Conversations in Drug Development Trends

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

Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. This process involves a careful assessment of medical history and daily bowel habits.

Clinical Trials

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories

LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.

Small Molecule

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development.

Clinical Trials

The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

Disease

LifeSciVC

MARCH 8, 2024

There definitely can be a #1 seed bank down to a #16, but all of these “seeds” could be helpful in the future. The adage of “pharma will be willing to pay more later for an asset further de-risked” by additional development does have truth to it.

Marketing

Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline.

Therapies

LifeSciVC

AUGUST 21, 2024

I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us. We will have to support an evolving clinical development plan and to keep manufacturing off the critical path.

Clinical Trials

Advarra

JUNE 6, 2022

Teaching them to understand doing things right and on time with desired, well-controlled results is the definition of quality. Covering the pre-clinical and clinical stages in development, this also means early inclusion of current good manufacturing practice (cGMP) requirements for any clinical trial material produced.

Compliance

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

Therapies

Agency IQ

AUGUST 9, 2024

The actual legal definition of a Phase 3 study can be found at 21 CFR 312.21 , and the DAP authority references this specific definition: “Phase 3 studies are expanded controlled and uncontrolled trials. As defined in statute , the DAP requirement for drug products applies to clinical studies for a “new drug.”

Science

The Pharma Data

JANUARY 12, 2021

LBS”), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. CARLSBAD, Calif., announced that the U.S.

FDA

The Pharma Data

DECEMBER 10, 2020

Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. and its affiliate NantKwest, Inc.

Vaccine

The Premier Consulting Blog

OCTOBER 21, 2024

The bridge from provisional to full approval Confirmatory trials are designed to definitively prove that a drug’s early benefits hold up in more extensive, longer-term studies using established clinical endpoints to more directly assess the clinical benefit.

Trials

The Pharma Data

SEPTEMBER 9, 2020

Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.

Vaccine

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S. Have diabetes.

Hospitals

The Premier Consulting Blog

OCTOBER 26, 2022

Definition of the manufacturing process description The Parenteral Drug Association defines the MPD as: A tool used to assist in execution of risk assessments, in the development of the Control Strategy, and for transfer of the process for commercial manufacturing.

Production

Agency IQ

AUGUST 18, 2023

Expert panels have two main tasks under the MDR and IVDR, which is to provide opinions and view as part of the clinical and performance evaluation consultation procedures (MDR Article 54 / IVDR Article 48). The second is ad hoc advice on clinical development plans and clinical investigation proposals.

Science

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars

FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

The Act defines substantial evidence as that consisting of “adequate and well-controlled [clinical] investigations” upon which qualified scientific experts could conclude that a drug will have its purported effect. However, the Act does not define what may constitute such confirmatory evidence.

FDA

Agency IQ

JUNE 26, 2023

As noted above, the criteria for a test to be considered a CDx is meeting the definition of “essential” for safety and performance of a drug product. That means that diagnostics or tests that are “not essential” to the safe and effective use of a drug product are not a CDx.

FDA

The Pharma Data

DECEMBER 12, 2020

Alexion ) have entered into a definitive agreement for AstraZeneca to acquire Alexion. AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond.

Regulations

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Senior Vice President and Head of Global Clinical Development at Regeneron. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — .

Virus

The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation.

Marketing

Agency IQ

JANUARY 4, 2024

FDA wrote that it “intends to consider whether, consistent with the FD&C Act, there are additional categories of guidance that would meet the definition of Level 2 guidance and be appropriate for issuance using the procedures for Level 2 guidance documents.” That sort of information is extremely important for some stakeholders.

FDA

Agency IQ

APRIL 12, 2024

Similarly, ARM suggested that the term “candidate potency-related quality attribute” be used in the early stages of clinical development to discuss product attributes that are thought to be linked to potency, but where the “criticality (mechanistic relationship) of the attributes” to product potency has not yet been established.

Production

Agency IQ

SEPTEMBER 15, 2023

In 2011, Merck conducted two clinical trials in SAR patients as part of its clinical development program for a phenylephrine formulation intended to provide higher systemic exposure through extended release of the drug. These recent studies evaluated patients with seasonal allergic rhinitis (SAR) and the common cold.

Science

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

FDA

The Pharma Data

JULY 15, 2021

Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars , including 100 million dollars in upfront and near-term clinical milestone payments Novo Nordisk will develop the phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy.

Disease

The Pharma Data

JUNE 26, 2021

Patients must have metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation. Among those enrolled, 12% had pre-treated and clinically stable brain metastases, 44% had squamous cell histology and 16% had locally advanced NSCLC that was not a candidate for definitive chemoradiation.

Treatment

The Pharma Data

JULY 15, 2021

0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. EFS was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause.

Therapies

Agency IQ

SEPTEMBER 22, 2023

The Heckler case helped to refine the definition of “substantial evidence” in two important ways. In 1997, Congress passed the FDA Modernization Act (FDAMA) , which—among other reforms— updated the definition of “substantial evidence” to allow for additional types of evidence, or “confirmatory evidence.” When should this occur?

FDA

The Pharma Data

JUNE 16, 2025

BioMarin Boosts Enzyme Therapy Business with Inozyme Acquisition BioMarin Pharmaceutical and Inozyme Pharma today announced that BioMarin has entered into a definitive agreement to acquire Inozyme for $4.00 per share in an all-cash transaction valued at approximately $270 million in total consideration.

Therapies

The Pharma Data

JANUARY 7, 2021

ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected in 2021. FACP and all the employees at Oncoceutics in developing a therapy for patients for which there is no available treatment.”. scientific founder Wafik El-Deiry, M.D.,

Clinical Trials

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. It also contains a definition of the term immunotoxicity— the unintended immunosuppression or stimulation (including hypersensitivity) —which was notably absent from the draft.

FDA

The Pharma Data

MARCH 23, 2021

There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Treatment