Drug Discovery World

APRIL 25, 2023

The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. “We So far, there have been no adverse events observed that were related to the treatment and the two participants are doing fine.”

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Drug Discovery World

MARCH 13, 2024

In the five JNJ-2113 treatment groups, as measured by the Psoriasis Area and Severity Index (PASI), response rates were maintained from Week 16 to Week 52, with the highest PASI 75 response observed in the 100mg twice daily group (78.6 Across JNJ-2113 treatment groups, 58.6% at 16 weeks and 76.2% at 16 weeks and 76.2% at 52 weeks).

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Drug Discovery World

NOVEMBER 10, 2023

Although the study was not powered to primarily assess efficacy, the kinetic visual field (Goldmann perimetry) increased significantly from baseline at days seven and 14 post treatment. KIO-301 was safe and well tolerated with no ocular and non-ocular serious adverse events, nor any signs of retinal inflammation.

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The Pharma Data

FEBRUARY 24, 2022

If successful, the results of the CONFIDENCE study could be of great significance to clinicians when considering how to optimize disease management and further delay kidney disease progression, while also providing additional insights into the safety of using these treatments in combination.”.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Aflibercept is a key treatment in ophthalmology.

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The Pharma Data

MARCH 28, 2022

mg dose of Ozempic ® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. mg doses for the treatment of type 2 diabetes in adults. The most common adverse events were gastrointestinal. Ozempic ® is now approved in the US at 0.5 mg and 2.0

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Drug Discovery World

JULY 3, 2023

In terms of the Bispecific and Multi-Specific Antibody Therapeutics programme, Dr Miguel Gaspar, Director, AstraZeneca, covered a breakout on T Cell redirection with bispecific antibodies, both in terms of strategies and clinical examples. This included broad antigen recognition, multivalent responses and the lack of MHC restrictions.

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) announced today that Gökhan Batur, Chief Executive Officer, will take part in a panel discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Thursday, January 7 from 8:00AM Eastern Standard Time. Investors can pre-register for the event here.

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Drug Discovery World

OCTOBER 2, 2023

DDW’s Megan Thomas heard from attendees about their key takeaways from the event. Dr Mindy Miller, Lead Research Scientist, Terumo Blood And Cell Technologies Conversations and data shared at the CAR-TCR 8 th Annual Summit highlighted the importance of optimising the science behind the therapies to broaden patient access.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Kimberly Smith, M.D., About the long-acting regimen of cabotegravir and rilpivirine.

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Drug Discovery World

MAY 3, 2023

Endothelial dysfunction Endothelial dysfunction is characterised by a proinflammatory and prothrombotic state with impaired microvascular blood flow, and it is a vascular hallmark of several common diseases.

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Drug Discovery World

JUNE 5, 2023

DDW’s Megan Thomas comments on the event. New approaches to partnering In this event in the Biotech track, Clive Cookson, Science Editor at the Financial Times, interviewed John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk.

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

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Drug Discovery World

APRIL 3, 2024

million from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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The Pharma Data

MARCH 7, 2022

Astellas”) today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.

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The Pharma Data

NOVEMBER 11, 2021

The primary efficacity endpoint is the time to first event of cardiovascular death or hospitalization for heart failure (NCT05093933). Joerg Koglin, vice chairman, Global Clinical Development and Therapeutic Area Head, Cardiovascular for Merck Research Laboratories. Gain a gestation test before the launch of treatment.

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The Pharma Data

NOVEMBER 11, 2021

Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. mg injection is approved for the treatment of adults with obesity or overweight in the US and UK, as an adjunct to diet and exercise. Once-weekly semaglutide 2.4

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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Conversations in Drug Development Trends

APRIL 5, 2024

Observed annually on the last day of February since 2008, Rare Disease Day has grown into a global movement for raising awareness, promoting research, and advocating for improved access to rare disease treatments and support services. We were overwhelmed by how excited the community was to participate!

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The Pharma Data

JULY 12, 2021

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits). Up to 40% of all patients with type 2 diabetes develop CKD.

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The Pharma Data

OCTOBER 18, 2020

(Janssen) has announced it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded use of Tremfya (R) (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU). In July 2020, the U.S.

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The Pharma Data

JUNE 7, 2023

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN). 6 There are currently no TROP2 directed ADCs approved for the treatment of lung cancer. Rahway, NJ, USA), an anti-PD-1 therapy.

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The Pharma Data

OCTOBER 18, 2020

Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD). Current treatment options are associated with poor outcomes. This voucher may be sold or transferred to another sponsor.

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Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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Drug Discovery World

OCTOBER 4, 2022

This year’s event will cover some of the most exciting advancements in areas spanning screening, automation, high content imaging, disease models, cell and gene therapies and how innovation is being driven through partnerships and collaborations. Collaborations.

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The Pharma Data

NOVEMBER 12, 2021

In addition, there were low rates of serious adverse events and Grade 3-4 adverse events (? As we approach the third time of the epidemic, we can anticipate that multiple treatment options will continue to be demanded, particularly for high- threat cases with complex health requirements.”. 1.617.2), Delta Plus (AY.1

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The Pharma Data

JANUARY 14, 2021

We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A. Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024. CEST / 8 a.m.

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The Pharma Data

JANUARY 17, 2021

To complement the internal capabilities, Aruvant is partnering with world-leading contract development manufacturing organizations. The strategic long-term manufacturing agreement with Lonza is a critical step to advancing the clinical development of ARU-1801 for sickle cell patients.

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Drug Discovery World

SEPTEMBER 6, 2022

Advanced therapies are providing new hope for patients and have the potential to revolutionise the way treatments are delivered, and possibly the healthcare landscape as a whole. . Many companies are still developing autologous products, but due to the highly personalised nature of products some companies are branching out.

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The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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The Pharma Data

APRIL 28, 2022

From an overall baseline HbA 1c of 8.13%, once-weekly insulin icodec achieved a superior reduction in estimated HbA 1 c of 0.93% compared to 0.71% for insulin degludec (estimated treatment difference: -0.22%). The rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) were 0.73

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The Pharma Data

APRIL 24, 2023

We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

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