Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

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Drug Discovery World

NOVEMBER 9, 2022

Unexpected metabolism can cause the failure of many late-stage drug candidates, or even the withdrawal of approved drugs. It is therefore essential to predict metabolism for potential drug candidates. . The post AI development duo to advance drug-metabolising enzymes appeared first on Drug Discovery World (DDW).

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Drug Discovery World

NOVEMBER 29, 2022

The technology can contribute to the development and production of vaccines and drugs for severe diseases much faster and at lower cost. . Now we have succeeded in designing our own DNA that contains the exact instructions to control the quantity of a specific protein,” said Aleksej Zelezniak. .

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. When PREA was first instituted, the statutory requirements did not apply to products that received Orphan Drug Designation (ODD). emphasis added).

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Bio Pharma Dive

MARCH 20, 2023

Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.

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Drug Discovery World

NOVEMBER 14, 2022

Early-stage biopharma company Atrogi initiated a Phase I study for its drug candidate ATR-258 targeting type 2 diabetes in Germany, which is expected to announce results at the end of the year. . Find out more: Collaboration to develop AAV vectors for diabetes gene therapy . Alternative to insulin.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 – Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos. The voluntary testing method developed by industry is not sensitive enough to screen for asbestos when compared to electron microscopy, the group said. Food and Drug Administration does not require testing talc supplies.

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Drug Discovery World

JANUARY 23, 2024

The world’s most comprehensive database for understanding microbial distribution and function in the ocean has been released, opening up new opportunities for drug discovery. ” The ability to collect and analyse such a new wealth of ocean data comes from major developments in DNA sequencing technology and computational power.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Camargo

DECEMBER 9, 2020

Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information. Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs.

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pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace. The Carillon device, developed by Cardiac Dimensions Inc.

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Drug Discovery World

DECEMBER 20, 2023

Using a novel approach, researchers from The Institute of Cancer Research, London have uncovered details of secondary breast cancer in the brain and spinal cord that may help with developing effective treatments. The post Discovery lights the way for new secondary breast cancer drugs appeared first on Drug Discovery World (DDW).

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FDA Law Blog

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. In all of these letters, CVM alleges that the distributors who “take orders” are selling unapproved drug products—typically for infection control—for use in fish and, in some cases birds.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.

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Drug Discovery World

OCTOBER 20, 2022

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Developing and securing human resources with digital skills. Government policies .

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FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. A summary of these new state law developments is included below.

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pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. Organ-on-a-chip.

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Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world.

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Pharma Mirror

NOVEMBER 4, 2022

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers.

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The Pharma Data

OCTOBER 4, 2021

In a recent paper, researchers at GlaxoSmithKline (GSK) and the Cambridge Crystallographic Data Centre (CCDC) combined their proprietary (GSK) and published (CCDC) datasets to better train machine learning (ML) models to predict stable polymorphs to use in new drug candidates. What are the key differences between the CCDC and GSK datasets?

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Pharmaceutical Technology

MARCH 14, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Purine derivatives-based cancer drug compositions. By means of geographic reach, Primmune Therapeutics Inc holds the top position.

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Drug Discovery World

OCTOBER 19, 2022

Yapan Bio has expanded its capabilities with a new process development facility at Genome Valley, Hyderabad, India, which has enhanced its ability to support end-to-end development and manufacturing of RNA, DNA and gene therapy products starting from plasmids. .

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Drug Discovery World

MARCH 28, 2023

SolasCure’s first investigational product, Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots which aims to accelerate wound debridement, is due to enter further Phase II efficacy-supporting trials. funding to develop Aurase Wound Gel appeared first on Drug Discovery World (DDW).

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Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

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Drug Discovery World

NOVEMBER 4, 2022

New research has furthered our understanding of the immune-related factors that drive infection and disease, which will be necessary for an effective tuberculosis (TB) vaccine to be developed. Instead, infection is either eliminated or contained by the infected individual. Most individuals infected with M.tb

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Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. Discoveries in these areas will identify new treatments which will become the cancer drugs of the future.” DDW’s Diana Spencer explores the city’s unique ecosystem.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.

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Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

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Drug Discovery World

JANUARY 9, 2024

Thirteen new-to-market therapeutics and drugs poised to launch in 2024 will achieve ‘blockbuster’ status by 2029 or deliver game-changing benefits to patients. The 2024 Drugs to Watch, are: 1.

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Drug Discovery World

OCTOBER 19, 2022

Ashley Rein , Global Market Manager for Topical Drug Delivery at Lubrizol Life Science Health (LLS Health), explains how by using mucoadhesive drug delivery, developers can bring novel drugs to market and maximise the efficacy of pre-existing APIs. . This journey is far from straightforward.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. According to GlobalData, Phase I drugs for Adrenal Insufficiency have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. It is a combination of drug and device.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The list also includes providers of behavioural insights, brand naming and development solutions, commercial recruiting solutions, digital and social media advertising, full-service commercial, medical communications, and several other solutions and products. Product claim advertising is allowed with a summary of the product risks included.

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Drug Discovery World

JULY 21, 2023

The most impactful drug discovery news this week is all linked with scientific research data. Analysts Phesi revealed that a third of clinical development programmes are cancelled during Phase II, and there were significant trial results for drugs for head and neck cancer and Alzheimer’s disease.

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