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Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.
Interest in the pulmonary route has also grown in recent years because delivering the drugs through the lungs allows direct systemic delivery and bypasses the first pass metabolism. Why is pulmonary drugdelivery a complex challenge? How can we accomplish drugdelivery to the lungs in nonclinical studies?
Genentech’s ocular implant drugdelivery system for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port delivery system into a surgically placed implant in the eye, allowing for continuous delivery of the drug.
CordenPharma, a global CDMO manufacturing complex drug substances and lipid nanoparticles (LNPs), has signed a partnership agreement with Certest, a Spanish company specializing in drugdelivery and API synthesis.
The 2023 Transdermal and Microneedle DrugDelivery Conference will explore real world applications of microneedles in drugdelivery and strategies for advanced and user-centric device design. Regulation of transdermal delivery systems will be another key theme addressed, in combination with clinical trial optimization.
Oramed Pharmaceuticals, a company focused on the development of oral drugdelivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.
Drugdelivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.
The French biotech company Vect-Horus has licensed its technology to the Danish big pharma Novo Nordisk to deliver drug cargoes to undisclosed disease targets in three programs.
Linker Stability : The stability of the linker, which attaches the chemotherapy agent to the antibody, is essential for efficient and precise drug-delivery. Researchers are actively looking for ways to solve these problems with the goal of finding the optimal balance between efficacy and toxicity for many of these drugs.
This technology is mainly employed when the access to the IV system is limited or inaccessible for drugdelivery due to reasons such as obesity, burns, fluid retention and drug abuse. Intraosseous infusion is reliable as it can aid in the delivery of a drug in a short time and has a great success rate in the first attempt.
The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.
The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Approval of the Month: FDA Approves First Closed-Loop Monitoring and DrugDelivery Device.
One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.
It indicates that nanomedicine also has the potential to combat the threat of antibiotic resistance via the use of nanomaterials with intrinsic antibacterial properties, as well as using nanoparticles as effective drugdelivery systems for antibacterial agents.
Leading experts from big pharma will be presenting case studies on recent advances in platform approaches in drugdelivery devices and smart devices, while a panel discussion will explore the emerging opportunities of platforms for injectable devices. Who should attend: Drug-delivery developers. Medical Device Engineers.
Interestingly, the regulatory landscape for medical devices is also evolving with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) implementing stricter regulations and oversight to ensure device safety and efficacy.
The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. Drug developers.
The Future of DrugDelivery and Combination Product Device Design. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products.
The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.
The switch to an injectable version of the drug could also help to extend the commercial lifespan for Tecentriq and reduce the impact when biosimilars of the IV version reach eventually reach the market – assuming of course Roche can persuade clinicians to switch.
By the end of this year, the EPA plans to propose an air pollution regulation to address EtO emissions at commercial sterilizers and to protect public health. As a result, the EPA is providing new information on specific facilities where lifetime risk levels are the largest to nearby communities.
Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. This was a topic at the December Food and Drug Law Institute conference on Current Developments in Digital Health Technology and Regulation.
Chinese biotech CanSino Biologics said in April it was starting trials of an inhaled COVID-19 vaccine, while others looking at nasal or inhaled delivery include Cadogenix, Phage Novo Bio, Precision Virologics, and Immune System Regulation (ISR). The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.
. “Psychedelic agents are a promising new class of therapeutic drug. We see a natural opportunity to apply XPhyto’s drug formulation expertise and Vektor’s proven drugdelivery platforms to these emerging APIs,” said Hugh Rogers, CEO and Director of XPhyto. About XPhyto Therapeutics Corp.
Over time, various research studies have demonstrated the potential of exosomes ( membrane bound extracellular vesicles) in disease diagnosis, drugdelivery and therapeutic applications. In addition, they are involved in regulating the expression of the targets that are linked to RNA as they can affect the expression of RNA.
On April 20, 2020, XPhyto announced a definitive development, technology purchase and licence agreement with 3a-Diagnostics for the development and commercialization of real-time, low-cost and easy-to-use screening tests using 3a’s pathogen specific biosensors and XPhyto’s oral dissolvable drugdelivery platform.
The devices are used to regulate blood glucose levels by delivering precise amounts of insulin based on readings from an integrated continuous glucose monitor (CGM). The pumps are mainly used by people with type I diabetes, but type 2 diabetics can also use them to regulate their glucose levels.
In the dynamic landscape of the healthcare sector, the evolution of drugdelivery systems plays a significant role in transforming the management of chronic diseases. These devices reduce injection anxiety, and are useful for patients who prefer a hands-free drugdelivery experience.
With this acquisition we are expanding our product pipeline to include psychedelic therapeutics, incorporating elements of our IP around drugdelivery technology in which we already have prototypes developed, which we believe will propel us towards clinical studies relatively quickly. Ahmad Doroudian, CEO of BetterLife.
Drug-eluting stents (DES): DES reduce the incidence of restenosis and are coated with drugs that inhibit scar tissue growth. DCBs: DCBs, such as the Agent DCB, combine mechanical widening of the artery with drugdelivery to the vessel wall to prevent cell proliferation.
In 2020, XPhyto confirmed successful activation of its peptide-based biosensor program when delivered using Vektor’s sublingual drugdelivery platform. Vektor will begin planning and development work for the incorporation of various psychedelic compounds into its drug formulations. About XPhyto Therapeutics Corp.
It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.
is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drugdelivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc.
” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). Midatech Pharma PLC (dual listed on LSE AIM: MTPH; and NASDAQ: MTP) isa drugdelivery technology company focused on improving the bio-delivery and bio-distribution of medicines.
According to Health Canada, “the information currently available at the Controlled Substances Directorate, 2-bromo-LSD is NOT CONTROLLED under the Schedules to the Controlled Drugs and Substances Act.”. The full Forbes article can be accessed here. BetterLife Pharma Inc.
In November 2023, the US Food and Drug Administration (FDA) sent a Class I notice to Baxter for a correction to one of its drugdelivery devices, the Novum IQ syringe pump, as opposed to a full-on product removal. One injury associated with the defect has been reported, with no reports of deaths.
In fact, federal law and regulation appear to require AbbVie to list these patents.” Kaleo also delisted, but not without noting that “the decision to list each of these patents was proper, consistent, and required by the applicable statutes, regulations, and FDA’s guidance available at the time of listing.”
is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drugdelivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc. For further information please visit www.abetterlifephama.com. About Transcend Biodynamics.
is accelerating the next-generation drugdelivery, diagnostic, and phytochemical investment opportunities: precision transdermal and oral dissolvable drug dosage forms; rapid, low-cost infectious disease and oral health screening tools; and validation of approved cannabinoid-based therapeutics focused on European markets.
is a bioscience accelerator focused on next-generation drugdelivery, diagnostic, and phyto-therapeutic investment opportunities: precision transdermal and oral dissolvable drug dosage forms; rapid, low-cost infectious disease and oral health screening tools; and emerging plant-based therapeutics focused on European markets.
Driven by the increasing need for safe and efficient medical devices and drugdelivery systems, the pharmaceutical polymers / medical grade polymers domain is advancing significantly. Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses.
Dr. Bryan began his career at Schering-Plough, engaging in formulation and drugdelivery. The company’s drug product candidates ‘1104 and ‘1805 modify how monocytes and macrophages respond to antigens, potentially directing the immune system towards a more regulated, balanced response.
A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Clarification is key and the employees’ job requirements must be clearly communicated. Employee Compensation and Rewards.
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