Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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DrugBank

SEPTEMBER 26, 2024

While some clinical trials are necessary to confirm safety and efficacy in humans, these are typically smaller and shorter in duration compared to the extensive trials required for novel biopharmaceuticals. These molecules pose major scientific and regulatory hurdles due to their intricate structures and potential for immunogenicity.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g.,

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Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? All key questions to consider and address before the therapy even leaves the lab.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

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The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

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The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. population will have obesity. About Boehringer Ingelheim.

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Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

SEPTEMBER 6, 2021

In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. These results will guide us to advance our clinical development strategy of eliapixant.”.

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Trials Clinical Trials Treatment International 52

The Pharma Data

MAY 27, 2022

of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.¹ Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events.¹. After a median follow-up of 12.6 months, 39.4%

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Treatment Therapies Clinical Trials Disease 52

SugarCone Biotech

JUNE 10, 2024

[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. These adverse events suggest widespread, uncoordinated and nonspecific immune activation.

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Immune Response Production Regulations Clinical Trials 88

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 This means study startup times can vary greatly.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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Disease Trials Treatment Clinical Trials 52

The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. About Eisai Co.,

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The Pharma Data

JUNE 7, 2023

Rahway, NJ, USA), an anti-PD-1 therapy. Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 31% of patients receiving doublet therapy and 58% of patients receiving triplet therapy. The percentage of ILD or pneumonitis events was similar across cohorts.

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Trials Protein Expression Therapies Treatment 40

The Pharma Data

OCTOBER 18, 2020

Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 2 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA. The focus is on cancer.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” In the initial 275 patients, rates of adverse events (AEs) were similar among groups.

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The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases.

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The Pharma Data

JULY 22, 2021

This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.

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The Pharma Data

JANUARY 19, 2021

The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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Clinical Trials Trials Clinical Development Pharmaceutical Companies 52

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

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Treatment Clinical Trials Therapies Molecular Biology 59

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. Key Takeaway RWD and RWE play an important role in rare diseases, where capturing relevant data to support drug development is challenging.

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Disease FDA FDA Approval Treatment 52

The Pharma Data

JANUARY 3, 2021

Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to that of cabozantinib alone. “We Median PFS was 9.2 months with cabozantinib and placebo. Exelixis, Inc.

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The Pharma Data

MAY 16, 2022

Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible. “We Through week 26, lenacapavir was generally well tolerated in CAPELLA, with no serious adverse events related to lenacapavir as determined by the study investigator. About Gilead Sciences.

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Treatment FDA Science Therapies 52

The Pharma Data

JANUARY 13, 2021

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. MindMed Co-CEO J.R. About MindMed. MindMed Forward-Looking Statements.

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Clinical Trials FDA Trials Production 52

The Pharma Data

DECEMBER 3, 2020

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. We are proud to be partnered with Clover in our endeavors to develop a safe and effective COVID-19 vaccine that will be readily accessible around the world to combat this ongoing pandemic.”.

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Vaccine Immune Response Virus RNA 52

The Pharma Data

FEBRUARY 13, 2022

Asundexian is an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke as well as for two additional conditions: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack).

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The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We Following U.S.

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Clinical Trials Trials Disease Therapies 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . “Results from this study, which we are calling SWARM- P.a. The SWARM- P.a. Forward-looking statements involve risks and uncertainties.

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Clinical Trials Trials Pharmaceuticals Drugs 52

The Pharma Data

MARCH 28, 2022

The adverse events (AEs) were mostly mild to moderate in severity and occurred at a similar rate across BIIB078 and placebo groups. Based on these results, the BIIB078 clinical development program will be discontinued, including its ongoing open-label extension study. “We Biogen Inc. Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc.

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RNA Therapies Disease Biosimilars 52

The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. 3 hemorrhagic events occurred in 2.3%

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The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. 22, 2021 12:00 UTC.

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. SINGAPORE, Oct. The company expects to share further details in early 2021.

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The Pharma Data

APRIL 27, 2023

It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. “New Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

OCTOBER 21, 2020

(Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20 for treatment of non-Hodgkin’s lymphoma (NHL). T cell therapy in NHL patients.

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FDA Immune Response Clinical Trials Engineering 40

The Pharma Data

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. Forward-Looking Statements. SOURCE Mirati Therapeutics, Inc.

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Small Molecule Immune Response Clinical Development Clinical Trials 52

The Pharma Data

APRIL 19, 2022

tumour response rate If approved, Enhertu to provide patients with a much-needed targeted therapy option. Enhertu is a HER2 – directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. Based on pivotal DESTINY-Lung01 results showing AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a 54.9%

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