Institute of Good Manufacturing Practices India

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Clinical Research Newsletter

31-03-2024

Pfizer declares positive results from phase 3 trial of Adcetris regimen in relapsed/refractory DLBCL patients

Pfizer Inc. has announced positive results from a phase 3 trial of Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for relapsed/refractory

31-03-2024

Aurobindo Pharma arm CuraTeQ reports omalizumab biosimilar candidate BP11 meets phase 1 trial endpoints

CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Ltd, announced that their omalizumab biosimilar candidate BP11 met phase 1 trial endpoints compared

31-03-2024

OcuTerra’s Phase II diabetic retinopathy trial misses endpoints

OcuTerra Therapeutics reported that its Phase II DREAM trial of nesvategrast (OTT166) eye drops for diabetic retinopathy (DR) didn't meet endpoints. The study aimed to

30-03-2024

Bristol Myers Squibb reports CheckMate -9DW trial of Opdivo plus Yervoy meets primary endpoint of OS to treat advanced HCC

Bristol Myers Squibb has announced positive findings from the phase 3 CheckMate -9DW trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line therapy

30-03-2024

Nuvectis Pharma reports positive preliminary data from NXP800 phase 1b trial in ovarian cancer (platinum-resistant ARID1a-mutated)

Nuvectis Pharma, Inc., a biopharmaceutical company, shared positive preliminary findings from a phase 1b trial of NXP800 for platinum-resistant ARID1a-mutated ovarian c

22-03-2024

Ionis Pharma reports positive results from the phase 2 study of ION224, demonstrating clinical efficacy in treating NASH/MASH

Ionis Pharmaceuticals, Inc. has released positive outcomes from a phase 2 trial of ION224, an investigational DGAT2 antisense inhibitor targeting metabolic dysfunction-

21-03-2024

GSK reports positive results from DREAMM-8 phase III trial for Blenrep vs standard of care combination in relapsed/refractory MM

GSK plc announced positive interim results from the DREAMM-8 phase III trial, comparing Blenrep (belantamab mafodotin) plus pomalidomide and dexamethasone (PomDex) agai

21-03-2024

Phase II KARDIA-2 study of zilebesiran in people with hypertension meets primary endpoint: Roche & Alnylam

Roche and Alnylam reported positive results from the phase II KARDIA-2 trial [NCT05103332] of zilebesiran, an investigational RNAi therapy for hypertension, a primary c

21-03-2024

BlueRock Therapeutics reports positive 18-month data from phase I trial for bemdaneprocel in Parkinson’s disease

Bayer AG and BlueRock Therapeutics LP, an independently operated subsidiary of Bayer AG, have disclosed 18-month data from a phase I clinical trial on bemdaneprocel, an

21-03-2024

MAIA Biotechnology declares positive data from NSCLC therapy trial

MAIA Biotechnology has released positive efficacy results from its Phase II THIO-101 trial, examining THIO combined with cemiplimab (Libtayo) for advanced non-small cel

16-03-2024

Viking Therapeutics, Inc. reported positive outcomes from its phase 2 trial of VK2735, a dual GLP-1 and GIP receptor agonist for metabolic disorders

Viking Therapeutics, Inc. (Viking), a clinical-stage biopharmaceutical company specializing in metabolic and endocrine disorder treatments, reported positive outcomes f

16-03-2024

GSK reports positive results for gepotidacin in uncomplicated urogenital gonorrhoea from EAGLE-1 phase III trial

GSK plc announced positive outcomes from the pivotal EAGLE-1 phase III trial of gepotidacin, an oral antibiotic targeting urogenital gonorrhea in adults and adolescents

16-03-2024

Biodexa reports an R&D update including positive results from the phase I trial of MTX110 in patients with diffuse midline glioma

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company, shares an R&D update. Positive top-line results from a recent phase 1 trial of MTX110 in di

15-03-2024

Bristol Myers Squibb declares positive results of Zeposia from phase 3 DAYBREAK open-label extension trial in patients with MS (relapsing forms)

Bristol Myers Squibb revealed findings from the phase 3 DAYBREAK trial, demonstrating Zeposia's (ozanimod) enduring efficacy and safety in relapsing forms of multiple s

15-03-2024

Cynata Therapeutics declares inspiring initial data from the phase 1 trial of CYP-006TK to treat a diabetic foot ulcer

Cynata Therapeutics Limited, a biotech firm specializing in cell therapeutics, completed the initial analysis of wound surface area in the first 16 patients of its phas

07-03-2024

Novartis proposes positive data from the SMART study of Zolgensma in older and heavier children with SMA at the 2024 MDA conference

Novartis revealed new data affirming the clinical advantages of Zolgensma (onasemnogene abeparvovec), the sole one-time gene therapy for spinal muscular atrophy (SMA).<

07-03-2024

Ultimovacs declares trial results of UV1 cancer vaccine.

Ultimovacs, a biotechnology company in its clinical stages, has unveiled data from the Phase II NIPU trial on the UV1 cancer vaccine, focusing on mesothelioma. This tri

07-03-2024

Pfizer notifies top-line results from Phase III RSV vaccine trial

Pfizer's Phase III RENOIR trial reveals top-line data on its respiratory syncytial virus (RSV) vaccine, ABRYSVO, targeting RSV-related lower respiratory tract disease (

06-03-2024

ViiV Healthcare demonstrates positive findings from the phase I study of cabotegravir long-acting injectable investigational formulation

GSK plc and ViiV Healthcare, a specialized HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders, announced positive phase I study results for cabo

06-03-2024

CASI and BioInvent declare positive data from lymphoma treatment trial

CASI Pharmaceuticals and BioInvent International unveiled positive initial efficacy findings from their Phase I trial of BI-1206 in relapsed/refractory indolent non-Hod

26-02-2024

Sanofi communicates positive results from trial of frexalimab for multiple sclerosis (MS)

Sanofi, a French pharmaceutical company, is developing frexalimab under an exclusive license from ImmuNext. Positive Phase II trial results were recently announced for

26-02-2024

Hemab notifies positive Phase I Glanzmann thrombasthenia therapy data

HMB-001 is assessed as a prophylactic treatment for a bleeding disorder, Glanzmann thrombasthenia. Hemab Therapeutics has unveiled encouraging preliminary data from the

25-02-2024

Phase III thyroid eye disease trial of Innovent fulfils primary endpoint

The antibody IBI311 showed favorable safety in Thyroid Eye Disease (TED) patients. Innovent Biologics disclosed positive results from the Phase III RESTORE-1 trial in C

25-02-2024

UroMems declares positive results for stress urinary incontinence implant

Stress urinary incontinence, marked by urine leakage during activities like exercise or sneezing, is the focus of UroMems' latest trial evaluating its UroActive device.

24-02-2024

NeuroSense expands data in Phase IIb ALS study with positive update

Symptoms of amyotrophic lateral sclerosis (ALS) include hand and arm motor control loss and limb usage impairment. NeuroSense released additional top-line data from its

20-02-2024

AstraZeneca’s Tagrisso exhibited overwhelming efficacy benefit for patients with unresectable, stage III EGFR-mutated lung cancer in LAURA phase III trial

The LAURA phase III trial highlights AstraZeneca's Tagrisso (osimertinib) as a promising intervention, demonstrating a statistically significant improvement in progress

20-02-2024

Tharimmune’s buccal film liver drug exhibits efficacy in Phase I trial

Tharimmune, a US biotech firm, has unveiled promising data on TH104, a transmucosal buccal film designed for liver-related and inflammatory conditions. TH104 targets ai

20-02-2024

Sanofi and Denali’s ALS therapy misses preliminary endpoint in Phase II trials

Sanofi and Denali Therapeutics' ALS therapy, SAR443820/DNL788, didn't meet its primary endpoint in the Phase II HIMALAYA trial. The trial aimed to gauge its effect on t

15-02-2024

Grifols registers positive topline outcomes from phase 3 fibrinogen clinical tr

Grifols, a leading producer of plasma-derived medicines, announced positive results from Biotest's phase 3 trial of fibrinogen concentrate (FC), BT524, for acquired fib

15-02-2024

Grifols documents positive topline outcomes from the phase 3 fibrinogen clinical trial

Grifols, a global leader in plasma-derived medicines, celebrates Biotest's phase 3 trial success with BT524, a fibrinogen concentrate (FC) for acquired fibrinogen defic

10-02-2024

Beacon registers positive 12-month data from phase 2 SKYLINE trial of AGTC-501 in patients with X-linked retinitis pigmentosa

Beacon Therapeutics Holdings Limited, a leading ophthalmic gene therapy company, presented interim results from the phase 2 SKYLINE trial for X-linked retinitis pigment

10-02-2024

Chugai Pharma’s mosunetuzumab accomplishes the primary endpoint in expansion cohort of the Japanese phase I trial for r/r follicular lymphoma

Chugai Pharmaceutical Co., Ltd. announced that the anti-CD20/CD3 bispecific antibody mosunetuzumab met the primary endpoint of complete response rate (CRR) in a Japanes