Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

Clinical Research 226

Clinical Research Research Gene Therapy Gene 226

pharmaphorum

APRIL 22, 2021

Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe to expand patient access to cell therapy. This thought leadership series has been paid and developed by Kite, a Gilead Company. Setting the standard in cell therapy.

Research 98

Research Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. They also control how much water and electrolytes are in the body, regulating blood pressure.

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Dr Olena Karpenko.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Read on to learn why life science and clinical research professionals are choosing a career with Medpace.

Clinical Research 111

Clinical Research Research Clinical Trials Clinical Trials 111

Pharmaceutical Technology

MARCH 6, 2023

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. However, struggles to prove to regulators the validity of or need for drugs in this realm still serve as a major barrier to success.

Drugs 363

Drugs Regulation Clinical Trials Clinical Trials 363

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

Clinical Development 52

Clinical Development Medicine Development Containment 52

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). Douglas collaborates with scientific researchers and external medical experts to advance clinical research. It operates in New Zealand, Fiji and the US.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). Douglas collaborates with scientific researchers and external medical experts to advance clinical research. It operates in New Zealand, Fiji and the US.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases.

Clinical Trials 52

Clinical Trials Clinical Trials Production Regulation 52

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. In 2024, we can expect another wave of innovative new drugs to be developed using the technology, given that the AI-fuelled small molecule discovery pipeline is growing by almost 40% annually.”

Genome 139

Genome Genomics Life Science Gene Therapy 139

XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. However, these complex treatments present challenges to developers over and above the well-documented hurdles of rare-disease research. Who wasn’t supposed to sit up.

Development 98

Development Gene Therapy Clinical Trials Clinical Trials 98

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

Clinical Development 40

Clinical Development Medicine Development Production 40

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. The company’s proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform, is designed to regulate the body’s intrinsic immune system.

Drugs 100

Drugs Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. The company’s proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform, is designed to regulate the body’s intrinsic immune system.

Drugs 100

Drugs Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need.

Drugs 100

Drugs Pharmacy Production Development 100

Drug Discovery World

APRIL 26, 2023

Researchers at the Icahn School of Medicine at Mount Sinai have demonstrated in a preclinical study a potential new therapeutic approach to treating the most common form of lung cancer. During tumour progression, the researchers found that bone marrow macrophages act to suppress the recruitment and activation of natural killer cells.

Antibody 52

Antibody Research Clinical Development Regulation 52

Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

Antibody 52

Antibody Trials Genetics Protein 52

Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

RNA 64

RNA In-Vivo In-Vitro DNA 64

Camargo

DECEMBER 20, 2021

A key provision of PDUFA VII is a budget and staffing increase for the Center for Biologics Evaluation and Research (CBER). The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. Beefing Up CBER. 2024: 48 staffers. 2025: 29 staffers. 2026: 15 staffers. 2027: 4 staffers.

Gene Therapy 184

Gene Therapy Gene Development Production 184

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Clinical Research 110

Drug Discovery World

SEPTEMBER 4, 2023

‘Cross-over arms in oncology clinical trials: An important consideration for patients’ was published by the Cholangiocarcinoma Foundation (CCF) with the aim of opening new doors for patients with limited treatment options. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development.

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Vaccination Vaccine Bacterium Protein 119

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

Clinical Trials 87

Clinical Trials Clinical Trials Trials Clinical Development 87

The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. Both small molecule inhibitors in Immuno-Oncology are being jointly developed in a strategic research alliance with the German Cancer Research Center (DKFZ) in Heidelberg, Germany.

Research 40

Research Clinical Trials Clinical Trials Trials 40

pharmaphorum

JANUARY 21, 2022

The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. According to Cancer Research UK, more than nine in every ten bile duct cancers start in the cells that line the bile ducts, the epithelial cells. This type of cancer is known as epithelial adenocarcinoma. “ODD

Drugs 64

Drugs Clinical Development DNA Regulation 64

pharmaphorum

SEPTEMBER 24, 2020

. “These discussions are part of our work to research ways of treating, limiting and hopefully preventing the virus so we can end the pandemic sooner.” That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

Vaccination 77

Vaccination Vaccine Trials Immune Response 77

Delveinsight

DECEMBER 24, 2020

research institutions. Examples include the development of breathalyzers capable of diagnosing a COVID-19 infection and detectors, recognizing the airborne virus in open spaces, such as meeting rooms and hospital hallways. GSK will lead to clinical development and beyond. However, patients often become resistant to them.

Research 52

Research Trials Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Delveinsight

AUGUST 20, 2020

regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) letter, which could cause a significant delay for any future approval, and canceled what would have been the first-ever approval for gene therapy in the bleeding disorder. J&J has agreed to pay USD 52.50

Gene Therapy 52

Gene Therapy Research Gene Antibody 52

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. What are the major challenges you’re facing right now in vaccine development?

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

NOVEMBER 17, 2020

Lead will lead the selection of a pre-clinical drug candidate, after which Roche will be responsible for further development and global marketing. The company has been working with Sanofi since 2015 on a small molecule targeting ROR gamma, a regulator of T-helper 17 immune cells. Roche last year signed a $792.5

Development 72

Development Drugs Sales Clinical Trials 72

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

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. The vaccine is top of the list of 35 potential coronavirus vaccines in clinical development, according to a list maintained by the World Health Organization.

Vaccination 83

Vaccination Vaccine Trials Protein 83

XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. It’s very positive and it’s going to help move forward the pathway for new drugs.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials.

Drug Trials 52

Drug Trials Trials Drugs Dermatology 52