PharmaFocus Today – Page 109 – media

Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower ...
- Source: drugdu
- 80
- May 5, 2024
PharmaLink partners with Recall Results on safety of drugs

PharmaLink has partnered with Recall Results on an accurate and responsive process for drug recalls, withdrawals and market actions in the pharmaceutical industry. The collaboration combines PharmaLink’s pharmaceutical returns processing expertise with Recall Results’ knowledge and advanced technologies for managing complex recalls.It will focus on the development of integrated systems to streamline the process of recalls, supporting recalls of any class to the patient level. It aims to cut down the time to identify and respond to potentially harmful pharma products in the market.With a focus on patient safety and compliance, the two companies are set to establish new standards in recall management. PharmaLink CEO Thierry Beckers stated: “Through this partnership, PharmaLink offers comprehensive services for the notification, product retrieval, processing, storage and disposal of recalled products from the healthcare supply chain.“We could not be more excited about the launch of this strategic partnership and the solutions it brings to ...
- Source: drugdu
- 122
- May 5, 2024
Sino Biological concludes SignalChem acquisition for $48m.

Sino Biological has concluded the acquisition of Canadian biotechnology company SignalChem Biotech (SCB) for $48m in a move that expands its product portfolio and strengthens its global presence. The related share purchase agreement was signed between the companies in October 2023. The deal includes all assets and assumed indebtedness, along with net cash deposits, marking a significant expansion for the Shenzhen stock exchange-listed biotech company. Sino Biological president and general manager Dr Jie Zhang stated: “SignalChem is at the scientific forefront of enzyme bioreagent development and production, as well as enzyme-based compound screening technologies. “The acquisition of SCB further strengthens Sino Biological’s robust presence in bioactive recombinant proteins and related contract research services.” SignalChem is engaged in developing bioactive enzymes, including kinases, proteases, phosphatases, ubiquitin and epigenetic enzymes. It is now integrated as a wholly-owned subsidiary of Sino Biological. SCB will offer exclusive ...
- Source: https://www.pharmaceutical-technology.com/news/sino-biological-signalchem-48m/
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- May 4, 2024
“Profound concern” over WHO’s pandemic agreement, says AIDS charity

The AHF Global Public Health Institute has voiced concerns over the World Health Organization’s (WHO) proposed pandemic agreement, saying that the private interest of pharmaceutical companies has taken priority over global health security. The AHF Global Public Health Institute, a joint initiative of the AIDS Healthcare Foundation and the University of Miami, outlined issues in the latest iteration of the text from the WHO via a 26 April press release. The Pandemic Agreement, also known as the pandemic accord, is a proposed international joint initiative to fight the next pathogen that threatens global health. The framework is meant to implement lessons learned from the response to Covid-19 to improve shared response between nations. Member states have a deadline of May 2024 to join the treaty accord. Research indicates that Covid-19 would have caused 40 million more deaths in the absence of preventative measures. Countries have been ...
- Source: https://www.pharmaceutical-technology.com/news/profound-concern-over-whos-pandemic-agreement-says-aids-charity/?cf-view
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- May 4, 2024
ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory

BY SEAN WHOOLEY The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro] ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory. It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows. ClearPoint Neuro designed its Prism bone anchor accessory for use with commercially available stereotactic systems. These systems work for intracranial and neurosurgical procedures. Such procedures require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems. The anchor provides short-term fixation and positioning of those instruments or accessories under image guidance. Chris Osswald, director, ...
- Source: https://www.massdevice.com/author/sean-whooley/
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- May 4, 2024
FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years

Don Tracy, Associate Editor Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy. Image Credit: Adobe Stock Images/Justlight Aquestive Therapeutics announced that the FDA has officially approved Libervant (diazepam) Buccal Film to treat seizure clusters in children aged two to five years. According to the company, the film works by being applied inside the cheek, where it naturally dissolves and provides a steady dose of diazepam. Currently, most prescriptions are being prepared, with Medicaid expected to be added at a later date. Libervant is the first and only FDA-approved orally administered rescue medication for seizures in this age group.1 “We are thrilled to have received FDA approval for Libervant in patients between the ages of two and five,” said Daniel Barber, CEO, Aquestive, in a press release. “Patients have been waiting years for Libervant, the first and ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
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- May 4, 2024
Urine Test to Revolutionize Lyme Disease Testing

Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing. If not addressed promptly and effectively, those affected may experience persistent symptoms known as Post-Treatment Lyme Disease Syndrome, which include issues with concentration and memory, dizziness, fatigue, body aches, depression, and sleep disturbances. Currently, the standard diagnostic approach involves an antibody blood test that detects the immune system’s response to the bacteria responsible for Lyme disease. Now, urine testing could revolutionize Lyme disease detection and diagnosis thanks to its many advantages over existing techniques. Researchers at George Mason University (Fairfax, VA, USA) have developed a urine test for Lyme disease that detects the Borrelia bacteria, which causes Lyme disease. This advancement allows for the confirmation of an infection shortly after a tick bite, leading to timely treatment and helping to avoid the ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801060/urine-test-to-revolutionize-lyme-disease-testing.html
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- May 4, 2024
Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing

Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages, which impact their ability to deliver timely test results and maintain satisfactory patient care. Now, an innovative robotic blood drawing device for the medical laboratory market could help ease staff workload and provide a more consistent patient experience. Developed by Vitestro (Utrecht, The Netherlands), this innovative blood-drawing device is designed to perform safe and accurate blood draws. It utilizes artificial intelligence (AI) for ultrasound-guided 3D reconstruction and ensures submillimeter precision in needle insertion. This high level of accuracy and consistency in blood collection is achieved through a combination of AI, advanced imaging technologies, and robotics. By automating blood draws, Vitestro’s device not only reduces the physical demand on staff but also enhances the satisfaction of both patients and healthcare providers. The ...
- Source: https://www.labmedica.com/pathology/articles/294801059/robotic-blood-drawing-device-to-revolutionize-sample-collection-for-diagnostic-testing.html
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- May 4, 2024
Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
- Source: https://medcitynews.com/author/fvinluan/
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- May 4, 2024
Cardinal receives FDA warning letter over unapproved syringes

Dive Brief Cardinal Health marketed convenience kits that include piston syringes not authorized by the Food and Drug Administration, the agency said in an April 24 warning letter. The agency found the violations during an inspection of Cardinal’s facility in Waukegan, Illinois. Cardinal distributed syringes made by Jiangsu Shenli Medical Production with “substantially different technological characteristics” than those cleared by the FDA, according to the letter. Cardinal has come under scrutiny after the company recalled some of its disposable syringes last year because their dimensions had changed, making them incompatible with certain infusion pumps. The FDA has also taken steps to block plastic syringes made by Jiangsu Shenli from being imported. Dive Insight The warning letter focuses on Cardinal’s Monoject luer-lock tip syringes, which are intended to inject fluids into the body or withdraw fluids, and Monoject enteral feeding syringes, which deliver fluid, food or medications to ...
- Source: https://www.medtechdive.com/news/cardinal-warning-letter-unapproved-syringes/714934/
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- May 4, 2024

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