Search Results for “FDA” – Page 120 – media

Palatin sells female libido drug Vyleesi to Cosette for $12M, plus more in potential milestones

In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market. The new buyer for Vyleesi, which was approved by the FDA in 2019, is another New Jersey drugmaker, Cosette Pharmaceuticals, which also is on the hook for $159 million in contingent, sales-based milestones. As one of two drugs hailed to potentially become the “female Viagra,” Vyleesi has not lived up to expectations. In September, when Palatin revealed its quarterly earnings, it reported fiscal-year sales of $12.5 million, compared to $5.8 million in the previous fiscal year. While Palatin CEO Carl Spana, Ph.D., said in a release that he was “excited” that Vyleesi’s net product revenue ...
- Source: drugdu
- 202
- December 22, 2023
The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™, have been published in The Lancet Rheumatology.

The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4). This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2). A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until ...
- Source: drugdu
- 113
- December 22, 2023
【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
- 168
- December 22, 2023
Cutting-Edge Lab Automation System Supports High-Volume Needs and Provides Faster Results

A new, innovative automation solution for clinical labs featuring smart technology can boost lab performance and flexibility, reduce turnaround time, and eliminate 80% of manual steps, thereby increasing reliability and minimizing errors to provide quicker lab results Abbott’s (Lake Forest, IL, USA) GLP systems Track is a cutting-edge technology and scalable automation solution that helps laboratories meet high-volume demand and maximize productivity. This system introduces innovative features that boost safety, productivity, and capacity to meet increasing laboratory demands. The flexibility of the GLP systems Track is a standout feature, offering laboratories the ability to tailor the system’s configuration to their specific requirements. A key innovation in this system is the CAR, a smart, self-propelled single sample carrier, which allows samples to move independently, not attached to rigid, fixed mechanized track systems. This innovation minimizes mechanical breakdowns that could halt operations, ensuring continuous functionality and adaptability to the lab’s evolving needs. ...
- Source: drugdu
- 103
- December 21, 2023
Illumina’s Antitrust Battles to End With Divestiture of Cancer Test Maker Grail

Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024. By FRANK VINLUAN Illumina is done fighting in the courts to keep cancer-detection company Grail. The gene-sequencing giant had previously pledged to divest Grail if it did not win either the U.S. or European appeals of anti-trust cases challenging the acquisition. A U.S. appeals court came down against the Federal Trade Commission’s case on Friday, but in a narrow way that hardly handed Illumina a clear victory. After reviewing the decision, Illumina said Sunday that it has decided against further litigation. The company will divest Grail. The planned divestiture is the latest step in a journey that started within Illumina. Grail began as research within the San Diego company. Grail spun out ...
- Source: drugdu
- 94
- December 20, 2023
Point Bio Prostate Cancer Therapy Meets Phase 3 Goal, But Results Still Disappoint

Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
- Source: drugdu
- 92
- December 20, 2023
GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
- Source: drugdu
- 190
- December 20, 2023
AI-Enabled Prescription Digital Therapeutics Should Be An Investment Priority

To identify true growth opportunities, investors must consider how companies are using AI to revolutionize the treatment journey. Some companies are doing just that via Software as a Medical Device (SaMD), particularly by developing prescription digital therapeutics (PDTs). By DAVID B. KLEIN The excitement around artificial intelligence has been palpable for some time, dominating industry discussions and mobilizing capital for investment opportunities, but as of late, there’s been a change in the air. The optimism that reached a fever pitch in the first half of the year has dissipated. Now begins the hard work of sorting through what it all means. As the healthcare industry responds to the burgeoning opportunities AI presents, especially in developing new, more effective therapeutics and enabling access to treatment, it’s critical that investors prioritize proof over positivity. They must determine if a company’s AI strategy will lead to a high return on investment, or if ...
- Source: drugdu
- 90
- December 19, 2023
Next-Generation Colorectal Cancer Screening Test Enables Earlier Disease Detection

Colorectal cancer (CRC) stands as the second leading cause of cancer-related deaths in the U.S. and is particularly prevalent in men under 50. Notably, there’s been a shift in CRC affecting younger individuals, with 20% of cases in 2019 occurring in people 54 and younger, a rise from 11% in 1995. Additionally, there has been an increase in advanced disease incidence, particularly in individuals under 65. A significant number of CRC cases and deaths can be prevented through regular screening, surveillance, and quality treatment. Now, a new technology offers convenient at-home test collection with the highest sensitivity available for non-invasive CRC screening. Geneoscopy Inc. (St. Louis, MO, USA) has developed a multi-target stool RNA (mt-sRNA) biomarker panel for detecting precancerous lesions and colorectal cancer. RNA, a dynamic molecule crucial for protein synthesis, adapts to disease conditions and regulates numerous genes in cellular processes. Changes in RNA pathways are linked to ...
- Source: drugdu
- 113
- December 18, 2023
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial

BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
- Source: drugdu
- 584
- December 18, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.