The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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FDA Law Blog: Drug Discovery

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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Cytel

SEPTEMBER 1, 2023

Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.

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The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

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The Pharma Data

JULY 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.

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The Pharma Data

AUGUST 13, 2020

The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications. Its use in these settings is supported by a rigorous clinical development programme, including eight Phase III studies. Source link.

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The Pharma Data

DECEMBER 21, 2020

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact. Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

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The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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The Pharma Data

JANUARY 17, 2021

“We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma” said Jeffrey H. These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J. and SINGAPORE , Jan. Buchalter , President and CEO of Tessa Therapeutics.

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The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.

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KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Zai Lab is leading clinical development in its territory. “We Although much of the U.S.

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The Pharma Data

SEPTEMBER 29, 2021

Patients are going to be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy like an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

MAY 16, 2022

Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). (Nasdaq: GILD) today announced the U.S.

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Conversations in Drug Development Trends

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. Tissue Sensitivity : The sensitivity of target tissues and nearby organs to radiation therapy can vary considerably.

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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.

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The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. This approach ensures timely completion of confirmatory trials in closer proximity to the initial approval.

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The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. Here’s a look at some of the upcoming target action dates on the FDA’s calendar. . The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We

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The Pharma Data

OCTOBER 18, 2020

ZURICH, Switzerland–( BUSINESS WIRE )– Versantis AG , a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Importantly, with this designation, we may qualify to receive a priority review voucher from FDA, at the time of marketing approval of VS-01.

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Agency IQ

SEPTEMBER 22, 2023

BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC SEP 18, 2023 9:24 PM CDT Background: FDA’s standards for evidence When seeking approval from the FDA, companies are required to demonstrate that their product is safe and effective when used as intended. In one landmark case, Warner-Lambert Co.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Bayer today announced that the U.S.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.

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The Pharma Data

NOVEMBER 22, 2020

Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. The FDA approved it under the brand name Gavreto on September 4. The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations.

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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.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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The Pharma Data

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. If approved, Dupixent would be the first medicine available in the U.S. In September 2020, the U.S.

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DrugBank

SEPTEMBER 26, 2024

While some clinical trials are necessary to confirm safety and efficacy in humans, these are typically smaller and shorter in duration compared to the extensive trials required for novel biopharmaceuticals. Food and Drug Administration (FDA) have been instrumental in shaping global regulatory frameworks for biosimilars.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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The Pharma Data

FEBRUARY 24, 2022

– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction. – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S.

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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.

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The Pharma Data

MAY 15, 2023

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.

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Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

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