The Pharma Data

NOVEMBER 2, 2020

Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups. In the U.S., About BioMarin.

Drugs 40

Drugs FDA Pharmaceuticals Treatment 40

Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” The regulation of dietary supplements in the U.S. As with dietary supplements, cosmetic products do not need to have FDA approval before they go on the market; they are regulated after the fact.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 118

Production Clinical Trials Trials Therapies 118

Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. . “The

Therapies 130

Therapies Clinical Trials Production Trials 130

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). J Front Immunol 9:1409 (2018).

Therapies 103

Therapies Engineering Molecular Biology Immune Response 103

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Government 40

The Pharma Data

NOVEMBER 4, 2020

Reaffirmed c linical trial results from study of VASCEPA in China are expected by year end 2020 : Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter. This compares with licensing and royalty revenue of $0.2

Production 40

Production FDA Trials Licensing 40

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. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Packaging Production 40

The Pharma Data

OCTOBER 14, 2020

This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. 2018) PLoS One. About TNX-1800. 1 Noyce RS, et al.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

FEBRUARY 4, 2021

billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. Recorded a $4.7

Production 52

Production International Clinical Trials Small Molecule 52

The Pharma Data

NOVEMBER 22, 2020

Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. This grant will support ICRC’s work with experienced trial sites in sub-Saharan Africa to enroll, follow and retain the large number of women required for this research.

Trials 52

Trials Clinical Trials International Production 52

Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

FDA 40

FDA Production Science Clinical Trials 40

The Pharma Data

MAY 4, 2021

The FDA action converts the 2018 accelerated approval to full approval. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. 7) BNT162b2 has not been approved or licensed by the U.S. If approved, TicoVac would be the first vaccine in the U.S.

Vaccine 40

Vaccine Production FDA Biosimilars 40

The Pharma Data

DECEMBER 15, 2020

months that we observed in this trial. These positive efficacy results across all endpoints give us a high degree of confidence in their repeatability in a randomized trial and we plan to meet with the regulatory authorities in order to agree on the fastest pathway forward in this indication. Kenilworth, N.J. , Kenilworth, N.J. ,

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. In a major double-blind clinical trial published in the American College of Endocrinology…. Numerous double-blind, randomized, and placebo-controlled trials have also found Rhodiola to…. It was like the floodgates burst wide open…. So what’s the fix here?

Production 52

Production Packaging Doctors Research 52

Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” Gene-edited bananas are not yet being grown commercially, to my knowledge, but a Dole plantation in Central America is starting field trials for a disease-resistant variety that was developed by Elo Life Systems , an American company. Money is also pouring into the field, fast.

DNA 52

DNA RNA Engineering Regulations 52

Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” Gene-edited bananas are not yet being grown commercially, to my knowledge, but a Dole plantation in Central America is starting field trials for a disease-resistant variety that was developed by Elo Life Systems , an American company. Money is also pouring into the field, fast.

DNA 52

DNA RNA Engineering Regulations 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. mentioned with approval an unappealed trial court ruling that, as to “strict liability,” a cellphone “app was not a product, and thus a products liability theory of recovery was not legally viable.” at 77 (citation omitted).

Production 52

Production International Trials Government 52

Drug & Device Law

JULY 26, 2023

That’s not likely to happen anymore because in 2018 the same court issued In re Accutane Litigation , 194 A.3d 2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. 3d 503, 523 (N.J. at *14-15. [I]n

Compliance 52

Compliance FDA Compliance FDA Clinical Trials 52