European Pharmaceutical Review

MAY 9, 2024

Biotechnology regulation: response to the Executive Order Following the issue of a Request for Information (RFI), consulting with the Office of Science and Technology Policy (OSTP), the US FDA, EPA, and USDA received comment from the public (88 in total). A sign-on letter from 6,000 industry members was also obtained.

FDA 70

FDA Communication 70

STAT

MAY 9, 2023

Thanks to advances in science, notably the completion of the Human Genome Project 20 years ago, we are able to treat diseases more effectively than ever before. Science is — and should be — the guide to determine the optimal approach for patients. Is it inside the cell or outside?

Patient Care 86

Patient Care 86

The People's Pharmacy

MARCH 30, 2023

” Aging Humans Benefit More If They Are Impaired: Older people also benefit from blueberry supplementation ( Journals of Gerontology, Series A, Biological Sciences & Medical Sciences , July 2019 ). As the researchers point out, no one knows yet the ideal dose of blueberries to improve cognitive function.

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Compounding 76

Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The programme aims to develop advanced technologies and applications to improve human health.

Communication 97

Communication FDA 97

European Pharmaceutical Review

APRIL 15, 2024

Further findings Based on the observations, the paper reported a higher occurrence of microorganisms common to the human microbiota: Staphylococcus epidermidis (15 percent) and Micrococcus spp. (13 The paper was published in the Brazilian Journal of Pharmaceutical Sciences. 13 percent). 23 percent) and Penicillium sp. (21

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European Pharmaceutical Review

NOVEMBER 23, 2022

The QIG will work in line with the priorities emphasised in EMA’s Regulatory Science Strategy to 2025 , in which the regulatory body identified key goals and core recommendations for human medicines. Catalysing the integration of science and technology in medicines’ development. The five key goals of this strategy are: .

Documentation 100

Documentation 100

pharmaphorum

SEPTEMBER 16, 2022

Human-first precision health. The purpose of collaborating with Sosei Heptares, Kim told pharmaphorum, was to streamline definition of those GPCR targets worth studying, while substantially reducing human hours spent trawling through data. Technological breakthroughs in molecular biology. What, then, is the solution?

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Immunization FDA 131

European Pharmaceutical Review

SEPTEMBER 7, 2023

In 2018, we found evidence of senescent cells in human Alzheimer’s,” stated Miranda Orr, PhD, Associate Professor of gerontology and geriatric medicine at Wake Forest University School of Medicine in the US.

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FDA 96

pharmaphorum

SEPTEMBER 6, 2022

That’s exactly what Bayer’s new paper, Science-Led Self-Care: Principles for Best Practice , sets out to achieve. Abbie Lennox, global chief regulatory, medical, safety and compliance officer for the organisation’s consumer health division, said she hoped it will “spark a conversation” around the need to promote science-led self-care. “We

Labelling 75

Labelling Communication 75

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences Human Health chief science officer Amin Khan said: “This is a tremendous opportunity for us to partner with a premier vaccine discovery team and use our mRNA platform to accelerate the development of coronavirus vaccines which are more broadly protective and durable than those currently available.”.

Vaccines 98

Vaccines Immunization 98

pharmaphorum

MARCH 24, 2022

The latest financing follows a $55 million first round in 2017 and a $50 million Series B last year, and gives LifeMine a healthy cash base to develop its Avatar-Rx platform, which exploits the evolutionary similarities between fungi and humans.

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Compounding Immunization 99

pharmaphorum

APRIL 1, 2022

With the new Health and Care Bill edging ever closer to receiving Royal Assent, life sciences companies in the UK are preparing to navigate the most significant piece of NHS legislation in a decade. Uday Bose , country managing director and head of human pharma, Boehringer Ingelheim. Key issues keeping pharma and ICS awake at night.

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pharmaphorum

OCTOBER 7, 2020

Charpentier – currently at the Max Planck Unit for the Science of Pathogens in Germany – and Doudna of the University of California, Berkeley (pictured left to right), are the first two women to share the prize awarded by the Royal Swedish Academy of Sciences. There is enormous power in this genetic tool, which affects us all.

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Roots Analysis

FEBRUARY 26, 2024

According to classical Greek mythology, human health management were initially a race of children free from all forms of maladies and sorrow. Soon after, humans started suffering from various illnesses and began to age and die. human health management also talks about primitive surgery and anesthetic techniques.

Vaccines 52

Vaccines 52

pharmaphorum

JUNE 16, 2021

Borrowing from the Computer-Aided Design and Manufacturing (CAD/CAM) approaches in the semiconductor industry, a similar concept, called Computer-Aided Biology (CAB), can be applied to the life sciences. In addition, successful human-centric lab modernisation requires scientists to have different skill sets than in the past.

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Pharmaceutical Technology

OCTOBER 28, 2022

This helps to reduce human error and provide more reliable, replicable results and increase the speed of drug discovery and development processes. Eli Lilly is the first big pharma company to publicly invest in Cloud robotics labs, having designed the Lilly Life Sciences Studio Lab with Strateos in the US.

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Compounding 124

Pharmaceutical Technology

MARCH 16, 2023

We see this collaboration as an investment in next-generation science and technology, allowing us to accelerate our understanding of human pathobiology and explore the potential of developing novel medicines through AI.” According to the company, Huntington’s disease affects nearly one in 10,000 people across the world.

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pharmaphorum

OCTOBER 22, 2021

Rich also covers how Healios is not just a digital application, but focuses on achieving better outcomes through the optimal combination of both digital and human intervention through direct virtual contact via text and video with an extensive care team of live clinicians.

Communication 107

Communication 107

pharmaphorum

NOVEMBER 26, 2021

Roberto outlines his early journey from being medical doctor to building one of the first digital agencies, which has now grown into an international company working with large life science organisations, technology start-ups and health systems, operating at the cutting edge of digital health.

Communication 93

Communication 93

European Pharmaceutical Review

NOVEMBER 16, 2023

The BTK inhibitor BRUKINSA ® (zanubrutinib) was recommended by the EMA’s human medicines committee last month. 2 One of the challenges that we have in treating cancer is that the human immune system is highly complex. Additionally, the company ’s anti-PD-1 antibody achieved EU approval for oesophageal cancer in September 2023.

Immunization 52

Immunization 52

The Checkup by Singlecare

FEBRUARY 1, 2024

The amount of phytoestrogens to consume daily to observe the positive impacts described in various animal studies and human studies is approximately 50 milligrams (mg); the average consumption in Western countries is only about 2 mg per day. Phytoestrogens and their health effect, Open Access Macedonian Journal of Medical Sciences (2019).

Mayo Clinic 95

Mayo Clinic Compounding FDA 95

The FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 42 U.S.C. §

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FDA 64

Pharmaceutical Technology

MAY 19, 2023

MT-101 will be evaluated in the first-in-human, multicentre, open-label, multiple ascending dose Phase I/II IMAGINE trial to treat refractory or relapsed peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) patients. We are pleased that such high-quality investors have joined with us to accelerate this effort.”

Labelling 98

Labelling 98

Hospital Pharmacy Europe

FEBRUARY 5, 2024

DS, caused by trisomy of human chromosome 21 (Hsa21), resulted in multiple conditions including learning and memory deficits, craniofacial alterations, and CHD, researchers wrote in the journal Science Translational Medicine.

Dosage 52

Dosage Immunization Hospitals 52

pharmaphorum

JULY 1, 2021

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Chemistry, engineering and computer science will have to play together in a much more integrated way than they have to date.

Pharmaceutical Companies 77

Pharmaceutical Companies Pharmaceutical Companies Patient Care Vaccines 77

Pharmaceutical Technology

FEBRUARY 16, 2023

For millennia, this has been the natural order of human life. However, in the last 25 years, humanity has made massive strides in understanding, and importantly manipulating, the ageing process. The biology of ageing Ageing is an intensely complex syndrome influenced by environmental, genetic, and epigenetic factors.

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pharmaphorum

SEPTEMBER 20, 2021

. “The miniature microscope can depicture neurons in the brain, thereby showing where compounds interact and how they affect the brain,” said Benjamin Hall, director of circuit biology at Lundbeck.

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Compounding 78

European Pharmaceutical Review

JANUARY 9, 2024

These innovations bestow visual inspection processes with unprecedented precision, identifying imperfections and anomalies that often elude human scrutiny. Deep Learning for Computational Biology. Opportunities and Obstacles for Deep Learning in Biology and Medicine. Figure 1 : adapted from Saha, G. J Am Coll Radiol.

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FDA 122

European Pharmaceutical Review

DECEMBER 19, 2022

Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. Chris Boyle is a life sciences lawyer and qualified veterinarian who advises and litigates in the highly regulated fields of human and veterinary medicinal products, medical devices, food and feed.

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pharmaphorum

JANUARY 25, 2023

Dr Robbert Zusterzeel, MPH, vice president of regulatory science and strategy at Woebot Health, added: “Unlocking this therapeutic effectiveness has the potential to improve both the quality and the scalability of mental health care, providing support to patients on waiting lists and in between clinical encounters.”

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Dosage FDA 98

Pharmaceutical Technology

JANUARY 12, 2023

The collaboration will use the vector biology, manufacturing capabilities and the drug development experience of Solid Biosciences and Phlox Therapeutics’ knowledge in genetic cardiomyopathies and RNA therapies. Solid Biosciences stated that the partnership boosts its scientific capabilities along with commercial potential in cardiac therapy.

Communication 52

Communication 52

Pharmaceutical Technology

NOVEMBER 10, 2022

NRG leverages breakthrough science in the mitochondrial biology field to create disease-altering therapies to slow down or stop the progression of diseases such as Parkinson’s and ALS. Led by Omega Funds, the financing round saw participation from new investor Brandon Capital and founding investor, The Parkinson’s Virtual Biotech. .

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Pharma Marketing Network

MARCH 2, 2022

According to Murray Aitken, IQVIA’s Senior VP and Executive Director of the IQVIA Institute for Human Data Science, “the pandemic has accelerated biopharmaceutical innovation.” More than 3,000 life sciences companies are involved in R&D work. IQVIA’s Report Highlights.

Vaccines 52

Vaccines 52

pharmaphorum

JANUARY 27, 2022

The first patient has been treated with an implantable bioelectronic device developed by Galvani Therapeutics, set up by GlaxoSmithKline and Alphabet’s Verily Life Sciences in 2016. Now, the start of human trials now means that the technology could be just a few years away from the market.

Immunization 101

Immunization 101

pharmaphorum

OCTOBER 6, 2022

The Royal Swedish Academy of Sciences has decided to award this year’s Nobel Prize in Chemistry to Carolyn R. BREAKING NEWS: The Royal Swedish Academy of Sciences has decided to award the 2022 #NobelPrize in Chemistry to Carolyn R. The Royal Swedish Academy of Sciences was founded in 1739.

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European Pharmaceutical Review

OCTOBER 1, 2022

In a study published in the Journal of Pharmaceutical Sciences , Fujiwara et al. evaluated the impact of external surface sterilization of P-PFSs filled with water for injection (WFI) or human serum albumin (HSA) solution – the later acting as a model protein therapeutic product.

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Packaging Immunization 72

European Pharmaceutical Review

JANUARY 10, 2024

The human microbiome is a key player in our understanding of health and disease. Conceptual challenges: basic ecosystem biology and microbiology The basis of many challenges is the dynamic nature of the microbiome, which is vastly underexplored and not well understood.

Immunization 52

Immunization Documentation 52