Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 95

Clinical Trials Clinical Trials Regulation Trials 95

Pharmaceutical Technology

FEBRUARY 13, 2023

SOPHiA GENETICS is expanding its collaboration with AstraZeneca to include multimodal approaches for developing cancer drugs. SOPHiA GENETICS and AstraZeneca will together examine ways to expedite clinical trials and improve clinical decision-making.

Genetics 130

Genetics Development Drugs Genome 130

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). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES. Novaliq’s CyclASol (0.1%

Development 147

Development Drugs Clinical Trials Clinical Trials 147

XTalks

NOVEMBER 14, 2023

Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals. In trial data shared by Novo in August, Wegovy (2.4 The SELECT trial began in 2018 and is Novo’s largest trial to date.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. 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

Outsourcing Pharma

JULY 12, 2023

Acasti Pharma, a late-stage biopharma company with drug candidates addressing rare and orphan diseases, has selected WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for aneurysmal subarachnoid haemorrhage (..)

Trials 91

Trials Clinical Development Development Drugs 91

Drug Discovery World

MARCH 15, 2024

Biotechnology company Allyx Therapeutics has reported positive Phase Ib clinical data for its lead compound, ALX-001, a first-in-class, synapse-targeted, disease-modifying oral therapy in development for neurodegenerative diseases. The findings were presented at the AD/PD 2024 Conference in Lisbon.

Trials 52

Trials Drugs Clinical Development Development 52

XTalks

JANUARY 23, 2024

Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development.

Development 72

Development Hormones Drugs Trials 72

STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development. Continue to STAT+ to read the full story…

Clinical Trials 105

Clinical Trials Clinical Trials Trials Drugs 105

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong.

Development 62

Development Research Drugs Antibody 62

Drug Discovery World

OCTOBER 20, 2023

A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials. The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi.

Clinical Trials 62

Clinical Trials Clinical Trials Trials Marketing 62

Worldwide Clinical Trials

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Clinical Research 130

Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

Drugs 130

Drugs Clinical Development Antibody Protein 130

Drug Discovery World

DECEMBER 5, 2023

The agreement will enable the parties to discuss opportunities for collaboration to support the charity’s research and clinical development activities, focusing primarily on its clinical trials run by its Centre for Drug Development.

Drugs 112

Drugs Research Trials Clinical Trials 112

Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. The US Food and Drug Administration (FDA) recently granted Orphan Drug Designation for FT011 for the treatment of systemic sclerosis (scleroderma).

Drug Trials 57

Drug Trials Trials Drugs Clinical Trials 57

Outsourcing Pharma

MARCH 5, 2024

Clerkenwell Health, a company that delivers clinical trials for the treatment of complex mental health volunteers for trials into the use of psychoactive medications for treating PTSD, is in search of 40 ex-military volunteers.

Trials 107

Trials Clinical Trials Clinical Trials Drugs 107

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Most said, “some of the time,” followed by “never.”

Development 52

Development Drugs Trials Clinical Development 52

Drug Discovery World

JUNE 27, 2023

The US Food and Drug Administration (FDA) has published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions, including psychiatric or substance use disorders. However, these are still investigational products.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

Drug Discovery World

APRIL 14, 2023

Oliver Schon, PhD, is VP Research & Development at BiVictriX Therapeutics, a UK-based emerging drug discovery and development company generating a pioneering first-in-class next-generation ADC anti-cancer therapeutics which exhibit superior selectivity towards cancer.

Antibody 52

Antibody Development Drugs Manufacturing 52

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

Clinical Development 52

Clinical Development Development Clinical Supply Packaging 52

Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

Outsourcing Pharma

DECEMBER 15, 2021

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

Trials 141

Trials Medicine Drugs Clinical Development 141

Pharmaceutical Technology

MAY 2, 2023

Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.

Production 130

Production Drugs Clinical Trials Clinical Trials 130

Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The initiative reflects the FDA’s recognition of this sector as a growing and increasingly important area of drug development.

Gene Therapy 184

Gene Therapy Gene Development Production 184

Outsourcing Pharma

APRIL 22, 2024

Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.

Trials 88

Trials Drugs Development Clinical Development 88

Drug Discovery World

MARCH 15, 2024

The collaboration has supported ongoing development of Exonate’s lead candidate, EXN407, following a recent successful Phase Ib/IIa study in November. The Phase IIb study is planned to initiate in 2024, following the successful completion of the company’s Phase Ib/IIa trial for EXN407.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

XTalks

NOVEMBER 15, 2023

Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP). The drug was approved by the FDA last year for the treatment of ALS.

Life Science 52

Life Science Trials Clinical Trials Clinical Trials 52

Drug Discovery World

MARCH 25, 2024

Cardior is focused on the discovery and development of therapies that target RNA to prevent, repair and reverse diseases of the heart. In a Phase Ib trial CDR132L was reported to be safe and well tolerated and the results suggested cardiac functional improvements in people with heart failure compared to placebo.

Development 52

Development RNA Trials Clinical Development 52

Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.

Life Science 162

Life Science Development Gene Therapy Genetics 162

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

Pharmaceutical Technology

JUNE 6, 2023

Gildeuretinol is the first and only medicine in clinical development to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials.

Genetics 279

Genetics Life Science Trials Clinical Development 279

Pharmaceutical Technology

APRIL 13, 2023

Fusion Pharmaceuticals (Fusion) has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107). The therapy will be assessed in a Phase I trial.

Clinical Development 147

Clinical Development Antibody Development Manufacturing 147

Worldwide Clinical Trials

OCTOBER 17, 2022

BioPharma Dive sat down with our Gary Fishbein for a conversation on how to de-risk trials without sacrificing cost or speed. These measures, applied across the continuum of a compound’s development, can improve the likelihood of successful late phase trials. Optimizing enrollment.

Trials 100

Trials Clinical Trials Clinical Trials Drugs 100