Search Results for “cancer” – Page 100 – media

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
- 182
- January 7, 2024
New Drug Application Accepted for Garsorasib (D-1553, KRAS G12C Inhibitor)

On December 29, 2023, China’s National Drug Administration (NMPA) has formally accepted the New Drug Application (NDA) for Garsorasib tablets (D-1553 tablets, KRAS G12C inhibitor) for the treatment of locally advanced or metastatic non-small-cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy, and with the presence of a KRAS G12C mutation confirmed by testing. metastatic non-small cell lung cancer. This NDA acceptance is primarily based on the results of a Phase II single-arm registrational clinical study (Study D1553-102, CDE Registry No. CTR20220745) conducted in China with Professor Lu Shun of Shanghai Chest Hospital as the principal investigator. Previously, the results of the Phase I clinical study of D-1553 in KRAS G12C mutation-positive non-small cell lung cancer were selected for an oral presentation at the World Conference on Lung Cancer (WCLC) in August 2022 and published in April 2023 in the Journal of Thoracic Oncology1 . ...
- Source: drugdu
- 169
- January 7, 2024
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec

Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
- Source: drugdu
- 145
- January 6, 2024
FDA Fast Tracks Candel Therapeutics’ Novel Treatment for Pancreatic Ductal Adenocarcinoma

Pharmaceutical Executive Editorial Staff Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group. The FDA granted Fast Track Designation to Candel Therapeutics, Inc’s aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC).1 The novel off-the-shelf therapy is administered by a localized injection that is believed to provide a safety benefit compared with standard systemic administration in this patient population. “We are pleased with the FDA’s decision to grant fast track designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, president and chief executive officer of Candel Therapeutics, in a press release.1 “This milestone follows our first interim data report from the randomized Phase II clinical trial in patients with ...
- Source: drugdu
- 170
- January 5, 2024
Henlius to Release Clinical Data at 2024 ASCO GI

Shanghai, China, January 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, HLX22, an innovative anti-HER2 mAb, and the approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), will be presented in posters at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 18-20. HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 ...
- Source: drugdu
- 130
- January 5, 2024
Automated Liquid Biopsy Detects Brain Tumor Cells in Children

Brain and other central nervous system (CNS) cancers are the primary cause of cancer-related deaths in children, ranking as the second most prevalent form of childhood cancer following leukemia. For treating CNS tumors, healthcare professionals traditionally rely on a series of magnetic resonance imaging (MRI) scans to gauge the effectiveness of treatments such as surgery, chemotherapy, and radiation. However, MRI scans have limitations, particularly in detecting microscopic diseases that might signal residual or recurring cancer cells. To bridge this gap, scientists have been on a quest to identify reliable, tumor-specific biomarkers. Prior research in adults has demonstrated that primary tumors release circulating tumor cells (CTCs) into the bloodstream, suggesting that CTCs could serve as dependable biomarkers for CNS tumors. A recent study conducted by researchers at the University of Texas MD Anderson Cancer Center (Houston, TX, USA) aimed to determine the effectiveness of a liquid biopsy tool designed to detect ...
- Source: drugdu
- 160
- January 4, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 212
- January 4, 2024
Inside AbbVie’s $10B buyout of ImmunoGen—and the bidding war it swooped in on

AbbVie is entering 2024 with a foothold in the antibody-drug conjugate (ADC) field thanks to its late-2023 buyout of ImmunoGen worth more than $10 billion. But according to a new securities filing, AbbVie didn’t pursue the cancer drugmaker until other suitors were already at the negotiating table. ImmunoGen’s recent round of M&A deliberations began in April, according to the filing, when a company only identified as “Party A” reached out to CEO Mark Enyedy expressing interest in a potential transaction. Before that, ImmunoGen had been routinely evaluating potential opportunities for deals of various types, but the interest from Party A struck up a round of talks that ultimately led to the sale. However, Party A’s note of interest came without a proposed purchase price, a move that the company’s advisors at Goldman Sachs and Lazard called “unusual but not unprecedented.” Before the talks moved along, ImmunoGen presented its first-quarter earnings ...
- Source: drugdu
- 171
- January 4, 2024
Making the Most of Real-World Data in Clinical Trials

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
- Source: drugdu
- 170
- January 3, 2024
A Monthly Summary of Hires and Layoffs

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
- Source: drugdu
- 205
- January 3, 2024

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