BioPharma Drive: Drug Pricing

FEBRUARY 15, 2024

Analysts pressed Alnylam executives on the reasons for the changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.

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Drug Discovery World

OCTOBER 2, 2023

Sophie Winandy , Executive Director of Medical Imaging at ICON explores the benefits of AI and how it can be integrated throughout medical imaging within clinical trials. These advances are seen in many indications of imaging as it relates to drug trials – oncological, cardiovascular, metabolic, NASH, musculoskeletal and other.

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BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

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Drug Discovery World

JUNE 20, 2024

Read More: UK research partners team up to accelerate MND drug discovery Drug trial targets the blood brain barrier In April, Axoltis Pharma received authorisation from ANSM, the French agency for the safety of health products, to launch the SEALS study for ALS, the most common form of MND.

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BioPharma Drive: Drug Pricing

JULY 17, 2023

The results come about two years after negative findings from an earlier phase of the study, and position the company to seek an approval in transthyretin amyloidosis cardiomyopathy.

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Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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Drug Discovery World

JUNE 9, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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BioPharma Drive: Drug Pricing

DECEMBER 9, 2023

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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The Pharma Data

OCTOBER 26, 2020

based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. The double-blind, placebo-controlled trial, which has 32 participants across the U.S., San Diego, Calif.-based Source link.

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Drugs.com

SEPTEMBER 22, 2023

22, 2023 – New research suggests some newer diabetes treatments may not be as beneficial for Black patients, after earlier drug trials included small numbers of non-white people. FRIDAY, Sept. Whether the medications -- called sodium-glucose.

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Drug Discovery World

NOVEMBER 29, 2023

By simulating the drug’s performance in individual patients, they rapidly modelled the outcome of short-term (78 weeks) and long-term (10 years) treatments and discovered that when treatment begins by age 60, it’s possible to reduce cognitive decline by five percent.

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Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. The greater the risk, the more likely a series of trials for market clearance or approval will be required.

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Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex., The Houston, Tex., Source link.

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The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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Drug Discovery World

MAY 21, 2024

In contrast, machine learning can facilitate epitope-specific design: directing the algorithm towards favourable epitopes that elicit favourable biological responses, which may improve the prospects for the antibody in drug trials. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). Indian makers of Sputnik V may seek waiver for local Phase-3 trials ( Economic Times ). . Trump tax law cut what US drugmakers owed.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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Drug Discovery World

OCTOBER 6, 2022

In the cancer space alone over the last five years, clinical trials have increased 500% for new drugs and new drug combinations. Identifying the population subsets who will benefit is essential to the success of these therapies in both the clinic and in the clinical trials that will bring these drugs to market. .

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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Drug Discovery World

NOVEMBER 7, 2022

Receiving a genetic diagnosis is important as it allows patients to receive access to family planning, specialised IVF, and drugs trials. It can also permit targeted screening of known disease complications and access to drug studies.

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. In turn, the FDA’s guidance recognized the difficulty in recruiting for rare diseases and encouraged sponsors to become more resourceful and intentional about trial enrollment.

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

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The Pharma Data

NOVEMBER 30, 2020

Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday.

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PPD

MARCH 28, 2024

One of the fundamental pillars of this efficiency is a well-thought-out trial design. By carefully planning the trial structure, including the selection of endpoints and the overall methodology, companies reduce the likelihood of costly delays or the need for additional trial arms.

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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The Open Targets Blog

OCTOBER 31, 2023

[ Deanne Taylor , lead Principal Investigator of MTP] In the US, formal clinical trials are required to establish the safety and utility of those treatments in pediatric cancers. Despite the evidence that pediatric cancers could benefit from the same drugs used to treat adult cancers, drug trials are much rarer in children than adults. To

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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The Pharma Data

NOVEMBER 10, 2020

Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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Drug Target Review

NOVEMBER 30, 2023

We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! Too few people know that Alzheimer’s-like characteristics develop in more than 98 percent of people with Down syndrome over age 40. COVID-19 has shown the revolutionary impact of vaccines.

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Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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The Pharma Data

AUGUST 16, 2020

Exploring the fact that drug trials predominantly involve white, male participants, and looking at how this may lead to inaccurate and harmful prescribing for other patients. Teaching on the history of medicine, including the exploitation of people of colour in scientific research.

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Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. ” A recent article in The New Yorker suggests a solution to the problem. Free-range mice? .”

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