The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan. Chipscreen Biosciences, Stock Symbol: 688321.SH

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Drug Target Review

JULY 6, 2023

Programme : the leader programme ASP3082 entered the clinical trial phase last year, and multiple forum programmes are currently under investigation in the light research phase. USA 98, 8554-8559 (2001) Zhang G, Zhang J, Gao Y, et al. ASP3082 experienced an expedited R&D process as it was targeting the KRAS G12D mutation.

Targeted Protein Degradation 98

Targeted Protein Degradation Small Molecule Clinical Trials Science 98

Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents.

Clinical Trials 40

Clinical Trials Trials Regulations Production 40

The Pharma Data

JANUARY 27, 2021

years) participating in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (1993 to 2001). Loomans-Kropp, Ph.D., The analysis included 139,896 individuals (mean age, 66.4 The researchers found that aspirin use was not associated with the incidence of any studied cancer type.

Trials 52

Trials Research 52

PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Drug Target Review

JANUARY 31, 2024

Since joining Allergan Aesthetics in 2001, my role in medical affairs has always focused, in one way or another, on supporting the journey of a drug/device from bench to bedside. One of the biggest obstacles I faced early in my career was the perception that women often quit their career to achieve a work-life balance.

Clinical Trials 97

Clinical Trials Production Science Research 97

Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. In 2001, he joined Astex Pharmaceuticals in Cambridge where he became an expert in fragment-based drug discovery working on diabetes, thrombotic and oncology drug targets.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). IV -Blocker max. PMID 28520381. July 2017).

FDA 62

FDA Clinical Trials Treatment Trials 62

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. Science 294(5542):605-609 (2001). J Hemotother 5(5):503-9 (1996). Girardi M, Glusac R, Filler R, et al.

Therapies 105

Therapies Engineering Molecular Biology Science 105

Drug Target Review

SEPTEMBER 26, 2023

Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role. 2001 Sep;24(9):517–26. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al. The electrophysiological development of cardiomyocytes.

Drugs 111

Drugs FDA Disease Animal Testing 111

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

Pharmaceuticals 40

Pharmaceuticals Clinical Trials Small Molecule Disease 40

The Pharma Data

DECEMBER 20, 2020

Cefepime/enmetazobactam has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial. Shanghai Haini) was founded in 2001. and EU based on these results. For more information, please visit our website, www.yangzijiang.com.

Licensing 40

Licensing Licensing Pharmaceuticals Pharmaceutical Companies 40

Agency IQ

AUGUST 16, 2024

Lykos Therapeutics’ New Drug Application (NDA) for MDMA capsules to treat post-traumatic stress disorder (PTSD) A lengthy regulatory history: The initial investigational new drug application for midomafetamine was filed in 2001. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA 40

FDA Trials Therapies Regulations 40

Practical Cheminformatics

JUNE 12, 2023

In the figure below, I performed 1000 trials, selecting a random LogS value from the BSD and adding normally distributed noise from a normal distribution centered at 0 with standard deviations of 0.17, 0.5, While previous publications estimated the experimental error in solubility measurements at 0.6 LogS = 0.5 - 0.01(MP

Drugs 116

Drugs Trials 116

Codon

MARCH 28, 2023

There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The money was earmarked for human trials and, afterward, to develop a neural prosthesis that could augment memories in healthy adults. ” Musk later wrote a check for one million dollars.

Engineering 52

Engineering Research Science FDA Approval 52

The Pharma Data

OCTOBER 19, 2020

Intellia has received approval to launch their Phase I trial of NTLA-2001 in hereditary ATTR. Their NTLA-2001 candidate uses their proprietary non-viral lipid nanoparticle platform, which will deliver this CRISPR/Cas9-based therapy. hATTR is an inherited DNA mutation of the TTR gene.

Therapies 52

Therapies Pharmacokinetics Trials Clinical Trials 52

PLOS: DNA Science

MARCH 21, 2024

A Long and Winding Diagnostic Road The story begins in 2011, with Alessandra Biffi, MD, head of the clinical trial for MLD at the San Raffaele Telethon Institute for Gene Therapy in Milan. Two of their children, Liviana and Giovanni, participated in the clinical trial. She passed away in 2013. Yes, the cost is horrifying.

Therapies 97

Therapies Clinical Trials DNA Trials 97

The Pharma Data

OCTOBER 21, 2020

In a trial of 63 patients, researchers found that the drug regimen frequently wiped out all signs of the cancer — a subtype of the blood cancer acute lymphoblastic leukemia (ALL). Park, a leukemia specialist at Memorial Sloan Kettering Cancer Center in New York City, was not involved in the trial. WEDNESDAY, Oct.

Therapies 52

Therapies Drugs Treatment Trials 52

The Pharma Data

OCTOBER 21, 2020

In a trial of 63 patients, researchers found that the drug regimen frequently wiped out all signs of the cancer — a subtype of the blood cancer acute lymphoblastic leukemia (ALL). Park, a leukemia specialist at Memorial Sloan Kettering Cancer Center in New York City, was not involved in the trial. WEDNESDAY, Oct.

Therapies 52

Therapies Drugs Treatment Trials 52

PLOS: DNA Science

JUNE 22, 2023

I recalled Heather’s early mastery of mitosis last week when the news reported promising clinical trial results for a cancer drug for brain tumors that targets a protein, called survivin , that controls the cell cycle. ” “Doesn’t everyone?” ” she answered. It must have been challenging being my kid.

Drugs 52

Drugs Small Molecule DNA Clinical Trials 52

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S.

Science 40

Science FDA Production Packaging 40

The Pharma Data

MAY 13, 2021

Nel 2001 la mia salute stava andando. Nel corso degli anni ho usato grandi. quantità di vitamine, minerali e vari integratori per cercare di normalizzare. i livelli di grasso nel sangue. I risultati sono stati molto scarsi e nel. corso del tempo i livelli di colesterolo erano saliti fino a quasi 400. Le cose comunque. del rischio di diabete.

FDA 52

FDA Production Vaccine Trials 52

The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance.

FDA 40

FDA Production Regulations Vaccine 40

Codon

JULY 21, 2024

According to Weary, the “recognition that the animal is an individual that has a life beyond this particular trial” positively influences their treatment at the hands of researchers. In an effort to continue this cycle, researchers at UBC also try to get their animals adopted at the end of their studies.

Research 122

Research Engineering Disease Science 122

PLOS: DNA Science

JULY 27, 2023

which spit out information guiding the trimming of tumors in real time, a bit reminiscent of its ancestor Hal the computer from 2001: A Space Odyssey. Next up: testing in real-world settings and submission of clinical trial findings to the FDA. And then in 2001 came us. Duke University neurosurgeon Oren Gottfried voiced 2.0,

Disease 92

Disease DNA Virus RNA 92

Codon

DECEMBER 12, 2024

Clarke — the British writer most famous for 2001: A Space Odyssey — published a little-known story called Technical Error , in which a power plant employee is transformed into his mirror image after an accidental short-circuit. In 2001, in an outbreak that had nothing to do with a lab leak, foot-and-mouth disease in the U.K.

RNA 103

RNA DNA Vaccine Virus 103

The Pharma Data

MAY 13, 2021

2001 Nov 16;12(16):3549-52. based weight loss intervention in adults with obesity: A randomized clinical trial. 2001 Sep;30(3):765-85. Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial. Neuroreport.

Disease 52

Disease Production Testimonials Science 52

Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA 128

DNA RNA Molecular Biology Laboratories 128

Codon

NOVEMBER 24, 2024

After six years of such trials, Rock marveled as fertilized eggs formed zygotes and entered the cleavage stage of embryonic development. Various techniques for using abnormal sperm in fertilization were trialed through the late 1980s, but by 1995, the clear winner was intracytoplasmic sperm injection (ICSI). Since IVF in the U.S.

Regulations 60

Regulations DNA Hospitals Trials 60

Drug & Device Law

MARCH 4, 2024

2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible. . ., and (2) suggesting that the Defendants can cross-examine [the expert] about this at trial. On analogous facts, Nelson v. Tennessee Gas Pipeline Co. , 3d 244 (6th Cir. There will be no “do-over” here.

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52

Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner. at *31, *32. That is important.

FDA Approval 105

FDA Approval Drugs Production FDA 105

Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” 341 (2001). 2001), aff’d , 358 F.3d at *22 (Florida), *23 (Indiana, Minnesota); and (2) improperly based expansive predictions on nothing more than trial court decisions. Camden County Board of Chosen Freeholders v.

Production 52

Production Trials Treatment Pharmaceuticals 52

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. Beyond such gold-plated research: [O]ther well-designed and well-conducted trials are also able to generate scientifically sound and clinically relevant information. . . . Plaintiffs Legal Committee , 531 U.S.

FDA 64

FDA Nurses Production Regulations 64

Drug & Device Law

OCTOBER 20, 2023

341 (2001), is so important. If the results are promising, the company submits an investigational New Drug Application to FDA, explaining those results and a clinical trial plan. After completing multiple rounds of clinical trials, the company can submit a New Drug Application, often 100,000 pages long. That’s why Buckman Co.

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

Drug & Device Law

SEPTEMBER 1, 2023

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later. So the plaintiffs pivoted. That is how we got to oral argument in the California Court of Appeal.

Production 64

Production Marketing Drugs Pharma Companies 64

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 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.” Huntington Ingalls Inc. ,

Production 52

Production Trials International Government 52