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.

Development 180

Development Protein Production Hormones 180

Pharmaceutical Technology

FEBRUARY 23, 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 Artificial Intelligence in Pharmaceuticals: In-silico drug discovery. However, not all innovations are equal nor do they follow a constant upward trend.

Drugs 189

Drugs DNA In-Vivo In-Vitro 189

Pharmaceutical Technology

APRIL 4, 2023

Evergreen Discovery has partnered with Orbit Discovery to discover specific cell-targeting peptides and advance the development of new radiopharmaceuticals. The Orbit platform will also conduct in vitro transcription conversion from DNA-encoded libraries on beads.

Development 130

Development In-Vitro DNA Drugs 130

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

In-Vitro 246

In-Vitro Genetic Disease Medicine Genetics 246

XTalks

NOVEMBER 25, 2024

Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. The drug also reduces exposure risks for healthcare workers by improving handling safety in oncology clinics.

In-Vivo 105

In-Vivo FDA Approval In-Vitro Drugs 105

Pharma Mirror

FEBRUARY 18, 2021

Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc.

Drug Delivery 130

Drug Delivery In-Vivo In-Vitro Drugs 130

Pharmaceutical Technology

SEPTEMBER 22, 2022

Abpro has entered a strategic collaboration with Celltrion for the global development and commercialisation of the former's antibody therapy, a t-cell engager known as ABP 102. The cancer molecule will be developed for treating patients with HER2+ cancer, including gastric, pancreatic and breast cancer.

Antibody 130

Antibody Development Bioinformatics In-Vitro 130

Pharmaceutical Technology

NOVEMBER 10, 2022

NRG Therapeutics has raised Series A funds worth $18.3m (£16m) to progress the development of mitochondrial therapeutics to treat neurodegenerative ailments such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS). 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

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.

Production 130

Production Drugs Marketing In-Vitro 130

Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

In-Vitro 130

In-Vitro Clinical Trials Clinical Trials Drugs 130

XTalks

APRIL 14, 2022

Conventional in vitro and in vivo studies are used in the drug development pipeline. However, could there be another way for developing biomedical products using in silico technology? This involves the use of an individualized computer simulation for medical device or drug development. Want to learn more?

Trials 98

Trials In-Vivo In-Vitro Clinical Trials 98

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up. Particle distribution. Grittiness.

Production 130

Production Manufacturing Development Bioequivalency 130

pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

Pharmaceutical Technology

NOVEMBER 4, 2022

The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. at closing.

In-Vivo 130

In-Vivo In-Vitro Genetics Drugs 130

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

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.

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

XTalks

MARCH 1, 2021

The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants. The study will be a part of current Phase I, II and III trials. The third booster will be given to participants from the Phase I study in the US.

Vaccine 111

Vaccine Vaccination Development In-Vitro 111

Pharmaceutical Technology

APRIL 12, 2023

FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. Repotrectinib has been developed to combat cancer resistance to existing therapies and exert consistent anti-tumor activity. The ROS1 gene is altered in approximately in 1-2% of lung cancer patients.

Genome 130

Genome Genomics In-Vitro Gene 130

pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device. If so, developers must develop and execute on a regulatory strategy.

Development 104

Development Regulation Production Life Science 104

Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. Nuvectis now has two precision oncology, clinical-stage drug candidates, each with several potential opportunities in cancers that represent serious conditions of unmet medical need.

In-Vivo 130

In-Vivo In-Vitro Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.

Development 105

Development Regulation Cosmetics Life Science 105

Pharmaceutical Technology

MAY 10, 2023

Under the two-year deal, both parties expect to develop new treatment methods for patients’ unmet AML and breast cancer needs at a reasonable price. The research teams will examine the use of CytoMed’s allogeneic gdTc on multiple AML and breast cancer subtypes in vitro and in vivo.

Gene Therapy 147

Gene Therapy In-Vivo In-Vitro Gene 147

XTalks

JANUARY 15, 2021

Ortho Clinical Diagnostics received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VITROS SARS-CoV-2 antigen test for detection of active COVID-19 infection. Related: COVID-19 Vaccine and Drug Development Coverage. active virus).

In-Vitro 105

In-Vitro Vaccination Vaccine Drugs 105

pharmaphorum

JANUARY 17, 2022

Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.

FDA Approval 123

FDA Approval In-Vitro Regulation Hormones 123

pharmaphorum

JANUARY 22, 2021

The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” said Gilead in its statement. “We The UK strain – known as B.1.1.7

In-Vitro 141

In-Vitro RNA Licensing Licensing 141

Pharmaceutical Technology

JUNE 1, 2023

Pneumagen has raised £8m ($10 million) for the further development of its intranasal antiviral drug neumifil in Phase II studies for chronic obstructive pulmonary disease (COPD) patients suffering from virus-induced exacerbations. million) for the Phase II development of neumifil in January 2022. million ($4.75

In-Vitro 130

In-Vitro Engineer Protein Vaccine 130

pharmaphorum

AUGUST 4, 2022

Training and development. Staff development and training programmes were largely on pause during the pandemic. Businesses need to ensure they prioritise the recruitment and development of staff to help ensure longevity and survival. Harness technology.

Development 98

Development In-Vitro Manufacturing Compliance 98

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

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.

FDA Approval 96

FDA Approval Drugs Sales In-Vitro 96

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

FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. As with any “child” they’ve matured and developed as they’ve grown into adulthood. By Jeffrey N.

In-Vitro 98

In-Vitro Regulation Production Compliance 98

Pharmaceutical Technology

MAY 24, 2023

Our board and management team believe that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need.” Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

Gene Therapy 130

Gene Therapy In-Vivo In-Vitro Immune Response 130

Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. According to GlobalData, Phase II drugs for Pancreatic Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases.

In-Vitro 100

In-Vitro Drugs Clinical Trials Clinical Trials 100

Pharmaceutical Technology

AUGUST 11, 2022

There is a clear correlation between the INHBE gene and metabolic syndrome, particularly T2D and coronary heart disease, and the potential development of targeted therapy in future could have broad benefits across these disorders.

Gene 130

Gene Biobanking Gene Expression In-Vitro 130

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

Pharmaceutical Technology

SEPTEMBER 10, 2008

The first activities of the company concerned the pre-clinical toxicological testing of several new candidate molecules showing cytostatic activity, initially developed by a former research institute, as well as the breeding and supplying of laboratory animals. . Dr Ivana Surovà: Biotest s.r.o. Can you reveal the results of these?

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Development 100