Camargo

MARCH 25, 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 Rare Pediatric Disease Designation.

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Production Drugs In-Vitro Containment 130

Pharma Mirror

APRIL 21, 2024

With the rapid development of biotechnology and molecular medicine, the introduction of mRNA as a vaccine or therapeutic agent enables the production of almost any desired functional protein/peptide within the human body.

In-Vitro 130

In-Vitro Drugs Genetic Disease RNA 130

Pharma Mirror

AUGUST 30, 2022

The testing facility, located in North Carolina, provides supportive technology at no cost allowing companies to test and prove their cell-based products at various stages of development. By eliminating the fluctuations and suboptimal transients caused by.

Medicine 130

Medicine In-Vitro Manufacturing Production 130

Pharmaceutical Technology

MAY 31, 2023

C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. It is expected to accelerate the development of CFT8919 in important international markets.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

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

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. 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. If so, developers must develop and execute on a regulatory strategy.

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Development Regulation Production Life Science 104

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?

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Trials In-Vivo In-Vitro Clinical Trials 98

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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Vaccine Vaccination Development Life Science 105

Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases.

In-Vitro 130

In-Vitro Clinical Trials Clinical Trials Drugs 130

Worldwide Clinical Trials

JUNE 21, 2024

Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline. Four distinct challenges were discussed at ASCO involving ADC development, including: Target Expression Levels : The targeted antigen must be sufficiently expressed on tumor cells.

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. These products are subject to the same regulatory requirements as any unapproved medical device”).

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In-Vitro Regulation Production Compliance 98

pharmaphorum

OCTOBER 4, 2022

In the final guidance, the FDA clarifies that certain types of CDS software functions are excluded from the definition of a medical device when such products meet all four of the criteria articulated in section 520(o)(1)(E) of the FD&C Act. Part 2 of this series is devoted to clinical decision support (CDS) software. Criterion 1.

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Development Regulation Cosmetics Life Science 105

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.

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FDA Approval Manufacturing Development RNA 105

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.

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Development In-Vitro Manufacturing Compliance 98

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

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

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In-Vitro RNA Licensing Licensing 141

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?

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In-Vitro Genotoxicity In-Vivo Development 100

pharmaphorum

OCTOBER 18, 2021

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). When the COVID-19 pandemic hit, it lit a fire under the regulatory system.

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Vaccination Vaccine Medicine Regulation 143

pharmaphorum

JANUARY 25, 2022

To demonstrate how quickly the digital therapeutics space is developing, it is easiest to state that the first such therapy was approved in 2018 and since that point the annual investment in the space has more than doubled in the intervening years. Developing a digital therapy. This equated to $21.3 This equated to $21.3

Medicine 111

Medicine In-Vivo In-Vitro Development 111

Roots Analysis

NOVEMBER 30, 2021

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. In fact, to obtain the regulatory approval for the biological products, such bioanalytical evaluations are must.

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Bioassay Gene Therapy Gene Development 52

Pharmaceutical Technology

JUNE 6, 2023

The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Buy the model here. over FY2021. in FY2021.

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Hormones In-Vitro Genotype Bacteria 100

Pharmaceutical Technology

AUGUST 26, 2008

It started to emerge in the mid 1990s, incrementally gathering speed as more products were approved in the last ten years,” says Reilly. “The pharmaceutical industry is increasingly embracing large molecule products and concepts.” “Biotechnology has exploded across the industry. .

Antibody 100

Antibody Licensing Licensing Production 100

FDA Law Blog

OCTOBER 18, 2022

The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations. If you would like to provide suggestions in the transition plan for Covid-19 related products or any other guidance documents, comments may be submitted to www.regulations.gov by December 26, 2022.

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Production In-Vitro Marketing Clinical Trials 52

Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Hoffmann-La Roche and currently in Phase II for Pancreatic Cancer. Buy the report here.

In-Vitro 100

In-Vitro Drugs Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 28, 2023

Under the deal terms, Chipscreen NewWay will develop and commercialise YH008 in Greater China, including Macau, Mainland China, Taiwan, and Hong Kong. Eucure Biopharma will retain the global rights for the development and commercialisation of the antibody outside Greater China.

In-Vivo 130

In-Vivo Antibody In-Vitro Licensing 130

The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. MUNICH, Germany, Jan.

Gene Therapy 52

Gene Therapy Gene Development In-Vivo 52

XTalks

JUNE 30, 2022

The photo shown is one of the company’s products, TruSource™ medical grade collagen. This 40 th 510(k) milestone is a testament to our team’s tireless commitment to developing meaningful innovation in regenerative medicine throughout our 25-year history. Collagen Matrix Inc. Photo courtesy of Collagen Matrix Inc.

In-Vitro 98

In-Vitro Production Marketing Medicine 98

pharmaphorum

OCTOBER 5, 2022

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

Antibody 110

Antibody In-Vitro Radiology Development 110

Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. Single- and multi-nation funding opportunities flooded in.

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Manufacturing Vaccine Vaccination RNA 130

BioTech 365

SEPTEMBER 14, 2020

– Lead product candidate, SB206 currently being evaluated in B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum with topline data targeted for Q2 2021 – – In vitro assessments of ability of NITRICIL™ to inhibit the replication mechanisms of SARS-COV-2 … Continue reading →

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In-Vitro Development Production 40

The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 anticipates that the successful development of its allogeneic Tmod candidate therapy will enable subsequently developed allogeneic Tmod candidates.

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Development Engineer Manufacturing In-Vitro 52

XTalks

JULY 22, 2021

We’ve heard of cell-based meat — meat produced by in vitro cell cultures of animal cells — but its seafood equivalent could be on the horizon. With the technology largely borrowed from cell-based meat production, it was not as much of a challenge to nail it down. The real challenge lies with consumers making the switch.

Protein 96

Protein In-Vitro Production Marketing 96

The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

Development 52

Development Contamination In-Vitro Production 52

Roots Analysis

DECEMBER 12, 2022

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. Brand Positioning Matrix Of Organ-On-Chip Key Players.

Production 40

Production In-Vitro Marketing Branding 40

FDA Law Blog

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). Most of these reclassified tests will supposedly be infectious disease and companion diagnostic IVDs.

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In-Vitro Regulation Development Production 116

FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

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In-Vitro Engineer Production Regulation 59

XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. Surmodics will manufacture and supply the device and realize revenue from product sales to Abbott as well as a share of profits from Abbott’s third-party sales. The balloon is designed for the treatment of patients with peripheral artery disease.

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FDA Approval Drugs Sales In-Vitro 96