BioPharma Reporter

OCTOBER 31, 2023

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.

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Licensing Licensing Drug Delivery Drugs 59

Worldwide Clinical Trials

JUNE 21, 2024

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.

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XTalks

JUNE 28, 2022

This technology is mainly employed when the access to the IV system is limited or inaccessible for drug delivery 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.

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Production Drug Delivery Drugs Regulation 98

XTalks

MAY 30, 2023

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.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Camargo

OCTOBER 14, 2020

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 Drug Delivery Device.

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BioPharma Reporter

MARCH 14, 2022

Novartisâ Sandoz has acquired UK-based medical and drug delivery device development company, Coalesce Product Development Limited.

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Drug Delivery Production Development Drugs 52

XTalks

AUGUST 30, 2022

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.

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Trials Drug Delivery Drugs Gene 83

Pharmaceutical Technology

OCTOBER 26, 2022

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 drug delivery systems for antibacterial agents.

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

pharmaphorum

MAY 4, 2022

Leading experts from big pharma will be presenting case studies on recent advances in platform approaches in drug delivery 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.

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XTalks

JUNE 18, 2024

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.

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Medicine Drug Delivery Development Regulation 101

pharmaphorum

NOVEMBER 17, 2021

The Future of Drug Delivery 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.

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Drugs Drug Delivery Engineer Production 52

FDA Law Blog

JUNE 13, 2024

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.

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Drug Delivery Systems Drugs Production Drug Delivery 116

pharmaphorum

AUGUST 2, 2022

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.

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Trials Drugs Marketing Pharma Companies 105

XTalks

AUGUST 24, 2022

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.

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Drug Delivery Systems Drug Delivery Regulation Packaging 98

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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FDA Law Blog

JANUARY 5, 2023

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.

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pharmaphorum

JUNE 30, 2021

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.

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Vaccination Vaccine Trials Immune Response 98

The Pharma Data

NOVEMBER 2, 2020

. “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 drug delivery platforms to these emerging APIs,” said Hugh Rogers, CEO and Director of XPhyto. About XPhyto Therapeutics Corp.

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Production Development Drug Delivery Drugs 52

Roots Analysis

MARCH 8, 2023

Over time, various research studies have demonstrated the potential of exosomes ( membrane bound extracellular vesicles) in disease diagnosis, drug delivery 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.

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RNA Drug Delivery DNA Development 52

The Pharma Data

OCTOBER 27, 2020

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 drug delivery platform.

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RNA Drug Delivery Production In-Vitro 52

XTalks

OCTOBER 7, 2024

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.

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Insulin Regulation Drug Delivery Drugs 52

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery 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 drug delivery experience.

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The Pharma Data

DECEMBER 20, 2020

With this acquisition we are expanding our product pipeline to include psychedelic therapeutics, incorporating elements of our IP around drug delivery technology in which we already have prototypes developed, which we believe will propel us towards clinical studies relatively quickly. Ahmad Doroudian, CEO of BetterLife.

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Drug Delivery Containment Production Development 52

XTalks

JUNE 11, 2024

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 drug delivery to the vessel wall to prevent cell proliferation.

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Drugs Drug Delivery Cardiology Marketing 52

The Pharma Data

JANUARY 27, 2021

In 2020, XPhyto confirmed successful activation of its peptide-based biosensor program when delivered using Vektor’s sublingual drug delivery platform. Vektor will begin planning and development work for the incorporation of various psychedelic compounds into its drug formulations. About XPhyto Therapeutics Corp.

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XTalks

AUGUST 30, 2022

Due to consistent changes in pharmaceutical regulation, pandemic-related disturbances and the ongoing effects of digitization, visionary leaders could find themselves co-constructing their vision. Thus, futuristic thinking is an important facet of visionary leadership. Transformational Leadership.

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Life Science Generic Drugs Drug Delivery Compliance 105

FDA Law Blog

SEPTEMBER 19, 2023

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.

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The Pharma Data

DECEMBER 28, 2020

is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc.

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Containment Drug Delivery Compliance Marketing 52

The Pharma Data

JANUARY 25, 2021

” 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 drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines.

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Containment Drug Delivery Licensing Licensing 52

The Pharma Data

JANUARY 18, 2021

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.

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FDA Law Blog

MARCH 12, 2024

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.”

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Drugs Drug Delivery Systems Regulation Production 45

The Pharma Data

DECEMBER 14, 2020

is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc. For further information please visit www.abetterlifephama.com. About Transcend Biodynamics.

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Drug Delivery Containment Manufacturing Drugs 40

The Pharma Data

NOVEMBER 9, 2020

is accelerating the next-generation drug delivery, 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.

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The Pharma Data

NOVEMBER 4, 2020

is a bioscience accelerator focused on next-generation drug delivery, 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.

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XTalks

JUNE 21, 2024

Dr. Bryan began his career at Schering-Plough, engaging in formulation and drug delivery. 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.

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Development Immune Response Drugs Regulation 52

XTalks

JULY 5, 2022

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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Life Science Compliance Packaging Packaging 52

Roots Analysis

MARCH 24, 2022

However, research related to metabolites is essential to increase the understanding of molecular level interactions, functions, modifications and regulations in cells, therefore, the field of metabolomics plays a vital role in biomarker discovery for early disease diagnosis and prognosis as well as for drug discovery and development processes.

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