Search Results for “ breast cancer” – Page 23 – media

FUTURE-SUPER study was published in The Lancet Oncology, China’s pharmaceutical innovation helps advanced TNBC to move towards precision treatment

Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
- Source: drugdu
- 162
- January 13, 2024
Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

COLUMBUS, Ohio, & SHANGHAI, Jan. 11, 2024 – Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 ...
- Source: drugdu
- 82
- January 12, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 124
- January 11, 2024
First to take 12 months of market exclusivity! Zhengda Tianqing Everolimus Tablets first generic listing

On December 26, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, approving the registration and listing of Everolimus Tablets (trade name: Chingvishi). Evervimox Tablet is not only the first generic in China, but also the first product that has been granted 12 months of market exclusivity due to “first generic approval + first successful patent challenge” since the implementation of the mechanism for early resolution of drug patent disputes (Drug Patent Linkage System) in China. The approved indications of Zhengda Tianqing Everolimus Tablets are: (1) Adult patients with advanced renal cell carcinoma who have failed prior treatment with sunitinib or sorafenib. (2) Adult patients with unresectable, locally advanced or metastatic, well-differentiated (moderately differentiated or highly differentiated) progressive pancreatic neuroendocrine tumors. (3) Adult patients with unresectable, locally advanced or metastatic, well-differentiated, progressive non-functional gastrointestinal or lung-derived neuroendocrine tumors (NET). (4) Adult and pediatric patients with ...
- Source: drugdu
- 186
- January 7, 2024
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
- 131
- December 14, 2023
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1

December 11, 2023—SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb (NYSE: BMY) today announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world. BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center Phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical ...
- Source: drugdu
- 126
- December 13, 2023
As ICER places a spotlight on pharma’s price hikes, J&J, Roche and more hit back

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
- Source: drugdu
- 95
- December 13, 2023
Pfizer and Arvinas plan vepdegestrant programme expansion after data at SABCS.

Pfizer and Arvinas are broadening their vepdegestrant programme to include more settings, as positive data is reported from the Phase Ib study of the drug to treat breast cancer. Vepdegestrant is an orally administered protein degrader designed as a proteolysis targeting chimera (PROTAC) that targets both wild-type and mutant oestrogen receptor (ER) found in some breast cancers. The collaboration between the two companies began in July 2021 in a $2.4bn deal to develop the PROTAC drug. Under the terms of the agreement, both firms would co-develop and market vepdegestrant. In the abstract on data from a Phase Ib study (NCT04072952) presented at the ongoing 2023 San Antonio Breast Cancer Symposium (SABCS), the reported clinical benefit rate (CBR) was 37.1% with 200mg and 38.9% with 500mg of the drug amongst 71 patients who received either dose (abstract no. Abstract GS3-03). The treatment was generally well tolerated, with the most common side ...
- Source: drugdu
- 102
- December 9, 2023
Eli Lilly advances small molecule drug portfolio with Prism Biolab partnership

Eli Lilly is building on its small drug molecule portfolio with a partnership with Prism Biolab to develop and commercialise small molecules that modulate targets picked by Lilly. As part of the agreement, Prism will receive upfront payments and up to $660m based on preclinical, clinical, and commercial development milestone payments, along with royalty payments. This alliance will utilise Prism’s PepMetics technology platform to discover oral protein-protein interaction (PPI) targets. Lilly has made several moves in the last couple of years to develop small-drug molecules. Earlier this month, the company was one of the investors in Alto Neuroscience’s $45m Series C financing round, which will support Alto’s clinical programme of four small-molecule CNS candidates to treat psychiatric disorders including depression and post-traumatic stress disorder. Alto is expecting positive topline data from Phase II studies investigating two of the molecules, ALTO-100 and ALTO-300, in H2 2024 and H1 2025, respectively. In ...
- Source: drugdu
- 101
- December 1, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 177
- November 26, 2023

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