XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

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pharmaphorum

MAY 7, 2021

It’s illegal in most countries including the US and UK but Small Pharma is convinced of its potential as a therapeutic medicine for depression and has already begun clinical development. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

Drug Trials 98

Drug Trials Trials Marketing Drugs 98

Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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Antibody Trials In-Vitro Clinical Trials 52

XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Clinical Trials Clinical Trials Trials Clinical Research 97

Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Clinical Trials Clinical Trials Trials Clinical Development 52

Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

Clinical Development 74

Clinical Development Clinical Trials Clinical Trials Development 74

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Antibody Marketing Drugs Licensing 98

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. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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Clinical Trials Clinical Trials Trials Development 130

Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

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Trials Clinical Trials Clinical Trials FDA Approval 52

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Sanofi has partnered with drug delivery specialist Enable Injections to develop the subcutaneous formulation.

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Trials Sales Drug Delivery Antibody 97

pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. Bringing a new cancer drug to market costs an average of $2.8 Bringing a new cancer drug to market costs an average of $2.8

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Trials Clinical Trials Clinical Trials FDA Approval 98

Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.

Trials 52

Trials Clinical Trials Clinical Trials Licensing 52

Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2% at 52 weeks). .”

Trials 52

Trials Dermatology Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Outsourcing Pharma

MAY 4, 2023

Sam Whittaker is founder, and CEO of multiple clinical trial technology companies, including Greenphire and Mural Health.

Clinical Development 52

Clinical Development Clinical Trials Clinical Trials Development 52

pharmaphorum

MAY 3, 2022

Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.

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Marketing Drugs Sales Pharma Companies 97

Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.

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Development Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

FEBRUARY 14, 2023

Under the deal, Corbus Pharmaceuticals will have exclusive rights to develop and commercialise CRB-701 in Canada, Australia, the UK, the EU (including the European Free Trade Area), and the US, while CSPC will retain SYS6002’s rights in the remaining markets. According to the agreement, CSPC will receive a $7.5m

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Antibody Drugs Clinical Development Licensing 130

pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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Clinical Trials Clinical Trials Trials Compliance 98

XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gaining patient input on marketing and recruitment materials. How the NIHR’s Patient Engagement in Clinical Development service can help.

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Clinical Trials Clinical Trials Trials Life Science 113

pharmaphorum

JANUARY 31, 2022

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The post Daiichi makes play for share of Japan’s COVID booster market appeared first on.

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XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

DECEMBER 7, 2022

Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012. In 2021, the global collagen market was valued at $9.75 Phesi’s analysis shows that just 27% of trials received industry funding.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). This includes an upfront payment of $2m from AstraZeneca. This includes an upfront payment of $2m from AstraZeneca.

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Development Gene Expression Licensing Licensing 264

Pharmaceutical Technology

SEPTEMBER 22, 2022

Under the deal, GSK will obtain an exclusive licence for the development and marketing of tebipenem pivoxil HBr in all countries. Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of paediatric infections limited to pneumonia, otitis media and sinusitis.

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Bacteria Marketing Trials Clinical Development 147

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Outsourcing Pharma

NOVEMBER 23, 2022

Hybrid and decentralized clinical trial specialist Castor is expanding into post-marketing studies with a service intended to reduce costs by 30%.

Marketing 52

Marketing Clinical Trials Clinical Trials Trials 52

pharmaphorum

JANUARY 12, 2023

Oramed Pharma has conceded defeat in its attempt to bring an oral formulation of insulin to market for people with type 2 diabetes, after its ORMD-0801 candidate missed the mark in a phase 3 trial. The post Phase 3 trial dashes Oramed’s oral insulin hopes appeared first on.

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Insulin Trials Development Drugs 57

Drug Discovery World

JANUARY 23, 2024

The analysis of 65,749 recruiting clinical trials was conducted by data analytics company Phesi, as part of an annual global analysis of clinical trials using data from its Trial Accelerator platform. The positive news is there has been an increase in trial recruitment across all the top five indications in 2023.

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Research Clinical Trials Clinical Trials Trials 52

pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.

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Gene Therapy Gene Trials Protein 101

BioPharma Reporter

JANUARY 23, 2023

Phesi led analysis reveals an overall decrease in the number of recruiting trials and higher proportion of Phase 2 terminations in 2022.

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Delveinsight

MARCH 1, 2021

Thus, it can be conveniently said that the Rare disease market, which was once barren land has now become fertile ground. First and foremost, the regulatory agencies were ready and willing, with ornaments in hand to decorate the Rare disease market with novel therapies. While more than 150 orphan drugs have been approved in the EU.

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Marketing Clinical Trials Clinical Trials Drugs 52

Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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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. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases.

Antibody 52

Antibody Trials Genetics Protein 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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