Clinical Research Newsletter

14-02-2020

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

13-02-2020

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

12-02-2020

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.

12-02-2020

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

12-02-2020

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

18-01-2020

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.

15-01-2020

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-

14-01-2020

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

14-01-2020

Data Missing on ClinicalTrials.gov 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

14-01-2020

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.

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13-01-2020

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

10-01-2020

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

09-01-2020

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

09-01-2020

Women experiencing repeat miscarriages could be treated with diabetes drug

 

08-01-2020

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

08-01-2020

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

07-01-2020

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

02-01-2020

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

30-12-2019

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.

30-12-2019

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&

27-12-2019

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

27-12-2019

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

23-12-2019

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

22-12-2019

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

 

As found in the recent study in EASD

22-12-2019

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

22-12-2019

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

20-12-2019

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

20-12-2019

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

18-12-2019

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 

17-12-2019

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

17-12-2019

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

 

The group of working people of Akda,

16-12-2019

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

16-12-2019

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), 

15-12-2019

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

14-12-2019

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

13-12-2019

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

11-12-2019

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

10-12-2019

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

10-12-2019

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

09-12-2019

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

09-12-2019

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

07-12-2019

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

06-12-2019

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

06-12-2019

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

06-12-2019

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

05-12-2019

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,

05-12-2019

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

04-12-2019

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

04-12-2019

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

03-12-2019

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).

27-11-2019

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

26-11-2019

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

25-11-2019

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

25-11-2019

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

22-11-2019

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

18-11-2019

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

16-11-2019

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

13-11-2019

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

13-11-2019

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

13-11-2019

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

13-11-2019

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

11-11-2019

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

04-11-2019

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

02-11-2019

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

02-11-2019

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

02-11-2019

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

02-11-2019

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

01-11-2019

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

01-11-2019

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

31-10-2019

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

30-10-2019

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

17-10-2019

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

17-10-2019

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

12-10-2019

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

12-10-2019

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

12-10-2019

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

12-10-2019

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

10-10-2019

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

07-10-2019

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

01-10-2019

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

13-09-2019

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

12-09-2019

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

10-09-2019

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

10-09-2019

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

07-09-2019

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

04-09-2019

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

03-09-2019

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

31-08-2019

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

31-08-2019

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

30-08-2019

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

29-08-2019

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

29-08-2019

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

28-08-2019

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

28-08-2019

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

15-08-2019

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

12-08-2019

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

08-08-2019

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

07-08-2019

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

07-08-2019

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

07-08-2019

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

07-08-2019

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

07-08-2019

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

05-08-2019

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

05-08-2019

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

05-08-2019

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

02-08-2019

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

02-08-2019

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

30-07-2019

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

29-07-2019

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