Pharmaceutical Technology

MAY 31, 2023

According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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In-Vitro Clinical Trials Clinical Trials Drugs 130

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.

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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.

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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.

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FDA Approval Drugs In-Vitro Clinical Trials 98

Camargo

NOVEMBER 29, 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. Characteristics of Biologic Products. Molecular Size and Structure. ADME and Dosing Regimen.

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Development Protein Production Hormones 180

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.

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In-Vitro Research Development Drugs 75

FDA Law Blog

AUGUST 3, 2022

Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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In-Vitro Regulation Production Compliance 98

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

OCTOBER 18, 2021

For some countries, it has taken many years to approve a drug that was already available elsewhere, and such delays clearly have a negative impact on patients in those countries. Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). And there are many.

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Vaccine Vaccination Medicine Regulation 143

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.

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In-Vitro Drugs Research Medicine 44

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV).

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RNA In-Vitro Genotype Marketing 97

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.

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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

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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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.

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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.

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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

XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.

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Sales FDA Approval Drugs Vaccine 64

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].

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RNA Genetics Gene Editing In-Vitro 52

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., It is important to note that these studies are required by U.S.

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Research Vaccine Vaccination Drugs 112

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

Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. In general terms these have failed to add the value originally anticipated as turning knowledge into safe and effective drugs is still a complicated, lengthy process.

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Antibody Licensing Licensing Production 100

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.

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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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Vaccine Vaccination Development In-Vitro 111

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

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Drugs Licensing Licensing Production 110

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

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FDA Approval Drugs Protein In-Vitro 52

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?

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FDA Approval In-Vitro Trials Bacteria 98

The Pharma Data

MAY 17, 2021

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests. . Posted 17 May 2021 | By Michael Mezher .

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In-Vitro Manufacturing Vaccine Vaccination 52

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 ).

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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.

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Bacteria Pharmacy Doctors Doctor 86