The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S.

FDA 52

FDA FDA Approval Licensing Licensing 52

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

Clinical Trials 52

Clinical Trials FDA Trials Production 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. What led to NPA’s lawsuit?

Production 59

Production FDA Licensing Licensing 59

The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. The target action date for the FDA decision is September 30, 2022. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

FDA 52

FDA Disease Trials FDA Approval 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. To accomplish this, we pay careful attention to both dosing and sample collection.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In the U.S.,

FDA 52

FDA Disease Treatment FDA Approval 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. WAKEFIELD, Mass., in July 2019, who have recently initiated a Phase 1 study with their formulation.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. The FTD is designed to make important new drugs accessible to patients faster. SHANGHAI, China, Jan.

FDA 40

FDA Clinical Trials Trials Treatment 40

Agency IQ

JULY 12, 2024

FDA gives companies leeway to go after misinformation, but not free reign In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. Promotional labeling information must be submitted to the FDA “at the time of initial dissemination.”

FDA 40

FDA Regulations Production Science 40

The Pharma Data

NOVEMBER 6, 2020

We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. CAMBRIDGE, Mass. and TOKYO, Nov. About Aducanumab’s Clinical Program.

Disease 40

Disease FDA Clinical Trials Licensing 40

Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA 40

FDA Science Regulations Production 40

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. 89 FR 61474.

Pharmacokinetics 52

Pharmacokinetics Drugs FDA Production 52

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). The FDA’s Fast Track designation is a process designed to expedite or facilitate the review of product candidates to treat serious conditions and fill an unmet medical need.

FDA 40

FDA Treatment Clinical Trials Clinical Development 40

The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

Disease 40

Disease FDA Treatment Therapies 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. But could it be a busy month for rulemaking?

FDA 40

FDA Science Regulations Production 40

The Pharma Data

AUGUST 21, 2020

Eli Lilly, on the heels of detailing a clinical win in China for PD-1 inhibitor Tyvyt, has decided to take a bigger stake in the drug developed by partner Innovent Biologics in an expanded deal that could vault it into the lucrative—yet ultra-competitive—U.S. Lilly first licensed Tyvyt from Innovent in 2015. lung cancer market.

Licensing 52

Licensing Licensing FDA Therapies 52

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” said Leonard S. Authorized Emergency Use.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

Crown Bioscience

MAY 4, 2021

Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e. used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

More than 90 percent of that contributory research was basic—that is, related to the discovery of fundamental biological mechanisms, rather than actual development of the drugs themselves. Previous attempts to quantify the contribution of federal funding to new drug development had looked primarily at patents.

Research 52

Research Science FDA Drug Development 52

The Pharma Data

DECEMBER 29, 2020

a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. Its drug development pipeline includes thymus, pancreas, and kidney regeneration. Declan Doogan.

Therapies 40

Therapies FDA Trials Disease 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA is also due to revise 24 other guidance documents at that time.

FDA 40

FDA Science Regulations Production 40

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1].

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

Conversations in Drug Development Trends

AUGUST 9, 2024

These include: FDA (U.S.) The FDA has established specific guidelines for adaptive trial designs, including requirements for pre-specification of adaptive features and interim analyses. An import license is necessary for any intellectual property or equipment used during the trial.

Trials 80

Trials Clinical Trials Regulations FDA 80

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND.

Therapies 59

Therapies Engineering Production FDA 59

The Pharma Data

OCTOBER 27, 2020

(NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. “We

Disease 40

Disease FDA Treatment Clinical Trials 40

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Stages of process validation Process validation involves three distinct stages as described in the 2011 FDA guidance, “Process Validation: General, Principles and Practices.”

Small Molecule 52

Small Molecule Drugs FDA Production 52

The Pharma Data

FEBRUARY 13, 2022

FDA a ccepts Dupixent ® (dupilumab) for Priority Review in c hildren a ged 6 m onths to 5 y ears with m oderate-to-severe a topic d ermatitis. The target action date for the FDA decision on this investigational use is June 9, 2022. If approved, Dupixent will be the first biologic medicine available in the U.S.

FDA 40

FDA Disease Treatment FDA Approval 40

Agency IQ

MAY 31, 2024

BY RACHEL COE, MSC | MAY 28, 2024 10:34 PM CDT Quick recap on platform technologies As part of the 2023 Consolidated Appropriations Act (Section 2503), Congress directed FDA to establish a new “Platform Technologies Designation” program. However, both deadlines came and went without any official action by the FDA.

Science 40

Science FDA Production Licensing 40

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA).

Treatment 52

Treatment FDA Hospitals Long-Term Care Facilities 52

Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

FDA 40

FDA Science Regulations Production 40

Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. Personally, I went from working in licensing and business development in big pharma straight to being a CEO. Gender diversity is a hot topic in pharmaceutical and biotech drug development.

Treatment 52

Treatment Small Molecule Clinical Trials Trials 52

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals 81

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81