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Pusan National University Announces Potential Breakthrough for Muscle Regeneration Using Nanotech

Pusan National University announced a potential breakthrough in muscle regeneration technology. Researchers at the university studied MXene nanoparticles (NP) in an attempt to better understand how these nanoparticles work. In a press release, the university details how a team of researchers used DNA sequencing on nanofibrous matrices which contained MXene NPs. The results revealed the genes and biological pathways that were activated by the NPs.This is considered a breakthrough because up until these findings, the specific mechanism these NPs used to promote muscles was unclear to researchers. Prior to this, MXene NPs were only shown in laboratory demonstrations to promote growth. The team of researchers includes associate professor Yun Hak Kim, professor Suck Won Hong, and professor Dong-Wook Han. Kim is from the Department of Anatomy and the Department of Biomedical Informatics, while Hong and Han are from the Department of Cogno-Mechatronics Engineering. MXene NPs could potentially be used in ...
- Source: drugdu
- 87
- January 23, 2024
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy. The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy. Balversa, a fibroblast growth factor (FGFR) inhibitor, is not recommended for patients who are eligible for, and were not previously administered, prior treatment with a PD-1 or PD-L1 inhibitor, according to the FDA.The FDA based the approval on data from Study BLC3001 cohort 1, which evaluated data from 266 patients with metastatic urothelial carcinoma harboring selected FGFR3 alterations and who previously received ...
- Source: drugdu
- 263
- January 23, 2024
January 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. On Thursday, the FDA and the Centers for Medicare & Medicaid Services (CMS) issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention, approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it ...
- Source: drugdu
- 114
- January 23, 2024
InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Greater Bay Area’s Early Access Program

BEIJING, China. Jan. 22, 2024 – InnoCare (HKEX: 09969; SSE:688428) today announced that tafasitamab (Minjuvi®) in combination with lenalidomide has been recently approved by the Medical Products Administration of Guangdong Province, under the early access program in Guangdong-Hong Kong-Macao Greater Bay Area (“Greater Bay Area” for short), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient. The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access ...
- Source: drugdu
- 157
- January 23, 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
- 87
- January 23, 2024
Biotech layoffs strike hard with PMV Pharma, Ikena, and Bayer sacking staff

Amidst a successful conclusion to the 2024 JP Morgan Healthcare Conference, biotech and pharma layoff numbers are on a consistent rise with PMV Pharmaceuticals and Ikena Oncology being the latest to follow pharma giant Bayer’s recent restructuring plans. PMV Pharmaceuticals plans to fire 30% of its workforce in a bid to free capital that will go towards the development of its lead tumour agnostic therapy PC14586.As per the New Jersey-based company, the strategic restructuring will extend PMV’s cash runway until the end of 2026 and will allow the company to focus on discovery research efforts and prioritise initiation of a Phase II clinical study of p53 reactivator PC14586 that is slotted for commencement in Q1 2024. The precision oncology company’s latest restructuring follows a March 2023 pipeline optimisation effort, in which the company announced that its WIP-1 inhibitor and R273H mutation-targeting programs had been shelved to drive the development of ...
- Source: drugdu
- 76
- 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
- 85
- January 23, 2024
Hai Zheng Pharmaceutical and Sinopharm Signed Strategic Cooperation Agreement on Retail Project

Hai Zheng Pharmaceutical (hereinafter referred to as “Hai Zheng Pharmaceutical”) signed a strategic cooperation agreement on retail project with Sinopharm Holdings Corporation (hereinafter referred to as “Sinopharm”) in Shanghai. (hereinafter referred to as “Sinopharm”) signed a strategic cooperation agreement on retail project in Shanghai, both parties will carry out in-depth cooperation in healthcare and retail channels, through the integration of the advantageous resources of both parties to maximize the synergistic effect, and to bring more personalized, convenient and efficient drug purchasing experience for the majority of patients to improve the level of service. At the meeting, HANHUI Pharmaceutical and Guozhong Quanzai introduced the company profiles and project plans of the two sides respectively, and launched in-depth exchanges and discussions on the strategic cooperation of the two sides’ retail projects. Chairman Shen Xinghu and his entourage also visited the corporate showroom in Sinopharm Building to understand the development history, business innovation ...
- Source: drugdu
- 73
- 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
- 122
- 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
- 120
- January 22, 2024

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