Pharmaceutical Executive Editorial Staff Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial show that Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula (niraparib) as maintenance therapy, achieved the primary endpoint of progression-free survival (PFS). The combination led to a statistically significant and clinically meaningful benefit across the overall patient population and among a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors in those with primary advanced or recurrent endometrial cancer. “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” Hesham Abdullah, senior ...
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024. By FRANK VINLUAN GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a ...
Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024. By FRANK VINLUAN Illumina is done fighting in the courts to keep cancer-detection company Grail. The gene-sequencing giant had previously pledged to divest Grail if it did not win either the U.S. or European appeals of anti-trust cases challenging the acquisition. A U.S. appeals court came down against the Federal Trade Commission’s case on Friday, but in a narrow way that hardly handed Illumina a clear victory. After reviewing the decision, Illumina said Sunday that it has decided against further litigation. The company will divest Grail. The planned divestiture is the latest step in a journey that started within Illumina. Grail began as research within the San Diego company. Grail spun out ...
On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023,— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). Welireg becomes the first drug in its class for patients with advanced RCC and the first novel-class treatment in the indication since 2015, Merck noted. The nod comes on top of its original approval to treat the rare von Hippel-Lindau disease, a hereditary condition that causes tumor growth in ...
On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
For a long time, visible signs of tumor growth on scans were the benchmark for initiating cancer treatment. However, the emergence of precision oncology tools, including circulating tumor DNA sequencing, is changing this approach. These advancements allow for earlier cancer detection and adaptation of treatment strategies to combat mutations that cause resistance to current therapies. They also offer the potential for less toxic alternatives to chemotherapy. New research led by a clinical scientist at UC Davis Health (Sacramento, CA, USA) highlights the benefits of using blood tests to search for cancer DNA. This method can speed up cancer detection and inform the use of targeted treatments. Cancer DNA circulating in a patient’s blood can be identified from a simple blood draw. This DNA is then sequenced to determine its genetic structure, helping to classify the cancer based on the findings in the blood sample. Unlike traditional tissue biopsies, which are ...
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