile application by the students for reporting Adverse Drug Reactions (ADR


MorphoSys declared positive results from L-MIND trial of combination of tafasitamab and lenalidomide in comparison to lenalidomide alone


A clinical-stage biopharmaceutical company, MorphoSys AG, proclaimed top line results from the initial analysis of the etrospective observational matched control cohort (Re-MIND). Th


Phase III POSEIDON trial by AstraZeneca of Imfinzi & tremelimumab for 1st line treatment of stage IV NSCLC obtains primary endpoint


AstraZeneca, proclaimed positive Progression-free Survival (PFS) results for Imfinzi (durvalumab) and tremelimumab, an antibody of anti-CTLA4 when incorporated to chemotherapy, from


Therapix Biosciences announced positive results from pre-clinical study of THX-210 to treat epilepsy


Therapix Biosciences Ltd proclaimed positive results in its pre-clinical study evaluating THX-210, a proprietary novel pharmaceutical preparation containing non-psychoactive cannabin


Lilly’s Phase 3 SEQUOIA trial fail to meet primary endpoint for pegilodecakin plus Folfox compared to Folfox alone in patients with metastatic pancreatic cancer


Eli Lilly and Company proclaimed top-line results from its phase III SEQUOIA trial accessing pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) in comparison to Folfox alone


FDA approval to Myeloma, Label Update in HER2+ Breast Cancer, Breakthrough Status in Prostate Cancer


An approval by FDA has been received for multiple myeloma which is an updated label in breast cancer, a breakthrough therapy designation in prostate cancer, grants awarded for resear


FDA approval to new medication Reyvow to treat acute migraine


An approval has been given by the U.S. Food and Drug Administration (FDA) for a new medication to treat acute migraine with or without aura called Reyvow. As per its manufacturer, El


Lilly Presents Positive Results for Taltz® (ixekizumab) in Paediatric Patients with Moderate to Severe Plaque Skin Problem


Eli Lilly and Company proclaimed that Taltz met co-primary endpoints in paediatric patients with moderate to severe plaque skin problem, demonstrating that 89% of patients treated wi


Incyte announced positive 52-Week results from irregular part two study of Ruxolitinib cream in patients with skin disorder


Incite announced the positive 52-week results from its irregular, double-blind, dose ranging, part two study evaluating ruxolitinib cream, a non-steroidal,&n


FDA Approval to Prevent Venous Thromboembolism


The US Food and Drug Administration (FDA) has paved the way for the geko device for stimulation of calf muscles to prevent venous thrombosis in non-surgical patients at risk for veno


Failed Phase III Clinical Trial of Keytruda for Mesothelioma


Results obtained from a phase III clinical trial distinguishing Keytruda (pembrolizumab) to standard chemotherapy highlights the immunotherapy drug still has a long way to go as a vi


Positive Results from Phase III IRIDIUM by Sosei Heptares regarding Study of Inhaled Combination QVM149 in Patients with Uncontrolled Asthma


Sosei Group Corporation has made an announcement regarding Novartis by sharing the positive results from its Phase III IRIDIUM trial.

The results demonstrated the combination


Roche presented positive results for phase III study of satralizumab for treatment of neuromyelitis optica spectrum disorder

Full pivotal phase III study results were presented by Roche for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system diseas


Chugai presented results regarding Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019

An announcement has been made by Chugai Pharmaceutical Co., Ltd., regarding the results from SAkuraStar Study which were demonstrated at the Congress of European Committee for Treatment and Researc


Positive data from phase III CASPIAN trial of Imfinzi presented by AstraZeneca for treatment of extensive-stage SCLC at WCLC 2019

Detailed results from phase III CASPIAN trial were presented by AstraZeneca, demonstrating Imfinzi (durvalumab) significantly enhanced overall survival (OS) in patients with previously-untreated ex


Novartis announces positive data from 5-year OLPT of Aimovig in patients with episodic migraine

An announcement has been made by Novartis regarding positive data from 5-year open-label treatment period (OLTP) accessing sustained efficacy and long-term safety of Aimovig (erenumab) in patients


Phase III study of CheckMate -498 trial of Opdivo in patients with newly diagnosed MGMT- unmethylated GBM fails to meet one of its primary endpoints

Bristol-Myers Squibb Company announced the phase 3 CheckMate -548 trial updates, accessing the addition of Opdivo (nivolumab) to current radiation therapy with temozolomide as compared to alone sta


Alnylam Pharma announces positive results from ORION-11 phase 3 study of inclisiran to treat hypercholesterolemia

One of the leading RNAi therapeutics company Alnylam Pharmaceuticals, Inc, provides complete positive results from the ORION-11 phase 3 study of inclisiran, an RNAi therapeutic in development for t


Phase III study show results of Xofluza reduces risk of developing flu after contact with an infected person by 86% : Roche

An announcement by Roche regarding the phase III BLOCKSTONE study demonstrated preventive treatment with Xofluza (baloxavir marboxil) after exposure to an infected household member significantly le


Phase III ASCLEPIOS I & II studies of ofatumumab by Novartis versus Aubagio for treatment of relapsing forms MS meets primary endpoints

An announcement by Novartis has been made regarding positive results for ofatumumab (OMB157) from the phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab showed superiori


Discontinuation of AbbVie R&D program as MERU phase 3 trial of Rova-T for SCLC treatment fails to meet endpoint

AbbVie has announced regarding MERU, a phase 3 trial accessing Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), showed no survival benefit at a pre-planned int


Phase III TULIP 2 trial of anifrolumab by AstraZeneca for treatment of systemic lupus erythematosus meets primary endpoint

An announcement has been made by AstraZeneca regarding the phase III TULIP 2 trial for anifrolumab, which is a potential novel medicine for the treatment of systemic lupus erythematosus (SLE), met


AstraZeneca gets positive results from phase III ETHOS trial of triple-combo therapy Breztri Aerosphere to treat COPD

An announcement was made by AstraZeneca regarding positive results of phase III ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very seve


Positive results announced by AstraZeneca regarding phase III ETHOS trial of triple-combo therapy Breztri Aerosphere to treat COPD

An announcement was made by AstraZeneca regarding positive results from phase III ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very se


Waiving clinical trials for EU approved medical devices soon: Health ministry

The Union health ministry is likely to forgo the need of clinical trials conduction in India for European Union (EU) approved medical devices through an amendment of Rule 63(1) under the Medical De


Phase IIb CONDUCT study by InDex Pharma with cobitolimod in ulcerative colitis meets primary endpoint

InDex Pharmaceuticals announced positive top line results from the dose optimization study CONDUCT, which is accessing cobitolimod for the treatment of moderate to severe ulcerative colitis. The st


Successful Completion of PAVmed Clinical Safety Study Procedures for CarpX™ 510(k) Re-submission

A highly distinguished, multiproduct medical device company, PAVmed Inc., has made an announcement that all 20 patients of its first-in-human (FIH) 510(k) clinical safety study underwent successful


1,213 adverse events reported for medical device in country since 2014 : MvPI

The Indian Pharmacopoeia Commission (IPC) receives 1,213 adverse events related with medical devices since 2014 across the country. IPC is the national coordinating centre to have materiovigilance


10 million individual may get killed by 2050 due to indiscriminate utilization of antibiotics: Survey by Delhi IPA

The students of Indian Pharmaceutical Association, Delhi branch conducted a survey regarding the indiscriminate antibiotics use. They estimate that around 10 million individuals may lose their live


Positive clinical trial results for MemorEM and Alzheimer’s TEMT trial

Positive clinical trial results for MemorEM and Alzheimer’s TEMT trial


Positive results have been announced by NeuroEM Therapeutics fo


Positive clinical trial results for Olaparib in advanced prostate cancer

The earlier results of an important phase III clinical trial demonstrates that the genetically targeted drug olaparib exceeds positive outcomes for men with advanced prostate cancer whose tumours h


Suspected ADRs associated with anti-retroviral drugs: PvPI

The Pharmacovigilance Programme of India (PvPI) reveals that major suspected adverse drug reactions associated with anti-retroviral drugs such as efavirenz, lamivudine and tenofovir.

PvPI i


Olaparib shows important PFS Benefit in Phase III mCRPC Trial

Olaparib (Lynparza) showed a statistically major improvement in radiographic progression-free survival (rPFS) compared with enzalutamide (Xtandi) or abiraterone acetate (Zytiga) in men with metasta


Recent Success of KEYTRUDA in Triple-Negative Breast Cancer proves I-SPY 2 Adaptive Platform Approach to Phase II Clinical Trials

The I-SPY 2 TRIAL is a combined effort among academic investigators from 20 prominent cancer research centers across the U.S. and Quantum Leap Healthcare Collaborative, the FDA, and the Foundation


Positive results for phase I trial of T20K for multiple sclerosis treatment

A Swedish biotech company, Cyxone renowned for autoimmune diseases announced that phase I clinical trial of T20K successfully attained its objective of confirming T20K's safety and tolerability in


Positive Phase 2 Results reported for Dry Powder Inhaler Formulation of Ensifentrine

A biopharmaceutical company, Verona Pharma plc, announces the positive Phase II data for dry powder inhaler (“DPI”) formulation of its lead development product, Ensifentrine. It is mean


Response required for Nestle’s clinical trials

Nestle is facing heat following the instructions of the Union Health Ministry to the Indian Council of Medical Research. Nestle was involved in conducting research in Indian hospitals which is agai


MONALEESA-3, a phase-III trial by Novartis of Kisqali to improve overall patient survival with HR+/HER2- advanced breast cancer

Novartis announced that Kisqali (ribociclib) achieved statistically significant improvement in overall survival during phase III MONALEESA-3 clinical trial. This being the second phase III clinical


Phase III study trial of Transgene oncolytic virus stopped for futility

A phase 3 trial of liver cancer of Transgene and SillaJen’s oncolytic virus has been halted early for futility.

SillaJen designed the 600-subject trial to exhibit whether administerin


MHRA Revised Clinical Investigation Guidance in Lined with EU MDR

Medical device clinical investigation guidance underwent a revision in 2013 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for reflecting the EU’s medical device


National guidelines for gene therapy product development issued by Health Ministry

Draft national guidelines for gene therapy development and clinical trials have been placed in public domain by the Union Health Ministry for suggestions from concerned parties like scientists, aca