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. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days.

Clinical Development 52

Clinical Development Therapies Clinical Trials FDA Approval 52

Drug Discovery World

SEPTEMBER 12, 2022

If anything, this period has been a reminder that people are the primary reason we do what we do, and the Patient Access, Healthcare & People track at Advanced Therapies Europe 2022 allowed DDW’s Multimedia Editor Megan Thomas to share several reflections on the topic. .

Clinical Trials 130

Clinical Trials Trials Therapies Science 130

Drug Discovery World

JULY 3, 2023

Dr Agapitos Patakas, CSO, Research & Development, Antibody Analytics, presented in this track on a customisable cell line platform for in vitro assessment of safety and efficacy of immune cell-directed therapies.

Engineering 130

Engineering Virus Therapies Treatment 130

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.

Therapies 264

Therapies Treatment Hospitals Production 264

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. Cell and gene therapies. In 2021, levels of investment hit an all-time high at $22.7

Drugs 130

Drugs Therapies Clinical Trials Cell Based Assays 130

Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

Therapies 130

Therapies Compliance Production International 130

Drug Discovery World

SEPTEMBER 14, 2023

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business. Chris Boshoff, M.D.,

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

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.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 52

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.

Small Molecule 130

Small Molecule Treatment Science Disease 130

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

The Pharma Data

DECEMBER 2, 2020

The incidence and severity of thrombotic events will also be assessed. treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot). treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot). About the BASIS study.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

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.

Trials 40

Trials Protein Expression Therapies Treatment 40

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.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

JUNE 25, 2021

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

Disease 52

Disease Therapies Treatment Medical Schools 52

Conversations in Drug Development Trends

APRIL 5, 2024

Each day throughout the month of February, we heard what was on the minds and hearts of patients and patient advocacy organizations, clinical developers driving treatments, and family members supporting people with rare diseases. We were overwhelmed by how excited the community was to participate!

Disease 52

Disease Clinical Trials Trials Treatment 52

The Pharma Data

JUNE 7, 2023

Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.

Clinical Trials 40

Clinical Trials Therapies Research Laboratories Vaccine 40

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.

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

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.

Clinical Development 52

Clinical Development Therapies Disease Research 52

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. A permanent gene edit to produce a difficult-to-titrate supply of GLP1 in the liver?

Small Molecule 139

Small Molecule Trials Therapies Disease 139

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.

Therapies 40

Therapies Treatment FDA Clinical Development 40

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.

Immune Response 88

Immune Response Regulations Production Clinical Trials 88

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.,

Disease 40

Disease Treatment Therapies FDA 40

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%

Treatment 52

Treatment Therapies Clinical Trials Engineering 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).

FDA 40

FDA Clinical Trials Trials Therapies 40

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.”.

Trials 52

Trials Clinical Trials International Treatment 52

The Pharma Data

APRIL 1, 2021

In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (?18 Tecartus is an autologous, anti-CD19 CAR T cell therapy. About Tecartus.

Virus 52

Virus Treatment Therapies FDA 52

The Pharma Data

MARCH 23, 2023

The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Trials 40

Trials Therapies Treatment Disease 40

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.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

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.

Disease 52

Disease FDA FDA Approval Regulations 52

The Pharma Data

JANUARY 14, 2021

NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Corneal events were reported more frequently in the bemarituzumab arm (67.1%

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

JANUARY 20, 2021

The CEC comprises clinical experts in cardiology and Intensive Care and has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events. In order to ensure an unbiased endpoint assessment, members of the CEC are blinded to treatment assignment. About Cardiol Therapeutics.

Hospitals 52

Hospitals Trials International Clinical Trials 52

Drug Discovery World

MAY 29, 2024

For biotechs, partnerships with pharmas provide a source of income, useful technical knowledge, and a path to progress programs into the later stages of clinical development and commercialisation, the latter of which the biotech is unlikely to be able to do on its own.

International 147

International Licensing Licensing Regulations 147

The Pharma Data

AUGUST 30, 2021

years versus placebo when added to maximum tolerated dose of guideline-directed therapy. A kidney outcome event occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo. 0.98]; p=0.0264) over a median duration of follow-up of 3.4 0.88]; p=0.0002). 0.98]; p=0.0264) over a median duration of follow-up of 3.4

Hospitals 52

Hospitals Disease Clinical Trials Therapies 52

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.

Treatment 40

Treatment Clinical Development Therapies Production 40

The Pharma Data

DECEMBER 29, 2020

HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company was officially included into the Shenzhen-Hong Kong Stock Connect program (the “Hong Kong Stock Connect”).

FDA 52

FDA Clinical Development Regulations Clinical Trials 52

The Pharma Data

NOVEMBER 8, 2021

The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development.

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52