Search Results for “cancer” – Page 102 – media

FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies

Shanghai, China, December 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation(FTD) for HLX42, an investigational EGFR-Targeting ADC that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a 3rd-generation EGFR tyrosine kinase inhibitor. Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and FDA. Yongqiang Shan, general manager of Henlius’ Global Innovation Center, said: “I am glad to see the continuous progress we have made in advancing our ADC portfolio. The grant of FTD represents FDA’s recognition of HLX42’s potential in addressing serious diseases that filled unmet medical needs. In the future, Henlius will maintain our focus on areas of unmet medical needs and accelerate the development and delivery ...
- Source: drugdu
- 234
- December 29, 2023
AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

Dec 26 (Reuters) – AstraZeneca (AZN.L) said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market. The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on Dec. 22. The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met. Shares of China-headquartered Gracell surged 60% in premarket trading in the United States. Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body. H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s ...
- Source: drugdu
- 176
- December 28, 2023
BMS agrees to acquire Karuna Therapeutics for $14bn

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
- Source: drugdu
- 190
- December 28, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 187
- December 27, 2023
M&A saw an uptick in 2023. Analysts expect the trend to continue

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 ...
- Source: drugdu
- 216
- December 26, 2023
Anke Biotechnology’s Joint Venture Company, Yuan Song Biotechnology, Receives FDA Approval for the First Oncolytic Virus National Class I New Drug IND Application

According to the announcement from Anke Biotechnology’s joint venture company, Yuan Song Biotechnology: Shanghai Yuan Song Biotechnology Co., Ltd. (hereinafter referred to as “Yuan Song Biotech”) announced that its independently developed oncolytic virus anticancer drug, “Recombinant L-IFN Adenovirus Injection,” obtained the Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) on December 21, 2023. Dr. Zhang Kangjian, Co-founder and General Manager of Yuan Song Biotech, stated that the successful completion of the IND in the United States is a significant milestone for Yuan Song Biotech, a company dedicated to the development of oncolytic virus anticancer clinical drugs. This achievement not only validates our research and development strategy and technological platform for industrialization but also demonstrates Yuan Song Biotech’s clinical development capabilities in the field of targeted gene-virus therapy. This includes oncolytic adenovirus process development, quality method research, high-quality preclinical studies, and clinical research. With the ...
- Source: drugdu
- 174
- December 26, 2023
Henlius Passes Its Second EU GMP Inspection

Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards. The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ...
- Source: drugdu
- 96
- December 26, 2023
Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F

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 ...
- Source: drugdu
- 81
- December 25, 2023
The First Da Vinci Xi Surgical Robot Made in China Officially “Onboarded”, Making High-Quality Medical Resources More Accessible

On December 18, the start-up ceremony of the Da Vinci surgical robot was successfully held in Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. This marks that the first domestic Da Vinci Xi surgical robot has officially settled in Gansu Hospital of Sun Yat-sen University Cancer Hospital, helping the construction of the national regional medical center, bringing more efficient, accurate and safer surgical treatments to the majority of patients, and marking the commercialization of the domestic Da Vinci surgical robot into the era. After the launching ceremony, the Da Vinci Xi surgical robot was formally “on duty” in the operating room of Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. With the assistance of the surgical robot, Executive Director Prof. Liu Zhuowei’s team successfully performed “robot-assisted partial nephrectomy” for the patient. Prof. Liu Zhuowei introduced that the surgical robot makes the surgical incision smaller, less painful, shortens the ...
- Source: drugdu
- 99
- December 21, 2023
Fluorescence Microscopy Combined with AI Enables Detection of Tumors at Early Stage

Detecting cancer in the body or monitoring it during therapy is typically a time-consuming process, often conducted in later phases when signs become obvious. Researchers engaged in cancer research are continuously seeking reliable and sensitive techniques to detect a developing tumor at a very early stage and to closely monitor the success or failure of cancer therapy. Therefore, a breakthrough in early cancer diagnosis is a significant advancement. Researchers have now achieved a breakthrough with the development of a test for early diagnosis of cancer. Researchers at the Paul Scherrer Institute (Würenlingen, Switzerland) have demonstrated that changes in the organization of the cell nucleus of certain blood cells can reliably indicate the presence of a tumor in the body. Using fluorescence microscopy, the team examined the chromatin of these blood cells – DNA packaged into a complex structure. They analyzed about 200 different characteristics, including the external texture, the packing ...
- Source: drugdu
- 107
- December 20, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.