XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

Pharmaceutical Technology

APRIL 17, 2023

The company will help in managing the clinical trials of the products once the regulators provide approvals for the proposed research and development programmes. French company Eurofins Scientific is currently developing and manufacturing both products.

Dermatology 130

Dermatology Clinical Trials Clinical Trials Production 130

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. Douglas collaborates with scientific researchers and external medical experts to advance clinical research.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. Douglas collaborates with scientific researchers and external medical experts to advance clinical research.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Pharmaceutical Technology

MAY 3, 2023

The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL). The company stated that the collaboration deepens its leadership in oncology and haematology, and expedites its development, manufacturing and commercialisation capabilities to deliver cell therapies.

Gene Therapy 147

Gene Therapy Sales Gene Development 147

XTalks

DECEMBER 28, 2023

It stands out as the sole reported therapy under clinical evaluation for treating alloimmunized pregnant individuals at significant risk of severe HDFN.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. The key challenge for all regulators next year is ensuring that they can keep up with the progress of the technology.”

Genome 139

Genome Genomics Life Science Gene Therapy 139

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

XTalks

MAY 28, 2024

XTALKS CLINICAL EDGE: Issue 2 — CSL Seqirus’ Interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

BioPharma Reporter

FEBRUARY 18, 2021

Massachusetts-based clinical research organization (CRO), Charles River Laboratories, is to acquire Cognate BioServices, a cell and gene therapy contract development and manufacturing organization (CDMO) for around US$875m in cash.

Gene Therapy 52

Gene Therapy Gene Clinical Research Manufacturing 52

XTalks

DECEMBER 22, 2022

NORD, along with its more than 330 member patient organizations, is committed to the identification, treatment and cure of rare disorders through education, advocacy, research and patient services. Since only about 5 percent of rare diseases have FDA-approved treatments, it is vital that we increase the pace of rare disease clinical research.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

Roots Analysis

MARCH 6, 2022

This complete process is in association with a complex and highly regulated assembly of proteins which involve several soluble and surface-bound complement components, including receptors and regulators, which are majorly generated by the liver. Complement Therapeutics: The Clinical Antidote for Complement-Associated Diseases.

Regulation 52

Regulation Protein Antibody Marketing 52

pharmaphorum

APRIL 27, 2021

The Serum Institute of India has manufactured the malaria vaccine and says it could deliver more than 200 million doses as soon as it is approved by regulators. Trials of the malaria vaccine began in 2019 and laid the foundations for the coronavirus shot that was quickly developed in partnership with AstraZeneca.

Vaccination 52

Vaccination Vaccine Immune Response Trials 52

Cloudbyz

MAY 19, 2021

Complexities arise while trying to establish a standard, cost-efficient, and expert process for research and manufacturing. This is also fairly driven by the high operational cost including logistics and manufacturing. Another major business format emergence is Contract Development and Manufacturing Organization ( CDMO ).

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

pharmaphorum

DECEMBER 16, 2020

Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve “It’s been a very interesting year to kick things off.”. We’re very grateful for that.

Vaccination 122

Vaccination Vaccine Life Science In-Vitro 122

Cloudbyz

AUGUST 2, 2022

In the past, post-marketing research, post-marketing surveillance and pharmacovigilance were synonymous with phase IV studies because the main activities of the regulatory agencies were focused on the monitoring of adverse drug events and inspections of drug manufacturing facilities and products. Essentials of Clinical Research.

Marketing 80

Marketing Research Clinical Trials Clinical Trials 80

pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Companies should monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner.

Life Science 98

Life Science Compliance Regulation Cosmetics 98

XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

pharmaphorum

AUGUST 31, 2021

The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Because physicians in the real world are not following a clinical trial protocol, there will always be less consistency in RWD relative to clinical trial data.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

Clinical Trial Podcast

JULY 18, 2020

This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical research space or simply curious about clinical trial costs, this post will serve you well. Clinical Research Assistants or Associates (CRAs). Patient Grant.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

The Pharma Data

DECEMBER 14, 2020

(“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech focused on the development and commercialization of cutting edge treatments, today announced the value proposition of its acquisition of Transcend Biodynamics, LLC ’s (“Transcend”) manufacturing patent “Process of synthesizing 2-Bromo-LSD.”.

Drug Delivery 40

Drug Delivery Containment Manufacturing Drugs 40

Drug Discovery World

DECEMBER 8, 2023

These therapeutics are complex and one of the major bottlenecks in their development is avoiding downstream impurities during manufacturing, which can cause major safety concerns. Also, this type of therapeutic is so new that only a handful of cell and gene therapies have been evaluated and approved by regulators.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

pharmaphorum

NOVEMBER 8, 2022

For those companies involved in the development and manufacture of approved vaccines and treatments, it led to a surge in revenue. Research published by Veeva found that 87% of sponsors and clinical research organisations had taken up some use of decentralised technology, representing a 59% increase compared to prior to the pandemic.

Trials 121

Trials Clinical Trials Clinical Trials Vaccination 121

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. My mission is to see cannabis regulators understand basic science and to consult experienced scientists to refine regulations.

Medicine 52

Medicine Scientist Production Regulation 52

Roots Analysis

MARCH 24, 2022

However, research related to metabolites is essential to increase the understanding of molecular level interactions, functions, modifications and regulations in cells, therefore, the field of metabolomics plays a vital role in biomarker discovery for early disease diagnosis and prognosis as well as for drug discovery and development processes.

Clinical Research 52

Clinical Research Development Research Drug Delivery Systems 52

Cloudbyz

MARCH 25, 2021

Clinical research companies have also become more thoughtful towards data security for their colossal clinical data repositories. What are the advantages of the Salesforce platform or Salesforce CTMS to clinical research? Salesforce platform delivers several advanced features and solutions for clinical research.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

Clinical research companies have also become more thoughtful towards data security for their colossal clinical data repositories. What are the advantages of the Salesforce platform or Salesforce CTMS to clinical research? Salesforce platform delivers several advanced features and solutions for clinical research.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

APRIL 7, 2021

The company managed to reduce overheads thanks to a decision early in van de Winkel’s stewardship to outsource manufacturing and sell off its production facility. Van de Winkel acknowledges the huge challenges that the company has faced over the last year – the interview is over zoom because of COVID-19 regulations. In good shape.

Antibody 91

Antibody Life Science Development Regulation 91

The Pharma Data

DECEMBER 15, 2020

CHIPSCREEN BIOSCIENCES BIOSCIENCES will exclusively grant HISUN PHARMACEUTICAL the right to promote Bilessglu® (Chiglitazar Sodium tablets), independently developed and manufactured by its wholly-owned subsidiary CHENGDU CHIPCREEN PHARMACEUTICAL CO., CHIPCREEN BIOSCIENCES remains as the owner and manufacturer of the drug.

Insulin 40

Insulin Drugs Production Clinical Trials 40

Cloudbyz

AUGUST 2, 2022

In the past, post-marketing research, post-marketing surveillance and pharmacovigilance were synonymous with phase IV studies because the main activities of the regulatory agencies were focused on the monitoring of adverse drug events and inspections of drug manufacturing facilities and products. Essentials of Clinical Research.

Marketing 52

Marketing Research Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Prior to joining Cidara, Kurtz served as head of commercial API manufacturing at Gilead Sciences. Immune Regulation – U.K.-based

Development 52

Development Gene Therapy Engineer Life Science 52

WCG Clinical

SEPTEMBER 26, 2023

We’re here today to talk about clinical research with psychedelic drugs. FDA published its first draft guidance on this topic in June in response to an increasing interest in clinical trials of psychedelic drugs to treat a range of diseases. And to be clear that we’re not trying to regulate.

Research 59

Research Drugs Trials Clinical Research 59

XTalks

JUNE 15, 2022

The featured speakers will discuss how life science manufacturers can now save time, money and resources and increase time to market by doing away with fully customized QMS solutions — while remaining compliant with industry regulations and standards.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drug Delivery 52

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Gene Therapy 52

Gene Therapy Life Science Production Clinical Development 52

STAT News

MARCH 6, 2023

But they said the sum covers only the direct costs of designing and manufacturing the vaccines ― which are tailored to the unique genetic makeup of each patient’s tumor ― and that the FDA has approved the breakdown of expenses. ” Leaders of the foundation, based in Chapel Hill, N.C.,

Vaccination 98

Vaccination Vaccine Drugs Clinical Trials 98