Search Results for “cancer” – Page 104 – media

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
- 121
- 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
- 91
- December 13, 2023
Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Last month, Bristol Myers Squibb made the surprise announcement that the FDA will convene an advisory committee meeting to discuss the company’s bid to move the CAR-T therapy Abecma into earlier lines of treatment. Now, we know at least one reason why the FDA wants more opinions on the application. Abecma showed no advantage in extending patients’ lives compared with standard combination regimens when used in multiple myeloma patients after two to four prior lines of therapy, according to an updated interim analysis of the phase 3 KarMMa-3 trial presented at the 65th American Society of Hematology annual meeting. The statistical analysis revealed a negligible 1% increased risk of death for Abecma. But median overall survival looks better for Abecma, as patients lived a median of 41.4 months versus 37.9 months for control. The lack of an overall survival showing came in stark contrast to the 51% reduction in the ...
- Source: drugdu
- 94
- December 13, 2023
Nanopore Sequencing Cuts Tumor Analysis Times and Costs, Finds Study

Copy number variations (CNVs), which activate oncogenes and inactivate tumor suppressor genes, play a crucial role in the development and progression of cancers. As such, CNV analysis is a vital component of tumor grading and diagnosis. Traditionally, this analysis relies on nucleotide hybridization and next-generation sequencing, methods confined to high-complexity centralized laboratories and requiring several days to complete. A more rapid, cost-effective, and straightforward approach to CNV analysis could significantly enhance clinical decision-making, refine surgical planning, and facilitate the identification of potential molecular therapies within the timeframe of surgical procedures. Researchers have now identified nanopore sequencing as a method to refine CNV analysis. A study conducted by researchers at Dartmouth-Hitchcock Medical Center (DHMC, Lebanon, NH, USA) has found nanopore sequencing to be a more efficient means for CNV analysis. They used Oxford Nanopore’s MinION device, which offers real-time interpretation of long-read nucleotide sequences. To adapt this technology for CNV detection, ...
- Source: drugdu
- 99
- December 13, 2023
Seagen’s Adcetris and Bristol’s Opdivo boost hopes for another ADC, PD-1 combo

If you can’t beat them, join them. After Bristol Myers Squibb’s Opdivo topped Seagen’s classical Hodgkin lymphoma (cHL) therapy Adcetris in a head-to-head trial, Seagen has trotted out new datasets suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together as part of a combination. In a midstage study, all patients with early-stage cHL who received a combination of Adcetris, Opdivo and the chemotherapy regimen AD (doxorubicin and dacarbazine) were alive without disease progression after one year of treatment. The analysis came from 150 patients enrolled in part C of the phase 2 SGN35-027 trial and was shared at the 65th American Society of Hematology annual meeting. The data look promising, but cHL is known to be relatively easy to treat. In an interview, Megan O’Meara, M.D., Seagen’s head of clinical development, acknowledged that people want to see longer-term data—and ultimately a survival benefit—in frontline cHL. ...
- Source: drugdu
- 107
- December 12, 2023
Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Groundbreaking? Game-changing? Transformational? Historic? None of the buzzwords sound adequate to describe Friday’s FDA approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) to treat sickle cell disease (SCD). The therapy is a long-awaited potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black. It’s also the first medicine using the revolutionary CRISPR gene-editing system, which earned its inventors a Nobel Prize in 2020 and holds tantalizing potential to cure diseases for which there is no treatment. Friday, in surprising timing, the FDA approved a second gene therapy for SCD, bluebird bio’s Lyfgenia (lovo-cel), which was due for a decision Dec. 20. Both approvals are for people 12 and older. The FDA has signed off on roughly two dozen cell or gene therapies, beginning with Novartis’ Kymriah in 2017, but none have the potential impact of Casgevy and Lyfgenia. ...
- Source: drugdu
- 110
- December 12, 2023
China Biopharm’s TQA3038 “siRNA” Phase I Clinic Completes Dosing in First Batch of Subjects

On December 5, China Biopharm announced that it is conducting a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038, a small interfering RNA (siRNA) targeting the hepatitis B virus (HBV) developed independently by China Biopharm for the indication of chronic hepatitis B (CHB). TQA3038 is a small interfering RNA (siRNA) drug developed independently by China Biopharmaceuticals targeting HBV, with the indication of chronic hepatitis B. The first human clinical trial of TQA3038 has been completed with the enrollment of the first batch of subjects, and the dosing process went smoothly, and post-dosing observation has been completed. Chronic hepatitis B is a serious public health problem worldwide, with approximately 290 million chronically infected patients worldwide. China is a high prevalence area of hepatitis B. It is estimated that there are about 86 million chronic HBV-infected patients, and a large number of patients ...
- Source: drugdu
- 102
- December 12, 2023
Dizal’s Golidocitinib Pivotal Trial Demonstrates Superior and Durable Clinical Benefits for Patients with r/r PTCL in Oral Presentation at 2023 ASH

Shanghai, December 10, 2023 – Dizal today presented the full analysis of the multinational pivotal study of golidocitinib for r/r PTCL (JACKPOT8 PART B) in an oral presentation at the 65th American Society of Hematology Annual Meeting and Exposition (2023 ASH, San Diego). The results were simultaneously published in the prestigious peer-reviewed journal The Lancet Oncology (Impact Factor: 54.4). This follows the publication of the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PART A) in Annals of Oncology (Impact Factor: 51.8) three months ago. Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. A total of 104 patients with r/r PTCL were enrolled in the JACKPOT8 PART B study to evaluate the efficacy and safety of golidocitinib as a monotherapy. At the cut-off date of August 31, 2023, per independent review committee ...
- Source: drugdu
- 94
- December 12, 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
- 99
- December 9, 2023
Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case

After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. The case stems back to 2017 and has its roots in Novartis’ Tafinlar, a melanoma therapy that the company acquired from GSK after a 2015 asset swap. Daiichi’s former subsidiary Plexxikon, which makes melanoma treatment Zelboraf, alleged that GSK scientists only gathered the knowledge necessary to develop the rival drug after consulting with Plexxikon for talks about a partnership that never came to fruition. Plexxikon’s patents date back to 2005, while GSK filed its first patent application on the drug in 2008, Plexxikon said. In 2021, a Northern California jury ruled in favor of Plexxikon, determining that Novartis stepped on two of the Daiichi subsidiary’s patents. Novartis was ordered to pay Daiichi’s subsidiary 9% royalty payments on future Tafinlar sales until certain Zelboraf patents expire ...
- Source: drugdu
- 99
- December 8, 2023

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