Indications – Kepplah http://kepplah.com/ Tue, 28 Jun 2022 18:54:27 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://kepplah.com/wp-content/uploads/2021/05/kepplah-150x150.png Indications – Kepplah http://kepplah.com/ 32 32 New Okanagan Valley Wine Regions Recognized https://kepplah.com/new-okanagan-valley-wine-regions-recognized/ Tue, 28 Jun 2022 15:32:04 +0000 https://kepplah.com/new-okanagan-valley-wine-regions-recognized/

Here are descriptions of each new sub-geographical indication and wineries that BC consumers and visitors to the province can visit, which tell the story of their unique terroirs and reflect their specific growing conditions:

East Slopes of Kelowna
East Kelowna Slopes spans approximately 2,900 hectares (7,166 acres) around the lower reaches of Mission Creek and its canyon. Kelowna’s East Slopes wineries include Camelot Vineyard, House of Rose Winery, Kitsch Winery, Mirabel Vineyards, Priest Creek Winery, Sperling Winery, Tantalus Winery, The View Winery, and Vibrant Vines Winery.

land of lakes
Lake Country covers 2,500 hectares (6,178 acres) along approximately 20 kilometers of the eastern shore of Okanagan Lake. Lake Country wineries include 50th Parallel Estate Vineyard, Gray Monk Estate Winery (owned by Andrew Peller Ltd.), Arrowleaf Cellars, O’Rourke Family Vineyards, Peak Cellars, Ex Nihilo Winery and Intrigue Winery.

South Slopes of Kelowna
South Kelowna Slopes spans approximately 800 hectares (1,977 acres) overlooking Okanagan Lake in the South Mission area of ​​Kelowna. South Kelowna Slopes wineries include Burnt Timber Vineyard, Cedar Creek Winery, Martin’s Lane Winery, St Hubertus Vineyards, Summerhill Winery and Scorched Earth Winery.

Summerland Bench
Summerland Bench spans approximately 60 hectares (148 acres) of vineyards near Giant’s Head Mountain. Summerland Bench wineries include Dirty Laundry Vineyard, Giant’s Head Winery, Lightning Rock Winery, Lunessence Winery, Sumac Ridge Winery, and Thornhaven Winery.

Summerland Lakeside
Summerland Lakefront spans 805 hectares (1,989 acres) along the western shore of Okanagan Lake in the Summerland District. Summerland Lakefront wineries include 8th Generation Winery, Okanagan Crush Pad Winery, Heaven’s Gate Winery, Sage Hills Winery, and Summerland Estate Winery.

Summerland Valleys
Summerland Valleys covers approximately 1,350 hectares (3,330 acres) in the District of Summerland, in the areas known as Prairie Valley and Garnett Valley, and includes SummerGate Winery.

]]> Dodgers RHP Daniel Hudson likely out for season with ACL injury https://kepplah.com/dodgers-rhp-daniel-hudson-likely-out-for-season-with-acl-injury/ Sat, 25 Jun 2022 03:56:15 +0000 https://kepplah.com/dodgers-rhp-daniel-hudson-likely-out-for-season-with-acl-injury/

Dodgers reliever Daniel Hudson suffered an ACL injury in Friday’s game against the Braves and will likely miss the rest of the season, according to manager Dave Roberts.

“It doesn’t look good by all indications,” Roberts said after the game. “So things can happen, but I just don’t see how it’s not the end of his season. So it’s potentially a huge loss for us.”

Hudson, 35, left the game after his leg bent coming off the mound in an attempt to field a fly ball that Ronald Acuña Jr. hit in front of home plate. The pitcher walked off the field with help, and Roberts said he’ll get CT scans on Saturday.

Hudson has played 25 games this season, recording a 2.22 ERA and five saves.

“Huddy is a guy that we rely on in different ways. On the pitch, one of the leaders in the clubhouse, always doing the right thing, saying the right thing and obviously with Blake (Treinen) down, we got each other. heavily leaning on him in leverage points,” Roberts said. “To not have him with us has an exponential effect on our ball club. But we have to move on.”

The Dodgers have already had several pitchers placed on the disabled list this season, including Dustin May, Walker Buehler and Caleb Ferguson, in addition to right fielder Mookie Betts.

(Photo: Jayne Kamin-Oncea/USA Today)

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Applied Therapeutics, Inc. Announces $30 Million Award https://kepplah.com/applied-therapeutics-inc-announces-30-million-award/ Thu, 23 Jun 2022 02:12:00 +0000 https://kepplah.com/applied-therapeutics-inc-announces-30-million-award/

NEW YORK, June 22, 2022 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (NASDAQ: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the price of its underwritten public offering of 20.0 million common shares, with a par value of $0.0001 per share, 10.0 million warrants of pre-funded subscription to purchase common stock in lieu of common stock from certain investors, and warrants (“common warrants”) to purchase up to 30.0 million shares of its common stock. Each Common Share and the accompanying Common Warrant are being offered at a combined public offering price of $1.00, less underwriting rebates and commissions, and each Pre-funded Warrant and Common Warrant accompanies are offered at a combined public offering price of $0.9999, less discounts and subscription fees. The pre-funded warrants have an exercise price of $0.0001 per share and the ordinary warrants have an exercise price of $1.00 per share. The Prefunded Warrants and the Ordinary Warrants are immediately exercisable and will expire five years from the date of issue. The Company’s gross proceeds from the offering, before deducting underwriting rebates and commissions and offering fees payable by the Company, are expected to be $30 million.

The Company intends to use the net proceeds of this offering for general corporate purposes. General business objectives may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidates, expanding the research and development capabilities of the Company, working capital and capital expenditures.

SVB Securities acts as sole bookrunner for the offering. The offering is expected to close on June 27, 2022, subject to customary closing conditions.

The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the final prospectus supplement and accompanying prospectus relating to the proposed offering, when available, may be obtained from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by phone at 1-800-808-7525 ext. 6105, or by email at syndicate@svbsecurities.com. Before investing, you should read the prospectus of this registration statement and other documents the Company has filed with the SEC for more complete information about the Company and the proposed offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, and there will be no sale of these securities in any state in which such offer, solicitation or sale would be unlawful. prior to registration or qualification under the securities laws of such state or territory.

About applied therapy
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s lead drug candidate, AT-007, is a novel central nervous system-penetrating aldose reductase inhibitor (ARI) for the treatment of rare metabolic CNS diseases, including galactosemia, SORD deficiency and PMM2-CDG. The Company is also developing AT-001, a powerful new ARI, for the treatment of diabetic cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003, an ARI designed to cross the back of the eye when administered orally, for the treatment of diabetic retinopathy, as well as novel PI3k dual inhibitors in preclinical development for orphan oncology indications.

Forward-looking statements
This press release contains “forward-looking statements”, including, but not limited to, statements regarding the Company’s intended use of the net proceeds of the offering and other statements regarding the offering, which involve substantial risks and uncertainties for safe harbor purposes. provided for by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding management’s strategy, future operations, prospects, plans and objectives, including including words such as “may”, “will”, “expect”, “anticipate”, “plan”, “intend” and similar expressions (as well as other words or expressions referring to future events, conditions or circumstances) are forward-looking statements. The forward-looking statements contained in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and therefore we cannot assure you that our plans, intentions , expectations or strategies will be met or achieved.

These risks and uncertainties include, but are not limited to, factors that could cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release are discussed in our filings with the Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

contacts

Investors:
Maeve Conneighton
(212) 600-1902 or
Appliedtherapeutics@argotpartners.com

Media:
media@appliedtherapeutics.com

]]> Orphan Indication Treatment Market Growth Prospects: 2022, Regional Demand, Qualitative Analysis and Dynamic Innovations | Bristol-Myers Squibb, Roche, Novartis https://kepplah.com/orphan-indication-treatment-market-growth-prospects-2022-regional-demand-qualitative-analysis-and-dynamic-innovations-bristol-myers-squibb-roche-novartis/ Tue, 21 Jun 2022 14:15:07 +0000 https://kepplah.com/orphan-indication-treatment-market-growth-prospects-2022-regional-demand-qualitative-analysis-and-dynamic-innovations-bristol-myers-squibb-roche-novartis/

The latest report published by SMI provides a comprehensive assessment of “Orphan Indications Treatment Market for the Forecast Year 2022-2028,” which is advantageous for companies, whatever their size and turnover. This report provides an in-depth insight into the future of the market. Increased demand for smart technologies and increased construction of skyscrapers and tall commercial buildings are expected to contribute significantly to the growth of the market.

A comprehensive study of Orphan Indication Treatment Market is carried out by the analysts of this report, considering key factors such as drivers, challenges, recent trends, opportunities, developments and competitive landscape. This report provides a clear understanding of the current and future scenarios of the Orphan Indications Treatment industry. Research techniques such as pestle and Porter’s five forces analysis have been deployed by the researchers. It has also provided accurate production, capacity, price, cost, margin, and revenue data, allowing players to gain a clear understanding of the overall existing and future market conditions.

Get a sample copy with table of contents, graphics, and list of [email protected] https://www.stratagemmarketinsights.com/sample/144146

Key Players Mentioned in the Orphan Indications Treatment Market Research Report:

Bristol-Myers Squibb, Roche, Novartis, Johnson & Johnson, Pfizer, Amgen, Sanofi, AstraZeneca, Takeda, Vertex Pharmaceuticals, AbbVie, Biogen, Eli Lilly

Main Drivers

The high-impact factors and renderers have been studied in this report to help readers understand the general development. Additionally, the report includes constraints and challenges that can be stumbling blocks in the players’ path. This will help users make informed, meticulous business-related decisions. The experts also focused on the upcoming trade prospects.

Sector outlook

The key segments including types and applications have been detailed in this report. Market reports have studied all segments and used historical data to provide market size. They also discussed the growth opportunities the segment could represent in the future. The study provides production and revenue data by type and application over the past period (2016-2021) and forecast period (2022-2028).

For product/service type segment

Organic, non-organic products

For end use/application segment

Hospital pharmacy, Retail pharmacy, Online sales

REGIONAL FRAMEWORK

The Orphan Indications Treatment Market report provides an in-depth overview of the industry, including qualitative and quantitative insights. It provides market insights and forecasts based on various segments. It also provides market size estimates and forecasts from the year 2022 to 2028 with respect to five major regions. The market for each region is further sub-segmented by respective countries and segments. The market report covers analysis and forecast on a global scale, as well as the current trend and opportunities prevailing in the region.

⇨ North America (United States, Canada and Mexico)
⇨ Europe (Germany, France, United Kingdom, Russia and Italy)
⇨ Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
⇨ South America (Brazil, Argentina, Colombia, etc.)
⇨ The Middle East and Africa (Saudi Arabia, United Arab Emirates, Egypt, Nigeria and South Africa)

Get a special discount on the first purchase of this report @- https://www.stratagemmarketinsights.com/discount/144146

This report also includes:

  • Stratagem Market Insights Methodology
  • Tactics and Suggestions for New Entrants
  • Segmented analysis
  • Economic indices
  • Strategic business developments
  • Market Growth Drivers and Restraints
  • Selected illustrations of market penetrations and trends

Key Questions Answered in the Orphan Indications Treatment Market Report

  • Who are the leading market players in the Orphan Indications Treatment market?
  • What are the major regions for dissimilar trades expected to witness astonishing growth for the market?
  • What are the regional growth trends and major revenue-generating regions for the market?
  • What will be the market size and growth rate by the end of the forecast period?
  • What are the key market trends impacting the growth of the market?
  • What are the main types of products on the market?
  • What are the main market applications?

Buy Full Orphan Indications Treatment Market Research Report @- https://www.stratagemmarketinsights.com/cart/144146

Contents:

Part 1: Overview of the treatment of orphan indications market
Part 2: Orphan Indication Treatment Carts: Global Market Status and Forecast by Regions
Part 3: Global Market Status and Forecast by Types
Part 4: Global Market Status and Forecast by Downstream Industry
Part 5: Market Driver Analysis
Part 6: Market Competition Status by Major Manufacturers
Part 7: Major Manufacturers Overview and Market Data
Part 8: Upstream and Downstream Market Analysis
Part 9: Cost and Gross Margin Analysis
Part 10: Analysis of the state of marketing
Part 11: Conclusion of the market report
Part 12: Treatment of orphan indications: research methodology and reference

Contact us:

Stratagem Market Overview
1001 4th Avenue, #3200 Seattle, WA 98154
Phone: USA +12067016702 / UK +4402081334027 / JAPAN +815055391737
E-mail: [email protected]

VB

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The high heat for Florida is not over yet https://kepplah.com/the-high-heat-for-florida-is-not-over-yet/ Sun, 19 Jun 2022 19:15:00 +0000 https://kepplah.com/the-high-heat-for-florida-is-not-over-yet/

It’s a hot weekend in central Florida, and more heat is likely heading into next week.


What do you want to know

  • Highs soared in the upper 90s
  • A second round of heat becomes likely
  • Highs could climb back into the upper 90s at the end of next week

From Wednesday to Saturday, there were daily highs at Orlando International Airport in the mid to high 90s, well above the average high of 91.

The good news is that cooler weather is forecast for Sunday and next week.

The bad news is that the slightly cooler temperatures won’t last long.

Computer guidance is beginning to indicate that a second high heat cycle is becoming likely. This round would start on Thursday and likely last until next weekend.

Once again, the highs are expected to move back into the mid 90s, with upper 90s very possible. This will increase the heat index, or “look-alike” temperatures to the point that heat advisories may be required.

So what causes all the heat through the sunshine state?

A high pressure ridge has formed over the southeastern United States. This ridge helps heat build up in an area, which is why many areas northwest of Florida experienced triple-digit temperatures.

The ridge will begin to break down early in the week allowing slightly cooler air to return.

But the ridge will recover later in the week, again opening the door for warm conditions to enter the area.

Currently, forecast highs are in the mid to upper 90s. But there are indications that temperatures above 90, and possibly over 100 degrees, could be possible in some parts. of the region at the end of the week until next weekend.

There’s good news with this ridge – it’s effective at warding off tropical systems.

Large ridges of high pressure help push tropical complexes away from their center. If a system were to develop, it would likely be sent far from Florida.

And the crest won’t last forever. Finally, a more typical Florida weather pattern should end June.

So while Florida is known for its heat, this severe heat has been a test for many. And that may not be going away anytime soon.

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GBP/USD awaiting directional indication after rally stall [Video] https://kepplah.com/gbp-usd-awaiting-directional-indication-after-rally-stall-video/ Fri, 17 Jun 2022 13:15:40 +0000 https://kepplah.com/gbp-usd-awaiting-directional-indication-after-rally-stall-video/

On the 1-hour chart, GBP/USD is forming higher highs and lowers after falling to a two-year low at 1.19341. Additionally, the bulls have made gains above the 50 and 200 exponential moving averages. Still, to ensure the uptrend continues, it is imperative for the pair to break through Thursday’s high at 1.24047.

In the short term, the candlestick bodies are getting shorter, implying that the positive momentum is fading, as the buying forces don’t seem strong enough to end on a higher note. In light of this, we shouldn’t be surprised if the price consolidates around the 200-EMA for a while until we get a better indication of market direction. A sustained rally in the pound should lead the price higher from its previous high, resulting in a larger candlestick body. If so, the pair may rise higher to test the resistance level of 1.24047. Assuming price moves above this roadblock for an extended period, the next hurdle would be 1.24700.

Alternatively, suppose price consolidation leads to increased selling pressure. The price may then move back down towards the support at 1.22507, which coincides with the 50-EMA. When this confluence breaks, the short-term uptrend will reverse and more sellers will enter the market, taking the pair to the 1.22061 level.

Momentum oscillators reflect a fading bullish bias. RSI is moving away from the buy region towards the neutral zone, suggesting that the buyers are giving up. Further, the momentum is moving away from its recent high, pointing towards the 100 threshold. Similarly, the MACD bars are declining into positive territory below the descending signal line.

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Nivolumab/ipilimumab and nivolumab/chemo indications improve the ESCC treatment landscape https://kepplah.com/nivolumab-ipilimumab-and-nivolumab-chemo-indications-improve-the-escc-treatment-landscape/ Wed, 15 Jun 2022 14:40:36 +0000 https://kepplah.com/nivolumab-ipilimumab-and-nivolumab-chemo-indications-improve-the-escc-treatment-landscape/ Approval of 2 nivolumab-containing combinations for patients with advanced or metastatic esophageal squamous cell carcinoma has opened the doors for immunotherapy to enter the landscape in this population, providing clinicians with options to help patients achieve their individual treatment goals.

Approval of 2 combinations containing nivolumab (Opdivo) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) has opened the doors for immunotherapy to enter the landscape for this population, providing clinicians with options to help patients achieve their individual treatment goals.1

Results from the Phase 3 CheckMate 648 trial (NCT03143153) supported the approval of nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy and nivolumab plus ipilimumab (Yervoy) for the first-line treatment of patients with advanced or metastatic CCHS. The study data showed that both combinations caused superior survival benefits and increased response rates compared to chemotherapy alone.1.2

The overall response rate was 47.4% (95% CI, 41.8%-53.0%), 27.7% (95% CI, 22.9%-32.9%) and 26 .9% (95% CI, 22.1%-32.0%) for nivolumab plus chemotherapy, nivolumab plus ipilimumab and chemotherapy alone, respectively. Additionally, the median overall survival (OS) was 13.2 months (95% CI, 11.1-15.7), 12.8 months (95% CI, 11.3-15.5) and 10.7 months (95% CI, 9.4-11.9), respectively. These improvements in OS resulted in a 16% and 12% reduction in the risk of death in the nivolumab plus chemotherapy arm and the nivolumab plus ipilimumab arm, respectively.2

In an interview with Live®Jaffer A. Ajani, MD, professor in the department of gastrointestinal (GI) medical oncology in the division of cancer medicine at the University of Texas MD Anderson Cancer Center in Houston, spoke about this unique trial and its endorsement .

What does the current treatment landscape look like for patients with CCHS?

The only approved agent at this time is pembrolizumab [Keytruda]. Although the FDA has approved pembrolizumab plus chemotherapy for all untreated patients with CCHS in the advanced setting, it is more effective if the combined positive PD-L1 score [CPS] is 10 or more. This is based on the KEYNOTE-590 study [NCT03189719].

It’s the only thing we currently have. National Comprehensive Cancer Network guidelines also recommend pembrolizumab plus chemotherapy if the CPS score is 10 or higher.

What stood out to you about the Checkmate 648 efficacy data?

This is a very remarkable and unique study because it had 2 experimental arms. [There was also] one chemotherapy arm as control, chemotherapy plus nivolumab as one of the experimental arms, and the other [arm] was without any chemotherapy [but with nivolumab plus ipilimumab].

The comparison of the two experimental arms was made to chemotherapy and not to each other and both experimental arms were better than chemotherapy. It’s unique that we have a no-chemo option.

The chemotherapy option with nivolumab was better than chemotherapy. [However,] it could be reserved for some very symptomatic patients with a lot of tumor who cannot wait for a response and need an immediate response. The immediate response comes from chemotherapy rather than immunotherapy.

One thing to recognize is that the study was not designed to determine which patients should get which experimental arm. It’s something that we [must] understand at the clinic. There’s kind of a general notion that my colleagues might agree that for an asymptomatic patient with a very low tumor burden you might consider the non-chemo arm for those provided there’s no contraindication.

This approval encompasses 2 different combinations with nivolumab, how do you approach treatment selection in clinical practice?

In my clinical practice, what I hope to do is, in some patients, to use a combination of immunotherapy drugs without chemotherapy, because chemotherapy will systematically reduce quality of life and lead to irreversible adverse effects. [AEs]. Immunotherapy can also do some of these things [but it is] a different group of IEs.

If you were to add chemotherapy to immunotherapy, you increase the risk to the patient. You give [the patient] AE of chemotherapy and immunotherapy [AEs]. Still, chemotherapy combined with nivolumab has its own benefits. If a patient has never been treated and is very symptomatic, they need fast relief. For [those patients] I’m going to use nivolumab plus chemotherapy.

But there are patients who don’t need immediate relief, they don’t have many symptoms. For [these patients]if you can avoid chemotherapy, you can maintain a fairly good quality of life for them.

Are there any unique factors to consider regarding AEs among this patient population?

Nivolumab and ipilimumab have been around for over 10 years. Most general oncologists are familiar with these drugs because they are approved for multiple types of tumors in multiple conditions. This [approval] is not going to place a lot of burden on the oncologist as to how to manage AEs.

The question is: how do you manage [the AEs] in this group of patients? The first cycle is the most important, where you really try to explain [the treatment to] the patient and his family. They usually cannot understand this because there is already a lot of stress. When they first [receive a] diagnosis, they want to be treated that day. And when they come to the clinic and you start explaining AEs, they disconnect. You [must] be very careful in the first cycle to closely monitor the patient and educate the caregiver.

You have to have that kind of approach where you use all available resources. After the first cycle, [you can learn some of] the spectrum of AEs a given patient is going to experience, and then you adjust everything accordingly. The same thing [applies] for the no chemotherapy arm, which was not necessarily more toxic than the chemotherapy arm, it was very similar to the chemotherapy arm in terms of [the types of] AEs and levels of [incidence].

Each patient may have a very different outcome in terms of efficacy and toxicity because they have never received these treatments. These are first-line treatments. Thus, a certain degree of extra care is required during the first cycle.

How does this approval potentially change the treatment paradigm in CCHS?

This will make it a bit simpler because the discrimination of PD-L1 expression was different than KEYNOTE-590. Here they watched the [tumor proportion score] TPS and the threshold was 1 or more because positive and less than 1 as negative. So it wasn’t 10. About 55% of patients had a GST of at least 1.

It will be easier to select patients [for these regimens], although the FDA has approved it independently of TPS. The FDA label says you use nivolumab plus chemotherapy on every patient in this setting or use nivolumab plus ipilimumab in this setting. We [must] make some discrimination based on the details of this study. I believe that will make things easier.

What future for nivolumab?

Since many oncologists are very familiar with nivolumab and pembrolizumab, these are the drugs we will rely on [for this patient population]. There are other PD-1 inhibitors and several trials, these molecules come from China, and how they will fit into the [treatment] the landscape is not clear.

These are all latecomers, pembrolizumab and nivolumab have been around for a long time. This is going to be interesting, but no other trial has really taken a non-chemotherapeutic approach. This is the first and only, and largest trial conducted for patients with untreated metastatic CCHS. This is about 950 patients, most other trials involve less than 600 patients.

it’s a nice challenge because before we didn’t have several options. If you have a patient in front of you, we only had one treatment we could give them. Standard of care was only one option. Now we have several options. We can give either pembrolizumab plus chemotherapy, or nivolumab plus chemotherapy, or nivolumab plus ipilimumab. It will be a very interesting learning curve in the future and I look forward to it.

References

  1. Opdivivo. Prescribing Information. Bristol-Myers Squibb; 2022. Accessed June 2, 2022. bit.ly/3NjJhnN
  2. FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line indications of esophageal squamous cell carcinoma. FDA. May 27, 2022. Accessed June 2, 2022. bit.ly/3zixPVg

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SI-BONE, Inc. Announces FDA Clearance for Expanded Indication of iFuse-TORQ® Implant System https://kepplah.com/si-bone-inc-announces-fda-clearance-for-expanded-indication-of-ifuse-torq-implant-system/ Mon, 13 Jun 2022 14:39:48 +0000 https://kepplah.com/si-bone-inc-announces-fda-clearance-for-expanded-indication-of-ifuse-torq-implant-system/

SANTA CLARA, Calif., June 13, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the Sacropelvic Anatomy, today announced FDA clearance for iFuse-TORQ® for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures. Together, these constitute a market opportunity of approximately $300 million.

Sacral fragility and insufficiency fractures are common and often devastating to patients and healthcare systems, where:

  • 120,000 fragility or sacral insufficiency fractures occur each year in the United States1
  • 78% of patients are treated with bed rest resulting in hospital stays of 14 to 45 days26
  • 27% mortality at 1 year results from complications associated with bed rest5.6

“Many elderly patients with sacral fragility fractures require long periods of immobility while their fracture heals, which often results in complications associated with bed rest,” said Michael Gardner, MD, chief of orthopedic trauma. at Stanford University Hospital. “A paradigm shift is needed. The strength and osseointegration characteristics of iFuse-TORQ make it the most attractive implant on the market to remobilize these osteoporotic patients.

“Since its launch in 2021, iFuse-TORQ has been used to treat many patients with pelvic fracture or sacroiliac joint dysfunction,” said Laura Francis, CEO of SI-BONE. “This extension of the pelvic fracture fixation indication follows the launch of iFuse Bedrock Granite and reinforces SI-BONE’s position as a market leader in the sacropelvic space.”

References

  1. Burge R, et al. J Bone Miner Res. 2007 March; 22(3):465-75.
  2. By Medicare ICD-10 Code Search includes patients > 65 by Watson Policy Analysis. June 2020.
  3. Alnaib et al J Orthop Traumatol. June 2012 ; 13(2): 97–103
  4. Breuil V, et al. Common bone vertebral column. 2008;75:585–8.
  5. Taillandier J, et al. Common bone vertebral column. 2003;70(4):287–289.
  6. Morris R, et al. Postgrad Med J. 2000;76 (900):646.

About SI-BONE, Inc.
SI-BONE is a world technology leader for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since 2009, when SI-BONE introduced the iFuse implant system for minimally invasive SI joint surgery, over 2,700 surgeons have performed a combined total of over 65,000 joint fusion procedures IF. A unique body of evidence, supporting the iFuse implant system, including two randomized controlled trials and more than 100 peer-reviewed publications, has enabled several government and private insurance payers to establish near universal coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System. Backed by this exclusive reimbursement benefit, SI-BONE has actively leveraged its market leadership position in recent years to pursue clinical research and develop and commercialize new surgical treatment solutions for SI-Joint pain, fixation sacropelvic and pelvic and pelvic trauma. For more information or to join our team, visit www.si-bone.com.

For more company or product information, including risks and benefits, please visit www.si-bone.com.

* The newly erased indication statement is:

The iFuse-TORQ Implant System is indicated for:

  • Sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint rupture and degenerative sacroiliitis
  • Fixation of pelvic fractures, including acute, non-acute and non-traumatic fractures

SI-BONE, iFuse Implant System, iFuse-TORQ, Bedrock and Bedrock Granite are registered trademarks of SI-BONE, Inc. ©2022 SI-BONE, Inc. All rights reserved.

A photo accompanying this ad is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/36baeebe-01cb-430d-bb1e-1d23d65e3e5c

Media Contact:
Joe Powers, Vice President of Marketing
jpowers@si-bone.com

Investor contacts:
Matt Basso
investors@si-bone.com

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Rising freight costs not unique to Fiji: Koya – FBC News https://kepplah.com/rising-freight-costs-not-unique-to-fiji-koya-fbc-news/ Sat, 11 Jun 2022 00:39:49 +0000 https://kepplah.com/rising-freight-costs-not-unique-to-fiji-koya-fbc-news/

There are indications that exorbitant transport costs will slowly decrease later this year.

Freight costs have been at their highest level in recent times since the start of the COVID pandemic and subsequently the Russian-Ukrainian crisis.

Commerce Minister Faiyaz Koya said consumer prices rose globally due to disruptions in shipping and the supply chain.
Koya says businesses will have to bear increased transport costs and supply chain issues for some time, as this is not unique to Fiji.


“I think the costs are starting to come down.” Supply chain issues have driven prices up. We will have to face it like anything else in the world. Geopolitical issues in Russia and Ukraine are also a contributing factor to rising costs in terms of moving goods to and from the rest of the world to Fiji.

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According to the Suva Retailers Association, transportation costs are a global issue and businesses are trying to adapt to the environment as there is no other option available.

President Jitesh Patel says they hope it’s not a long-term problem hoping things will be better in the next six to eight months.

According to the World Trade Organization, the war in Ukraine has impacted the global economy at a critical time and its effects will be felt around the world, especially in low-income countries.

He adds that governments and multilateral organizations must work together to facilitate trade at a time of strong inflationary pressures on essential supplies and growing pressures on supply chains.

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Filament Health and Jaguar Health Sign Letter of Intent to Develop Prescription Botanical Medicines for Specific Mental Health Indications https://kepplah.com/filament-health-and-jaguar-health-sign-letter-of-intent-to-develop-prescription-botanical-medicines-for-specific-mental-health-indications/ Thu, 09 Jun 2022 12:30:00 +0000 https://kepplah.com/filament-health-and-jaguar-health-sign-letter-of-intent-to-develop-prescription-botanical-medicines-for-specific-mental-health-indications/

Drug discovery collaboration will leverage both companies’ botanical drug development expertise

VANCOUVER, BC, June 9, 2022 /CNW/ – Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) and Jaguar Health, Inc. (NASDAQ: JAGX) today announced that the companies have signed a letter of intent to enter into an agreement to collaborate to develop drugs prescription botanicals for specific indications of psychoactive targets in United States. The objective of the collaboration is to extend the botanical drug development capabilities of both companies to develop standardized pharmaceutical-grade drug candidates and to partner with a potential future licensee regarding the development and commercialization of these new herbal medicines for indications such as attention deficit/hyperactivity disorder (ADHD) and social anxiety disorder.

“We are excited about this collaboration with Filament Health, a company focused on the discovery, development and standardization of botanical medicines as well as delivery to patients with mental health issues,” said Steven King, PhD, Jaguar’s Head of Sustainable Sourcing, Head of Ethnobotanical Research and Intellectual Property, and Head of the Company’s Entheogen Therapeutics (ETI) Initiative. Jaguar’s ETI aims to discover and develop breakthrough, innovative and natural medicines derived from psychedelic and psychoactive plants for the treatment of mood disorders, neurodegenerative diseases, addiction and mental health disorders. “Jaguar and Filament are identifying plant candidates that may prove beneficial in treating indications such as ADHD and social anxiety disorder, for which we plan to work collaboratively to develop botanical medicines.”

“Filament is a leader in the development of botanical medicines, and we are committed to supporting the treatment of mental health conditions through our expertise and technology,” said Benjamin Lightburn, CEO of Filament Health. “We have developed new manufacturing and standardization techniques which we have applied to psilocybin, psilocin and ayahuasca. We are delighted to partner with Jaguar and look forward to working with their team to identify and standardize new entheogens.

Under the partnership, Jaguar will be responsible for the identification of plants that may offer novel mechanisms of action, as well as the development of botanical drugs and the raw material supply chain. Filament will be responsible for developing the manufacturing techniques needed to produce standardized pharmaceutical-grade drug candidates. The two companies will then jointly seek a partnership with a potential licensee for the full development and commercialization of new drug candidates, with proceeds from the relationship split equally between Jaguar and Filament.

“We very much look forward to working with Filament on this initiative,” said Lisa Conte, Chairman, CEO and Founder of Jaguar. “Jaguar’s core team began focusing more than 30 years ago on the development and commercialization of herbal prescription medicines, and our Mytesi® (crofelemer), approved by the US FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, is the only oral herbal prescription medication approved by the FDA Botanical Guidance. Filament’s expertise in natural product chemistry and drug development leverages a key asset we’ve generated over 30 years – a library of 2,300 medicinal plants and 3,500 plant extracts, all derived from a survey first-hand ethnobotany by Jaguar and our ETI Science Strategy Team (SST).”

The ETI SST will support this collaboration and is composed of world-renowned ethnobotanists, physicians and pharmacologists, as well as experts in the fields of natural product chemistry and neuropharmacology:

  • Michael J. Balickdoctorate: Considered one of the greatest ethnobotanists and economic botanists in the world; specialist in medicinal plants and poisonous plants and their use by indigenous peoples; research associate of the Brain Chemistry Labs of the Institute of Ethnomedicine; member of the original science strategy team that helped develop Jaguar’s plant library.
  • Thomas CarlsonMD, MS: Ethnobotanist, botanist, physician; professor of integrative biology at University of California, Berkeley; member of the original science strategy team that helped develop the Jaguar Plant Library; key architect of the ethnomedical field research process conducted by ethnobotanist/physician teams from Jaguar’s predecessor company, Shaman Pharmaceuticals.
  • Pravin Chaturvedidoctorate: Pharmacologist with specialty in neuropharmacology; Chairman of the Scientific Advisory Board of Napo Pharmaceuticals (Napo), a wholly owned subsidiary of Jaguar, and Chief Scientific Officer of Jaguar; Over 25-year career, led discovery and/or development activities for several new chemical entities, including the development of Napo’s FDA-approved drug, Mytesi® (crofelemer), the only oral herbal medicine approved by the FDA Botanical Guidance.
  • Julie Anne Chinnock, ND, MPH, ARNP/CRNA: ethnobotanist; doctor of naturopathic medicine; owner and manager of Ketamine Clinic; member of the original Shaman Pharmaceuticals field research teams; public health specialist.
  • Stephen DahmerMD: Researcher in ethnomedicine and practicing integrative physician; endocannabinoid expert who has conducted ethnomedical field research in tropical regions.
  • Wade Davisdoctorate: Ethnobotanist, anthropologist, writer and professor of anthropology at University of British Columbia; extensive international ethnobotanical field research.
  • Elaine Elisabetsky, Ph.D.: Among the best ethnopharmacologists in the world; professor in the departments of pharmacology and biochemistry of the Universidade Federal do Rio Grande do Sul in Brazil; member of the original science strategy team that helped develop Jaguar’s plant library.
  • Nigel GerickeMBBCh. : Physician, ethnobotanist and ethnopharmacologist; former member of the United States Pharmacopoeia Advisory Board; long-time member of the World Wide Fund for Nature’s Medicinal Plants Specialist Group; founding member of the Association for African Standards of Medicinal Plants.
  • Maurice Iwudoctorate: Chairman of the Bioresources Development Group and founder of the International Center for Ethnomedicine and Drug Development (InterCEDD) in Nigeria; member of the original science strategy team that helped develop Jaguar’s plant library.
  • Steven R. Kingdoctorate: ethnobotanist; Napo Sustainable Sourcing and Ethnobotanical Research Manager; managed Napo’s original science strategy team and its results; associate researcher at the Brain Chemistry Labs of the Institute of Ethnomedecine.
  • Charles LimbachMD: Ethnomedical specialist and family physician; member of the original science strategy team that helped develop Jaguar’s plant library.
  • David Sesindoctorate: Natural products chemist; manufacturing director of Jaguar; created an insulation and manufacturing process for Mytesi (crofelemer).

About Filament Health
(OTCQB: FLHLF) (NEO: FH) (FSE: 7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. Filament believes that safe, standardized, naturally derived botanical medicines can improve the lives of many people, with a mission to get them into the hands of everyone who needs them as soon as possible. Filament’s proprietary intellectual property platform enables the discovery, development and delivery of natural medicines, including psychedelic drugs, for clinical development. The filament is leading the way with the very first natural psychedelic drug candidates.

Learn more about www.filament.health and on Twitter, instagram and LinkedIn

About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals and Napo Therapeutics

Jaguar Health, Inc. is a commercial-stage pharmaceutical company focused on developing novel herbal, non-opioid, and sustainably-derived prescription medicines for people and animals with gastrointestinal disorders, including chronic and debilitating diarrhea. Jaguar Animal Health is a trading name of Jaguar Health. Jaguar Health’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc., is focused on the development and commercialization of proprietary human plant-based pharmaceutical products from plants responsibly harvested from rainforest areas. Our drug candidate crofelemer is the subject of on target study, an ongoing pivotal Phase 3 clinical trial for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics SpA (f/k/a Napo EU SpA), an Italian company created by Jaguar Health in Milan, Italy in 2021 which focuses on expanding access to crofelemer in Europe.

For more information about Jaguar Health, visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

Forward-looking statements

Certain statements contained in this press release constitute “forward-looking statements”. These include statements regarding the expectation that the collaboration between Jaguar and Filament will identify candidate herbs that may prove beneficial in treating indications such as ADHD and social anxiety disorder, and the expectation that this collaboration identify and standardize new entheogens. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, ” could”, “intend”, “target”, “project”, “consider”, “believe”, “estimate”, “predict”, “potential”, or “continue” or the negative form of these terms or other similar expressions. The forward-looking statements contained in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections regarding future events. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control.Except as required by applicable law, Jaguar does not does not intend to publicly update or revise the statements forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise.

SOURCE Filament Health Corp.

For further information: Jaguar Health: Peter Hodge, Jaguar Health, Inc., [email protected], Jaguar-JAGX; Filament Health: Anna Cordon, Director of Communications, [email protected]

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