Camargo

OCTOBER 14, 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. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence. Orientation.

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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.

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STAT News

SEPTEMBER 26, 2022

Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol.

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Pharmaceutical Technology

MAY 10, 2023

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC).

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Scienmag

DECEMBER 18, 2020

– A University of Arkansas biologist is part of a global team of researchers developing a strategy to detect and intercept diseases emerging from wildlife in Africa that could eventually infect humans. […]. FAYETTEVILLE, Ark.

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Scienmag

SEPTEMBER 7, 2021

A research group in Japan has successfully developed a “nanoporous super multi-element catalyst” (1) that contains 14 elements (2) which are mixed uniformly at the atomic level and used as a catalyst.

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Medical Xpress

MARCH 23, 2023

The omentum contains lymphoid aggregates (immune cell clusters) that are referred to as milky spots. Recently, two researchers from Osaka University further examined the molecular and cellular details of how these milky spots develop and mature to better understand their role in the abdominal immune system.

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Sciensano

APRIL 18, 2023

In order to reduce the amount of packaging waste, the zero-waste trend (bying food in bulk) has recently developed. It is characterisez by the purchase, transport and storage of food using its own containers. But is this trend safe? Who initiated this study? Sciensano will only use this information to compile general statistics.

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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. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

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Drug Discovery World

DECEMBER 6, 2022

As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. Ideally, research assessing NPIs would also pre-specify the effect size, which could inform their implementation or withdrawal, especially when weighed against socioeconomic costs. .

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Medical Xpress

APRIL 6, 2023

For example, research has shown that increased consumption of the cruciferous vegetable decreases incidences of cancer and type 2 diabetes.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Not yet, according to Ewart.

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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. About REALM-DCM.

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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. The product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.

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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. Containment challenges.

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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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Scienmag

SEPTEMBER 27, 2021

28, 2021) – The microbiota in the nose and upper throat likely contains biomarkers for assessing how sick an individual infected with SARS-CoV-2 may get and for developing new treatment strategies to improve their outcome, researchers say. AUGUSTA, Ga. Credit: Michael Holahan, Augusta University AUGUSTA, Ga.

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Pharmaceutical Technology

MAY 11, 2023

The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atezolizumab).

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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. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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Drug Discovery World

NOVEMBER 14, 2022

Find out more: New human beta cell model enables discoveries in diabetes research . Based on research into adrenergic signaling by professor Tore Bengtsson at Stockholm University, ATR-258 is a small molecule therapy that works by selectively stimulating b2-adrenergic receptors to translocate GLUT4 to the cell membrane. .

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pharmaphorum

MAY 6, 2021

UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months. . “One area of research we are particularly excited about is the ability of IPX formulations to degrade biofilms,” McGoldrick told us.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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pharmaphorum

JANUARY 18, 2023

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. The idea of ‘genetic superheroes’ and precision medicine is captivating for researchers, but the concept can be abstract and distant for participants. First, start co-development with participants early on in the process.

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The Pharma Data

JANUARY 3, 2021

Ltd (“ CIMC Sanctum “) recently started R&D of liquid nitrogen biological containers for long-term cryogenic storage of vaccines, stem cells, plasma, semen, embryos and various tissues and organs for the needs of the biomedical industry. The equipment is specifically developed for cryogenic storage of biological samples.

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Eye on FDA

SEPTEMBER 28, 2022

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). But for now, we wait.

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Trialfacts

OCTOBER 3, 2022

The kind of bacteria in the human gut during infancy may affect the development of allergic disease later in life. An infant allergy development prevention research study is being done across multiple research sites in the United States and Australia. Siolta Therapeutics is sponsoring this research study.

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Trialfacts

OCTOBER 3, 2022

The kind of bacteria in the human gut during infancy may affect the development of allergic disease later in life. An infant allergy development prevention research study is being done across multiple research sites in the United States and Australia. Siolta Therapeutics is sponsoring this research study.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

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Advarra

MARCH 31, 2023

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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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. We hope that our models and discoveries serve as valuable resources for other researchers in this area.

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Trialfacts

JANUARY 20, 2023

More Study Details Study Location Research Center: Energy Balance and Nutrition Laboratory – University of Delaware Location: 100 Discovery Blvd, Newark, DE 19713 Lead Researchers: Jillian Trabulsi, Ph.D.; This development is ongoing, however, infancy plays an important role in forming a robust microbiome and overall health.

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Pharmaceutical Technology

APRIL 28, 2023

It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. PREVNAR 20 has been developed on the basis of Pfizer’s approved PREVNAR 13 vaccine.

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Scienmag

MAY 27, 2022

Tokyo, Japan – Researchers from Tokyo Metropolitan University have developed a new carbon capture system which removes carbon dioxide directly from the atmosphere with unprecedented performance.

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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Trialfacts

JUNE 25, 2023

More Study Details About the Research Center: Location: Research Center: The University of Illinois Chicago Location: The University of Illinois Chicago, 1747 W. Roosevelt Rd, Chicago, IL 60608, United States Lead Researcher: Robin Mermelstein, Ph.D. Participants will be helping to advance health research. Roosevelt Rd.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Streamlined development, flexibility in manufacturing, and improved product quality at reduced costs, while gaining access to capabilities and capacity are some of the factors fuelling the pharmaceutical solid dosage contract manufacturing market. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.

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Pharmaceutical Technology

APRIL 4, 2023

KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen. The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. Results showed that patients treated with Padcev along with KEYTRUDA achieved a confirmed ORR of 68%.

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