European Pharmaceutical Review

DECEMBER 6, 2023

Over one-third of those patients require blood transfusions at least once per year, according to research published in a 2017 paper in Blood and a 2022 paper in Annals of Hematology. Approval of iptacopan for the aforementioned indication is based on two Phase III studies.

Food and Drug Administration 86

Food and Drug Administration Patients Physicians Food 86

Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year.

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Sales Marketing Pharmaceutical Medicine 59

Pharmaceutical Technology

DECEMBER 25, 2023

PRGN-3007 is under clinical development by Precigen and currently in Phase I for Hematological Tumor.

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Pharmaceutical Technology

MARCH 28, 2023

Multimillion collaboration marred by clinical data Cusatuzumab was previously studied in a multimillion-dollar collaboration between argenx and the Janssen Pharmaceuticals subsidiary Cilag International. Additionally, 10 patients experienced a complete remission (CR) with or without hematologic recovery. In the study, 45.5%

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Patients Pharmaceutical Medical 52

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz.

Prescription 68

Prescription Pharmaceutical products Networking Manufacturing 68

European Pharmaceutical Review

OCTOBER 2, 2023

Commenting on the validation of the MAA, Dr John Scarlett, Geron’s Chairman and Chief Executive Officer declared: “Based on the clinical profile of imetelstat to date, we are optimistic about its potential to become a standard of care and address longstanding unmet needs of lower risk MDS patients.”

Food and Drug Administration 89

Food and Drug Administration Food Patients Medicine 89

Pharmacy Times

SEPTEMBER 30, 2022

The functional and physical well-being and other scores from the survey are more favorable for those who were treated with the therapy, investigators say.

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European Pharmaceutical Review

DECEMBER 5, 2023

The promise of telomerase inhibitors for treating blood cancer Trial results The clinical trial enrolled a total of 178 patients. Significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.

Food and Drug Administration 98

Food and Drug Administration Patients Food Medicine 98

European Pharmaceutical Review

SEPTEMBER 1, 2023

mRNA stability and delivery specificity are two of the main obstacles hindering progress for oncology therapy approvals, according to Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData. Additionally, there are 178 mRNA-based oncology therapies in total across all clinical stages of development. subvariant. subvariant.

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Marketing Sales Competition Pharmaceutical 92

Pharmaceutical Technology

NOVEMBER 22, 2022

The robust expertise of IASO in monitoring possibly best-in-class CARs leveraging its fully-human antibody discovery platform (IMARS), quickly conducting clinical trials and its in-house GMP facility for producing plasmid, virus vector and CAR-T cells intends to make its new therapies available to larger population across the world.

Biopharma 110

Biopharma Engineering Manufacturing Patients 110

European Pharmaceutical Review

DECEMBER 5, 2022

MOMENTUM was a randomised, double-blind Phase III clinical trial of momelotinib versus danazol in symptomatic and anaemic myelofibrosis patients treated with a US Food and Drug Administration (FDA)-approved JAK inhibitor. The Phase III trial for momelotinib. Further developments for the myelofibrosis treatment.

Food and Drug Administration 78

Food and Drug Administration Marketing Food Medicine 78

PharmaTech

JULY 26, 2022

AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.

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European Pharmaceutical Review

MARCH 14, 2023

Pfizer stated the intended combination with Seagen would double its early-stage oncology clinical pipeline. Its portfolio includes four approved medicines that are first- or best-in-class across solid tumours and hematologic malignancies.

Food and Drug Administration 109

Food and Drug Administration Medicine Engineering Food 109

Pharmacy Times

JANUARY 13, 2023

Developments may soon impact clinical practice in hematology and oncology.

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European Pharmaceutical Review

OCTOBER 13, 2023

Advancing treatments for follicular lymphoma Despite advances in the treatment landscape, follicular lymphoma patients “often relapse and experience shorter response times to subsequent treatments,” according to Dr Mehrdad Mobasher, Chief Medical Officer of Hematology at BeiGene.

Medicine 98

Medicine Safety Patients Healthcare 98

Pharmaceutical Technology

SEPTEMBER 2, 2022

Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.

Biopharma 105

Biopharma Leads Patients Pharmaceutical 105

Pharmaceutical Technology

FEBRUARY 24, 2023

Amlitelimab is under clinical development by Kymab and currently in Phase II for Asthma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It employs its proprietary technology platform to discover human antibody candidates against disease targets.

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European Pharmaceutical Review

NOVEMBER 16, 2023

Clinical data from ongoing Casgevy/exa-cel clinical trials MHRA highlighted that in the ongoing trial for sickle-cell disease, 45 patients have received Casgevy. In the ongoing clinical trial for transfusion-dependent β-thalassemia, 54 patients have currently received Casgevy.

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Safety Side effects Medicine Patients 96

European Pharmaceutical Review

JANUARY 5, 2023

The clinical study for the telomerase inhibitor met its primary efficacy endpoint of eight-week TI and a key secondary endpoint of 24-week TI. Patients also experienced a statistically significant (p=0.042) and clinically meaningful mean reduction in red blood cell (RBC) transfusion units compared to placebo. dL for placebo.

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Safety Patients Medical Pharmaceutical 52

European Pharmaceutical Review

NOVEMBER 16, 2023

In the past couple of months, BeiGene has experienced regulatory progress for two of its oncology assets in clinical development. What is the main challenge in advancing a drug through the clinical development process? Clinical trials account for over 90 percent of the cost and time of developing a new medicine.

Medicine 52

Medicine Manufacturing Medical Patients 52

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Malignant Mesothelioma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz.

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Prescription Pharmaceutical products Networking Manufacturing 40

European Pharmaceutical Review

AUGUST 9, 2023

GlobalData’s analyst also shared that the company’s analysis revealed there are “almost 200 products in clinical trial Phases I, II, and III for different cancer types [in the ADC pipeline].” ADC drugs are versatile and have “potential to change oncology care,” commented Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData.

Marketing 93

Marketing Pharmaceutical Manufacturing 93

Pharma Leaders

JUNE 5, 2023

The study demonstrated a clinical benefit rate of 93.8% Innovent Biologics senior vice-president Dr Hui Zhou said: “We are glad to see the NMPA grants another BTD for olverembatinib, marking a major milestone in its clinical development and demonstrating its therapeutic potentials beyond hematologic malignancies. “We

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Pharma Patients Medical 52

Pharma Leaders

APRIL 12, 2023

ImmuneBridge is developing allogeneic NK cell-based immunotherapies to treat solid tumours and hematologic malignancies. The company’s orthogonal approach leverages an expansion technology and a diverse clinic-ready source for accelerating the discovery and translation of potent cell therapies. “It

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Engineering Manufacturing Medicine Management 52

European Pharmaceutical Review

OCTOBER 12, 2023

Additionally, 14 new small molecules for treating lung cancer are currently undergoing Phase III clinical trials, GlobalData noted. This ensures that a wider spectrum of patients can reap the benefits of targeted small-molecule medicines like Tagrisso,” Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData commented.

Marketing 84

Marketing Sales Medicine FDA 84

Medgadget

OCTOBER 27, 2022

With many anti-cancer therapies failing at the clinical trial stage and the ethical considerations of animal studies, there is a need for better in vitro cancer models that allow for advanced therapeutic testing. The scientists used a technique called aspiration-assisted bioprinting to achieve this.

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Ethics Engineering Safety Patients 126

European Pharmaceutical Review

APRIL 19, 2023

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study.

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FDA Food and Drug Administration Food Patients 111

European Pharmaceutical Review

FEBRUARY 24, 2023

Treating muscle inflammation with CAR-T cells “CAR T-cells are immune cells withdrawn from the patient’s blood and genetically engineered to carry a CAR,” explained Professor Andreas Mackensen, Director of Department of Medicine 5 – Hematology and Oncology. The researchers modified the patients’ own immune cells.

Medicine 128

Medicine Engineering Physicians Patients 128

Pharmaceutical Technology

MARCH 3, 2023

Bristol Myers Squibb Hematology Development senior vice-president Noah Berkowitz said: “Beta thalassemia is an inherited blood disorder that puts patients at significant risk for long-term clinical complications due to anaemia, leaving a substantial need for treatment options, regardless of a patient’s dependence on blood transfusions.

Marketing 59

Marketing Safety Patients Pharma 59

European Pharmaceutical Review

NOVEMBER 7, 2022

It identifies candidates with preliminary clinical evidence offering substantial improvement over existing therapies. Elranatamab clinical trial data. Updated trial data will be presented at the American Society of Hematology Annual Meeting and Exposition (ASH) in December 2022. The majority were either Grade 1 (43.2

Food and Drug Administration 97

Food and Drug Administration Medicine Safety FDA 97

Pharmaceutical Technology

JUNE 27, 2022

BMS US Hematology senior vice-president and general manager Ester Banque said: “As part of our commitment to developing innovative cancer treatments for patients with critical unmet need, Breyanzi offers a potentially curative option for more patients.

Food and Drug Administration 105

Food and Drug Administration FDA Food Safety 105

Pharmaceutical Technology

SEPTEMBER 8, 2022

With our proven track record in cancer immunotherapy, we are well-positioned to leverage our deep discovery, development, clinical, and manufacturing capabilities and worldwide reach to potentially bring innovative products from this programme to patients as fast as possible.”.

Biopharma 111

Biopharma Manufacturing Patients Pharma 111

European Pharmaceutical Review

OCTOBER 26, 2023

In August 2023, Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData shared that HER2-positive breast cancer “seems to be a major focus” in ADC drug development. Clinically meaningful PFS benefit was seen in patients with non-squamous tumours. What are the current trends in clinical development for oncology?

Patients 96

Patients Pharmaceutical Safety Marketing 96

European Pharmaceutical Review

AUGUST 16, 2022

BeiGene is developing tislelizumab internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumour and hematologic cancers. BeiGene said it was planning to share the full clinical trial results at an upcoming medical conference. The BLA is still under review.

Food and Drug Administration 98

Food and Drug Administration Patients Safety Food 98

World of DTC Marketing

SEPTEMBER 7, 2022

According to JAMA , “in a cross-sectional study, between May 1, 2016, and May 31, 2021, there were 207 cancer drug approvals in oncology and malignant hematology. ASH Clinical News takes it a step further. The biggest battle arena by far is oncology. ” The U.S. oncology therapeutics market has reached $71 billion.

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Pharma Food and Drug Administration Marketing Prescription 210

European Pharmaceutical Review

NOVEMBER 21, 2023

Clinical data for BRUKINSA The EC’s decision is based on positive results from the Phase II ROSEWOOD trial , which compared the combination treatment with obinutuzumab monotherapy in 217 patients. These findings are expected to be shared at the 2023 American Society of Hematology (ASH) meeting next month.

Engineering 96

Engineering Medical Patients Medicine 96

Pharmaceutical Technology

MAY 31, 2023

ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also has pre-clinical research and development to extend its product development.

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