pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. 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. Personal approach. About the author.

Regulation 105

Regulation Development Drugs Clinical Trials 105

Pharmaceutical Technology

MARCH 10, 2023

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

The paper presents the scoping review results, opportunities to increase uptake identified at the Expert Meeting, and proposes key questions that medical product developers and regulators may use to inform clinical development strategy and optimize trial design with disease progression models.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Production 81

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Outsourcing Pharma

SEPTEMBER 13, 2023

In the rapidly evolving world of pharmaceutical development, high-potency active pharmaceutical ingredients (HPAPIs) are becoming powerful tools.

Regulation 95

Regulation Development Clinical Development 95

Worldwide Clinical Trials

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

pharmaphorum

SEPTEMBER 3, 2020

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. Another was hospitalised with suicidal ideation. The post Compass plans $100m IPO to fund magic mushroom depression drug appeared first on.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

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

BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 4, 2020

The Wall Street Journal reported the news first, quoting an unnamed source directly involved in the development that some early batches of raw materials had failed to meet standards, causing production delays. The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator.

Vaccine 125

Vaccine Vaccination Production Regulation 125

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 80

Clinical Development Clinical Trials Clinical Trials Development 80

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

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. The Xtalks White Paper, The Intersection of Rare Disease and Advanced Therapies: What it Means for Clinical Development , is available for free download. Partnering with regulators early.

Development 98

Development Gene Therapy Clinical Trials Clinical Trials 98

Pharmaceutical Technology

JULY 26, 2022

Several drugs in the pipeline have novel mechanisms of action (MOAs), including novel calcium channel regulator acetylleucine and cyclodextrin therapies, adrabetadex and Trappsol Cyclo. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Marketing 306

Marketing Gene Branding Clinical Development 306

BioTech 365

FEBRUARY 4, 2022

Evotec SE / Key word(s): Miscellaneous Evotec SE: Bayer discontinues clinical development candidate eliapixant (BAY1817080), Evotec regains the rights to all P2X3 assets 04-Feb-2022 / 13:17 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation … Continue reading →

Clinical Development 40

Clinical Development Development Regulation 40

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8

Vaccine 122

Vaccine Vaccination Antibody Regulation 122

Pharmaceutical Technology

MAY 19, 2023

“Our therapeutic approach of inhibiting sodium channel function aims to limit the hypersensitivity reaction to pain by regulating the misfiring of peripheral nerves that transmit the perceived pain to the central nervous system.” The company stated that the grant from NIDA will support the clinical development of its NaV1.8

Development 130

Development Clinical Development Regulation Drugs 130

Camargo

DECEMBER 20, 2021

The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. A key provision of PDUFA VII is a budget and staffing increase for the Center for Biologics Evaluation and Research (CBER). The projected staff increases over the next five fiscal years are as follows: 2023: 132 staffers.

Gene Therapy 184

Gene Therapy Gene Development Production 184

Pharmaceutical Technology

NOVEMBER 2, 2022

There are currently 378 drugs indicated for rare diseases under pre-clinical and clinical development, 66% of which are in late-stage development (Phase II to Pre-registration stage).

Drugs 147

Drugs Development Clinical Development Regulation 147

XTalks

MARCH 17, 2025

Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections. Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating.

Hormones 59

Hormones Drugs Sales Insulin 59

Pharmaceutical Technology

DECEMBER 6, 2022

The companies reported the outcome of a Phase II meeting with the FDA in March, where the regulator discouraged submission based on the single-arm Phase II TIDAL trial of zandelisib in relapsed or refractory (r/r) follicular lymphoma patients. .

Development 147

Development Trials Clinical Trials Clinical Trials 147

Outsourcing Pharma

MARCH 18, 2024

In an encouraging development, neuromodulation, a form of bioelectric medicine, has emerged as a promising avenue for enhancing health by regulating the nervous system.

Regulation 96

Regulation Medicine Development Clinical Development 96

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

pharmaphorum

DECEMBER 4, 2020

Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

Worldwide Clinical Trials

AUGUST 23, 2023

To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

BioPharma Reporter

OCTOBER 18, 2023

Emma Harvey is global head of medical affairs at F2G Ltd, a UK and Austria based biotech where she is responsible for the global medical and commercial strategies for a novel antifungal drug for serious systemic infections, in clinical development.

Clinical Development 98

Clinical Development Development Drugs Regulation 98

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

The Pharma Data

JULY 28, 2021

Orexin plays a critical role in regulating a person’s sleep wake cycle, and supports the body’s natural wake promoting pathways in the brain.”.

Clinical Development 52

Clinical Development Development Regulation Drugs 52

BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

Clinical Development 52

Clinical Development Vaccine Vaccination Development 52

The Pharma Data

SEPTEMBER 29, 2021

They also control how much water and electrolytes are in the body, regulating blood pressure. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

Clinical Development 52

Clinical Development Development Clinical Trials 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.

Vaccine 104

Vaccine Vaccination Trials Protein 104

pharmaphorum

SEPTEMBER 24, 2020

” A vaccine is seen as a way out of the social distancing and lockdown regulations that are crippling large parts of the economy and causing immense disruption to peoples’ lives. 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.

Vaccine 98

Vaccine Vaccination Trials Immune Response 98

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.

Clinical Development 52

Clinical Development Development Trials Regulation 52

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

Production 230

Production Packaging Packaging Development 230

XTalks

MARCH 1, 2021

Pfizer/BioNTech are executing the three-dose study to also determine the effectiveness of a third dose against evolving variants as part of their clinical development strategy. Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow.

Vaccine 111

Vaccine Vaccination Development In-Vitro 111