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"Clinical Development"
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Corpus: 1990-03-17 – 2025-12-01
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EFTA01734942
Dataset 10
2016-09-16
15p
5,915w
…guidance is to assist sponsors in developing drugs for the treatment of low 20 sexual interest, desire, and/or arousal in women.2 Specifically, this guidance addresses the Food 21 and Drug Administration's (FDA's) current thinking regarding the overall
clinical development
22 program, with a focus on phase 3 trial designs, to support an indication for the treatment of these 23 conditions. This draft guidance is intended to serve as a focus for continued discussions among 24 the…
https://www.justice.gov/epstein/files/DataSet%2010/EFTA01734942.pdf
EFTA00292520
Dataset 9
2014-07-17
20p
1,258w
…Cell Gene Therapy Financial Support from: arum CALIFORIIIA7 /TEM CELL RGEnCY State of California Stem Cell Research and Cures Initiative publicly funded program to advance scientific discoveries in stem cell biology • Pre-clinical grant award (April, 2016) - $3.8M / Covered 80% of all pre-
clinical development
costs • Clinical grant application — (Q2, 2017) — up to $5M / Covers 70% of Phaselb Clinical trial costs Therapeutic focus: • Rebuild new blood and immune system by transplanting E-CEL cord blood stem cells (transplantation) in…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00292520.pdf
EFTA01034153
Dataset 9
2019-04-09
2p
518w
Subject:
PRESS RELEASE: Sigrid Therapeutics Presents at the American Diabetes Association 79th
From:
"Sana Alajmovic" <
…The presentation will be given by Dr. Maria Lindgren, Head of
Clinical Development
at Sigrid Therapeutics, in the category 12-F Clinical Therapeutics/New Technology— Other Therapeutic Agents. "We are excited to present details of our lead product candidate SiPore15TM to an international audience of experts dedicated to improving the life of people with diabetes. We are pleased that leading diabetes experts recognize the potential of SiPore15TM to prevent and treat type 2 diabetes in a novel and safer way…
https://www.justice.gov/epstein/files/DataSet%209/EFTA01034153.pdf
EFTA00633529
Dataset 9
2012-11-08
3p
863w
Subject:
Re: FDA Registration and validation
From:
Jean Luc Brunel <
To:
"
[email protected]
" <
[email protected]
>
…with FDA as we prepare a number of clinical studies for disease states with high unmet clinical needs." Robert Sexauer, EVP of
Clinical Development
stated "We can now begin to move forward with our plans for in- human clinical studies such as lower limb ischemia by applying to Institutional Review Boards (IRB's) with study EFTA00633529 protocols and laboratory processes that will be compliant with the federal and state regulations. By operating under regulations for 21 CFR 1271.10 regulations…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00633529.pdf
EFTA00633452
Dataset 9
2014-01-07
3p
872w
Subject:
FW: Foundation Medicine Extends and Expands Collaboration to Provide Molecular Information
From:
Boris Nikolic <
To:
"Jeffrey Epstein
[email protected]
<jeevacationggmail.com>
…and pediatric cancers. Novartis uses these capabilities to support its targeted therapy EFTA00633452
clinical development
efforts by helping to align the genomic profile of individual patient's cancer with clinical trial enrollment criteria and clinical outcome analysis. About Foundation Medicine Foundation Medicine® (NASDAQ: FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00633452.pdf
EFTA00506070
Dataset 9
2013-08-22
36p
3,940w
…EPB-348 was statistically non-inferior to higher dose Valtrex • Data is directionally consistent with dose dependent improvement De-risked & cost effective late stage
clinical development
plan • Ability to go against placebo for pain and antiviral endpoints in Phase 3 trials • Phase 3 trials cost significantly offset if performed in countries with =credits • No competing shingles trials actively recruiting 8 EFTA00506077 Phase 2b shingles study designed to show EPB-348 efficacy versus Valacyclovir Screening 72 h Rankrrinsion Days 2.7…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00506070.pdf
EFTA00654244
Dataset 9
2012-11-17
1p
235w
Subject:
RE:
From:
MICHAEL BUCHHOLTZ <
To:
[email protected]
From: MICHAEL BUCHHOLTZ < To:
[email protected]
Subject: RE: Date: Sat, 17 Nov 2012 13:39:33 +0000 III take care of it Thanks for your help. The management team has impressive credentials. The senior vice president for
clinical development
; Dr Vincent Miller; was here in New York. We had several patients in common and have spoken on numerous occasions. I can call him as well. It is a VERY competitive marketplace and genomics is the future of oncology…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00654244.pdf
EFTA02360213
Dataset 11
2012-11-17
1p
238w
Subject:
RE:
From:
MICHAEL BUCHHOLTZ < >
To:
[email protected]
From: MICHAEL BUCHHOLTZ < > Sent: Saturday, November 17, 2012 1:40 PM To:
[email protected]
Subject: RE: III take care of it Thanks for your he=p. The management team has impressive credentials. The senior vice p=esident for
clinical development
; Dr Vincent Miller; was here in New York.=We had several patients in common and have spoken on numerous occasions.&n=sp; I can call him as well. It is a VERY competitive marketplace and=genomics is the future of oncology…
https://www.justice.gov/epstein/files/DataSet%2011/EFTA02360213.pdf
EFTA00306883
Dataset 9
2014-06-02
7p
4,747w
…attended Merck's ASCO analyst meeting today where the company reviewed new Pharmaceuticals — Major 8 data and development plans for its PD-1 (pembrolizumab). Overall, we increasingly Specialty see Merck playing a leadership role in the immuno-oncology space given its Chris Schott, CFA AC aggressive
clinical development
approach to pembro with compelling data seen thus (1-212) 622-5676 far in melanoma (Yervoy-naive and refractory), NSCLC (I st-line and pre-treated), and head and neck cancer. Further…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00306883.pdf
EFTA00589347
Dataset 9
2012-11-20
3p
1,134w
…The agreement was entered into by Sihuan Pharmaceutical through its wholly- owned subsidiary Sun Moral International (HK) Ltd. and by NeuroVive through its subsidiary NeuroVive Pharmaceutical Asia Ltd. CicloMulsion® and NeuroSTAT8 are in
clinical development
by NeuroVive for the treatment of heart reperfusion injury after stenting and traumatic brain injury respectively. These are indications of huge medical need for which there are currently no approved pharmaceutical treatment options. Both products act to prevent the death of mitochondria in damaged cells…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00589347.pdf
EFTA01113739
Dataset 9
37p
2,922w
…Cancer vaccines targeting only one Tumoral antigen : i.e. MAGE or MUC in
clinical development
in first line (or maintenance) treatment in advanced NSCLC Ipilimumab Yervoy ® acting on CTLA4 checkpoint ( increasing T cell responses) and registered in melanoma / New anti PD1 acting on PD1 checkpoint. OSE Pha EFTA01113746 NSCLC: New therapies critically needed NSCLC treatments insufficiently effective: 5-year survival at 4% for patients with distant disease (Horner et al. 2009) Current therapies registered for advanced NSCLC stages: Stable…
https://www.justice.gov/epstein/files/DataSet%209/EFTA01113739.pdf
EFTA01113072
Dataset 9
2012-11-20
3p
1,137w
…The agreement was entered into by Sihuan Pharmaceutical through its wholly- owned subsidiary Sun Moral International (HK) Ltd. and by NeuroVive through its subsidiary NeuroVive Pharmaceutical Asia Ltd. CicloMulsion® and NeuroSTAT8 are in
clinical development
by NeuroVive for the treatment of heart reperfusion injury after stenting and traumatic brain injury respectively. These are indications of huge medical need for which there are currently no approved pharmaceutical treatment options. Both products act to prevent the death of mitochondria in damaged cells…
https://www.justice.gov/epstein/files/DataSet%209/EFTA01113072.pdf
EFTA01620729
Dataset 10
7p
889w
…think of him like this 09:28:37 pm EFTA01620732 O 09:28:48 pm ri 2017/09/19 Mitochondrial idea / arch capital very interested and am going to talk to their company called UNITY today They also believe/do mitochondrial stuff but not for brain Want me to come up wan ask 1. Do I want to run the
clinical development
program under their company 2. Do I want to be a consultant and involved from a distance 3…
https://www.justice.gov/epstein/files/DataSet%2010/EFTA01620729.pdf
EFTA00300337
Dataset 9
2014-05-22
9p
5,425w
…adults. Physicians we spoke to viewed the phase 2a data as "very AnLipain Rama promising," but were understandably cautious on extrapolating the results to children (the larger opportunity). Of note, no therapies arc approved for active Carter L Gould RSV; Synagis is approved as a prophylaxis in a narrow segment of infants and very few assets are in
clinical development
. GS-5806 is not included in JPM or Street models; confirmation is needed in patients with active infection, but •. Morgan…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00300337.pdf
EFTA00857649
Dataset 9
2018-03-16
4p
1,957w
Subject:
Fwd: Veru Announces Presentation of Data Demonstrating Efficacy of VERU-111 in a Inane
From:
Harry Fisch <1
To:
"
[email protected]
" <
[email protected]
>
…in 2018), and VERU-111 a novel oral anti-tubulin cancer therapy targeting alpha & beta tubulin for a variety of malignancies, including metastatic prostate, breast, endometrial and ovarian cancers (planned Phase 1/2 in 2018). EFTA00857650 To help support these
clinical development
programs, the company markets and sells the PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation which is being co-promoted with Timm Medical Technologies, Inc. and the FC2…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00857649.pdf
EFTA00668688
Dataset 9
2012-11-28
4p
1,496w
Subject:
Fw: Fwd: NeuroVive news release - signs development deal for cyclosporine in China
From:
Cecile de Jongh
To:
JEE
[email protected]
>
…The agreement was entered into by Sihuan Pharmaceutical through its wholly-owned subsidiary Sun Moral International (HK) Ltd. and by NeuroVive through its subsidiary NeuroVive Pharmaceutical Asia Ltd. CicloMulsion° and NeuroSTAr are in
clinical development
by NeuroVive for the treatment of heart reperfusion injury after stenting and traumatic brain injury respectively. These are indications of huge medical need for which there are currently no approved pharmaceutical treatment options. Both products act to prevent the death of mitochondria in damaged cells…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00668688.pdf
EFTA01114703
Dataset 9
24p
16,478w
…Titration Schedule In addition to the adverse reactions reported in Table 4 above, the followng adverse reactionswith Day 2 Days 3-6 Days 7-10 Days 11-14 Day 15 relationship to GRALISE were reported during the
clinical development
for the treatment of posthr 600 mg 900 mg 1200 mg 1500 mg 1800 mg Events in we than 1% of patients but equally or more frequently in the GRALISE-treated patient the placebo group included blood pressure increase, confusional state…
https://www.justice.gov/epstein/files/DataSet%209/EFTA01114703.pdf
EFTA02683561
Dataset 11
2014-09-24
9p
2,522w
Subject:
Re: CONFIDENTIAL: Greengard/Heintz OCD/Depression Project
From:
Maren E. Imhoff
To:
Debra Black
…nearly 100 CNS cell types, including many of those that comprise the CSTC circuitry relevant to OCD. These studies have resulted in identification of novel therapeutic targets for a variety of CNS disorders—including Parkinson's disease, schizophrenia, and age-related cognitive decline—that have already led to
clinical development
programs within the pharmaceutical industry. To address the pathophysiological molecular mechanisms operant in OCD, MD, and AD and develop effective, new therapeutic strategies for their treatment, the Greengard/Heintz team…
https://www.justice.gov/epstein/files/DataSet%2011/EFTA02683561.pdf
EFTA02714282
Dataset 11
8p
3,952w
…to raise their own antibodies against the virus, which could lead to a functional cure for the infection. TKM-HBV is developed as a multi-component RNAi therapeutic that targets different sites on the HBV genome and will employ a liver-centric- LNP formulation that is more potent than any LNP currently in
clinical development
. The Company is expecting to file an Investigational New Drug (IND) application in the second half of 2014, and also advance the therapy to chronically…
https://www.justice.gov/epstein/files/DataSet%2011/EFTA02714282.pdf
EFTA00810552
Dataset 9
24p
3,148w
…2732C431., COmeree Plume Clekof Report 3/ 17 axl FDA SdeiroDoCurnenl BRUDAC AcNiscee rneerg 17/16 EFTA00810557 a Zuclomiphene
clinical development
plan: Phase 2 trial design veru IND accepted 7/18 Phase 2 placebo controlled dose finding study First subject expected in 9/18 & final data expected 1H 2019 0 mg Plan to enroll 120 men who have moderate & severe hot flashes on ADT in 10 US clinical sites • Primary efficacy endpoint- mean change in frequency of moderate 8, severe hot…
https://www.justice.gov/epstein/files/DataSet%209/EFTA00810552.pdf
1–20 of 23 results · page 1 of 2
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23 total
Set 9
18
Set 10
2
Set 11
3