Drug Discovery World

OCTOBER 20, 2023

Protocol amendments slow down clinical development and are extremely costly. The post Free clinical trial health check to bring drugs to market faster appeared first on Drug Discovery World (DDW). The average Phase III protocol experiences 3.3 months of implementation time.

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Fierce BioTech

JUNE 18, 2024

Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years pri | CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch.

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Drug Discovery World

JANUARY 11, 2024

They are called: mRNA technology may hold the future for a cytomegalovirus vaccine ; Predictive diagnostics: closing the precision medicine gap ; and FAIR Game: making data work harder in the race to market. The post New podcast: Revolutionary technology for drug discovery and development appeared first on Drug Discovery World (DDW).

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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Drug Discovery World

JULY 12, 2024

High levels of cancellations at Phase II not only increase the costs of clinical development, but also have a knock-on effect on the rate at which new therapies reach patients. Yet clinical development practices have struggled to adapt to more specific patient inclusion criteria and smaller patient pools.”

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Drug Discovery World

APRIL 18, 2023

While the global proteasome inhibitors market is expected to reach nearly $2.3 AVA3996 is in pre-clinical development with the aim of submitting an Investigational New Drug (IND) application to allow clinical development to begin during 2024.

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Drug Discovery World

JULY 12, 2024

Therapeutics that receive this designation benefit from eligibility for more frequent meetings with the FDA to discuss the clinical development plan and possible eligibility for Accelerated Approval and Priority Review.

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Drug Discovery World

JANUARY 11, 2024

They are called: mRNA technology may hold the future for a cytomegalovirus vaccine ; Predictive diagnostics: closing the precision medicine gap ; and FAIR Game: making data work harder in the race to market. The post Revolutionary technology for drug discovery and development appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JANUARY 23, 2024

The prospective market for Covid therapies is less attractive for investment, and we expect to see this downward trend to continue.” These high levels of attrition at Phase II may slow the rate at which new therapies reach market and are likely to have an ongoing effect on the clinical development industry, adding to rising costs.

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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.

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Drug Discovery World

NOVEMBER 21, 2023

Fosun Pharma USA and Treehill Partners have formed a jointly operating vehicle for investment in clinical stage assets. The new business will be looking for high-quality, mid- to late-stage assets, clinically focused on the US market.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture.

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Drug Discovery World

OCTOBER 24, 2023

One of the key presentations will be given by Dr Qasim Ahmad, Chief Medical Officer of IO Biotech, a Clinical Oncologist with two decades of strategic clinical development, medical affairs, and marketing authorisation expertise.

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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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Drug Discovery World

FEBRUARY 10, 2023

Three of the top five most-studied disease areas fell within oncology, with prostate cancer the third most-studied disease, solid tumours fourth, and stroke fifth. “Oncology remains an area of high investment in clinical development, however, 2022 has seen a widespread scale back of overall activity.

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Drug Discovery World

SEPTEMBER 7, 2023

Dr Richard Mason, Chief Executive Officer of Apollo Therapeutics, said: “Apollo has built a broad and diversified pipeline focused on major commercial markets and this latest fund-raising enables us to take our most advanced programs to key clinical value inflection points.” The post Apollo Therapeutics closes $226.5

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The Pharma Data

SEPTEMBER 29, 2021

Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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Drug Discovery World

AUGUST 22, 2022

“With the speed to start Phase I studies, quality of clinical sites and a favorable Australian R&D tax credit, Australia is an optimal market for early phase clinical research,” said Alliance CCO Vito Saccente. The post Alliance Pharma expands into Australia appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MARCH 7, 2024

The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX. Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages.

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Drug Discovery World

AUGUST 22, 2024

Challenges in going to market Despite promising developments in gene therapies, such as the recent approvals of the first CRISPR-based gene editing treatment for sickle cell disease first by the FDA in December 2023 and most recently in the EU in 2024, Dr Rosenzweig-Lipson says that challenges persist in bringing more CGTs to the market.

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Drug Discovery World

MARCH 8, 2024

In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target. TSLP is an epithelial cell-derived alarmin cytokine and triggers both T2 and non-T2 inflammation in asthma. IBI3002 has high-efficient dual-blocking function on both IL-4Rα and TSLP.

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Drug Discovery World

JANUARY 5, 2023

AmerisourceBergen Corporation has completed its acquisition of PharmaLex Holding, a provider of tech-enabled services from clinical development consulting to marketing authorisation. .

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Drug Discovery World

MARCH 25, 2024

“By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development,” said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. “We

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Drug Discovery World

JANUARY 25, 2024

Orphan Drug Designation is granted to medicines that treat or prevent life-threatening or chronically debilitating rare disease, and with either no currently approved method of prevention or treatment or with significant clinical benefit when compared with existing treatments. cases per 100,000 population, Globocan).

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Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. In 2024, we can expect another wave of innovative new drugs to be developed using the technology, given that the AI-fuelled small molecule discovery pipeline is growing by almost 40% annually.”

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The Pharma Data

JANUARY 24, 2021

. (“Citius” or the “Company”) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0

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The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

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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.

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Drug Discovery World

MAY 16, 2023

What opportunities and challenges are emerging and can therapies get to market faster? Moreover, he says that global supply chain pressures will continue into 2023, combined with instability in the financial markets that will make cost of goods high on his watchlist of risks to manage. DDW’s Megan Thomas finds out. The solution?

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Drug Discovery World

OCTOBER 3, 2023

The agency is inviting a limited number of sponsors to participate in the programme, which allows for more frequent communication with FDA staff to address clinical development issues. “We

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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. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

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Cytel

JUNE 20, 2023

How might this affect pediatric drug development? Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has been relatively scarce.

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