Pharmaceutical Technology

DECEMBER 11, 2024

The prevailing treatment paradigm for newly diagnosed multiple myeloma (NDMM) patients who have received autologous stem cell transplantation (SCT) primarily consists of chemotherapy or Johnson & Johnsons (J&J) Darzalex in combination with chemotherapy.

Chemotherapy 59

Chemotherapy 59

Pharmacy Times

MARCH 14, 2025

Tarlatamab was approved by the FDA in May 2024 for patients who progressed after platinum-based chemotherapy.

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Chemotherapy 47

Pharmacy Times

DECEMBER 11, 2024

Assessing pre-treatment TIL levels in young breast cancer patients could help predict response to neoadjuvant chemotherapy.

Immunization 52

Immunization Immunity Chemotherapy 52

Big Molecule Watch

JANUARY 10, 2025

Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

European Pharmaceutical Review

MAY 20, 2024

This includes antibody production, chemotherapy drug and linker synthesis, conjugating the drug-linker to the antibody, as well as filling of the completed ADC substance, AstraZeneca confirmed. The pharmaceutical firm stated that it is planning to begin the design and construction of the manufacturing facility by the end of 2024.

Chemotherapy 98

Chemotherapy 98

European Pharmaceutical Review

OCTOBER 25, 2024

The biologic ZL-1310 is being investigated in an ongoing Phase Ia/Ib study in these patients who have had at least one platinum-based chemotherapy regimen. This initial data on ZL-1310 was presented this week at the EORTC-NCI-AACR (ENA) Symposium 2024.

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Chemotherapy Compounding Immunity Immunization 97

Pharmaceutical Technology

SEPTEMBER 6, 2022

Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. . It also boosts the drug’s safety, tolerability and efficacy.

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Chemotherapy Drug Development 98

Pharmaceutical Business Review

APRIL 25, 2024

GSK has received the US Food and Drug Administration’s (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel). It was conducted in two parts.

Chemotherapy 59

Chemotherapy 59

PharmExec

DECEMBER 5, 2023

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Chemotherapy 52

Chemotherapy 52

European Pharmaceutical Review

FEBRUARY 21, 2024

TAGRISSO as a combination treatment with chemotherapy was recently approved in the US, based on data from the FLAURA2 Phase III trial. Results from a Phase III trial in the neoadjuvant setting are expected later in 2024. According to AstraZeneca, the small molecule treatment TAGRISSO is also being investigated in two Phase III trials.

Chemotherapy 105

Chemotherapy 105

pharmaphorum

AUGUST 31, 2022

In May, a Phase 2 study started, comparing Kaiku’s electronic patient-reported outcome (ePRO) approach to evaluating immune-related adverse events to the standard model of care in cancer patients treated with checkpoint inhibitor drugs, with results due towards the end of 2023 or in early 2024.

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Chemotherapy Immunity Immunization Hospitals 116

Big Molecule Watch

FEBRUARY 6, 2025

Chinas National Medical Products Administration (NMPA) previously accepted the new drug application (NDA) for HLX11 on December 4, 2024. The BLA for HLX11 is supported by data from a series of studies for HLX11 versus PERJETA, including analytical similarity studies and two comparative clinical studies.

Biosimilars 59

Biosimilars Chemotherapy 59

Pharmaceutical Business Review

AUGUST 19, 2024

The application for ENHERTU is supported by data from the DESTINY-Breast06 Phase III trial, which was highlighted at the 2024 American Society of Clinical Oncology Annual Meeting. These patients had not received prior chemotherapy for advanced disease and had undergone at least two lines of endocrine therapy in the metastatic setting.

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Chemotherapy Labelling 59

pharmaphorum

MARCH 25, 2022

facility at Kent Science Park (KSP) in Sittingbourne is due to open in 2024, and when fully operational will create more than 100 new highly skilled jobs. If trials are successful, nabiximols could become one of the first additions to treatment for glioblastoma patients since temozolomide chemotherapy in 2007. The 60,000 sq.

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Chemotherapy Pharmaceutical Manufacturing 98

Pharmaceutical Business Review

OCTOBER 23, 2024

The transaction is expected to be finalised in the fourth quarter of 2024, subject to standard closing conditions. It is used in combination with chemotherapy for adult patients with metastatic HER2-positive breast cancer who have previously undergone two or more anti-HER2 regimens.

Chemotherapy 52

Chemotherapy 52

Express Pharma

MAY 6, 2024

This antibody-directed killing of cancer has the potential to substantially increase the outcomes of current cancer therapies, such as chemotherapy. One of its drugs, Rina-S, is a potential best-in-class ADC that was granted Fast Track designation by the FDA in early 2024 for the treatment of ovarian cancer. billion in 2023.

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Chemotherapy 93

Express Pharma

JUNE 13, 2024

CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, chemotherapy remains the mainstay of treatment across the first and second line for advanced pancreatic cancer.

Chemotherapy 105

Chemotherapy 105

Big Molecule Watch

FEBRUARY 7, 2025

CuraTeQ Biologics DYRUPEG , a biosimilar referencing NEULASTA (pegfilgrastim), is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Biosimilars 59

Biosimilars Chemotherapy Diabetes 59

Pharmacy Times

SEPTEMBER 16, 2024

Abstracts from the OrigAMI-1 and MARIPOSA-2 trials indicated the treatment benefits of amivantamab-vmjw and chemotherapy in multiple cancer indications.

Chemotherapy 20

Chemotherapy 20

Express Pharma

AUGUST 2, 2024

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and paediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Chemotherapy 52

Chemotherapy Labelling 52

Pharmaceutical Business Review

JULY 5, 2024

The medication is indicated for use in various patient groups, including those with newly diagnosed Acute Myeloid Leukemia (AML) who are over 75 years old or have other health conditions that prevent them from undergoing intensive chemotherapy.

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Dosage Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

JANUARY 23, 2023

The drug achieved an impressive 84% overall survival rate over 18 months in patients with advanced GEA who received it as a first-line therapy in combination with chemotherapy, according to data from the open-label study. GEA is the fifth most common cancer worldwide, and around one in five patients have tumours that are HER2-positive.

Chemotherapy 52

Chemotherapy Labelling 52

Big Molecule Watch

DECEMBER 16, 2024

IMFINZI was approved for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted after securingPriority Reviewand Breakthrough Therapy Designation for this indication in August 2024.

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Chemotherapy 45

Big Molecule Watch

SEPTEMBER 29, 2023

FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 20, 2024, for the application. The post FDA Grants Priority Review to Merck’s Application for KEYTRUDA (pembrolizumab) as Part of Treatment for Early-Stage Cervical Cancer appeared first on Big Molecule Watch.

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Chemotherapy 45

Pharmaceutical Business Review

APRIL 8, 2024

As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion.” Submissions for New Drug Applications (NDAs) in the US and EU are expected in 2024. The post US FDA grants breakthrough status to Dizal’s sunvozertinib appeared first on Pharmaceutical Business review.

Chemotherapy 59

Chemotherapy 59

European Pharmaceutical Review

AUGUST 12, 2024

The deal is anticipated to be finalised in Q3 of 2024. It is the first anti-PD-1 therapy approved for use together chemotherapy in adults who have primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.

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Research Laboratories Chemotherapy Drug Development 59

Pharmaceutical Technology

MAY 2, 2023

Part of the proceeds will be used to fund our wholly owned pamrevlumab programme as we anticipate five Phase III readouts to occur before mid-2024.” FibroGen CEO Enrique Conterno stated: “With the current momentum across our development programmes, this financing strengthens our balance sheet.

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Chemotherapy 52

Pharmaceutical Business Review

MARCH 19, 2024

The acquisition is a significant step in AstraZeneca’s strategy to transform cancer treatment by offering more targeted therapies as alternatives to traditional treatments like chemotherapy and radiotherapy. This represents a 126% premium to Fusion’s closing market price on 18 March 2024, and a 111% premium to the 30-day VWAP.

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Chemotherapy 59

Pharmacy Times

DECEMBER 14, 2024

Adding anthracyclines to chemotherapy may improve survival in high-risk breast cancer patients.

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Chemotherapy 26

Pharmaceutical Technology

JUNE 15, 2023

PEMRYDI RTU is indicated as an initial treatment, along with pembrolizumab and platinum chemotherapy, for metastatic non-squamous non-small cell lung cancer patients with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour aberration.

Chemotherapy 52

Chemotherapy 52

Big Molecule Watch

DECEMBER 16, 2024

On December 3, 2024, Accord BioPharma, Inc. UDENYCA , the only biosimilar to Amgens NEULASTA in the United States, is administered the day after chemotherapy treatment to decrease the incidence of infection by febrile neutropenia. Accord), the U.S. specialty division of Intas Pharmaceuticals, Ltd.

Biosimilars 45

Biosimilars Chemotherapy 45

PharmaShots

JUNE 19, 2023

This test can help veterinary professionals to detect kidney injury before it affects kidney function & may result in better patient outcomes The test will be conducted at IDEXX Reference Laboratories in the US & Canada with plans to roll out in the EU in 2024. IDEXX’s suite of kidney health diagnostics incl.

Chemotherapy 40

Chemotherapy 40

European Pharmaceutical Review

DECEMBER 28, 2023

As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients. We have now already treated the first patients and are expecting the first results from this study in the first half of 2024. 

Immunity 84

Immunity Immunization Chemotherapy Medical Schools 84

pharmaphorum

MARCH 8, 2022

In the study, Trodelvy (sacituzumab govitecan) met its objective of reducing progression-free survival in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment – including endocrine drugs, CDK4/6 inhibitors and two to four lines of chemotherapy.

Chemotherapy 52

Chemotherapy Documentation Labelling 52

epicur

MAY 6, 2024

More Resources Building a Successful Inventory Management System with Nicole Clausen May 6, 2024 No Comments In her recent Meet the Team blog, Advisory Council member Nicole Clausen shared great insights on how far veterinary inventory management has come since she joined the profession. Thanks for sharing these great tips, Nicole!

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Customer Service Compounding Chemotherapy Online Pharmacies 52

European Pharmaceutical Review

JULY 18, 2024

1,2 This is especially important in forms of cancer where chemotherapy remains the main treatment option. Because ADCs offer a good way to specifically deliver an effective treatment to tumour systems, this could be an improvement on the systemic impact of chemotherapy. Rise of Antibody-Drug Conjugates: The Present and Future.

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Chemotherapy Clinical Pharmacology 59

pharmaphorum

OCTOBER 10, 2022

The study showed that the combination has the potential to “provide a safer and better tolerated alternative” to the use of PD-1/PD-L1 drugs plus chemotherapy in first-line NSCLC, the current standard of treatment, according to Dr Chris Redhead of Goetz Partners. month mPFS with Keytruda plus chemo, with fewer side effects.

Chemotherapy 59

Chemotherapy Biosimilars 59