AR | Jotup

Template for a European Union herbal monograph

Retrieved on:

Thursday, April 18, 2024

Key Points:

Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Retrieved on:

Thursday, April 18, 2024

The completed comments form should be sent to

Key Points:

The completed comments form should be sent to
[email protected]
10
11
Keywords
Committee on Herbal Medicinal Products; HMPC; European Union herbal
monographs; European Union list of herbal substances, preparations and
combinations thereof for use in traditional herbal medicinal products; herbal
medicinal products; traditional herbal medicinal products; traditional use;
well-established medicinal use; benefit-risk assessment; assessment report

12

1
2

Changes introduced in section 6 Overall conclusions.
Peer-reviewer

If not the same peer-reviewer
since last version, all peerreviewers should be listed, and
the version specified in
brackets.
22

23

on
.
It is a working
24

document, not yet edited, and shall be further developed after the release for consultation of the

25

.
The principle of the template is to make clear
distinctions between presentation of data (methodology and results)
and the assessment of the data (?assessor?s comment?).
likely from an article but it seems it is concluded by
the rapporteur; ?According to the author? to be added.
Chapters with
a heading including the word ?conclusion? should include a summary
of all critical assessment of the assessor for that particular
chapter.
If an assessor?s comment is not needed, the Rapporteur
should delete the box inserted in the template.
?
The report should be sufficiently detailed to allow for secondary
assessment of the available data by other HMPC experts.
Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
preparation(s) and relevant constituents thereof ........................................................... 16
97
98

3.3.
Overall conclusions on clinical pharmacology and efficacy ........................................ 27
Assessment report on
EMA/HMPC/418902/2005

Page 4/41

119

5.
This sections is related to
available quality standards and there is no need to repeat information
on all preparations included in the monograph.
Search and assessment methodology
161

The Rapporteur shall undertake a comprehensive search of relevant
scientific literature and articles, Acts of law and regulations and
other relevant sources.
Cross-reference to the list of
references in Annex, which should list separately the references
supporting the assessment report.
143
144
145
150
151
152
153
154

162
163
164
165
166
167
168
169
170
171
172
173
174
175

Herbal substance(s)

Herbal preparation(s)

Relevant constituents for this assessment report

Examples of scientific databases to be searched are Medline, PubMed,
Cochrane Database of Systematic Reviews, EMBASE etc.
Assessment report on
EMA/HMPC/418902/2005
Page 6/41

176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192

Additional relevant references could also be retrieved from the checked
references.
Examples of books are Hagers Handbuch, The Complete German
Commission E Monographs, PDR for herbal medicines etc.
In addition, information from non-EU regulatory
authorities for examples Health Canada monographs or WHO monographs
could be searched, if relevant to herbal substances and preparations in
EU.
221
225
226
227

232

When the assessment report is revised, the rapporteur should briefly
summarise the main changes under this section.
Data are collected using the template entitled ?Document
for information exchange for the preparation of the assessment report
for the development of European Union monographs and for inclusion of
herbal substance(s), preparation(s) or combinations thereof in the
list? (EMEA/HMPC/137093/2006).
Assessment report on
EMA/HMPC/418902/2005
Page 8/41

Herbal substance/

Indication

Posology and
method of

preparation

administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use
As reported in
the market
overview

As reported in
the market
overview

As reported in
the market
overview.
Assessment report on
EMA/HMPC/418902/2005
Page 10/41

Herbal substance/

Indication/Medicinal

Posology and

preparation

use

method of
administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use

Regulatory Status

Type of
regulatory
status where
possible, date,
Country

287

This overview is not exhaustive.
Clinical Safety/Pharmacovigilance
836
837
838
839
840
841

See ?Assessment of clinical safety and efficacy in the preparation of
EU herbal monographs for well-established and traditional herbal
medicinal products?(EMA/HMPC/104613/2005) for further details.
Overall conclusions on clinical safety
1067

1068

In terms of structure, the conclusion should follow the presentation of
the results above.
Overall conclusions
1092

1093

1101

Describe key aspects only briefly, these will already have been
described in detail in the respective sections.
This section should
cover all recommended ?well-established use? and ?traditional use?
indications and conclusions shall be provided for each therapeutic
indication and each herbal preparation.
1102
Well established use monograph

1103
1104

The clinical studies supporting well-established use should be
specified for each therapeutic indication and each herbal preparation.
The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
be briefly discussed/justified.
1153
List entry

1154

The conclusions should include a statement pointing to the
possibility/non-possibility to support a European Union list entry.

AIXTRON receives Gold Supplier Award from BOE HC SemiTek for Micro LED collaboration

Retrieved on:

Wednesday, April 10, 2024

Automation, Pressure, Gallium nitride, Partnership, Herzogenrath, Asp, MicroLED, Gallium arsenide, OEM, Airline

Herzogenrath, April 08, 2024 – AIXTRON (FSE: AIXA) has received the prestigious Gold Supplier Award from BOE HC SemiTek for their collaboration in the field of Micro LED technology.

Key Points:

Herzogenrath, April 08, 2024 – AIXTRON (FSE: AIXA) has received the prestigious Gold Supplier Award from BOE HC SemiTek for their collaboration in the field of Micro LED technology.
BOE HC SemiTek, a leading supplier in the display segment, operates multiple AIXTRON GaN and GaAs (gallium arsenide) tools worldwide.
AIXTRON systems have been instrumental in accelerating the development of Micro LED products, which has led to multiple repeat orders for AIXTRON’s GaN and GaAs tools in preparation of a volume ramp of Micro LED products in BOE HC SemiTek.
“The collaboration with BOE HC SemiTek is very significant for us as a company and for the development of Micro LED technology in general.

ORIC Pharmaceuticals Presents Preclinical Data on Two Programs at the 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on:

Monday, April 8, 2024

PRC2, Prostate cancer, Regulation, EED, Cell, Patient, CYP, SAN, Doctor of Philosophy, EZH2, AACR, TRIM37, PLK4, Optimism, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 08, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced two oral presentations on ORIC-944, a potent and selective allosteric inhibitor of PRC2, and presentation of a new discovery candidate, ORIC-613, an orally bioavailable, potent and selective PLK4 inhibitor, at the 2024 American Association for Cancer Research (AACR) Annual Meeting.

Key Points:

ORIC-944, a potent and selective allosteric PRC2 inhibitor, demonstrates superior preclinical drug properties and longer clinical half-life which supports a potential best-in-class profile versus competitor PRC2 inhibitors
First data presentation on ORIC-613, a potential first- and best-in-class development candidate selectively inhibiting PLK4
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 08, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced two oral presentations on ORIC-944, a potent and selective allosteric inhibitor of PRC2, and presentation of a new discovery candidate, ORIC-613, an orally bioavailable, potent and selective PLK4 inhibitor, at the 2024 American Association for Cancer Research (AACR) Annual Meeting.
“ORIC-944 in combination with AR inhibitors demonstrates anti-tumor activity in multiple AR-positive prostate cancer models, supporting the planned expansion of our ORIC-944 clinical program in combination with AR inhibitors in metastatic prostate cancer,” said Lori Friedman, PhD, chief scientific officer.
“These encouraging preclinical findings, coupled with potential best-in-class drug properties and deepened understanding of the mechanism driving synergy, fuel our optimism for advancing this program.
Additionally, the unveiling of preclinical characterization of ORIC-613, a potential first- and best-in-class selective PLK4 inhibitor, marks a significant milestone in our discovery program, with preclinical data demonstrating synthetic lethality in TRIM37-high tumors.”
ORIC-944, a potent and selective allosteric PRC2 inhibitor with potential best-in-class properties, demonstrates combination synergy with AR pathway inhibitors in prostate cancer models (Presentation will be available on ORIC website on Tuesday, April 9, 2024 at 2:30 p.m. PT)
Key findings of the presentations:
Discovery of ORIC-944 was enabled through structure-based drug design and leveraged a cryptic pocket in an allosteric site in EED, a subunit of PRC2
Comprehensive profiling supports ORIC-944's best-in-class properties versus competitor PRC2 inhibitors, including PF-06821497, tazemetostat, and CPI-0209:
Clinical half-life estimated at approximately 20 hours, with no sign of CYP autoinduction that is observed with first-generation PRC2 inhibitors
Demonstrated that EED and EZH2 inhibitors act through the same mechanism of action, making prostate cancer cells more susceptible to AR inhibition:
Transcriptional changes induced by ORIC-944 were comparable to those of EZH2 inhibitors in prostate cancer models, indicating no mechanistic distinction between molecules targeting different core subunits of PRC2
RNA sequencing of prostate cancer models revealed that ORIC-944 increases AR signaling and luminal cell fate, thereby rendering these cells more susceptible to AR inhibition
ORIC-613, a potential first- and best-in-class, orally bioavailable, potent and selective PLK4 inhibitor with synthetic lethality in TRIM37 high cancer models
Key findings of the presentation:
ORIC-613 is an orally bioavailable, potent and exquisitely selective small molecule inhibitor of PLK4, which is synthetic lethal in tumor cells with high levels of TRIM37
Preclinical assessment in cancer cell lines revealed synthetic lethality, with ORIC-613 inducing apoptotic tumor cell death specifically in TRIM37-high breast cancer and neuroblastoma cells versus TRIM37-wildtype cells
These results position ORIC-613 as a potential first- and best-in-class development candidate, which has the potential to benefit patients with TRIM37-high tumors

Alamos and Argonaut Close Previously Announced Private Placement

Retrieved on:

Thursday, April 4, 2024

Indian stock exchange, Private placement, Private, Common, AGI, Attention, Brookfield Place, Suite, TSX, Transaction, Security (finance)

TORONTO, April 04, 2024 (GLOBE NEWSWIRE) -- Alamos Gold Inc. (“Alamos”) (TSX:AGI; NYSE:AGI) and Argonaut Gold Inc. (“Argonaut”) (TSX:AR) today announced the closing of their previously announced non-brokered private placement, pursuant to which Alamos subscribed (the “Private Placement”) for 174,825,175 common shares of Argonaut (the “Acquired Shares”), representing approximately 13.8% of Argonaut’s total outstanding common shares (the “Common Shares”) after giving effect to the Private Placement.

Key Points:

TORONTO, April 04, 2024 (GLOBE NEWSWIRE) -- Alamos Gold Inc. (“Alamos”) (TSX:AGI; NYSE:AGI) and Argonaut Gold Inc. (“Argonaut”) (TSX:AR) today announced the closing of their previously announced non-brokered private placement, pursuant to which Alamos subscribed (the “Private Placement”) for 174,825,175 common shares of Argonaut (the “Acquired Shares”), representing approximately 13.8% of Argonaut’s total outstanding common shares (the “Common Shares”) after giving effect to the Private Placement.
The Private Placement was conducted pursuant to the terms of the arrangement agreement between Alamos and Argonaut entered into on March 27, 2024 (the “Arrangement Agreement”) pursuant to which Alamos will acquire all of the issued and outstanding shares of Argonaut pursuant to a court approved plan of arrangement (the “Transaction”).
Immediately prior to the closing of the Private Placement, Alamos did not have beneficial ownership of, or control or direction over, any Common Shares.
After giving effect to the Private Placement, Alamos has beneficial ownership of, or control or direction over, 174,825,175 Common Shares, or approximately 13.8% of the issued and outstanding Common Shares.

Bank OZK Announces Increase to Quarterly Common Stock Dividend and Announces Preferred Stock Dividend

Retrieved on:

Monday, April 1, 2024

Bank OZK, OZK, ROCK, Bank, Policy, Federal Deposit Insurance Corporation, Index, Holding company

The common stock dividend is payable on April 19, 2024 to shareholders of record as of April 12, 2024.

Key Points:

The common stock dividend is payable on April 19, 2024 to shareholders of record as of April 12, 2024.
Bank OZK has increased its quarterly cash dividend on its common stock in each of the last fifty-five quarters.
Bank OZK’s consistent track record of increasing its common stock dividend has led to it being included in the S&P High Yield Dividend Aristocrats® index (Ticker: SPHYDA) since January 2018.
Bank OZK (Nasdaq: OZK) is a regional bank providing innovative financial solutions delivered by expert bankers with a relentless pursuit of excellence.

Glucose Health, Inc. Announces Expansion of Fiber Up® Brand – More Drink Mix Flavors and New Fiber Up® Gumdrops

Retrieved on:

Monday, April 1, 2024

Punch (drink), Fruit, OTC, Love, Person

The two new drink mix flavors, Fiber Up® Tropical and Fiber Up® Fruit Punch, are formulated to provide consumers with refreshing and delicious options to support metabolic health with soluble nutrition.

Key Points:

The two new drink mix flavors, Fiber Up® Tropical and Fiber Up® Fruit Punch, are formulated to provide consumers with refreshing and delicious options to support metabolic health with soluble nutrition.
These new Fiber Up® flavors combine the clinically benefits of soluble fiber with delicious taste, making it easier for individuals to incorporate fiber into their daily routines.
In addition to the two new Fiber Up® drink mix flavors, Glucose Health, Inc. is launching Fiber Up® Gumdrops, another convenient and enjoyable way for consumers to add soluble fiber to their diets.
With Fiber Up® Gumdrops, consumers will enjoy the benefits of soluble fiber in a fun, convenient and delicious format.

Bank OZK Announces Date for First Quarter 2024 Earnings Release and Conference Call

Retrieved on:

Thursday, March 28, 2024

Bank OZK, PIN, ROCK, Interest, Telephone, Webcast, Bank, Federal Deposit Insurance Corporation

LITTLE ROCK, Ark., March 28, 2024 (GLOBE NEWSWIRE) -- Bank OZK (the “Bank”) (Nasdaq: OZK) expects to report its first quarter 2024 earnings after the market closes on Wednesday, April 17, 2024.

Key Points:

LITTLE ROCK, Ark., March 28, 2024 (GLOBE NEWSWIRE) -- Bank OZK (the “Bank”) (Nasdaq: OZK) expects to report its first quarter 2024 earnings after the market closes on Wednesday, April 17, 2024.
Management’s comments on the first quarter of 2024 will be released simultaneously with the earnings press release and will be available on the Bank’s investor relations website.
Management will conduct a conference call to take questions at 9:00 a.m. CT (10:00 a.m.
Bank OZK (Nasdaq: OZK) is a regional bank providing innovative financial solutions delivered by expert bankers with a relentless pursuit of excellence.

JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

Retrieved on:

Thursday, March 28, 2024

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .

Key Points:

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .
As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

Tyson Foods Announces Second Quarter Earnings Conference Call and Webcast

Retrieved on:

Wednesday, March 27, 2024

Tyson Foods, TSN, Central Time

SPRINGDALE, Ark., March 27, 2024 (GLOBE NEWSWIRE) -- Tyson Foods, Inc. (NYSE: TSN) will release second quarter 2024 financial results on Monday, May 6, 2024.

Key Points:

SPRINGDALE, Ark., March 27, 2024 (GLOBE NEWSWIRE) -- Tyson Foods, Inc. (NYSE: TSN) will release second quarter 2024 financial results on Monday, May 6, 2024.
Management will host a conference call and webcast beginning at 9:00 a.m. Eastern Time (8:00 a.m. Central Time).
Participants may join the audio-only version of the conference call by calling:
Please note: All dial-in participants should ask to join the Tyson Foods call.
For those who cannot participate at the scheduled time, a replay of the live webcast and accompanying slides will be available at http://ir.tyson.com .