Search Results for “FDA” – Page 100 – media

HPV Self-Collection Solution Improves Access to Cervical Cancer Testing

Annually, over 604,000 women across the world are diagnosed with cervical cancer, and about 342,000 die from this disease, which is preventable and primarily caused by the Human Papillomavirus (HPV). A staggering 90% of these deaths occur in low- and middle-income countries. Screening for HPV is crucial as it helps identify women at risk of developing cervical cancer, thereby enabling early intervention before the cancer can develop. In regions where healthcare resources are scarce, enhancing the accessibility of screening and reducing obstacles to sample collection are critical to preventing this disease. Now, a novel HPV self-sampling method expands the availability of cervical cancer screening by allowing patients to collect their samples privately while at a healthcare facility. Roche (Basel, Switzerland) has received FDA approval for its HPV self-collection solution, one of the first available in the United States where more than half of the women diagnosed with cervical cancer have ...
- Source: drugdu
- 93
- May 21, 2024
J&J expands dermatology portfolio with $850m Proteologix acquisition

In a bid to solidify its footing in dermatology, Johnson & Johnson (J&J) has announced that it will purchase the immune-mediated disease-focused biotech Proteologix in a $850m cash buyout, with the potential for additional milestone payments. The host of bispecific antibodies brought by Proteologix to the deal will add depth to J&J’s immunology pipeline, and more specifically, bolster its position to address atopic dermatitis (AD). Among Proteologix’s assets is PX128, a bispecific antibody designed to target interleukin (IL)-13, as well as the cytokine TSLP, which is being developed for the treatment of patients with moderate to severe AD and moderate to severe asthma. The acquisition also covers the preclinical stage candidate, PX130, a bispecific antibody designed to target both IL-13 and IL-22 to inhibit inflammation, restore the skin barrier, and prevent environmental trigger-mediated inflammation of the skin. The asset is under development for the treatment of moderate to severe AD. ...
- Source: drugdu
- 79
- May 21, 2024
Ionis and Biogen discontinue experimental ALS drug after Phase I/II flop

Ionis and Biogen are halting the development of their experimental treatment for amyotrophic lateral sclerosis (ALS) after it failed to show improvement in patients in a Phase I/II study. Data from the 99-patient ALSpire study (NCT04494256) demonstrated that BIIB105 failed to significantly reduce neurodegeneration or improve functional measures such as breathing. BIIB105, an investigational antisense oligonucleotide was designed to reduce the expression of ataxin-2 (ATXN2) protein. Despite demonstrating statistically significant ATXN2 reductions in the study, the drug showed no evidence of clinical benefit in any subgroup evaluated in the study. This marks another setback in the search for new treatments for ALS, a progressive neurodegenerative disease that causes muscle weakness and paralysis. Last month, Amylyx Pharmaceuticals axed its ALS drug Relyvrio (AMX0035) from the market after its Phase III Phoenix trial failed to meet any of its endpoints. However, this trial failure does not mark the end of Ionis and ...
- Source: drugdu
- 103
- May 20, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 73
- May 17, 2024
Companies prepare for ADC trial readouts at ASCO 2024

As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
- Source: drugdu
- 110
- May 17, 2024
New Respiratory Syndromic Testing Panel Provides Fast and Accurate Results

Respiratory tract infections are a major reason for emergency department visits and hospitalizations. According to the CDC, the U.S. sees up to 41 million influenza cases annually, resulting in several hundred thousand hospitalizations and as many as 51,000 deaths. Syndromic testing systems have improved the detection of co-infections, thus reducing the need for further testing. These systems provide rapid results, enabling healthcare providers to make timely decisions and stop unnecessary antibiotic treatments when viral pathogens are identified, which helps reduce antibiotic use and supports responsible antimicrobial stewardship. A new respiratory syndromic testing panel now allows for the accurate diagnosis of respiratory infections and the detection of co-infections. This panel delivers results in about one hour and requires less than one minute of hands-on time, while providing easy access to cycle threshold (Ct) values and amplification curves. QIAGEN N.V. (Venlo, the Netherlands) has received clearance from the U.S. Food and Drug ...
- Source: drugdu
- 88
- May 16, 2024
First Patient Dosed in Phase I Clinical Trial of Degu Insulin Liraglutide Injection

Tong Hua Dong Bao Pharmaceutical Co., Ltd (hereinafter referred to as the “Company”) has initiated the Phase I clinical trial in China after receiving the notification of approval for the clinical trial of Degu Insulin Liraglutide Injection from the State Drug Administration and has recently successfully completed the first case of patient dosing. The completion of Phase I clinical trial of Degu Insulin Liraglutide Injection is another significant progress in the development of GLP-1RA compound formulation of insulin analog, which will further enhance the competitiveness of the Company in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has ...
- Source: drugdu
- 75
- May 16, 2024
J&J’s Megadyne discontinues pediatric electrode pad after burn reports

Dive Brief Johnson & Johnson’s Megadyne business has discontinued a pediatric electrode pad after receiving reports of patients being burned during procedures where the device was used. The electrode pad is included in a line of products that were part of a Megadyne recall in December. At that time, the J&J unit restricted the use of four products in patients under the age of 12, but it did not change instructions for one device designed for people who weigh 0.8 to 50 pounds. J&J, which announced the recall Friday, is discontinuing the product indicated for use in people weighing up to 50 pounds after tests on the causes of four reported injuries found a combination of factors that could result in burns. Dive Insight Physicians use Megadyne Mega Soft electrode pads to prevent the risk of burns in procedures that use electrosurgical instruments. When the devices are in place, currents ...
- Source: drugdu
- 73
- May 15, 2024
Understanding Payer Perceptions

Tasmina Hydery, PharmD With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount. Tasmina Hydery, PharmD, Associate Director, Market Access and Healthcare Consulting, Cencora Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months. The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.1 Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers ...
- Source: drugdu
- 74
- May 15, 2024
Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

On May 13, 2024, GlaxoSmithKline (“GSK”) announced that ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration (“SDA”) for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China (“SDA”) for HIV-1 pre-exposure prophylaxis (“PrEP”) in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections (“STIs”) in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release. Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. ...
- Source: drugdu
- 115
- May 15, 2024

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