New Drug Approvals

JUNE 11, 2025

5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. Jump up to: a b Halbreich U, Montgomery SA (1 November 2008). The FDA rejected approval for gepirone in 2002 and 2004. [5] 5] SYN Synthesis Ormaza, V. Psychological Medicine.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. First developed in 2008, by Toshiro Sato, Hubrecht Institute at Utrecht University, these structures range from mini-brains to mini-guts with varied applicability from drug discovery to personalised medicine. Nature Cancer.

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The Pharma Data

MAY 2, 2023

a clinical trial data collection company, since 2021. From 2008 to 2021, Mr. Bonello held roles of increasing responsibility at Nasdaq-listed PRA Health Sciences, Inc., a clinical trial data collection company, from November 2021 to present. a clinical trial data collection company, since 2021.

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Quanticate

OCTOBER 16, 2020

By the end of 2007, and towards the beginning of 2008, the Clinical Data Interchange Standards Consortium (CDISC) gained ground in its mission to develop a global set of standards. Gathering all the heterogenous data and mapping to the internal standards of the pharma companies proved to be the greatest challenge of the time.

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Conversations in Drug Development Trends

APRIL 5, 2024

Observed annually on the last day of February since 2008, Rare Disease Day has grown into a global movement for raising awareness, promoting research, and advocating for improved access to rare disease treatments and support services. For others, this rare day is aptly the day we honor rare disease communities.

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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. Procedure no.: July 2017).

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Waterworth notes that the findings come on the heels of early results released in March from a clinical trial testing the cardiovascular safety of the GLP1R-targeted drug Victoza® (liraglutide), which confirm the newly reported genetic findings [4]. December 2008. [2] Food and Drug Administration. 2012 Jul 6;337(6090):100-104. [4]

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Drug Target Review

SEPTEMBER 20, 2023

How AI/ML technology has accelerated drug discovery Although AI for drug discovery (AIDD) can be viewed as being in the initial phases of development and acceptance, compounds discovered using AIDD platforms are already entering clinical trials.

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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. J Immunol 180(9):6044-6053 (2008). Liu Z, Eltoum I-E, Guo B, et al.

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Vial

FEBRUARY 23, 2024

In 2008, prior to ARRA and the HITECH Act, only 10% of hospitals in the United States had transitioned from paper-based methods into EMRs, primarily due to their exorbitant set-up costs. To learn about the history of these trial technologies and their adoption within the clinical research industry, read more here !

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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. 2008 Mar;153 Suppl 2(Suppl 2):S1-209. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al. LinkedIn Profile [Internet]. cited 2023 Jun 15].

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The Pharma Data

JUNE 28, 2021

The application is based on evidence from adequate and well-controlled studies of Xarelto in adults with additional data from two Phase III clinical trials of Xarelto in pediatric patients: EINSTEIN-Jr., Since launch in 2008, more than 86 million patients have been treated. EINSTEIN-Jr. About the EINSTEIN-Jr. by Bayer and in the U.S.

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The Pharma Data

AUGUST 9, 2020

The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date. “We 2008; 14(supp 2):S4–S5. [6] In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint.

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The Pharma Data

DECEMBER 17, 2020

“The findings also suggest that clinical trials should not rely on physician reports alone to evaluate the side effects of treatments; patient-reported outcomes provide an important complement to physician evaluations.” ” Press Release. The investigators found that 13.1

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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DrugBank

JUNE 27, 2023

Modern advances in “omics,” as well as biomarker development, clinical trial design, and mathematical modelling (including artificial intelligence) have revolutionized our ability to precisely define or “stratify” patient populations, splitting them into groups based on their characteristics. 12 , 713230 (2021).

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Metabolite Tales Blog

JULY 5, 2023

However, more de novo designed molecules in this “beyond the Rule of 5 chemical space” have emerged, with the first in this class, plerixafor , approved in oncology in 2008. Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed.

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Metabolite Tales Blog

JULY 5, 2023

2] However, more de novo designed molecules in this “beyond the Rule of 5 chemical space” have emerged, with the first in this class, plerixafor , approved in oncology in 2008. Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed.

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Drug Target Review

MAY 21, 2024

Organoids are being used in more and more clinical trials. Vicky’s journey started with a PhD from Cardiff University in 2008, focusing on cancer genetics. We all want to get to the stage where the next blockbuster drug couldn’t have been discovered any other way.

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The Pharma Data

NOVEMBER 5, 2020

Prior to joining Navitor, Hughes served as president and CSO of Zafgen and previously led Zafgen as CEO from 2008 to 2017. O’Day has been a principal investigator for more than 200 clinical trials. Hughes, CEO of Navitor Pharmaceuticals, to the board of directors. Intravacc – Virgil Schijns was named CSO of Netherlands-based Intravacc.

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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.

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Codon

APRIL 9, 2024

After confirming they experienced no side effects, Tu and her colleagues carried out the first clinical trial on human patients in Hainan between August and October 1972, which continued to demonstrate qinghao extract’s high efficacy. Few journal articles were written about the project using her (or anyone’s) name before 2010.

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Drug Target Review

OCTOBER 26, 2023

Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial. Journal of virology 82 , 5887-5911 (2008). Russell S, et al. The Lancet 390 , 849-860 (2017). Wang D, Tai PW, Gao G. Grimm D, et al.

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Codon

OCTOBER 22, 2024

However, I think caution is warranted when drawing sweeping conclusions from these studies because they were each conducted over only a decade (between 1998 and 2008) in just two medical journals (the British Medical Journal and The Annals of Emergency Medicine.) These numbers are quite low and do not inspire confidence.

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New Drug Approvals

SEPTEMBER 29, 2024

Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S. The company was also planning a trial in Parkinson’s disease to begin in 2022.

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The Pharma Data

DECEMBER 15, 2020

And during two testing periods — 2008/2010 and again in 2012/2014 — participants underwent repeated assessments (for an average of four years) designed to track changes in memory, language skills, concentration, attention, motor speed and mental “flexibility.”

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The Pharma Data

AUGUST 16, 2020

Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. We thank the NMOSD community, including patients and investigators who participated in ENSPRYNG clinical trials.”. Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

JANUARY 26, 2021

Their blood sugar was checked in 2006, and again in 2008, and they were tracked through 2017. Between 2006 and 2008, about 45% of the participants reverted from prediabetes to normal blood sugar. Studies such as this one, he noted, cannot show causation the way a randomized clinical trial can.

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New Drug Approvals

DECEMBER 3, 2022

1] [6] Navitoclax entered clinical trials , [1] [6] and showed promise in haematologic cancers , but was stalled when it was found to cause thrombocytopenia (severe loss of platelets ), which was discovered to be caused by the platelets’ requirement for Bcl-xL for survival. [1] 2008): 360–367. nM, and 197.8 nM, respectively.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022.

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Agency IQ

OCTOBER 6, 2023

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), “between 2008 and 2015, amphetamine-related hospitalizations more than tripled, increasing from 55,447 instances to 206,180. While stimulant use disorder is increasing, there are currently no FDA-approved medications.

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Agency IQ

MAY 10, 2024

The first version of the plan, whose goal was reduction of use of pesticides (or “plant protection products, as the plan called them ) was unveiled in 2008 with the aim of cutting pesticide use in half by 2018.

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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. To contact the author of this item, please email Rachel Coe ( rcoe@agencyiq.com ).

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The Pharma Data

AUGUST 17, 2021

The detailed results from the FIGARO-DKD study and data from the FIDELITY analysis will be presented within the following live-streamed, late-breaking clinical trial session: • FIGARO-DKD: finerenone in patients with chronic kidney disease and type 2 diabetes o Hot Line – FIGARO-DKD / FIDELITY Analysis; August 28, 2021, 17:25 (CEST).

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The Pharma Data

DECEMBER 1, 2020

“It is important to remember that this is a single clinical trial,” Maruthur said. The authors performed an observational analysis of the Boston Birth Cohort between 2008 and 2016 and found that the prevalence of cardiovascular risk factors was higher in U.S.-born ” Press Release. Garima Sharma, M.D.,

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New Drug Approvals

APRIL 9, 2025

This new antibiotic is currently being investigated in three phase 3 clinical trials. Chemical synthesis The synthesis of gepotidacin has been described in two patents in 2008 and 2016 and comprises 11 steps (Fig. WO2008128942A1 References: GLAXO GROUP LIMITED WO2008/128942, 2008, A1Yield:- Steps: Multi-step reaction with 12 steps 1.1:

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