Search Results for “Clinical Trial” – Page 74 – media

Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients. By FRANK VINLUAN Sales for Gilead Sciences cancer drug Trodelvy are growing, but the company is counting on additional approvals to boost the product to blockbuster status and justify the premium price it paid to acquire the therapy. The drug’s failure in a pivotal lung cancer study is a setback to that strategy. Treatment with Trodelvy, an antibody drug conjugate (ADC), fell short of a Phase 3 study’s main goal of showing statistically significant improvement in overall survival in patients with advanced cases of non-small cell lung cancer (NSCLC), Gilead announced Monday. Nevertheless, the company pointed to numerical ...
- Source: https://medcitynews.com/author/fvinluan/
- 179
- January 24, 2024
Opdivo Plus Yervoy Reduces the Risk of Colorectal Cancer Disease Progression or Death by 79% Versus Chemotherapy

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. Image Credit: Adobe Stock Images/Crystal light The combination of Bristol Myers Squibb’s Opdivo (nivolumab) with Yervoy (ipilimumab) showed significant improvements in progression-free survival (PFS) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)in the Phase III CheckMate -8HW trial. The combination produced a 79% reduction in the risk of disease progression or death compared to chemotherapy, according to the trial. “Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, MD, head of the medical oncology department, Sorbonne University, Hospital Saint-Antoine, Paris, France, in a press release. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 76
- January 24, 2024
Pfizer’s Talzenna recommended by NICE for advanced breast cancer

Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
- Source: drugdu
- 84
- January 23, 2024
World’s First Perioperative Immunization Phase III Study Results in Esophageal Cancer Presented at 2024 ASCO GI

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment. Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world’s first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. ...
- Source: drugdu
- 81
- January 23, 2024
FastWave Medical kicks off first-in-human study of its IVL tech

FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures with the hosting investigator, Dr. Antonio Muñoa. “I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform. Their team has rapidly developed an easy-to-use system to address existing technological gaps, marking a significant milestone in achieving the company’s near-term goals,” Montero-Baker said in a news release. Minneapolis-based FastWave’s IVL platform is meant to treat calcific artery disease by fracturing calcium deposits with a balloon catheter that deliversshock waves. The company says its peripheral IVL technology offers a user-friendly design with a deliverable, low-profile, rupture-resistant balloon. The system delivers durable ...
- Source: drugdu
- 119
- January 22, 2024
FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL

Pharmaceutical Executive Editorial Staff NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor. The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.1 NX-5948 has previously demonstrated that it is highly potent across a range of tumor cell lines with BTK inhibitor–resistance, which is an important treatment consideration for heavily pretreated patients with CLL and SLL, according to Nurix. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed ...
- Source: drugdu
- 118
- January 22, 2024
Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders. The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission. In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510. Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital. The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel ...
- Source: drugdu
- 82
- January 22, 2024
Gearing Up to Challenge Pfizer in a Rare Disease, BridgeBio Secures Up to $1.25B

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital. By FRANK VINLUAN BridgeBio Pharma is preparing to compete against a blockbuster Pfizer product for a rare disease with few treatment options. A new financing deal provides the company with the capital to support planned commercialization of its drug, which is currently under FDA review. The agreement announced Thursday calls for Blue Owl Capital and Canada Pension Plan Investment Board to pay BridgeBio $500 million cash in exchange for royalties of 5% from sales of the biotech’s drug, acoramidis. The deal provides the Palo Alto, California-based biotech an additional $450 million in committed capital by refinancing its lending agreement with Blue Owl. The company could also receive ...
- Source: drugdu
- 169
- January 20, 2024
Gene-Edited Cell Therapy Casgevy Gains FDA Approval for Transfusion-Dependent Beta Thalassemia

Pharmaceutical Executive Editorial Staff Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease. The FDA has granted another approval to Vertex Pharmaceuticals’ and CRISPR Therapeutics’ gene-editing therapy Casgevy (exagamglogene autotemcel [exa-cel]) as a one-time treatment for transfusion-dependent beta thalassemia (TDT) in patients 12 years of age and older.1 Last month, Casgevy became the first FDA-approved novel genome editing technology for sickle cell disease (SCD), which was a significant advancement in gene therapy. The latest approval was months ahead of the FDA’s assigned Prescription Drug User Fee Act (PDUFA) date. “We are pleased with the approval of Casgevy in TDT well ahead of the PDUFA date,” said Samarth Kulkarni, PhD, chairman and chief executive officer of CRISPR Therapeutics.2 “The approval is a reflection of the power and versatility of the CRISPR ...
- Source: drugdu
- 112
- January 19, 2024
China is a Key Pillar for Novartis

Speaking to Sina Finance in Davos, NOVARTIS Global CEO Vas Narasimhan said he is optimistic about the global economy and the company’s next steps, which are characterized by enormous business opportunities despite many challenges. Vas said he was impressed by the continued upgrading and improvement of China’s healthcare system. China is NOVARTIS’ second-largest and fastest-growing market in the world. Overall, I feel very optimistic,” Wansheim said of his experience at Davos. One of the interesting things about Davos is that it brings together so many people who are passionate about improving the world, and so many new ideas in one place.” “As we know, we face many challenges, both in terms of the geopolitical situation and the global economy. But at the same time, I think there are also tremendous opportunities. We are gaining insights into how AI can impact many aspects of life and improve our productivity. At the ...
- Source: drugdu
- 184
- January 19, 2024

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