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FDA drafts guidance outlining real-world evidence for medical device submissions

Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
- Source: drugdu
- 118
- December 21, 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
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- December 21, 2023
Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components. By JOAN LAU Thanks to simultaneous achievements in gene therapy and medicine delivery platforms, new solutions to intractable problems are bringing us to a real watershed moment in the treatment of respiratory disease. This synchronicity of science and tech advancements is no accident; along with colleagues in my own and other organizations, I have been working for the past several years on the medical and technological leaps that together signal hope for respiratory-disease patients with unmet need. This is especially true for those with cystic fibrosis (CF), for whom the standard of care is in urgent need of update. And now that we have the science and the technology in place, we must push to scale-up efforts; patients are waiting. Right now, CF patients ...
- Source: drugdu
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- December 21, 2023
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition. By FRANK VINLUAN The rare inherited disorder epidermolysis bullosa, or EB, leads to skin so fragile that it tears like tissue paper. The resulting wounds and blisters are slow to heal and prone to infection. On Tuesday, the FDA approved a Chiesi Group drug developed to promote faster wound healing in EB patients. Privately held Chiesi will market its new drug as Filsuvez, the same brand name for the product in Europe, where it won its first regulatory approval last year. The FDA decision for this topical gel covers the treatment of patients age six months and older. EB stems from a mutation to the gene that codes ...
- Source: drugdu
- 103
- December 21, 2023
Phase III Clinical Study of New Generation sleep medication Daridorexant Dosed the First Patient in China

On December 17, 2023, the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets （Daridorexant）, dosed the first patient at the xx hospital. Daridorexant is a novel sleep medication collaborated between Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) and Idorsia Pharmaceutials Ltd. (Idorsia), for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning. This study is led by Professor Yuping Wang at Xuanwu Hospital of Capital Medical University and conducted in 33 centers across China. It is a local pivotal registry study of Daridorexant in China. Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. This impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to ...
- Source: drugdu
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- December 21, 2023
reminder on known risk of gambling disorder

The MHRA has reminded healthcare professionals prescribing aripiprazole to be alert to the known risk of patients developing addictive gambling, following a rise in the number of reports received in 2023 Aripiprazole is an important medicine for the treatment of schizophrenia and bipolar disorder. Patients are advised to tell their doctor if they or their family and friends notice they are having unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. Patients should continue taking aripiprazole as advised. Stopping aripiprazole without medical advice can be harmful. In the last 14 years, the MHRA’s Yellow Card scheme received 69 reports of gambling or gambling disorder where aripiprazole was suspected to be the cause. Thirty-two of these reports were received between 1 January and 31 August this year. In March 2023, the MHRA asked gambling clinics to ...
- Source: drugdu
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- December 21, 2023
After missing out on FDA voucher, bluebird quickly raises funds to support gene therapy launches

Despite bluebird bio winning a recent FDA nod for its much-anticipated sickle cell disease gene therapy Lyfgenia, the regulatory triumph left something to be desired for the company because the agency didn’t grant a lucrative priority review voucher (PRV). That came as a surprise to bluebird, which had previously inked a deal to sell a potential PRV to Novartis for $103 million. Now, bluebird is hurrying to raise millions of dollars—through two separate avenues—to fund the launch of its new sickle cell disease gene therapy and others. In one fundraising approach, bluebird said it reached an agreement to hand over future gene therapy revenues to Alterna Capital Solutions in exchange for up-front funding. The deal covers a maximum credit of $100 million for bluebird, the company said in an SEC filing (PDF). Additionally, bluebird is working with Goldman Sachs and J.P. Morgan Securities to sell $150 million in new shares. ...
- Source: drugdu
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- December 21, 2023
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

A German court has dealt the first blow against CureVac amid the company’s heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. The German Federal Patent Court ruled that one of eight CureVac patents involved in the litigation is invalid, the company said in a Tuesday release. The patent in question covers a process that improves the expression of mRNA in cells, Juve Patent reports. The ruling came as a surprise to CureVac, which noted that the court in April issued a preliminary opinion in favor of the patent’s validity. Still, CureVac believes its “pioneering role in mRNA technology and continuing innovation in the field made essential contributions to safe and efficacious COVID-19 vaccines,” CEO Dr. Alexander Zehnder said in a statement. The company will “continue to defend our claim for recognition and fair compensation and will take appropriate action by appealing this decision,” Zehnder added. CureVac’s appeal ...
- Source: drugdu
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- December 21, 2023
Signing ceremony between the Municipality of Bogotá, Colombia and SINOVAC for the official launch of the joint venture BogotáBio

On December 18th, local time in Colombia, a signing ceremony was held between the Municipality of Bogotá and SINOVAC. Claudia López Hernández, Mayor of Bogota, and Weidong Yin, Chairman, President and CEO of SINOVAC, signed the cooperation agreement on behalf of the two parties for the Bogota Vaccine Plant Project and announced the official launch of BogotáBio, a joint venture company jointly funded by the two parties. The Bogotá Vaccine Factory project will promote the localized production of a variety of vaccines in Colombia as well as the research and development of new vaccines and innovations, thereby enhancing the local capacity to respond to infectious diseases and prepare for the next pandemic. The signing ceremony was attended by Colombian Foreign Minister Álvaro Leyva Durán, Chinese Ambassador to Colombia Zhu Jingyang, Colombian Deputy Minister of Trade, Industry and Tourism Quintero, and nearly 60 guests from the Colombian central government, Bogota city ...
- Source: drugdu
- 147
- December 21, 2023
The First Da Vinci Xi Surgical Robot Made in China Officially “Onboarded”, Making High-Quality Medical Resources More Accessible

On December 18, the start-up ceremony of the Da Vinci surgical robot was successfully held in Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. This marks that the first domestic Da Vinci Xi surgical robot has officially settled in Gansu Hospital of Sun Yat-sen University Cancer Hospital, helping the construction of the national regional medical center, bringing more efficient, accurate and safer surgical treatments to the majority of patients, and marking the commercialization of the domestic Da Vinci surgical robot into the era. After the launching ceremony, the Da Vinci Xi surgical robot was formally “on duty” in the operating room of Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. With the assistance of the surgical robot, Executive Director Prof. Liu Zhuowei’s team successfully performed “robot-assisted partial nephrectomy” for the patient. Prof. Liu Zhuowei introduced that the surgical robot makes the surgical incision smaller, less painful, shortens the ...
- Source: drugdu
- 106
- December 21, 2023

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