PharmaFocus Today – Page 179 – media

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cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the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
Ultrasensitive Molecular Diagnostic Tools Detect Asymptomatic Malaria

Malaria remains a significant cause of illness and death, particularly in low-income countries, striking hardest among young children and pregnant women. In 2022 alone, the World Health Organization reported 608,000 malaria deaths globally, with a staggering 95% of these occurring in the African region. A key challenge in controlling malaria, especially in endemic areas, is identifying and treating asymptomatic carriers of the disease. In response to this challenge, researchers have developed advanced diagnostic tools capable of detecting even minimal traces of malaria in individuals who carry the parasite but do not exhibit symptoms. A collaborative effort between scientists from the University of Washington (Seattle, WA, USA) and Med Biotech Laboratories (Kampala, Uganda) has led to significant advancements in malaria detection. The researchers observed that malaria parasite densities in the blood can suddenly fall below the detection threshold of traditional tests due to the evolving nature of the malaria pathogens. This ...
- Source: drugdu
- 166
- January 22, 2024
New Algorithm Detects and Identifies Novel Bacterial Organisms

Hospitals frequently encounter unknown germs, and identifying these pathogens is crucial for efficient bacterial infection treatment. Typically, medical laboratory analysis can identify these pathogens, but standard methods sometimes fall short, especially when dealing with unclassified bacterial species or those difficult to cultivate. Since 2014, a dedicated research team has been collecting and analyzing patient samples containing such elusive germs, leading to the discovery of over 30 new bacteria species, some linked to significant clinical infections. The team at the University of Basel (Basel, Switzerland) examined a total of 61 unidentified bacterial pathogens from various patient blood and tissue samples. These pathogens had previously eluded identification by conventional lab techniques like mass spectroscopy or partial bacterial genome sequencing. The researchers then employed a more recent method to sequence the complete genetic material of these bacteria. By comparing the genomes with known strains using an online tool, they identified 35 previously unknown ...
- Source: drugdu
- 136
- January 22, 2024
Comanche raises $75m to develop preeclampsia therapy

US-based Comanche Biopharma has raised $75m in an oversubscribed Series B financing round to develop its small interfering RNA (siRNA) therapy, CBP-4888, as a treatment for preeclampsia. The financiers included Google Ventures, F-Prime Capital, Lilly Asia Ventures, Longview Healthcare Ventures, New Enterprise Associates (NEA), and Atlas Venture. Furthermore, Scott Gottlieb from NEA and David Grayzel from Atlas will join Comanche’s board. Preeclampsia is persistent high blood pressure that develops during the second trimester of pregnancy or up to six weeks following delivery. It can be associated with high levels of proteins in the blood, decreased blood platelets, fluid in the lungs, or seizures. It occurs in 2-9% of pregnancies and the only management is premature delivery. Recent studies have found that excess circulating placental soluble fms-like tyrosine kinase 1 (sFlt1) is present in patients with preeclampsia, and can therefore, contribute to its pathogenesis. A 2023 study found that the administration ...
- Source: drugdu
- 95
- January 22, 2024
AI Governance Alliance calls for stronger global collaboration

As global leaders and industry power players gather in Davos to address the world’s most pressing problems, the World Economic Forum’s (WEF) AI Governance Alliance (AIGA) has called for stronger collaboration to create a framework for advanced AI. In a series of three new reports, AIGA has focused on unlocking the value and creating a framework for generative AI (GenAI) usage. AIGA said a global effort is needed to create equitable access to AI. According to Cathy Li, head of AI, data and metaverse at the WEF: “The AI Governance Alliance is uniquely positioned to play a crucial role in furthering greater access to AI-related resources, thereby contributing to a more equitable and responsible AI ecosystem globally.” “We must collaborate among governments, the private sector and local communities to ensure the future of AI benefits all,” she added. AIGA has called for experts in various sectors to address key areas ...
- Source: drugdu
- 97
- January 22, 2024

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