Hear from an expert on the best products and tips for transitioning your baby to solid foods!
Hear from an expert on the best products and tips for transitioning your baby to solid foods!
“I was just wearing it to seize some joy for myself. I had no idea that it might also bring some joy to others, too.”
Filtration Group—a global leader producing best-in-class filtration solutions to make the world safer, healthier and more productive—today announced the launch of the Porex Life Sciences Institute, a new business unit dedicated to the advancement of life science technologies.
Proving your COVID-19 vaccination status may be one of the easiest ways to return to school, clinical rotations, and everyday life as many colleges and universities across the country implement vaccine mandates. But what happens to the millions of Americans who can't receive the vaccine? To those with underlying medical complications or closely held religious and philosophical beliefs who are unable to be vaccinated?
Shares of NVIDIA (NASDAQ: NVDA) climbed today while shares of rivals Intel (NASDAQ: INTC) and AMD (NASDAQ: AMD) dipped after NVIDIA unveiled a new CPU that will put competitive pressure on the latter companies in the important market for data center processors. NVIDIA kicked off its annual GPU Technology Conference (GTC) today with a slew of announcements, but the unveiling of a new CPU easily stole the show as the most meaningful new product. The company has long specialized primarily in GPUs instead of CPUs, and NVIDIA's prior efforts to develop CPUs have been lackluster.
AccurePCI, a project partnership of Miami foundation Global CoCreation Lab and Silicon Valley-based Cipherome announced today, will address a growing health equity gap with innovative genomics technology for the region's medical community. The new tools will enable personalized treatment of heart disease patients, including populations historically underrepresented in medical research.
Compass Minerals Snow Event Data and Salt Sales
Aberdeen Asia-Pacific Income Fund, Inc. (NYSE American: FAX) (the "Fund"), a closed-end fund, today announced that it will pay on April 30, 2021, a distribution of US $0.0275 per share to all shareholders of record as of April 23, 2021 (ex-dividend date April 22, 2021).
Intel has laid out a plan to help automakers dealing with the global semiconductor shortage that has left companies like GM canceling production shifts.
* Spain will initially prioritise people between the ages of 70 and 79 for inoculation with Johnson & Johnson's vaccine. * Ireland is set to restrict use of AstraZeneca's vaccine to people over the age of 60, RTE reported. * Confusion and complacency in addressing COVID-19 means the pandemic is a long way from over, but it can be brought under control in months with proven public health measures, WHO Director-General Tedros Adhanom Ghebreyesus said.
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Sage Mountain Advisors LLC, a boutique independent wealth management firm, announced today that Russ Allen has joined the firm as Director of Investment Strategy. In this role, Allen will be responsible for expanding the investment solutions Sage Mountain offers its growing client base.
John Thero to Retire as President and CEO on August 1, 2021 Board Appoints Karim Mikhail, Current SVP and Head of Commercial for Europe, as Successor DUBLIN, Ireland and BRIDGEWATER, N.J., April 12, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that John F. Thero, 60, has informed the board of directors of his plan to retire as president and chief executive officer, effective August 1, 2021. He will also step down from the board at that time. The board has appointed Karim Mikhail, 50, Amarin’s senior vice president and head of commercial for Europe, to succeed Mr. Thero as the company’s next president and chief executive officer. Mr. Mikhail will join the board upon his effective date. Mr. Thero will continue to provide his guidance and expertise to the company in an advisory capacity through the end of 2021. Mr. Mikhail joined Amarin in 2020 from THEODON, a global commercial strategy consultancy he founded in 2018. Prior to this, Mr. Mikhail spent more than 20 years at Merck, where from 2014 to 2018 he served as global commercial leader for Merck’s $4 billion lipid franchise, overseeing P&L and leading the worldwide launch of ezetimibe with the IMPROVE-IT study indication. In this role, he was responsible for reversing the business’ decline in the U.S. market and globally, accelerating revenue by an additional $380 million through the launch of ATOZET and driving EBITDA growth through international expansion. Prior to that, Mr. Mikhail led the successful commercial launch of dozens of products, including ezetimibe and various molecules in diabetes, hypertension, immunology, and oncology, and served as Merck’s chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. At Amarin, Mr. Mikhail has been responsible for preparing commercialization of the company’s lead product in Europe, for which regulatory approval was received on March 30, 2021. Dr. Lars Ekman, Chairman of Amarin’s Board of Directors, commented, “After 12 years at Amarin, and the last seven as CEO, John has decided now is the right time to announce his retirement. We owe enormous gratitude to John as under his leadership roles, with the support of the entire Amarin team, the company has completed multiple successful clinical trials, launched its lead product VASCEPA® (icosapent ethyl) in the United States, and has initiated its international expansion plans, including commercialization in Europe following the recent marketing authorization of VAZKEPA from the European Commission. John and the entire board have taken a thoughtful approach to succession planning designed to ensure that Amarin is best positioned to both continue its progress in the United States and accelerate its growth trajectory globally. The board has been increasingly impressed with Karim’s strategic and operational capabilities, and his clear passion for VASCEPA and vision for continuing Amarin’s progress worldwide make him the clear choice to succeed John. We look forward to an exciting new chapter for the highly capable Amarin team under Karim’s leadership.” “While announcing my retirement is a bittersweet moment for me, I have every confidence in Amarin and its outstanding employees who are dedicated to the patients and shareholders we serve,” said Mr. Thero. “2021 is a pivotal year for Amarin as we continue to develop markets for our important drug, VASCEPA. As the first-and-only drug approved by each of the U.S. FDA, European Commission, and Health Canada for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy, we are proud of our role in ushering in a new era in cardiovascular care. With our unique therapeutic solution and deep bench of internal talent, I believe that now is an ideal time to transition leadership to Karim as we work to realize Amarin’s full potential. Since Karim joined Amarin last year, he has proven himself to be an invaluable member of the leadership team and a true partner to me as we prepare for the commercialization of VAZKEPA in Europe. I am excited to continue working closely with him and the board to facilitate a successful transition over the coming months.” Mr. Mikhail stated, “I joined Amarin last year because I was inspired by the company’s entrepreneurial spirit in addressing such a large unmet medical need and the potential to set a new standard of cardiovascular care. I am honored to take on this new role. We have an unparalleled product with outstanding evidence, positive efficacy and safety profile, and tremendous momentum with our near-term European launch plans and expected commercial approval in China near the end of 2021. Amarin’s team is first rate and I am excited to build upon the strong commercial progress in the United States. I look forward to working with John, the board and the entire Amarin team as we capture the significant growth opportunities ahead.” About Karim Mikhail Mr. Mikhail, 50, joined Amarin in July 2020, and currently serves as senior vice president and head of commercial for Europe where he has responsibility for the company’s commercialization of VAZKEPA in Europe. He was previously with Merck for 22 years, in seven different countries, spanning three continents, where he held positions of increasing responsibility, including as global commercial leader for Merck’s $4 billion lipid franchise and chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. Mr. Mikhail led THEODON, a global commercial strategy consultancy he founded in 2018. Mr. Mikhail is a pharmacist by training and holds a master’s degree in biopharmaceutical marketing and management from the graduate school of business in Paris, École Supérieure de Commerce de Paris (ESCP). About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management. About Cardiovascular RiskCardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.1 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4,5 About REDUCE-IT®REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com. About VASCEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. Indications and Limitation of Use (in the United States)VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below: Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT VASCEPAPlaceboVASCEPA vs PlaceboN = 4089n (%)Incidence Rate (per 100 patient years)N = 4090n (%)Incidence Rate (per 100 patient years)Hazard Ratio (95% CI)Primary composite endpointCardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)705(17.2)4.3901(22.0)5.70.75(0.68, 0.83)Key secondary composite endpointCardiovascular death, myocardial infarction, stroke (3-point MACE)459(11.2)2.7606(14.8)3.70.74(0.65, 0.83)Other secondary endpointsFatal or non-fatal myocardial infarction250(6.1)1.5355(8.7)2.10.69(0.58, 0.81)Emergent or urgent coronary revascularization216(5.3)1.3321(7.8)1.90.65(0.55, 0.78)Cardiovascular death 174(4.3)1.0213(5.2)1.20.80(0.66, 0.98)Hospitalization for unstable angina 108(2.6)0.6157(3.8)0.90.68(0.53, 0.87)Fatal or non-fatal stroke98(2.4)0.6134(3.3)0.80.72(0.55, 0.93) Includes adjudicated cardiovascular deaths and deaths of undetermined causality. Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Forward-Looking StatementsThis press release contains forward-looking statements, including statements about expectations for continued company progress in the United States and accelerated growth trajectory globally, anticipated regulatory approvals and related timing and a smooth management transition. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could impact future regulatory assessment, such as delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans or other information, uncertainties associated with litigation generally and patent litigation specifically; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; and uncertainties associated generally with research and development and regulatory submissions, reviews, action dates and approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent annual report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries) Solebury Troutamarinir@troutgroup.com Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries) AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States. 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American HeartAssociation. Circulation. 2020;141:e139–e596. 2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemiamanagement. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol.2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs,and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascularrisk. J Am Heart Assoc. 2018;7(15):e008740.5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights fromepidemiology, genetics, and biology. Circ Res. 2016;118:547-563.6 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.7 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.8 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
PRINCETON, N.J., April 12, 2021 (GLOBE NEWSWIRE) -- Clearway Energy, Inc. (NYSE: CWEN, CWEN.A) plans to report First Quarter 2021 financial results on Thursday, May 6, 2021. Management will present the results during a conference call and webcast at 8:00 a.m. Eastern. A live webcast of the conference call, including presentation materials, can be accessed through the Company’s website at http://www.clearwayenergy.com and clicking on “Presentations & Webcasts” under the Investor Relations section. The webcast will be archived on the site for those unable to listen in real time. About Clearway Energy Clearway Energy, Inc. is one of the largest renewable energy owners in the US with over 4,200 net MW of installed wind and solar generation projects. Clearway Energy’s over 8,000 net MW of assets also includes approximately 2,500 net MW of environmentally-sound, highly efficient natural gas generation facilities as well as a portfolio of district energy systems. Through this environmentally-sound diversified and primarily contracted portfolio, Clearway Energy endeavors to provide its investors with stable and growing dividend income. Clearway Energy’s Class C and Class A common stock are traded on the New York Stock Exchange under the symbols CWEN and CWEN.A, respectively. Clearway Energy, Inc. is sponsored by its controlling investor Global Infrastructure Partners III (GIP), an independent infrastructure fund manager that invests in infrastructure and businesses in both OECD and select emerging market countries, through GIP’s portfolio company, Clearway Energy Group. Investor:Akil Marsh, email@example.com Media: Zadie Oleksiw, 202-836-5754 firstname.lastname@example.org
Franklin Resources, Inc. (Franklin Templeton) (NYSE: BEN) today reported preliminary month-end assets under management of $1,498.9 billion at March 31, 2021, compared to $1,500.5 billion at February 28, 2021. This month’s AUM reflected slightly positive market gains offset by long-term net outflows, primarily driven by a single fixed income institutional redemption of nearly $6 billion that had minimal impact on revenue.
MIND Technology, Inc. (NASDAQ: MIND) ("MIND" or the "Company") today announced financial results for its fiscal 2021 fourth quarter and year ended January 31, 2021.
BGC Partners, Inc. (NASDAQ: BGCP) ("BGC"), a leading global brokerage and financial technology company, today announced the details regarding its first quarter 2021 financial results conference call. This call will take place on Thursday, April 29, 2021 at 11:00 a.m. ET.
Laureate Education, Inc. (NASDAQ: LAUR) plans to release results for the quarter ended March 31, 2021, on Thursday, May 6, 2021, before the stock market opens. Following the release, the Company will host a telephone conference call with investors and analysts at 8:30 a.m. ET to discuss the first quarter results and the Company's business outlook.
Kaman Corp. (NYSE:KAMN) announced today that it will report its first quarter 2021 results after the stock market closes on Tuesday, May 4, 2021, and host a live webcast and conference call at 8:30 am ET on Wednesday, May 5, 2021.
HIGH POINT, N.C., April 12, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that results from the JDRF-supported SimpliciT-1 Study will be presented at A Scientific Symposium: In celebration of the 100th anniversary of the University of Toronto’s discovery of insulin (Insulin100) held virtually, April 15 & 16, 2021. The presentation titled “The SimpliciT-1 Study: Hepatoselective Glucokinase Activation Via TTP399 For The Treatment Of Type 1 Diabetes Mellitus" was awarded first place in the symposium’s Post Doc - Clinical Category and earned the opportunity to be presented to the world’s leading experts on type 1 diabetes. Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and Sub-Principal Investigator of the SimpliciT-1 study, will present the data in a 15 minute presentation on April 15th in a session held from 1:10-1:25pm ET. Registration is available here. The Insulin100 symposium, chaired by Dr. Daniel Drucker of the University of Toronto, celebrates the 100th anniversary of the life-saving discovery of insulin and aims to provide comprehensive updates on the latest advances in diabetes treatment and management. “We are pleased that vTv’s research in type 1 diabetes is being recognized by the diabetes community,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “We are dedicated to advancing TTP399 and believe that it has the potential to be a new treatment option for type 1 diabetes that improves patients’ lives.” vTv is currently conducting a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes and is planning a pivotal trial that will be initiated later this year. About the SimpliciT-1 Study The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period. Results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Importantly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. TTP399 exhibited a favorable safety profile, with abnormal serum and urine ketones detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes. About vTv TherapeuticsvTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics. Forward-Looking StatementsThis release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements. Contacts Investors: Corey DavisLifeSci AdvisorsCDavis@LifeSciAdvisors.comorMedia: PR@vtvtherapeutics.com Source: vTv Therapeutics Inc.
Timely and convenient access to vaccinations is critical, now and in the futureTEMPE, Ariz., April 12, 2021 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company engaged in the design and manufacture of the Invisalign system, iTero intraoral scanners, and exocad CAD/CAM services for orthodontic and restorative dentistry, today announced its support to expand access to vaccinations by U.S. dentists. As seen over the last year, managing health care resources during a pandemic or other health crisis is a complex mix of preparation and execution, with access to responsible care being a key consideration. Federal, state, and local public health officials and health care providers have worked to balance access to COVID-19 testing and healthcare while also meeting other health needs – both routine and unexpected – that continue even during a pandemic. As the number of people vaccinated against COVID-19 increases across the U.S., it is important to review and build on lessons learned in order to optimize responsiveness for future events. One of those lessons is the potential value of using networks of existing, trusted, community-level health care providers when rolling out vaccination plans. “Since the start of the pandemic, Align’s customers – primarily dentists and orthodontists across the country – have been at the forefront of their profession and healthcare, in general, using social media and virtual appointment and treatment monitoring tools to stay connected with and communicate public health and safety protocols to their patients,” said Julie Coletti, Align Technology senior vice president, chief legal and regulatory officer. “As essential health care providers of ongoing health care services, they have earned their patients’ trust by staying current with the latest health and safety protocols and public health requirements to safely and responsibly treat their patients.” As trusted, highly qualified health care professionals, dentists can expand the number of care providers that offer immunizations. According to the American Dental Association, 9 percent of Americans (31 million people) see a dentist every year, but do not see a physician1. This is a significant statistic to be considered as part of any future plans for vaccine administration. Dentists Provide Experienced Care Before completing dental school and becoming licensed, dentists are professionally trained to administer intraoral and extraoral injections into nerve tissue for local anesthesia – which is arguably more difficult to effectively administer than a vaccine injected into the shoulder muscle. Further, many states permit dentists to administer dermal fillers, Botox® injections, and to start IVs for procedures requiring sedation. Building on Pandemic Policies A majority of states have established the foundation for dentist-provided vaccinations by affirmatively permitting dentists to administer COVID-19 vaccinations. On March 16, 2021, the U.S. Department of Health and Human Services amended an emergency declaration under the Public Readiness and Emergency Preparedness Act to authorize additional providers, including dentists and dental students, to vaccinate patients for COVID-19 nationwide regardless of state laws that prevent dentists from doing so.3 Align believes that these recent pandemic-related policies should be the start of additional integration of dentists to vaccinate against other diseases. For example, augmenting the role of the dental profession in routine immunization of oral health related diseases such as Human Papillomavirus (HPV) would increase society’s access to future immunizations.2 Such steps would establish a more robust vaccine program by expanding access at a community level through trusted and competent dentists. 1 ADA Health Policy Institute, “Could Dentists Relieve Physician Shortages, Manage Chronic Disease?”, David Leader, D.M.D., M.P.H.; Marko Vujicic, Ph.D.; Brittany Harrison, M.A.; http://www.ada.org/~/media/ADA/Science%20and%20Research/HPI/Files/HPIBrief_1218_1.pdf 2 North Carolina Oral Health Collaborative (NCOHC), “Dentists’ Role in Vaccination: An Opportunity for Public Health Impact”, Zachary Brian, DMD, MHA, https://oralhealthnc.org/dentists-role-in-vaccination-an-opportunity-for-public-health-impact/ 3 https://www.federalregister.gov/documents/2021/03/16/2021-05401/seventh-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for About Align Technology, Inc.Align Technology designs, manufactures and offers the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers, and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat over 9.6 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information. For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero systems and services, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com. Align TechnologyMadelyn Homick408email@example.comZeno GroupSarah Johnson828firstname.lastname@example.org