Pharmaceutical Technology

APRIL 12, 2023

Foundation Medicine has announced it will supply a tissue-based test as a companion diagnostic for Bristol Myers Squibb’s (BMS) recently acquired ROS1/TRK inhibitor repotrectinib. FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples.

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Genome Genomics In-Vitro Gene 130

Worldwide Clinical Trials

JUNE 21, 2024

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

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Antibody Clinical Trials Clinical Trials In-Vitro 162

Pharmaceutical Technology

NOVEMBER 10, 2022

The funding proceeds will be used to progress the potential brain-penetrant small molecules of the company to studies that will facilitate the submission of an investigational new drug (IND) application. This could possibly stop or substantially slow down disease progression in Parkinson’s or ALS patients.

Development 130

Development In-Vitro Clinical Development Medicine 130

The Pharma Data

OCTOBER 16, 2020

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform. In vitro antiviral technology proves effective against SARS-CoV-2 in human airway infection model.

In-Vitro 52

In-Vitro Clinical Trials Clinical Trials Trials 52

XTalks

JANUARY 9, 2023

recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus). Gilead Sciences, Inc.

FDA Approval 98

FDA Approval Drugs In-Vitro Clinical Trials 98

Scienmag

SEPTEMBER 21, 2020

(Boston)– Responding to the COVID-19 pandemic caused by the novel coronavirus, SARS-CoV-2, requires models that can duplicate disease development in humans, identify potential targets and enable drug testing.

In-Vitro 75

In-Vitro Research Development Drugs 75

Scienmag

FEBRUARY 9, 2021

The work, led by NYU Tandon and the New York Stem Cell Foundation Research Institute, could lead to efficient, detailed artificial bone tissue, opening doors to disease modeling, in vitro cell research on targeted therapies, drug screening and more.

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In-Vitro Research Drugs Engineer 75

Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase II drugs for Pancreatic Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pralsetinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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In-Vitro Drugs Clinical Trials Clinical Trials 100

pharmaphorum

FEBRUARY 19, 2021

Snipping out this viral code with powerful CRISPR gene editing technology, which last year won Drs Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for chemistry, would in theory prevent the need for drugs to suppress the virus and the development of AIDS.

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Gene Editing In-Vivo DNA In-Vitro 105

Scienmag

MARCH 24, 2021

An international team of researchers has found that three commonly used antiviral and antimalarial drugs are effective in vitro at preventing replication of SARS-CoV-2, the virus that causes COVID-19. The work also underscores the necessity of testing compounds against multiple cell lines to rule out false negative results.

In-Vitro 44

In-Vitro Drugs Research Medicine 44

The Pharma Data

JANUARY 6, 2021

The research collaboration is aimed at identifying novel lead compounds and repurposing existing drugs for rheumatoid arthritis and nonalcoholic steatohepatitis, leveraging Standigm’s AI-powered drug discovery platforms : Standigm BEST , Standigm Insight , and Standigm ASK. Standigm is an AI-driven drug discovery company.

FDA Approval 52

FDA Approval Life Science Drugs In-Vivo 52

The Pharma Data

JANUARY 6, 2021

(“CytoDel” or “the Company”), a privately-held corporation, today announces the publication of preclinical data on the Company’s lead product, Cyto-111, in the peer-reviewed journal, Science Translational Medicine. Cyto-111 was conceived, expressed and purified in the laboratory of Konstantin Ichtchenko, Ph.D.,

Medicine 52

Medicine Antibody Protein In-Vitro 52

XTalks

JUNE 30, 2022

a leader in the development of collagen and other biomaterial-based medical devices for regenerative medicine, announced this week that the company received a 510(k) clearance from the US Food and Drug Administration (FDA) for their new Fibrillar Collagen Wound Dressing. Collagen is an abundant structural protein in animals.

In-Vitro 98

In-Vitro Production Marketing Medicine 98

pharmaphorum

SEPTEMBER 9, 2020

The Wavre-based biotech says it has conducted clinical trials in around 2,000 patients to see how effective Sedakit is at relieving pain and anxiety without the use of drugs. She came up with the idea for Sedakit after living through the stress of watching one of her own family members fight cancer.

In-Vitro 82

In-Vitro Clinical Trials Clinical Trials Development 82

XTalks

JANUARY 6, 2021

Nanobodies are attractive therapeutic agents because of their small size and simple structure, which allow them to be more easily used as templates to design antibody drugs compared to human antibodies. The study was led by neuroscientists Thomas J. “TJ” TJ” Esparza, BS, and David L.

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Antibody Protein Bacteria In-Vitro 105

pharmaphorum

NOVEMBER 1, 2022

Investigating the next generation of genetic medicine through RNA based therapies. RNA therapeutics is a rapidly expanding industry with increasingly growing potential for immunotherapy, personalised medicines, and treatment of genetic, infectious, and chronic diseases. Heads of Translational Medicine. Website: [link].

RNA 52

RNA Genetics Gene Editing In-Vitro 52

FDA Law Blog

AUGUST 18, 2024

Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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In-Vitro Radiology Cosmetics Medicine 69

The Pharma Data

JANUARY 27, 2021

FDA Investigational New Drug (“IND”)-enabling pharmacology studies. Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. About BetterLife Pharma: BetterLife Pharma Inc.

In-Vitro 52

In-Vitro Containment Drugs Production 52

XTalks

MARCH 1, 2021

In addition, the companies are also engaged in discussions with regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency, with respect to a registration-enabling study for the evaluation of a variant-specific vaccine with a new mRNA code. The new mRNA sequence would be based on the B.1.351

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Vaccination Vaccine Development In-Vitro 111

Roots Analysis

SEPTEMBER 4, 2024

The main purpose of in vitro diagnostic solutions is to perform non-invasive / minimally invasive test procedures in order to detect a variety of health conditions using samples, such as blood, tissue or urine. Such tests help to diagnose health conditions, monitor treatments, perform disease screening and aid in early diagnosis of diseases.

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Marketing In-Vitro Compliance Development 40

Roots Analysis

AUGUST 18, 2023

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions.

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Production In-Vitro Branding Drugs 52

The Pharma Data

JANUARY 31, 2021

Ion channels represent a large but under-exploited class of drug targets beyond G protein-coupled proteins (GPCRs). Collaboration combines Sosei Heptares’ leading structure-based drug design platform with Metrion Biosciences’ ion channel expertise. TOKYO and CAMBRIDGE, England , Feb.

Drugs 52

Drugs Protein In-Vitro Development 52

XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis?

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

Druggist

DECEMBER 2, 2020

Antibiotic creams are prescription-only medicines. In reality, however, there is no clear cut between both types of drugs. In today’s post, I will review over the counter antibiotic creams in the UK. Can you buy over the counter antibiotic cream? . Buy antibiotic cream online – private services.

Bacteria 86

Bacteria Pharmacy Doctor Doctors 86

The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. ” ABOUT ALLOY THERAPEUTICS Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all. .”

Antibody 52

Antibody In-Vivo In-Vitro Scientist 52

Druggist

FEBRUARY 17, 2021

Hydrocortisone cream is classified as pharmacy-only medicine (P), which means it can only be sold in pharmacies, including online chemists and sellers on Amazon.co.uk. For many customers, ointment or cream for insect bites is the first line of rescue in stings management. What causes bite itchiness and redness? 822 Reviews. £3.19.

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Pharmacy Containment Production Sales 98

The Pharma Data

DECEMBER 14, 2020

The move follows announcements of high-profile collaboration agreements with Takeda Pharmaceuticals and Morphic Therapeutic, to leverage the benefits of Engitix’ human ECM-based discovery platform to improve the success rate of drug discovery and development. 15, 2020 09:00 UTC. About Engitix Ltd.

Life Science 52

Life Science In-Vitro Development Drugs 52

pharmaphorum

OCTOBER 29, 2020

insitro uses machine-learning technology to discover novel drug targets and patient segments. The platform applies machine learning, human genetics, and functional genomics to generate predictive in vitro models that provide insights into disease progression.

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Development DNA In-Vitro Genome 45

pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. A £16 million Series A financing – led by Omega Funds – has been announced by the innovative neuroscience company NRG Therapeutics Ltd.,

In-Vitro 52

In-Vitro Bioavailability Medicine Clinical Trials 52

The Pharma Data

MAY 15, 2023

Leveraging human model systems, the institute aims to accelerate drug discovery and development by improving the understanding of how organs function and how diseases develop. Ultimately, this will help to bring medicines to patients faster. Human model systems such as organoids are the future of our industry.

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In-Vitro Medicine Scientist Development 40

The Pharma Data

JANUARY 19, 2021

On January 19, its investigational new drug (IND) for GC019F, a FasTCAR-enabled CAR-T therapy in relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL) was approved by China’s National Medical Products Administration (NMPA). Ortho Clinical Diagnostics is a leader in in vitro diagnostics.

In-Vitro 52

In-Vitro Production Trials Manufacturing 52

The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Evrysdi is now approved in the US to treat SMA in children and adults of all ages.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

The Pharma Data

APRIL 29, 2022

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Food and Drug Administration in 2017. In 2021 Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery.

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Protein In-Vitro Medicine Development 52

Roots Analysis

SEPTEMBER 4, 2023

On the other hand, cases wherein a large firm acquired another well-established company, represent 11% of the total instances; examples include the acquisition of GRAIL by Illumina (2021), QIAGEN by Thermo Fisher Scientific (2020) and Foundation Medicine by Roche (2018).

Development 52

Development Marketing Medicine Contract Manufacturing 52

pharmaphorum

AUGUST 24, 2020

She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Lynne was previously employed at Roche Biomedical Laboratories, the University of Maryland at Baltimore’s School of Medicine, and earned her B.S.

Contamination 52

Contamination In-Vitro Production Containment 52

The Pharma Data

AUGUST 27, 2020

FoundationOne Liquid CDx is available to order, as of 28 August 2020, replacing Foundation Medicine’s currently available liquid biopsy test FoundationOne Liquid. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours.

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FDA Approval Genome Genomics Gene 52