Jakubowitz Law announces that securities fraud class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies who purchased shares within the class periods listed below. Shareholders interested in representing the class of wronged shareholders have until the lead plaintiff deadline to petition the court. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. For more details and to speak with our firm without cost or obligation, follow the links below
Meta Platforms, Inc. (NASDAQ:FB)
CONTACT JAKUBOWITZ ABOUT FB: https://claimyourloss.com/securities/meta-platforms-inc-loss-submission-form/?id=26486&from=1
Class Period: March 2, 2021 - February 2, 2022
The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) Apple's iOS privacy changes were having a material impact on Meta's ability to provide the kind of targeted advertising that its customers wanted and, as a result, customer ad spending was dropping precipitously; (2) Meta's mitigation efforts were either not properly implemented or ineffective; (3) measurement of ads was not accurate as mitigation efforts were failing; and (4) Meta did not have a plan in place to properly address the impact of the iOS privacy changes.
CONTACT JAKUBOWITZ ABOUT ABBV: https://claimyourloss.com/securities/abbvie-inc-loss-submission-form/?id=26486&from=1
Class Period: April 30, 2021 - August 31, 2021
The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) safety concerns about Pfizer Inc.'s drug Xeljanz extended to Abbvie's drug Rinvoq and to other Janus kinase enzyme inhibitor drugs; (2) as a result, it was likely that the U.S. Food and Drug Administration would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.
CONTACT JAKUBOWITZ ABOUT MYPS: https://claimyourloss.com/securities/playstudios-inc-loss-submission-form/?id=26486&from=1
This lawsuit is on behalf of a class consisting of all persons and entities other than defendants who: (a) purchased, or otherwise acquired securities of Playstudios between June 22, 2021 and March 1, 2022, both dates inclusive, including, but not limited to, those who purchased or acquired Playstudios securities pursuant to the offering of the private investment in public equity; (b) held common stock of Acies as of May 25, 2021, and were eligible to vote at Acies' June 16, 2021 special meeting who exchanged their shares of Acies stock for shares of Playstudios stock pursuant to the merger of Acies and Old Playstudios; and/or (c) purchased or otherwise acquired Playstudios common stock pursuant to or traceable to Acies' documents issued in connection with the June 2021 merger.
The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (i) Playstudios was having significant problems with its flagship game, Kingdom Boss; (ii) Playstudios would not be releasing Kingdom Boss as expected; and (iii) Playstudios had not revised its financial projections to account for the problems it had encountered with Kingdom Boss. As a result of defendants' wrongful conduct, Class members paid artificially inflated prices for their Playstudios securities and suffered substantial losses and damages.
Jakubowitz Law is vigorous in pursuit of justice for shareholders who have been the victim of securities fraud. Attorney advertising. Prior results do not guarantee similar outcomes.
JAKUBOWITZ LAW 1140 Avenue of the Americas 9th Floor New York, New York 10036 T: (212) 867-4490 F: (212) 537-5887
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Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.
"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."
"Allergan Aesthetics' global presence in the aesthetic space and goal to further enhance aesthetic medicine combined with Sirona's disruptive technology made this all possible," reports Dr. Linda Pullan, of Pullan Consulting.
Under the license agreement, Sirona will a receive an upfront payment and further payments on achievement of milestones and royalties on product sales and has also agreed to financial terms as a supplier of its compounds.
About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's current pipeline includes further cosmetic related products for cell preservation and repair, keloid therapy, scar therapy, anti-aging, anti-wrinkle, and cellulite treatment. In the pharmaceutical space, Sirona Biochem is working on a therapeutic for diabetic animals and new anti-viral therapies for humans. An extensive list of viable options for future programs applicable to the platform technology is maintained by Sirona's chemistry team in France to ensure continued growth of the company.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's scientific development unit, TFChem in France, is recipient of multiple scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
For more information regarding this press release, please contact:
Investor Enquiries: Jonathan Williams Managing Director Momentum PR Phone: 1.450.332.6939 Email: jwilliams@momentumpr.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: uncertainty and risks relating to the progress and timing of development and commercialization of products licensed to Allergan Aesthetics, the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its or licensed products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its or licensed products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia. “For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.” The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months. “Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively. In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%). About ZINBRYTA™ (daclizumab) ZINBRYTA (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. ZINBRYTA modulates IL-2 signaling without general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Biogen Safe Harbor This press release contains forward-looking statements, including statements about the anticipated timing of the EC’s decision on the marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA, if approved. These statements may be identified by words such as “believe,” “expect,” “may,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that the EC may fail to approve or may delay approval of ZINBRYTA or may not follow the recommendation of the CHMP, uncertainty of success in commercialization of ZINBRYTA For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel. According to Fierce Biotech:
Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung. Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars. The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion. Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.
Click here to read the full article on Fierce Biotech.
-- Report is aimed at helping practitioners and the industry understand and prepare for the future by supporting the evolving needs of patients --
-- Built on robust market research and analysis of global social listening data, industry research, academic studies, and Allergan Aesthetics* proprietary global research into thousands of consumer attitudes 1 --
-- Developed with specialist trend forecasting agency Wunderman Thompson Intelligence and validated by interviews with 13 leading aesthetics practitioners from around the world 1 --
- Allergan Aesthetics, an AbbVie company, and a global leader in medical aesthetics treatments, today launched 'The Future of Aesthetics' global trends report via a high-profile virtual event for media and industry. Commissioned by Allergan Aesthetics and independently developed by specialist trend forecasting agency Wunderman Thompson Intelligence, the report aims to help the industry understand the developments driving today's aesthetics market, and to highlight the key trends that may shape it in the years ahead.
Register HERE to receive a copy of the report.
Consumer interest in medical aesthetics continues to rise, with the number of dermal filler treatments worldwide growing by almost two million between 2017 and 2020. 2,3,4,5 In parallel, 'The Future of Aesthetics' global trends report found that physicians around the world are now catering to an increasingly diverse patient population spanning different ages, races and genders. 1
Carrie Strom , SVP, AbbVie and President, Global Allergan Aesthetics, comments; "The Future of Aesthetics global trends report, helps us to understand what is driving aesthetics today and what will shape the aesthetics industry of tomorrow. The report builds on our 2019 research – Allergan 360° Aesthetics Report™ – about evolving global beauty perceptions and priorities 6 and reaffirms our commitment to innovative science and the future growth of the market. The input we received from practitioners and consumers provides a unique view of what tomorrow may hold for aesthetics. It's an exciting time to be in this industry and we are thankful to our partners who participated in this important study."
Today's launch was led by prominent experts from the world of aesthetics, innovation and futurology. It was opened by leading aesthetic surgeon and report co-contributor Dr Jonquille Chantrey, UK, who talked delegates through the drivers behind today's behaviour change: Beauty Empowerment , Untabooing Treatments , Aesthetics-Fluency and a desire to move Back to Nature . 1 Dr Chantrey then gave an overview of the 10 major trends identified in the report as most likely to impact medical aesthetics practice in the coming five years, 1 more on which can be found here: https://global.allerganaesthetics.com/ . Guest panellists also included: Geraldine Wharry , Futurist, US; Dr Steven Liew , Specialist Plastic Surgeon, Australia ; Vania Goy , Journalist, Brazil ; Dr. Leonard Nenad Josipovic , Germany / Dubai ; Elliot Langerman , Creative Director, ZS.
Dr Chantrey, commented; "I'm proud to be a part of the launch of 'The Future of Aesthetics' global trends report - a must-read for anyone interested or involved in the aesthetics industry. The report represents three important things: change, choice and curiosity. We have all had to change, significantly. We have the power to decide what change represents in the future, and what it represents for patients. We need to support our patients to make the best possible choices as practitioners by applying our curiosity to cultural shifts and being as creative as possible in our work. This report will enable us to understand the patients of tomorrow and implement practical changes that appeal to them."
'The Future of Aesthetics' global trends report was validated via interviews with 15 world leading aesthetics practitioners** from 13 trend-led countries *** between May and September 2021 . 1 It is informed by extensive research and analysis across consumer and business media, social listening data, and market research from around the globe.
Healthcare professionals and media can sign up to receive a copy of the report. To register your interest and receive a copy when it goes live in your country, or for more information on the trends identified and about Allergan Aesthetics, please visit us at https://global.allerganaesthetics.com/ .
For more information, please contact your local Allergan Aesthetics representative.
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.
Wunderman Thompson Intelligence is Wunderman Thompson's futurism, research and innovation unit. It charts emerging and future global trends, consumer change, and innovation patterns—translating these into insight for brands. It offers a suite of consultancy services, including bespoke research, presentations, co-branded reports and workshops. It is also active in innovation, partnering with brands to activate future trends within their framework and execute new products and concepts. The division is led by Emma Chiu and Marie Stafford , Global Directors of Wunderman Thompson Intelligence.
Chytra Anand , Cosmetic Dermatologist, India; Jonquille Chantrey , Aesthetic Surgeon, United Kingdom, Ligia Colucci , Dermatologist, Brazil; Dmitry Durdyklychev , Dermatologist, Russia; Tijion Esho , Cosmetic Doctor, United Kingdom; Nobutaka Furuyama , Plastic and Cosmetic Surgeon, Japan; Lana Kashlan , Consultant Dermatologist, UAE; Steven Liew , Specialist Plastic Surgeon, Australia; José R. Montes , MD and Oculoplastic Surgeon, Puerto Rico/USA; Roni Munk , Medical and Cosmetic Dermatologist, Canada; Kyung-Ho Park , MD and Dermatologist, South Korea; Chantal Sciuto , Dermatologist, Italy; Rashmi Shetty , Dermatologist, India; Danru Wang , Professor of Cosmetic Surgery, China; Gong Wei , Editor-in-Chief of Medical Aesthetics Observer, China
Australia, Brazil, Canada, China, France, Germany, Japan, Italy, Russia, Spain, Taiwan, Thailand, Turkey, UAE, UK
1 Allergan Aesthetics, The Future of Aesthetics global trends report. March 2022 ALL-AGNA-220005 2 ISAPS international survey 2017. Available at ISAPS_2017_International_Study_Cosmetic_Procedures_NEW.pdf . Accessed March 2022 . 3 ISAPS international survey 2018. Available at: ISAPS-Global Survey Results 2018.indd . Accessed March 2022 . 4 ISAPS International survey 2019. Available at: Global Survey_2019_Stand_2020.indd (isaps.org) . Accessed March 2022 . 5 ISAPS international survey 2020. Available at: ISAPS-Global-Survey_2020.pdf . Accessed March 2022 . 6 Allergan 360 Aesthetics Report. 2019. RES-214052
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Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Bosh" or the "Company"), a premier plant-based brands in the in-health food sector, provides the following update summary:
Greg Gilbert has been named CFO of Beanfields and is an experienced finance leader focused on growing shareholder value as CFO for mid-stage food and beverage companies.
Greg's experience in the industry spans across start-up to multi-national strategic businesses; across dry, frozen, and fresh categories, and across all market channels, including in-depth experience scaling/incubating emerging/natural brands.
Greg has served as Chief Financial Officer of Beanfields since Q1 2020 where he led the work to optimize the business model; utilizing his depth of experience and inventiveness, to meet evolving investor needs.
West Bonebrake: Director of Operations Beanfields
(From the left to right: Wes Bonebrake, TJ Walsh, Colton Marples, and Greg Gilbert) To view an enhanced version of this graphic, please visit: https://orders.newsfilecorp.com/files/7944/128129_89302b48848df9db_002full.jpg
Boosh Plant-Based Brands Founder and CEO Connie Marples states, "I could not be more proud of our team through the successful integration of Beanfields into the Boosh Plant-based family of brands. The addition of Greg Gilbert and Wes Bonebrake to our management group has been seamless and their industry expertise plus history with Beanfields is highly valued."
On behalf of the Board of Directors
Connie Marples Founder/President connie@booshfood.com Telephone: 778 840 1700 www.Booshfood.com
About Boosh Plant-Based Brands Inc.:
Boosh Plant-Based Brands Inc., through its wholly owned subsidiary, Boosh Food (www.booshfood.com), offers high quality, non-GMO, gluten free, 100% plant-based nutritional comfort foods for the whole family. Through a separate subsidiary, Beautiful Beanfields, the Company owns Beanfields, a plant-based chips brand sold in over 7,000 stores throughout North America. Boosh, good for you and good for planet earth.
The information in this news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute forward-looking statements. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the Company's expectations concerning the size of the Financing, its ability to close the Financing in whole or in part or at all and its plan for the proceeds of the Financing.. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although the Company believes that the expectations reflected in forward-looking statements are reasonable, it can give no assurances that the expectations of any forward-looking statements will prove to be correct. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/128129
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- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and FORTIFY 1-4
- As early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with SKYRIZI versus placebo, as were co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52 1-4
- Crohn's disease is chronic, systemic and progressive; most patients experience unpredictable symptoms that have a significant impact on daily life 5-8
ABBVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI ® (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). 4 In two induction and one maintenance clinical trials, SKYRIZI demonstrated significant improvements in endoscopic response (defined as a decrease of greater than 50% from the baseline Simple Endoscopic Score in CD [SES-CD] or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline) and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150), compared to placebo, as both an induction and maintenance therapy. 4
Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/8978352-abbvie-fda-crohns-disease/
"We are proud to offer the first new treatment option in six years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "With more than 30 ongoing or planned trials in inflammatory bowel disease, AbbVie is committed to advancing the standards of care for patients by exploring and investing in research for those living with immune-mediated, gastroenterological conditions."
The dosing regimen for SKYRIZI for the treatment of CD is 600 mg administered by intravenous infusion over at least one hour at week 0, week 4, and week 8, followed by 360 mg self-administered by subcutaneous injection (SC) with an on-body injector (OBI) at week 12, and every 8 weeks thereafter. 4 A 180 mg self-administered SC maintenance dose option remains under review by the FDA.
Endoscopic and Clinical Outcomes 1-4 The co-primary endpoints of the clinical trials were endoscopic response and clinical remission. In the 12-week induction studies, ADVANCE and MOTIVATE, a significantly greater proportion of patients treated with SKYRIZI achieved endoscopic response and clinical remission compared to placebo. As early as week 4, clinical response (defined as a 100-point reduction in CDAI) and clinical remission were achieved in a significantly greater proportion of patients receiving SKYRIZI as compared to placebo.
In the 52-week maintenance trial, FORTIFY, a significantly greater proportion of patients achieved the co-primary endpoints of endoscopic response and clinical remission as compared with the placebo group (risankizumab induction responders) after one year.
"In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo," said Marla Dubinsky , M.D., chief, division of pediatric gastroenterology for the Mount Sinai Health System, co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai.* "This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn's disease."
Safety 4 SKYRIZI may cause serious side effects, including:
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. Also, tell your doctor if you plan to or recently received a vaccine. Liver problems in Crohn's disease: A patient in the clinical trial with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do liver blood tests before and during treatment and may stop treatment with SKYRIZI if you develop liver problems.
SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.
Patient Access and Support AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients, who may also be reimbursed for out-of-pocket costs related to IV administration. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist .
A bout Crohn's Disease Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain. 5-7 It is a progressive disease, meaning it gets worse over time, and in many cases leads to surgery. 6,7 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease. 8
About the ADVANCE and MOTIVATE Studies 1-2 The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, in adults with moderately to severely active Crohn's disease, compared to placebo. Both studies included different sets of primary and secondary endpoints for outside U.S. (OUS) protocol and U.S. protocol. The primary endpoints were achievement of clinical remission (per PRO-2 for the OUS protocol, which was measured by daily stool frequency and abdominal pain score, and per CDAI for the U.S. protocol, which was measured by a CDAI score less than 150) and endoscopic response (for both protocols) at week 12. Endoscopic response is defined as a decrease of greater than 50% from the baseline SES-CD or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline, as scored by a central reviewer.
The ADVANCE study included a mixed population of patients who had responded inadequately or were intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. Topline results of the studies were shared in January 2021. More information can be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).
About the FORTIFY Study 3 The FORTIFY study is a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal in patients who responded to risankizumab induction treatment in the ADVANCE and MOTIVATE studies. This study included different sets of primary and secondary endpoints for the OUS analysis plan and U.S. analysis plan due to regulatory requirements in the different regions. The co-primary endpoints were achievement of endoscopic response and clinical remission at week 52. Endoscopic response is defined as a decrease of greater than 50% from the baseline SES-CD or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline, as scored by a central reviewer. Clinical remission is defined by SF/AP, which was measured by daily stool frequency and abdominal pain score, in the OUS analysis plan and defined by CDAI, which was measured by a CDAI score less than 150, in the U.S. analysis plan.
Topline results were announced in June 2021. An open label extension of FORTIFY will continue to assess the long-term safety of risankizumab in subjects who completed participation in FORTIFY. More information can be found on www.clinicaltrials.gov (NCT03105102).
*Dr. Dubinsky is a paid consultant and advisor for AbbVie.
About SKYRIZI ® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. 9,10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease. 10 The approved dose to treat adults with moderately to severely active Crohn's disease is 600 mg administered by intravenous infusion over at least one hour at week 0, week 4, and week 8, followed by 360 mg administered by subcutaneous injection at week 12, and every 8 weeks thereafter. 4 SKYRIZI is also approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults, and the recommended dosage is 150 mg administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter. 4 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing. 11,12
SKYRIZI U.S. Uses and Important Safety Information 4
SKYRIZI is a prescription medicine used to treat adults with:
What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious side effects, including:
Serious Allergic Reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"
Liver problems in people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach(abdominal) pain, tiredness(fatigue), loss of appetite, yellowing of the skin and eyes (jaundice) and dark urine.
The most common side effects of SKYRIZI in people treated for Crohn's Disease include upper respiratory infections, injection site reactions, fever, headache, stomach(abdominal) pain, back pain, joint pain, and low red blood cells (anemia).
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600mg/10mL intravenous infusion, and a 360mg/2.4mL single-dose prefilled cartridge with on-body injector.
This is the most important information to know about SKYRIZI. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .
Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
+1 (973) 307-6145 sara.sanders@abbvie.com
View original content: https://www.prnewswire.com/news-releases/skyrizi-risankizumab-rzaa-receives-fda-approval-as-the-first-and-only-specific-interleukin-23-il-23-to-treat-moderately-to-severely-active-crohns-disease-in-adults-301570300.html
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The quarterly rebalancing of the CSE 25 Index will result in the following changes, effective after the close on Friday, June 17,2022.
Le rééquilibrage trimestriel de l'indice composé du CSE 25 entraînera les modifications suivantes, en vigueur à la fermeture le vendredi 17 juin 2022.
Deletions from CSE 25 do not necessarily mean a deletion from the Composite. Les suppressions de CSE 25 ne signifient pas nécessairement une suppression du composite. For more information about the CSE 25 Index, including the full list of securities and the index methodology, visit the CSE website.
Pour plus d'information sur l'indice composé du CSE 25, incluant la liste complète des titres et la méthodologie indicielle, rendez-vous sur le site Web du CSE.
Index Management/Gestion de l'indice : Robert Cook Senior Vice-President Market Development/Vice-président principal du développement Robert.Cook@thecse.com (416) 367-7349
Media Relations/Relations avec la presse: Richard Carleton, CEO Richard.Carleton@thecse.com (416) 367-7360
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The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: POTVF) ("GUMY" or the "Company"). On Tuesday, June 14, 2022, OTC Markets informed the Company that it became aware of certain promotional activities concerning the Company and its common stock traded on the OTCQB Marketplace, specifically the distribution of promotional emails on June 8, 2022 and June 14, 2022, by an unaffiliated third-party that contained certain charting and technical analysis as well as recent business milestones which were previously publicly disclosed by the Company. The promotional materials did not have a material impact on the Company's common share price. After inquiry, the Company determined that the third party, which was not engaged by the Company or any of its officers, directors, controlling shareholders or any third-party service providers, distributed the promotional emails. The Company had no editorial oversight of the promotional material nor any opportunity to review in advance of the distribution; however, the Company has subsequently reviewed the specific details related to the Company that were included in such promotional emails and has confirmed the factual details included therein are not materially false andor misleading. The Company cautions readers that the opinions made in the promotional materials are speculative in nature. For more complete and specific information regarding the Company, its prospects and the risks associated with those prospects, readers should review the Company's Listing Statement dated as of May 26, 2022 and other public filings on SEDAR, its website and other reliable sources. The Company encourages investors to contact their investment advisors prior to making any investment.
Further, the Company understands this promotional activity coincided with increased trading activity in the Company's common shares beginning on or about June 8, 2022 The Company does not believe the promotional activities were a factor in the recent increase in trading volume of the Company's common shares. Instead, the Company attributes the increased trading volume to currently heightened investor interest as a result of its recent press releases which disclosed that the Company has completed its initial production and secured sales partnerships with the "Bard on the Beach Shakespeare Festival" as well as Flair Airlines.
After an inquiry by management, none of the Company's executive officers, directors or, to the knowledge of the Company, any controlling shareholders or third-party service providers sold or purchased common shares of the Company within the past 90 days.
In the last twelve months, the Company has engaged Investing News Network (as previously disclosed in a press release dated February 16, 2022), Stockwatch, and World of Vegan (as previously disclosed in a press release dated March 17, 2022) for marketing services.
OTC Markets has further requested that the Company state whether it has issued any shares or convertible instruments allowing conversion to equity securities at prices constituting a discount to the current market rate at the time of the issuance. As disclosed in its public filings on SEDAR, the Company has from time to time issued shares or convertible instruments allowing conversion to equity securities at prices constituting a discount to the current market rate at the time of the issuance in accordance with the policies of the Canadian Securities Exchange. Please refer to the Company's Listing Statement (Form 2A) dated May 26, 2022, which is filed under the Company's profile on SEDAR, for a full list of such share issuances.
We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.
Charlie Lamb, President & CEO, Director
Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656 E-mail: investors@shopgummies.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/128114
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Investing in the biotech industry can be a long road to gains given the sector’s volatility.
Even with a good understanding of the system, no one can predict which treatment, device or therapy will give the biggest return, making biotech exchange-traded funds (ETFs) a more secure option than individual biotech stocks.
An ETF is a relatively safe investment route that can minimize losses while offering exposure to multiple companies instead of focusing on the gains and losses of a single biotech stock.
With that in mind, here’s a brief look at the five top biotechnology ETFs by total assets. Data was sourced from ETFdb.com on May 27, 2022, and all data was current as of that time.
The iShares NASDAQ Biotechnology ETF was launched on February 5, 2001, and tracks 377 holdings. This iShares ETF is a diversified fund in that it provides exposure to biotechnology, pharmaceutical and life science tools and services. Its overarching investment goal is to track NASDAQ-listed companies focused on these areas.
Its top three holdings are: Amgen (NASDAQ:AMGN), weighted at 9.84 percent; Gilead Sciences (NASDAQ:GILD) with a 8.58 percent weight; and Regeneron Pharmaceuticals (NASDAQ:REGN) at a weight of 7.55 percent.
Established on February 6, 2006, the SPDR S&P Biotech ETF is a largely equally weighted fund that focuses mostly on biotech companies with some pharmaceutical companies. As noted by ETF.com, it focuses on small- and micro-cap companies, which makes the weight of each holding smaller than the holdings of other ETFs in this sector.
The SPDR S&P Biotech ETF has 158 companies in its portfolio, with the top three being: Halozyne Therapeutics (NASDAQ:HALO), which has a 1.52 percent weighting; United Therapeutics (NASDAQ:UTHR), weighted at 1.51 percent; and Biohaven Pharmaceutical Holding Company (NYSE:BHVN), with a 1.38 percent weight.
The ARK Genomic Revolution Multi-Sector ETF came into existence on October 31, 2014, and tracks 48 holdings. This ETF has a specific industry area of focus and follows companies that develop products such as: CRISPR technology, bioinformatics, molecular diagnostics and stem cells.
This top biotechnology ETF's three most significant company holdings are: Exact Sciences (NASDAQ:EXAS), weighted at 8.9 percent; Ionis Pharmaceuticals (NASDAQ:IONS) at a weight of 7.48 percent; and Teledoc Health (NYSE:TDOC) at 5.35 percent.
The First Trust Amex Biotechnology Index entered the market on June 23, 2006, and aims to track the NYSE Arca Biotechnology Index as closely as it can. Companies in this fund are generally involved in areas such as recombinant DNA technology, molecular biology, genetic engineering and genomics.
The fund has only 31 holdings; this means they are largely equally weighted. The top three holdings of the fund are the following large-cap companies: Grifols (NASDAQ:GRFS) at a 4.69 percent weighting; United Therapeutics, representing a 4.47 percent weight; and Gilead Sciences, coming in at a 3.98 percent weight.
Founded on May 28, 2015, the Direxion Daily S&P Biotech Bull 3x Shares ETF does not mirror an index. Instead, its goal is to obtain daily investment results of at least 300 percent of the S&P Biotechnology Select Industry Index.
Like some of the other ETFs on this list, companies in the Direxion Daily S&P Biotech Bull 3x Shares ETF have an equally weighted average. Its top holdings include: Halozyme Therapeutics, which has a 0.88 percent weight; United Therapeutics with a weight of 0.85 percent; and Alkermes (NASDAQ:ALKS) at a weight of 0.79 percent.
This is an updated version of an article first published by the Investing News Network in 2016.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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