Indications – Kepplah http://kepplah.com/ Sat, 25 Sep 2021 11:04:19 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://kepplah.com/wp-content/uploads/2021/05/kepplah-150x150.png Indications – Kepplah http://kepplah.com/ 32 32 The oat milk ad on the grand finale airs A fair indication that the demons of Melbourne are playing – The Betoota Advocate https://kepplah.com/the-oat-milk-ad-on-the-grand-finale-airs-a-fair-indication-that-the-demons-of-melbourne-are-playing-the-betoota-advocate/ https://kepplah.com/the-oat-milk-ad-on-the-grand-finale-airs-a-fair-indication-that-the-demons-of-melbourne-are-playing-the-betoota-advocate/#respond Sat, 25 Sep 2021 09:57:52 +0000 https://kepplah.com/the-oat-milk-ad-on-the-grand-finale-airs-a-fair-indication-that-the-demons-of-melbourne-are-playing-the-betoota-advocate/

WENDELL HUSSEY | Cadet | CONTACT

While most people in the South, West and North Central regions are already aware, there was official confirmation tonight that the Melbourne Demons are playing in the AFL Grand Final.

The check comes after viewers were assaulted by an oat milk commercial, reminding sports fans that the downtown Dees are playing in tonight’s game.

They would face the Western Bulldogs at the culmination of the 2021 season, in what is a quintessential battle between toffs and tradies.

The distinction between the underdogs Suburban Dogs and the upper class Tesla fans driving Dees was perfectly illustrated by the aforementioned advertisement.

“Sure, they’ve got an Oatly ad in the middle of a big final on Saturday night,” laughed a neutral Victorian football fan living in our Desert County today.

“Surprised that there is also no announcement for the 2022 season at Mt Buller,” he said with a laugh.

“Just quietly, as a lactose intolerant man myself, I’m actually a bit of a fan of this stuff, but I’m not going to miss an opportunity to give these Dees fans shit.”

“Up the dogs,” he said before walking away to order himself another odd-sized beer the Victorians drink.

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Man working at Vermont ski resort dies after zipline accident – NECN https://kepplah.com/man-working-at-vermont-ski-resort-dies-after-zipline-accident-necn/ https://kepplah.com/man-working-at-vermont-ski-resort-dies-after-zipline-accident-necn/#respond Fri, 24 Sep 2021 22:57:18 +0000 https://kepplah.com/man-working-at-vermont-ski-resort-dies-after-zipline-accident-necn/

Stowe Police and the Vermont Occupational Safety and Health Administration were investigating the death of a man who collided with an anchor platform on a zipline at Stowe Mountain Resort on Friday, officials said.

Stowe emergency services were called to the resort at around 3:15 p.m. Thursday after receiving a report of a man injured while ziplining.

The victim, Scott Lewis, of Stowe, collided with the platform holding the line, police said. Lewis, who was working for the complex when he died, could not be resuscitated, police said.

Stowe Police said preliminary indications were that mechanical failure could be a factor, but said Friday it was too early to tell what happened.

“We’re working on it,” Stowe Police Detective Fred Whitcomb said.

Stowe Mountain Resort, which is owned by Vail Resorts, said in a statement that resort officials were working with authorities to determine what had happened.

“Stowe Resort and the entire Vail Resorts family extend their deepest sympathy and support to the family and friends of this employee,” the statement said. “We’re also making sure our team members get the care and support they need during this time. “

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Nagaland’s ‘Sweet Cucumber’ Obtains Geographical Indication Label https://kepplah.com/nagalands-sweet-cucumber-obtains-geographical-indication-label/ https://kepplah.com/nagalands-sweet-cucumber-obtains-geographical-indication-label/#respond Fri, 24 Sep 2021 11:42:39 +0000 https://kepplah.com/nagalands-sweet-cucumber-obtains-geographical-indication-label/ KOHIMA:

Nagaland ‘sweet cucumber’ has been given a Geographical Identification (GI) label as an agricultural product under the provisions of the Geographical Indications of Goods (Registration and Protection) Act 1999.

The naga cucumber is known for its sweetness and unique green color. It is rich in potassium and low in calories. The cucumber isn’t the first product from the small state to receive a much-vaunted GI label. The regional variants of the tree tomato (tamarillo) and the famous royal Naga pepper are also labeled IG.

Cucumber is one of the most important crops in the Northeast region. Nagaland has the fifth highest crop of this fruit in terms of area and ranks third in terms of production.

The GI label is an important sign used on products with a specific geographic origin and reputation and denotes the authenticity not only of the product, but also of the method in which it was produced. This means that the identity of the labeled product is limited to strict guidelines. In the case of King Naga Pepper or Sweet Naga Cucumber, no other cultivar can produce these products if they are not grown in Nagaland under stipulated quality conditions.

The GI label aims to protect the truly unique traditions of communities from appropriation by large industries, and thus enable these regions to prosper economically by manufacturing, producing and marketing their traditional knowledge.

TNT-The Northeast Today is now on WhatsApp: CLICK HERE to receive more updates on your phone

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SELLAS Life Sciences announces derivative settlement https://kepplah.com/sellas-life-sciences-announces-derivative-settlement/ https://kepplah.com/sellas-life-sciences-announces-derivative-settlement/#respond Thu, 23 Sep 2021 20:05:00 +0000 https://kepplah.com/sellas-life-sciences-announces-derivative-settlement/

NEW YORK, September 23, 2021 (GLOBE NEWSWIRE) – SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), an advanced-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a wide range of indications, today announced that on September 10, 2021, the United States District Court for the District of New Jersey (the “court”) issued an order (the “preliminary order” ) providing for the preliminary approval of the proposed settlement of the claims relating to the Company’s predecessor, Galena Biopharma, Inc., and derivative asserted on behalf of the Company against the individual defendants named in the previously disclosed shareholder derivative actions (i) Keller v. Ashton, et al, Civil Action n ° 2: 17-cv-1777 (DNJ); and (ii) Johnson v. Schwartz, et al, Civil Action No. 2: 18-cv-00903 (DNJ) pending before the Court in accordance with the Settlement Stipulation, dated June 15, 2021 (the “Stipulation”). The Stipulation also resolves all claims made in another derivative action arising from the same facts, Jacobs v. Schwartz, et al, Case No. CIVMSC17-01222, (Calif. Sup. Ct., Contra Costa). The Stipulation requests the Company to adopt certain policies relating to the potential future commercialization of the Company’s clinical candidates and the Company’s insurer to pay the plaintiff’s counsel up to $ 270,000 in legal fees and reimbursement. spending. The preliminary order set a final settlement approval hearing for November 19, 2021.

As required by the Preliminary Order, the Clause and the Notice of Proposed Settlement (the “Notice”) have been posted in the Investor Relations section of our website and can be viewed at https: / /www.sellaslifesciences.com/investors/ Investor-resources / defaulat.aspx # section = derivative-litigation.

About SELLAS Life Sciences Group, Inc.
SELLAS is an advanced clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a wide range of indications. SELLAS ‘lead product candidate, GPS, is licensed by Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is found in a variety of tumor types. GPS has potential both as monotherapy and in combination to treat a wide range of hematologic malignancies and solid tumor indications. SELLAS ‘second product candidate, nelipepimut-S (NPS), is a cancer immunotherapy directed against HER2 that can treat patients with early-stage breast cancer with low to intermediate HER2 expression, also known as the name of HER2 1+ or 2+, which includes TNBC Patients, depending on the standard of care.

For more information on SELLAS, please visit www.sellaslifesciences.com.

Forward-looking statements
This press release contains forward-looking statements. All statements other than statements of historical fact are “forward-looking statements”, including those relating to future events. In some cases, forward-looking statements may be identified by words such as “plan”, “expect”, “anticipate”, “could”, “could”, “will”, “should”, “plan”, ” believe, “” estimate “,” predict “,” potential “,” intend “or” continue “and other words or terms with similar meaning. These statements include, but are not limited to, statements relating to the settlement of certain disputes. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and timing of events could differ materially from those anticipated in these forward-looking statements due to these risks and uncertainties, which include, without limitation, the risks and uncertainties associated with the COVID-19 pandemic, and ” other risks and uncertainties affecting SELLAS and its development programs, as discussed under “Risk Factors” in SELLAS ‘Annual Report on Form 10-K filed on March 23, 2021 and in its other documents filed with the SEC . Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS ‘forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Forward-looking statements herein are made only as of the date hereof. SELLAS assumes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date on which the forward-looking statements have been done.

Investor contacts
Valter Pinto / Allison Soss
KCSA strategic communication
E-mail: SELLAS@kcsa.com
Telephone: 914.907.2675 / 215.272.2707

Media contacts
Caitlin Kasunich / Raquel Cona
KCSA strategic communication
E-mail: SELLAS@kcsa.com
Telephone: 212.896.1241 / 212.896.1276

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Wednesday September 22 (The Scenestar) https://kepplah.com/wednesday-september-22-the-scenestar/ https://kepplah.com/wednesday-september-22-the-scenestar/#respond Wed, 22 Sep 2021 23:46:40 +0000 https://kepplah.com/wednesday-september-22-the-scenestar/


TO BUY TICKETS: John Legend with War and the Treaty at the Greek Theater

The midweek point is here, Scenestar readers. It’s not exactly the weekend, but don’t let that stop you from enjoying the sounds of our Show of the Night selection: John legend! Her Bigger Love 2021 tour ends tonight at Greek theater, or John legend will be joined by the opener The war and the treaty.

If you can’t take part in our show of the night, your other music options include performances by A giant dog, Iggy Azalea, Grand Delta Black, Patrick droney, Durand Jones and directions, Shredded Baptist Club, Lily kershaw, My Laferté, The Luminous, Migos, Owen, Paraeven, Pit bull, Regrets, Syd (of Strange future), Reggie Watts, and much more. Click here for ticket links and information on all of today’s shows as well as upcoming local shows on our concert calendar. For any other updates, also be sure to follow us on Twitter for all breaking news and set times (posted daily in the comments section) if available for certain shows!

NIGHT SHOWS

John Legend with the war and the treaty @ The Greek Theater

Durand Jones and indications with 79.5 @ Hollywood Palladium

Syd (from Odd Future) with the Los Angeles Philharmonic @ The Ford (FREE with RSVP)

Big Black Delta with Band Aparte and DeadxLife @ Teragram Ballroom

Paraleven with Lauren Mia, Jackson Englund and Alex Angard @ The echo

Jagged Baptist Club with marzipan and your favorite color @ Silverlake Lounge (FREE with RSVP)

A giant dog with Reckling & The Haunts @ Highland Park Ebell

Owen with Sonoda @ The Moroccan Salon

Patrick Droney with Lily Kershaw @ The Troubadour

Olivia Kaplan with Madeline Kenney and Teira Church @ Zebulon

Pitbull with Iggy Azalea @ YouTube Theater

Clinic with Luke Andy @ Station1640

A conversation with Migos @ The Grammy museum

Team Coco with Bill Burr, Jena Friedman, Tom Papa and Maggie Maye @ Largo at Coronet

Inside a Typewriter with Reggie Watts @ Dynasty typewriter at Hayworth

Chuck Johnson’s jazz fusion @ Catalina Bar & Grill

Comedy Madness with Kevin Devila, Zach Weiss, Louie G, Andre Shannon, Josh Lewis, Ty Kwon, Shameka Lovvet, Adam Damper, Zavior Phillips, Clayton Horowitz, Reggie B @ The Hotel Cafe – Main stage (10 p.m.)

Cynthia Levin and her friends @ The Hotel Cafe – Second stop (9:00 p.m.)

Free the archers with the Aether Realm and the Seven Realms @ 1720

Screenplay with Koran Shaheed, G Frequent and Daddy Kev @ The love song (FREE with RSVP)

Armen Paul with Carley Carpenter, Carson Shmyr and Greg Duffy @ Mint

Hippie Death Cult with Void Vator and Lords of Dust @ DTLA resident

Breaking Sound LA with. Moon Cougar, The Strayngers and The Things @ Kiss Kiss Bang Bang

Breaking Sound LA with About You, Yooforea and Austin P. McKenzie @ Only adults

Rod Stewart Live! @ Roadhouse of the permanent archives

Jamael Dean and the Afronauts @ Gold diggers

Belle, Book & Candle: Mabon – Occult Burlesque w / DJ Nuit Noir @ El Cid (7:00 p.m.)

Integrated security @ El Cid (10 p.m.)

Strange hotels @ Harvelle’s Santa Monica

Red Rock Engine with Wicked Man Xperiance, Thing Of Twins, In The Stars, Fallen Fury, I, Hat Pin Panic and Sean Mullin @ Le Whiskey A Go Go

Monkey Mindz with Doc Gunn, Over Yonder and Eighth House @ Bar Redwood

Field day @ Sardines

Brain Party Trubute @ Alex’s Bar (FREE with RSVP – 7:00 p.m.)

DJ Babykait @ Alex’s Bar (FREE with RSVP – 9:00 p.m.)

BLXST @ The Observatory

RØBBER with Big Rig, Carsex and Vanillaroma dollhouse @ The traveler

Country evening @ The Canyon Club – Agoura Hills

My Laferté @ Ventura Theater

The Luminous @ Bowl of Santa Barbara

The Regrets with Pancho and The Wizards @ SOhO Restaurant & Music Club

Father John Misty with the Los Angeles Philharmonic @ The Ford (CANCELED)

Ghost Country Observatory @ The Regent (CANCELED)

Yemi Alade @ Fonda Theater (CANCELED)

Always Woozy with LoveLeo @ Le Novo (RETURNED)

Eckhart Tolle @ Shrine Expo Hall (RETURNED)

Chris Isaak @ Fred Kavli Theater (RETURNED)

BLXST @ Constellation Room (RELOCATED)

* Scenestar favorites in BOLD

For a list of upcoming shows with links in and around Los Angeles, please visit our online concert calendar here.


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Enlivex doses the first patient in phase IIb placebo-controlled https://kepplah.com/enlivex-doses-the-first-patient-in-phase-iib-placebo-controlled/ https://kepplah.com/enlivex-doses-the-first-patient-in-phase-iib-placebo-controlled/#respond Wed, 22 Sep 2021 10:00:00 +0000 https://kepplah.com/enlivex-doses-the-first-patient-in-phase-iib-placebo-controlled/

The first data from the multicenter randomized trial is expected in the second quarter of 2022

Nes-Ziona, Israel, September 22, 2021 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced the launch of the dosage in its multicenter, Phase IIb, placebo-controlled, randomized, blinded clinical trial evaluating AllocetraMT in severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS).

The phase IIb trial is expected to enroll up to 152 severe or critical COVID-19 patients (76 AllocetraMT plus standard of care, 76 placebo plus standard of care) in clinical centers in Israel and some European countries, and is designed to evaluate the safety and efficacy of AllocetraMT when given in addition to standard therapy. The primary endpoints of the trial are survival and recovery without ventilation for each of its two patient subpopulations (severe and critical). In addition, the trial will assess several secondary endpoints, including the assessment of long-term COVID-19 symptoms. The first data from the trial is expected in the second quarter of 2022.

“We believe the recent outbreaks induced by variant COVID-19 cases around the world have underscored the need for new treatments that can treat the more severe forms of the disease,” said Dr Oren Hershkovitz, CEO of Enlivex . “They also reinforce our belief that even with the vaccines available, COVID-19 will go from pandemic to endemic, with multiple variants continuing to circulate in the population. Through the continued development of Allocetra, we hope to provide physicians with an effective treatment option that can improve survival and reduce the length of hospital stay for critically or critically ill patients. The initiation of the assay in our Phase IIb trial represents an important step towards this goal. The study has already been approved by several ethics boards from major Israeli hospitals, and we are committed to speeding up patient recruitment by opening multiple sites both in Israel and in some EU countries as quickly as possible. “.

Professor Dror Mevorach, Scientific Director of Enlivex, added: “We believe that AllocetraMT has a widely applicable mechanism of action for reprogramming macrophages and this has been demonstrated by promising results from previous clinical trials in severe and critical COVID-19 patients. We aim to build on this data as this placebo-controlled Phase IIb study progresses and look forward to its continued advancement. “

Enlivex previously reported the first positive results from investigator-initiated Phase Ib and Phase II clinical trials of AllocetraMT in COVID-19 patients in severe and critical condition. Aggregated data from the two trials demonstrated that AllocetraMT was safe and well tolerated. In addition, at the end of the 28-day follow-up periods for these trials, a 0% (0/21) mortality rate was observed and 90.5% (19/21) of patients recovered from their condition. severe / critical respective and got their leave. from hospital after an average of 5.6 days after AllocetraMT administration.

ABOUT ALLOCETRAMT

AllocetraMT is developed as a universal, ready-to-use cell therapy designed to reprogram macrophages to their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many more reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring homeostasis of macrophages, AllocetraMT has the potential to provide a novel mechanism of immunotherapeutic action for potentially life-threatening clinical indications that are defined as “unmet medical need”, as stand-alone therapy or in combination with leading therapeutic agents.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing AllocetraMT, a universal, ready-to-use cell therapy designed to reprogram macrophages to their homeostatic state. Resetting non-homeostatic macrophages to their homeostatic state is essential for rebalancing the immune system and resolving life-threatening conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects”, “plans”, “projects”, “will”, “may”, “anticipate” “,” Believes “,” “should”, “would”, “could”, “intends”, “believes”, “suggests”, “has the potential to” and other words with similar meanings , including statements regarding expected cash balances, market opportunities for the results of clinical studies and preclinical experiences, efficacy, expected timing of clinical trial results and market opportunities for ALLOCETRAMT programs, as well as potential changes in the level of severity of the COVID-19 pandemic (including due to new variants of the virus) and the effect of these changes on the rate of patient recruitment into clinical trials, manufacturing delays and changes in market opportunities. All such forward-looking statements are made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which could affect the business and prospects of Enlivex, including the risks that Enlivex may not be successful in generating revenue or developing commercial products; that the products in development may fail, not achieve the expected results or efficacy and / or not generate data that would support the approval or commercialization of these products for the indications under study or for other indications ; that ongoing studies may be delayed and / or may not continue to show substantial or any activity; and other risks and uncertainties that could cause results to differ materially from those stated in forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early stage trials may differ significantly from the results of more developed and later stage trials. The development of any product using ALLOCETRAMT The product line could also be affected by a number of other factors including unexpected safety, efficacy or manufacturing issues, additional lead times for data analysis and decision making, impact of regulation of the pharmaceutical industry, the impact of competitive products and prices, and the impact of patents and other property rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider economic, competitive, government, technological and other factors discussed in documents filed by Enlivex with the Securities and Exchange Commission, including in the most recent annual report. recent from the Company on form 20-F filed with the Commission de Sécurité et d’Echanges. The forward-looking statements contained in this press release speak only as of the date on which they were made, and we assume no obligation to update any forward-looking statements, except as required by applicable law.

CONTACT ENLIVEX
Shachar Shlosberger, Chief Financial Officer
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com

CONTACT INVESTOR RELATIONS
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com

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circuit overturns judgment and reinstates jury verdict for provoked offense | Jones Day https://kepplah.com/circuit-overturns-judgment-and-reinstates-jury-verdict-for-provoked-offense-jones-day/ https://kepplah.com/circuit-overturns-judgment-and-reinstates-jury-verdict-for-provoked-offense-jones-day/#respond Tue, 21 Sep 2021 23:16:57 +0000 https://kepplah.com/circuit-overturns-judgment-and-reinstates-jury-verdict-for-provoked-offense-jones-day/

In short

The situation: The Hatch-Waxman Act allows manufacturers of generic drugs to omit from their labeling approved indications that are covered by the innovator’s patents. Although these “thin labels” can be used to support a non-infringement defense, in particular GlaxoSmithKline v. Teva Pharmaceuticals, the Federal Circuit examined whether the generic version of Teva from GSK’s COREG® induced infringement although Teva omitted from its label the indication for the treatment of heart failure, which was claimed in a GSK patent.

The result: On August 5, 2021, the United States Court of Appeals for the Federal Circuit ruled that substantial evidence supported the conclusion that Teva had induced an infringement of GSK’s patent even during the period when Teva was using a “thin label” or an exclusion from section viii, which omitted the indication of heart failure. The Federal Circuit ruled that Teva’s conduct in marketing and advertising the generic drug was sufficient to establish an incentive despite the meager label.

Look ahead: Although this decision is unlikely to have an impact on the analysis of “thin labels” in a pre-market context, once a generic drug is launched, innovative companies should pay attention to how whose generic advertises and markets the product, because this evidence, including any statements regarding therapeutic equivalence with the innovator product – may be sufficient to establish the induced infringement even with an exclusion from section viii

Background

On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was responsible for causing the infringement of GSK’s patent. This decision set aside the grant of the judgment as a question of law (“JMOL”) that had been rendered by the trial court and restored the jury’s verdict for GSK.

The case involved so-called “thin labels,” also known as Section viii waivers – a reference to the provision in the Hatch-Waxman Act that allows a generic manufacturer to change the label of its products. products compared to that of the listed reference drug. in order to exclude one or more indications patented by the innovator. In this case, Teva sought and obtained FDA approval for a generic version of GSK’s COREG.® product but has withdrawn from its label the approved indication for the treatment of heart failure, in order to avoid a GSK patent claiming this use.

Years after launching the product with the “skinny” label, the FDA ordered Teva to add the heart failure indication to its label. GSK sued for patent infringement, claiming that Teva was responsible for instigating infringement of its patent even during the period when Teva’s label omitted the indication of heart failure. GSK argued that Teva’s label was ambiguous and that Teva’s conduct in the actual marketing and advertising of its generic drug was sufficient to establish inducement under 35 USC § 271 (b).

The jury agreed with GSK, but the trial judge allowed Teva’s motion in favor of JMOL, finding in law that Teva could not have induced an infringement because it had expressly relied on of the exclusion procedure of Article viii and had removed the patented indication from its label. GSK appealed, and in October 2020, the Federal Circuit overturned and restored the jury’s verdict, based largely on promotional material from Teva, which advertised its credits as being therapeutically equivalent to GSK’s COREG.®.

In February 2021, the panel allowed Teva’s request for a rehearing, quashed its opinion, and scheduled a new oral argument to fight counterfeiting during the lean label period.

Opinion of 5 August 2021

In a 2-1 opinion, the panel again concluded that “the close and case-specific examination of the substantial evidence” supported the jury’s verdict of Teva-induced infringement.

Similar to its October 2020 opinion, the panel determined that Teva’s marketing and promotional material presented evidence of intent to induce infringement, even during the period when its label did not include the indication. heart failure. He found that Teva could have advertised its drug as a cardiovascular agent, leaving doctors to question its indications, but instead took affirmative action via press releases to market its generic as a ‘”AB-rated equivalent” of COREG®. This, according to the panel, was “Teva in a press release telling the world its credits are a substitute for GSK’s COREG.”®“for all approved indications, regardless of what Teva’s narrower label said, and it was reasonable for the jury to conclude as much.

Unlike the October 2020 notice, however, the second panel ruling also included a discussion of the remaining (i.e. not deleted) indications in Teva’s label. While Teva created the patented indication for “treatment of heart failure”, it did not create the indication for the treatment of post-myocardial infarction left ventricular dysfunction (“post-MI LVD”) . The GSK expert testified that the treatment of post-MI LVD patients overlapped with the treatment of heart failure patients, meaning that the exclusion of Teva was not a “skinny label” but rather a “label. partial “.

The court ruled in favor of GSK. He said Teva did not take issue with GSK’s expert testimony, and even Teva’s own expert admitted that there was some overlap. The court also clarified that infringement through overlapping indications was a question of fact for the jury, not a legal issue for the district court to consider. de novo.

to summarize

This case highlights the unsettled and contentious nature of counterfeiting in the context of skinny labels. The ruling states that using a skinny label is not a non-infringement argument, at least after the product is launched; courts can examine all evidence, including the label, expert testimony, and marketing and promotional material to assess infringement. This was a post-market case, so questions remain as to how it will be applied to “standard” Hatch-Waxman cases where counterfeit issues are addressed prior to FDA approval and launch. of a generic.

Three key points to remember

  1. Using the Hatch-Waxman section viii exclusion procedure alone may not be sufficient to avoid a finding of infringement, at least in the post-market context.
  2. The indications on the label of a generic combined with marketing materials and press releases promoting the generic drug as the AB equivalent of the brand may be sufficient to demonstrate infringement.
  3. The court’s decision to rescind its October 2020 opinion and reissue a new opinion reaching the same conclusion suggests an attempt to narrow its hold to the unique facts of this case.
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Global CBD Companion Animal Market Report 2021-2028 – Focus on CBD Products for General Health, Wellbeing, Anxiety & Stress – ResearchAndMarkets.com https://kepplah.com/global-cbd-companion-animal-market-report-2021-2028-focus-on-cbd-products-for-general-health-wellbeing-anxiety-stress-researchandmarkets-com/ https://kepplah.com/global-cbd-companion-animal-market-report-2021-2028-focus-on-cbd-products-for-general-health-wellbeing-anxiety-stress-researchandmarkets-com/#respond Tue, 21 Sep 2021 12:46:00 +0000 https://kepplah.com/global-cbd-companion-animal-market-report-2021-2028-focus-on-cbd-products-for-general-health-wellbeing-anxiety-stress-researchandmarkets-com/

DUBLIN – (COMMERCIAL THREAD)–The “Global CBD Pets Market Size, Share and Trend Analysis Report 2021-2028” report was added to ResearchAndMarkets.com offer.

The global pet CBD market size is expected to reach USD 4.79 billion by 2028. It is expected to grow at a CAGR of 58.9% from 2021 to 2028.

Rising healthcare spending and growing health concerns among pet owners are driving the market. In addition, the growing demand for cannabidiol (CBD) infused food products is driving the growth of the market.

For example, in 2019 Purina, owned by Nestlé, a pet food company, announced its decision to invest in the production of CBD-infused dog food. In addition, the increased use of natural supplements in the treatment of various lifestyle disorders in pets is fueling growth.

During the COVID-19 outbreak, the pet industry faced manufacturing challenges, including altered consumption patterns, improved demand, worker protection protocols, a shortage of employees, and one-off packaging shortages, which affected the company’s activities in the first months of 2020.

However, sales growth figures driven by consumer demand and increased spending on pets allowed the industry to make a strong comeback at the end of 2020. The Pet Brand of Paw CBD company, cbdMD, Inc. March 2020 quarter sales of approximately $ 750,000 to approximately $ 1,229,000 for the June 2020 quarter.

The cannabidiol infused product is also found to be useful in cancer pain in animals. The increasing adoption of pets and increasing their healthcare spending are further expected to place the market on accelerated growth platforms over the next few years. For example, according to the 2019-2020 National Pet Owner Survey conducted by the American Pet Products Association (APPA), approximately 67.0% of U.S. households own a pet that constitutes 85.0 million of families in the country.

The major players are focusing on product innovation strategies due to the high awareness among pet owners and the shift in preference towards natural supplements for pets. Major market players are engaged in various strategies, such as new product development and mergers and acquisitions, for better market penetration.

In May 2020, Puration, Inc. announced its intention to complete the purchase of a CBD infused sunscreen business. PURA targets acquisitions of CBD products that can be enhanced with PURA’s patented technology, thereby strengthening its position in the market.

Highlights of the CBD Pets Market Report

  • Increased Use Of Cannabidiol Infused Products And Growing Lifestyle Disorders In Pets Are Driving Market Growth

  • In the animal-like segment, the vitamin and supplement segment dominated the market in 2020 due to the increased availability and consumption of the products. Additionally, the growing popularity of supplements in humans as well as in pets is driving demand.

  • As a rough guide, general health / wellness dominated the market in 2020. The growth can be attributed to increasing spending on pet health care and growing health concerns for pet owners.

  • The Anxiety / Stress Indications segment is expected to experience the fastest growth during the forecast period due to the increasing application of cannabidiol in anxiety-related disorders in companion animals.

  • Based on end-use, e-commerce held the largest share of revenue in 2020 due to product availability and ease of ordering

Main topics covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary

Chapter 3 Variables, Trends and Scope of the CBD Pets Market

3.1 Market Lineage Outlook

3.1.1 Parents’ Market Outlook

3.1.2 Related / Auxiliary Market Outlook

3.2 Mapping of penetration and growth prospects

3.3 Market dynamics

3.4 CBD Pet: Market Analysis Tools

3.5 Regulatory framework

3.6 Product pipeline analysis

3.7 Impact of Covid-19 on the companion animal market

Chapter 4 CBD Pets Market: Competitive Analysis

4.1 Categorization of market participation

4.2 Competitive Outlook of the CBD Pet Market

4.3 Public enterprises

4.4 Private companies

Chapter 5 CBD Pets Market: Segment Analysis, by Animal Type, 2016-2028 (USD Million)

5.1 Definition and scope

5.2 Animal Types Market Share Analysis, 2020 and 2028

5.3 Global CBD Pets Market, by Animal Type, 2016 to 2028

5.4 Market size and forecast and trend analysis, 2016 to 2028

5.4.1 Dog

5.4.1.1 Dog, 2016 – 2028 (USD million)

5.4.1.2 Food / Treats

5.4.1.2.1. Food / Treats, 2016 – 2028 (USD million)

5.4.1.3 Vitamins and Supplements

5.4.2 Chat

5.4.2.1 Cat, 2016 – 2028 (million USD)

5.4.2.2 Food / Treats

5.4.2.2.1 Food / Treats, 2016 – 2028 (USD million)

5.4.2.3 Vitamins and Supplements

Chapter 6 CBD Pets Market: Segment Analysis, by Indication, 2016-2028 (USD Million)

6.1 Definition and scope

6.2 Indications Market Share Analysis, 2020 and 2028

6.3 Global CBD Pets Market, by Indication, 2016 to 2028

6.4 Market size and forecast and trend analyzes, 2016 to 2028

6.4.1 Joint pain

6.4.2 Anxiety / Stress

6.4.3 Epilepsy

6.4.4 General health / well-being

Chapter 7 CBD Pets Market: Segment Analysis, End Use, 2016-2028 (USD Million)

7.1 Definition and scope

7.2 End Use Types Market Share Analysis, 2020 and 2028

7.3 Global CBD Pets Market, End Use, 2016-2028

7.4 Market size and forecast and trend analysis, 2016 to 2028

7.4.1 Specialty pet stores

7.4.2 Electronic commerce

7.4.3 CBD store

Chapter 8 CBD Pets Market: Regional Market Analysis, by Animal Type, Indication and End Use, 2016-2028 (USD Million)

8.1 Definition and scope

8.2 Regional market overview

8.3 Market Size and Forecast, Volume and Trend Analysis, 2016 to 2028

Chapter 9 CBD Pets Market: Company Profiles

  • Honest paws

  • Canna-Pet

  • Fomo bone

  • Pet relief

  • HolistaAnimals

  • Joy Organic

  • Wet nose

  • CBD Live

  • Pets

  • Petco

  • Charlotte’s canvas

For more information on this report, visit https://www.researchandmarkets.com/r/bz0soy

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]]> https://kepplah.com/global-cbd-companion-animal-market-report-2021-2028-focus-on-cbd-products-for-general-health-wellbeing-anxiety-stress-researchandmarkets-com/feed/ 0 US strike kills al-Qaida leader in Syria, “no indication” of civilian casualties (CENTCOM) https://kepplah.com/us-strike-kills-al-qaida-leader-in-syria-no-indication-of-civilian-casualties-centcom/ https://kepplah.com/us-strike-kills-al-qaida-leader-in-syria-no-indication-of-civilian-casualties-centcom/#respond Mon, 20 Sep 2021 21:03:30 +0000 https://kepplah.com/us-strike-kills-al-qaida-leader-in-syria-no-indication-of-civilian-casualties-centcom/

US forces carried out a strike against a “top al-Qaeda leader” in Syria today, a spokesperson for the US central command said.

“The first indications are that we have hit the individual we were targeting, and there is no indication of civilian casualties as a result of the strike,” said Navy Lt. Josie Lynne Lenny, spokesperson for the CENTCOM

Lenny declined to comment on the name of the top al-Qaida leader or the method of the strike.

Rescue workers and a war monitor described it as a drone strike that hit a vehicle traveling on a rural road in rebel-controlled northwest Syria, killing at least one person.

The Civil Defense team, known as the White Helmets, said the unidentified body was removed from the car along the Idlib-Binnish road in eastern Idlib province.

The totally charred vehicle, split in the middle, lay by the side of the rural road in an orchid.

Britain-based Syrian Observatory for Human Rights said the US-led coalition was behind the strike on the vehicle, which was carrying an activist from one of the groups. radicals operating in the province. The Observatory did not identify the group but said it was linked to al-Qaida.

The United States has previously carried out attacks in Idlib, targeting al-Qaida militants and ISIS group leader Abu Bakr al-Baghdadi, who was in hiding in the province after fleeing eastern Syria.

Large parts of Idlib and the neighboring provinces of Aleppo remain in the hands of the Syrian armed opposition, dominated by radical groups, including Hayat Tahrir al-Sham, once linked to al-Qaeda. There are also more than 4 million civilians living in the region, most of them displaced by previous episodes of violence in the Syrian conflict which has lasted 10 years. The Syrian government has pledged to reestablish control of all territories beyond its control, but a ceasefire negotiated last year in Idlib has been tenaciously held.

The strike came hours before Pentagon spokesman John Kirby told reporters that an Air Force general officer would investigate the wandering August 29 drone strike in Afghanistan that killed 10 people, including seven children. This strike mistakenly targeted an Afghan aid worker believed to be a member of ISIS-K.

Defense Secretary Lloyd Austin has tasked the Air Force with appointing a general to conduct a review of the investigation into the Aug. 29 Hellfire missile strike in Kabul that allegedly killed 10 people, Kirby told the journalists Monday.

In a note dated Friday, he said, Austin asked Secretary of the Air Force Frank Kendall to pick a three-star or higher to investigate what was wrong, how the targeting of the strikes might be changed in the future and whether anyone involved in the assignment should be disciplined. .

Family accounts, documents from colleagues seen by the Associated Press, and the scene at the family home – where Zemerai Ahmadi’s car was hit by a Hellfire missile just as he pulled into the driveway – all painted a picture of a family who had worked for the Americans and were trying to get visas for the United States, fearing for their lives under the Taliban.

Howard Altman is an award-winning editor and journalist who was previously a military reporter for the Tampa Bay Times and before that for the Tampa Tribune, where he covered USCENTCOM, USSOCOM, and SOF at large among many other topics. .

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Aadi Bioscience appoints Brendan Delaney as COO https://kepplah.com/aadi-bioscience-appoints-brendan-delaney-as-coo/ https://kepplah.com/aadi-bioscience-appoints-brendan-delaney-as-coo/#respond Mon, 20 Sep 2021 12:57:03 +0000 https://kepplah.com/aadi-bioscience-appoints-brendan-delaney-as-coo/

LOS ANGELES, September 20, 2021 (GLOBE NEWSWIRE) – Aadi Bioscience, Inc (“Aadi”) (Nasdaq: AADI), a clinical-stage biopharmaceutical company specializing in precision therapies for genetically defined cancers with alterations in genes of the mTOR path, today announced the appointment of Brendan Delaney as Chief Operating Officer (COO). Brendan has had a well-established career in oncology-focused business leadership roles, launching several revolutionary new products and building effective and cohesive business teams. Most recently, Brendan was Commercial Director of Constellation Pharmaceuticals, which was acquired by MorphoSys AG for $ 1.4 billion prior to the commercial launch of pelabresib, a first-in-class BETi inhibitor with blockbuster potential in several hematologic indications. Previously, as Commercial Director at Immunomedics, Inc. Brendan led the launch of TRODELVY®, the first antibody-drug conjugate directed by TROP-2 for the treatment of triple negative breast cancer that was acquired by Gilead Sciences, Inc. for $ 21 billion.

“Brendan and I worked closely together when I was Executive Chairman of Immunomedics to bring TRODELVY to market, and I am delighted to have Brendan back in his new role as Aadi becomes a fully integrated biopharmaceutical company,” said Behzad Aghazadeh , Ph.D., Managing Partner and Portfolio Manager, Avoro Capital and Member of the Board of Directors of Aadi. “Brendan has an exceptional track record in bringing orphan oncology drugs to market, leading sales teams at three major oncology companies that have now been acquired. As well as being an invaluable addition to society at this time, Brendan will also establish Aadi’s presence on the East Coast as he is based in the Tri-State region.

“We are delighted that Brendan has accepted the role of COO. His business expertise will be essential as we prepare to launch ABI-009 for the malignant PEComa and expand our attention to the broader applications of this exciting product, ”said Neil Desai, CEO of Aadi. “In his role as COO, we will be able to leverage his extensive leadership experience to strengthen various functions in this important phase of business growth. “

Mr. Delaney began his career at Bristol-Myers, Genentech and Chiron in roles of increasing responsibility in oncology marketing and strategy, and led global branding, strategy and franchises in the division of Novartis oncology for successful brands. At Immunomedics, Mr. Delaney led the establishment of the marketing, sales, market access and business operations teams related to TRODELVY. Prior to his role as Commercial Director at Constellation and Immunomedics, Mr. Delaney was Vice President, US Commercial Hematology Oncology at Celgene Corporation, prior to its acquisition by Bristol-Myers Squibb in 2019.

Mr Delaney commented, “I am delighted to join Aadi at this pivotal time ahead of the Prescription Drug User Fee Act (PDUFA) target date of November 26, 2021 from its experimental candidate, ABI-009 for PEComa. I look forward to leveraging my marketing expertise to bring this promising research candidate to market and maximize the utility of the to catch-sirolimus technology platform in tumor agnostic indications – such as in patients with solid tumors TSC1 Where TSC2 inactivating changes, for which we plan to launch a trial registration by the end of the year. “

Mr. Delaney holds an MBA from the Stern School of Business at New York University and a BA in Biology from Rutgers University.

About Aadi Bioscience and FYARRO ™

Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically defined cancers. Aadi’s main goal is to provide transformational therapies to cancer patients with alterations in the motor of the mTOR pathway such as alterations in TSC1 Where TSC2 genes, where other mTOR inhibitors do not or cannot be exploited effectively due to problems of pharmacology, efficient drug delivery, safety or efficient targeting to the disease site. Aadi’s flagship product candidate is FYARROMT (nanoparticles bound to sirolimus albumin for suspension for injection; to catch-sirolimus; ABI-009), a human albumin-bound mTOR inhibitor that has demonstrated significantly higher tumor accumulation, greater suppression of the mTOR target, and increased tumor growth inhibition compared to other mTOR inhibitors in preclinical models2.

Aadi’s Registration Trial on FYARRO in Advanced Malignant PEComa (the “AMPECT Trial”) Demonstrated Significant Clinical Efficacy in Malignant PEComa1, a type of cancer with the highest known rate of damage to TSC1 Where TSC2 Genoa. FYARRO has received Breakthrough Therapy, Fast-Track, and Orphan designations from the United States Food and Drug Administration (FDA). A Continuing Drug Application (NDA) was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi priority review status with a target action date under the Prescription Drug User Fee Act (“PDUFA”) of November 26. , 2021.

Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 Where TSC2 deactivation of alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registration trial in mTOR inhibitor-naive solid tumors harboring TSC1 Where TSC2 inactivation of the alterations by the end of 2021. Aadi also has ongoing studies to evaluate the dosage of FYARRO in combination treatment regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on Aadi’s website at www.aadibio.com.

Forward-looking statements

Aadi Bioscience, Inc. (“Aadi”, “The Company”) warns you that certain statements included in this press release that are not a description of historical fact are forward-looking statements. These statements are based on Aadi’s current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding clinical responses and safety profile, regulatory approval and marketing, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in these forward-looking statements due to these risks and uncertainties, which include, but are not limited to: risks related to Aadi’s ability to obtain, or the timing to obtain, the regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi’s ability to market successfully, including the timing of the commercial launch of FYARRO in the advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the initiation, recruitment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and may not necessarily predict final outcomes; the risk that one or more of the clinical outcomes may change significantly as patient recruitment continues, as a result of more comprehensive data reviews, and as more patient data becomes available; the risk that unwanted effects or unforeseen side effects may occur during the development and testing of FYARRO; risks associated with the inability to realize any value from FYARRO in light of the risks and difficulties inherent in successfully bringing product candidates to market; risks associated with Aadi’s estimates of future expenses, capital requirements and the need for additional financing; and the risks associated with the impact of the COVID-19 epidemic on Aadi’s operations, the biotech industry and the economy in general.

Additional risks and uncertainties that could cause actual results to differ materially from those contemplated by forward-looking statements are included under “Risk Factors” and elsewhere in Aadi’s reports and other documents that Aadi has. filed or will file with the SEC from time to time and available at www.sec.gov.

All forward-looking statements contained in this press release are only current as of the date hereof and, except as required by applicable law, Aadi assumes no obligation to revise or update any forward-looking statements, or to make any other forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This warning is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

FYARRO ™ is a trademark of Aadi Bioscience, Inc.

The references:

1 Summary of ASCO 2020: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

2 Summary of AACR 2019: https://cancerres.aacrjournals.org/content/79/13_Supplement/348

3 Summary of ASCO 2021: https://meetings.asco.org/abstracts-presentations/197602

Contacts

Investors:

Investors:
Irina Koffler
ikoffler@lifesciadvisors.com

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