pharmaphorum

JULY 19, 2022

Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.

Drug Development 105

Drug Development Communication 105

pharmaphorum

MARCH 10, 2017

2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region.

Drug Development 52

Drug Development 52

pharmaphorum

MARCH 24, 2022

GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. Greg Verdine – LifeMine.

Compounding 105

Compounding Immunity Immunization Drug Development 105

European Pharmaceutical Review

JANUARY 11, 2024

chronic neuropathic pain is at present, mainly managed with antidepressants… antiepileptic drugs… as well as opioids” Neuropathic pain affects over 400 million people worldwide, according to Hoba Therapeutics. He has been responsible for development programmes in multiple indications, spanning all phases of drug development.

Drug Development 102

Drug Development Medical Schools 102

Pharmaceutical Technology

JUNE 12, 2023

In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.

Immunity 143

Immunity Immunization Drug Development 143

pharmaphorum

MARCH 23, 2021

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis.

Labelling 98

Labelling Drug Development 98

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives.

Drug Development 52

Drug Development Immunity Immunization Hospitals 52

European Pharmaceutical Review

JULY 7, 2022

Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. Brian Hughes replaces Hafrun Fridriksdottir who became Teva’s President of Global Generics R&D in 2017. .

Research Laboratories 98

Research Laboratories Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing 52

pharmaphorum

JANUARY 3, 2023

The drug is a sodium channel blocker thought to work by blocking the post-synaptic release of glutamate, a neurotransmitter, and offering an alternative mechanism to existing schizophrenia drugs that block dopamine. ” The new data could accelerate partnering efforts of the drug this year.

Labelling 105

Labelling Drug Development 105

pharmaphorum

MARCH 16, 2021

The Cardiff, Wales startup is combining machine learning and phage display techniques to model antibody-antigen binding and says it can cut the time it takes to develop a drug candidate. It’s one of the few AI drug discovery companies operating in the antibody category, as most are focused on small molecules.

Drug Development 101

Drug Development 101

European Pharmaceutical Review

DECEMBER 21, 2022

What sponsors should know about psychedelic drug development. Although some psychedelics have a long history in traditional medicine, regulatory agencies must evaluate psychedelic compounds the same way they assess any other drug. Fast track designation. Accelerated approval. Psychedelic research: progress through collaboration.

Compounding 119

Compounding Drug Development Controlled Substances 119

European Pharmaceutical Review

OCTOBER 31, 2022

The characterisation resulting from this process is also required to inform the scaleup of drug substance and product, a separate milestone in these initial stages of drug development. Scaling up small molecule drugs manufacturing. Trends in FDA drug approvals over last 2 decades: An observational study.

Compounding 125

Compounding Drug Development Pharmaceutical Companies Pharmaceutical Companies 125

pharmaphorum

APRIL 27, 2021

On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

STAT

MARCH 6, 2023

A spokeswoman for the FDA said federal law prohibits regulators from commenting on pending requests to make experimental drugs available, inside or outside a clinical trial. In 2017, he was diagnosed with advanced cancer of the esophagus and told he probably had  only months to live.

Vaccines 246

Vaccines Bioethics Immunity Immunization 246

RX Note

JULY 8, 2023

Introduction Drug development is an expensive and lengthy process , taking about 2-3 billion dollars and over 10 years to discover and develop a drug to commercialization. Drug Development Timeline Discovery and Development Research for a new drug begins in the laboratory.

Drug Development 52

Drug Development Compounding 52

Express Pharma

AUGUST 10, 2024

Divergent regulatory requirements between NDCTR 2019 and Medical Device Rules 2017; between NDCTR 2019 and biologics guidelines; and the need for animal studies for approved new drugs with modified or new claims would make the regulatory process time-consuming and costly for a startup.

Drug Development 105

Drug Development Vaccines Dosage Documentation 105

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. 4,5 What is the key consideration drug developers should apply to gene therapies?

Drug Development 96

Drug Development Pharmaceutical Companies Pharmaceutical Companies Diabetes 96

pharmaphorum

OCTOBER 29, 2020

By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.

Documentation 101

Documentation Drug Development 101

Pharmaceutical Technology

AUGUST 1, 2022

One key scientific challenge is the ability to develop antibiotics that can penetrate gram-negative bacteria’s built-in defence mechanisms and kill these drug-resistant pathogens.

Vaccines 93

Vaccines Pharmaceutical Companies Pharmaceutical Companies Chemotherapy 93

pharmaphorum

JULY 8, 2022

Source: Izmailova et al, 2017. Pharma companies have begun to explore a host of novel digital endpoints that could have far-reaching implications for accelerating drug development and adoption. Table 1: Digital and sensor technology available for use in clinical trials. Novel digital endpoints. About the interviewees.

Drug Development 100

Drug Development Diabetes 100

pharmaphorum

MARCH 19, 2021

As data and digital technology become vital to every aspect of life sciences, the industry is increasingly looking beyond biologists, chemists, and doctors to drive its drug development – and finding that technology has a chief role to play in the future of medicine. According to an article by Stephens, Zachary D.,

Drug Development 59

Drug Development 59

pharmaphorum

NOVEMBER 24, 2021

Not only can it benefit patients by better addressing unmet needs and improving outcomes, but it makes financial sense.

Drug Development 59

Drug Development 59

pharmaphorum

OCTOBER 12, 2022

“We founded Whitelab Genomics after realising the potential to use data, data science, and AI in a more systematic way to develop genomic therapies,” Del Bourgo says. Since 2017, Debiopharm has invested in 14 digital health companies, typically leading the investment rounds. Forging an AI-enabled path toward precision medicine.

Drug Development 105

Drug Development Immunity Immunization Vaccines 105

Pharmaceutical Technology

FEBRUARY 8, 2023

Since the first approval in 2017, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cell and gene therapies. Despite the challenges that drug developers must overcome to produce gene therapies for rare diseases, Hart underscored the FDA’s intent to encourage more innovation in this space. “We

Documentation 105

Documentation Drug Development Communication 105

pharmaphorum

JUNE 8, 2021

All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. From 2008 to 2017, he served as an executive director of the clinical development department at Celgene (now part of Bristol-Myers Squibb). About the author.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

pharmaphorum

SEPTEMBER 30, 2022

The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017. An oral version of edaravone was cleared this year. Bad news for Biohaven.

Specialty Pharmacies 98

Specialty Pharmacies Labelling Hospitals Drug Development 98

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

pharmaphorum

SEPTEMBER 20, 2022

The two companies have been talking to each other since 2017 and formally working together since 2019, when Pfizer started using CytoReason’s biological models in research aimed at developing new drugs for immune-mediated diseases and cancer immunotherapies.

Drug Development 52

Drug Development Immunity Immunization Pharmaceutical Companies 52

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Additional concerns for the caregiver include a strain on physical and mental health.

Labelling 98

Labelling Drug Development 98

European Pharmaceutical Review

OCTOBER 30, 2023

4 The pandemic highlighted the need to significantly shorten the overall vaccine development process, where mRNA vaccine technology was utilised for the first time in commercially available immunisations. About the author Graham Griffiths joined Vaccitech as Chief Business Officer in October 2017.

Vaccines 114

Vaccines Drug Development 114

pharmaphorum

NOVEMBER 6, 2020

Shah is retiring from a role that only became part of the drugmaker’s executive committee in 2017, reflecting the relatively late acknowledgement of the strategic value of information technology in the pharma industry. A search is now underway for her successor.

Drug Development 56

Drug Development 56

pharmaphorum

JUNE 9, 2022

In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products. The challenge with traditional antibiotics . References.

Drug Development 104

Drug Development Diabetes Chemotherapy 104

pharmaphorum

APRIL 13, 2021

She is an experienced executive in drug development and has over 30 years’ experience in the biotechnology and pharmaceutical industry. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences. from September 2005 to August 2008.

Drug Development 111

Drug Development 111

Pharmaceutical Technology

JANUARY 23, 2023

Mirikizumab has lost significant ground in the anti-IL23 drug class to AbbVie’s Skyrizi, and to a lesser extent Janssen’s Tremfya. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively. Ther Innov Regul Sci.

Labelling 59

Labelling Compounding Drug Development 59

pharmaphorum

NOVEMBER 22, 2022

Francis, who is currently CEO of gene therapy specialist Purespring Therapeutics and cardiovascular drug developer company Forcefield Therapeutics, is due to take the top job at Teva on 1 January, and will serve as the pharma company’s president. Richard Francis.

Drug Development 59

Drug Development 59

pharmaphorum

MARCH 2, 2022

The number of active clinical trials studying psilocybin alone has increased more than three-fold from 2017. The reason research interest is high in the area is because psychedelic therapies are achieving strong results in the area of mental health.

Compounding 105

Compounding Drug Development 105