Big Molecule Watch

FEBRUARY 6, 2025

On February 2, 2025, Shanghai Henlius Biotech, Inc. Henlius) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentechs PERJETA. This marks the first U.S.BLAacceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer.

Biosimilars 59

Biosimilars Chemotherapy 59

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Biosimilars 126

Biosimilars Chemotherapy Immunization Immunity 126

pharmaphorum

AUGUST 22, 2021

The PD-1 inhibitor has been approved to treat patients regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status, and UC becomes the third indication for Opdivo as an adjuvant therapy after oesophageal/gastro-oesophageal cancer and melanoma.

Chemotherapy 78

Chemotherapy Immunity Immunization 78

Pharmaceutical Technology

JUNE 4, 2023

Patients with resectable stage II, IIIA, and IIIB (T3-4N2) disease of both squamous and non-squamous histology were randomized to receive neoadjuvant Keytruda with platinum-based chemotherapy followed by adjuvant Keytruda, or placebo with platinum-based chemotherapy followed by placebo. At a median duration of follow-up of 25.2

Chemotherapy 75

Chemotherapy Hospitals 75

pharmaphorum

AUGUST 9, 2022

The data provide proof-of-principle for the use of MET-targeting drugs to offset Tagrisso resistance, and charts a way forward towards regulatory approvals of the combination as an alternative to chemotherapy for these patients. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Chemotherapy 52

Chemotherapy Labelling 52

European Pharmaceutical Review

JUNE 27, 2024

Immunotherapy in oncology “The addition of pembrolizumab to chemotherapy represents a new frontline therapeutic option for patients with primary advanced or recurrent endometrial carcinoma” Moreover, last week saw US regulatory approval of a combination treatment for endometrial cancer : KEYTRUDA (pembrolizumab) plus chemotherapy.

Chemotherapy 64

Chemotherapy 64

pharmaphorum

OCTOBER 19, 2022

Zanidatamab is an HER2-targeted bispecific antibody with multiple novel mechanisms of action that has demonstrated ‘compelling’ anti-tumour activity in several HER2-expressing cancers, operating both as a monotherapy and in combination with chemotherapy and other agents. Zanidatamab is based on Zymeworks’ Azymetric platform.

Chemotherapy 40

Chemotherapy 40

Quality Matters

FEBRUARY 6, 2025

Because of a monoclonal antibody's ability to recognize and connect to a cancer cell, it can serve as a delivery vehicle for other treatments, such as chemotherapy and radiation. josh.levin@usp.org Thu, 02/06/2025 - 15:01 Biologics

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Immunity Immunization Biosimilars 52

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. 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

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

pharmaphorum

MARCH 9, 2021

Now, people living with particular types of lymphoma have individualised options beyond chemotherapy for the first time.”. Our strategy for 2020-2025: Changing how people live with lymphoma. Last accessed March 2021. Lymphoma Action. Fundraising Support Assistance: Recruitment Pack. 2018, page 3. Lymphoma Action. Available at: [link].

Chemotherapy 52

Chemotherapy Communication Immunization Immunity 52

European Pharmaceutical Review

FEBRUARY 3, 2025

EMAs human medicines committee (CHMP) recommended eight medicines for EU marketing authorisation at its January 2025 meeting. Biosimilars given a positive opinion Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy.

Vaccines 52

Vaccines Generic Medicine Chemotherapy Biosimilars 52

LifeProNow

FEBRUARY 3, 2025

January 28, 2025: “Pfizer will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress.

Chemotherapy 130

Chemotherapy Labelling 130

Express Pharma

FEBRUARY 11, 2025

According to the release, the data will be presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium 2025 in San Francisco. The combination of enfortumab vedotin and pembrolizumab was associated with a 49 per cent reduction in the risk of death compared to chemotherapy, with a hazard ratio of 0.51

Chemotherapy 66

Chemotherapy 66