Health Care https://www.benzinga.com/views/taxonomy/term/140295 en Phio Pharma Shares Are Trading Higher On Cancer Immunotherapies Pact With AgonOx https://www.benzinga.com/general/biotech/21/03/19912406/phio-pharma-shares-are-trading-higher-on-cancer-immunotherapies-pact-with-agonox <p><strong>Phio Pharmaceuticals Corp</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/phio#NASDAQ" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">PHIO</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/03/n19909871/phio-pharmaceuticals-and-agonox-inc-announce-collaboration-on-clinical-development-of-novel-t-cell" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">entered into a clinical development collaboration</a>&nbsp;with&nbsp;<strong>AgonOx Inc</strong>&nbsp;to develop novel T cell-based cancer immunotherapies.</p> <ul> <li>The collaboration will use Phio&#39;s lead INTASYL based ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19912406/phio-pharma-shares-are-trading-higher-on-cancer-immunotherapies-pact-with-agonox alt=Phio Pharma Shares Are Trading Higher On Cancer Immunotherapies Pact With AgonOx>Full story available on Benzinga.com</a></p> Biotech Cancer Immunotherapy News Penny Stocks PHIO Health Care Contracts FDA General PHIO News Biotech Penny Stocks Health Care Contracts FDA General Benzinga Mon, 01 Mar 2021 14:01:00 +0000 Vandana Singh 19912406 at https://www.benzinga.com Health Insurance Expert Gleans Years of In-Depth Research to Construct a Healthcare Plan That Will Benefit Both the United States and its Citizens https://www.benzinga.com/pressreleases/21/03/g19912582/health-insurance-expert-gleans-years-of-in-depth-research-to-construct-a-healthcare-plan-that-will <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p>DISTRICT HEIGHTS, Md., March 01, 2021 (GLOBE NEWSWIRE) -- After an election that was largely focused on healthcare reform in the United States, it is crucial for the leader of our country, along with the legislative branch, to implement a system that benefits not only the American people but also the country itself. Thomas J. Scurlock, III, an experienced health insurance expert, has found that solution after years of in-depth research into the United States healthcare system. Scurlock presents his examination of the current U.S. healthcare system in his debut book, &#34;Reforming Healthcare: How to Fix the System Without the Destruction of the American Way&#34; and proposes an entirely new system built from tangible solutions, including integrating existing healthcare insurance companies and implanting a tax plan to fund coverage.</p> <p>Scurlock was inspired to write this book after listening to President Barack Obama discuss his healthcare plan. Scurlock was shocked by the cost of this federal statute, especially since the U.S. had an insurmountable debt. He began working on ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19912582/health-insurance-expert-gleans-years-of-in-depth-research-to-construct-a-healthcare-plan-that-will alt=Health Insurance Expert Gleans Years of In-Depth Research to Construct a Healthcare Plan That Will Benefit Both the United States and its Citizens>Full story available on Benzinga.com</a></p> Health Care Politics Analyst Ratings Press Releases General Mon, 01 Mar 2021 14:00:00 +0000 Globe Newswire 19912582 at https://www.benzinga.com FDA Strikes Out CorMedix's DefenCath Application https://www.benzinga.com/general/biotech/21/03/19912332/fda-strikes-out-cormedixs-defencath-application <p>The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/03/g19911717/cormedix-receives-complete-response-letter-from-fda-for-defencath-catheter-lock-solution" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">FDA has issued a Complete Response Letter</a>&nbsp;for&nbsp;<strong>CorMedix Inc&#39;s</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/crmd#NASDAQ" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">CRMD</a>) marketing application seeking approval for DefenCath (taurolidine/heparin catheter lock solution) for catheter-related bloodstream infections.</p> <ul> <li>FDA noted concerns at the third-party manufacturing facility after reviewing records, ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19912332/fda-strikes-out-cormedixs-defencath-application alt=FDA Strikes Out CorMedix&#039;s DefenCath Application>Full story available on Benzinga.com</a></p> Biotech bloodstream infections CRMD News Health Care Small Cap FDA General CRMD News Biotech Health Care Small Cap FDA General Benzinga Mon, 01 Mar 2021 13:55:46 +0000 Vandana Singh 19912332 at https://www.benzinga.com Oliveda International, Inc. (OLVI) Announces Plan for Subsidiary Regulation A+ Offering https://www.benzinga.com/pressreleases/21/03/g19912360/oliveda-international-inc-olvi-announces-plan-for-subsidiary-regulation-a-offering <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="left">Santa Monica, CA, March 01, 2021 (GLOBE NEWSWIRE) -- Oliveda International, Inc. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/OLVI#OTC" rel="nofollow">OLVI</a>), a leading international natural cosmetics and wearable beauty and health technology innovator, today announced the intention of its wholly owned Oliveda Group Inc. subsidiary, a California corporation, to file a Regulation A+ Tier 2 stock offering to raise up to $15 million in 2021.  Proceeds of the planned offering are currently targeted for expansion of Oliveda operations in the United States and will only involve Oliveda Group stock, not the stock of Oliveda International, Inc.<br /></p> <p align="left">Oliveda Group Inc.&#039;s U.S. expansion plans include new Oliveda flagship stores in Los Angeles (Abbot Kinney Boulevard area), New York, San Francisco, and Miami; broader marketing of Oliveda products throughout the country; ownership of olive tree groves, the launch of new products; and potentially the acquisition of additional beauty and health companies.</p> <p>Legal counsel has been retained and work has been initiated on ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19912360/oliveda-international-inc-olvi-announces-plan-for-subsidiary-regulation-a-offering alt=Oliveda International, Inc. (OLVI) Announces Plan for Subsidiary Regulation A+ Offering>Full story available on Benzinga.com</a></p> OLVI Health Care Press Releases Mon, 01 Mar 2021 13:50:28 +0000 Globe Newswire 19912360 at https://www.benzinga.com Satsuma Pharma Shares Rise After Raising $80M Via Private Placement, Plans New Pivotal Study For Migraine https://www.benzinga.com/general/biotech/21/03/19911082/satsuma-pharma-shares-rise-after-raising-80m-via-private-placement-plans-new-pivotal-study-for-mi <p><strong>Satsuma Pharmaceuticals Inc</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/stsa#NASDAQ" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">STSA</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/03/g19907895/satsuma-pharmaceuticals-announces-updated-sts101-development-plan" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">will conduct a new Phase 3 efficacy trial</a>&nbsp;for STS101 (dihydroergotamine (DHE) nasal powder) as an acute treatment option for migraine.</p> <ul> <li>The study will start in mid-2021, with topline data expected in the second half of 2022.</li> <li>The new Phase 3 trial takes into account findings from the previous Phase 3 EMERGE study.</li> <li>STS101&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/20/09/17452788/satsumas-migraine-drug-flunks-late-stage-study-stock-sinks-to-record-low" style="color: rgb(14, 16, 26); background: ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19911082/satsuma-pharma-shares-rise-after-raising-80m-via-private-placement-plans-new-pivotal-study-for-mi alt=Satsuma Pharma Shares Rise After Raising $80M Via Private Placement, Plans New Pivotal Study For Migraine>Full story available on Benzinga.com</a></p> Biotech Migraines News Phase 3 Trial STSA Health Care Offerings FDA General STSA US8593193035 News Biotech Health Care Offerings FDA General Benzinga Mon, 01 Mar 2021 13:43:58 +0000 Vandana Singh 19911082 at https://www.benzinga.com Kazia Therapeutics Licenses Cantrixil To Oasmia Pharmaceutical For Ovarian Cancer https://www.benzinga.com/general/biotech/21/03/19907806/kazia-therapeutics-licenses-cantrixil-to-oasmia-pharmaceutical-for-ovarian-cancer <p><strong>Kazia Therapeutics Ltd</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/kzia#NASDAQ" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">KZIA</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.co.uk/news-releases/kazia-licenses-cantrixil-a-clinical-stage-first-in-class-ovarian-cancer-drug-candidate-to-oasmia-pharmacetical-ab-885769945.html" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">entered an exclusive worldwide licensing</a>&nbsp;agreement with&nbsp;<strong>Oasmia Pharmaceutical AB</strong>&nbsp;(OTCMKTS: OASMY) for Cantrixil under development the treatment of ovarian cancer.</p> <ul> <li>The agreement will see Sweden-based Oasmia assume exclusive worldwide rights to develop and commercialize Cantrixil for all indications, with an initial focus on ovarian cancer.</li> <li>Oasmia&#39;s lead ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19907806/kazia-therapeutics-licenses-cantrixil-to-oasmia-pharmaceutical-for-ovarian-cancer alt=Kazia Therapeutics Licenses Cantrixil To Oasmia Pharmaceutical For Ovarian Cancer>Full story available on Benzinga.com</a></p> Biotech KZIA News OASMY Ovarian Cancer Health Care Contracts FDA General KZIA OASMY News Biotech Health Care Contracts FDA General Benzinga Mon, 01 Mar 2021 13:39:17 +0000 Vandana Singh 19907806 at https://www.benzinga.com CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution https://www.benzinga.com/pressreleases/21/03/g19911717/cormedix-receives-complete-response-letter-from-fda-for-defencath-catheter-lock-solution <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="left">BERKELEY HEIGHTS, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRMD#NASDAQ" rel="nofollow">CRMD</a>), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath&#x2122; (taurolidine/heparin catheter lock solution) in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously.<br /></p> <p>Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns. If an inspection is required, the FDA is currently facing a backlog due to the pandemic and are actively working to define an approach for scheduling outstanding inspections once safe travel may resume. CorMedix will request a meeting with the FDA, which we estimate will occur by mid-April, to obtain agreement with the Agency on our proposed plan for resolution of the issues at our third-party manufacturing facility.</p> <p>FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with FDA, the Agency added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19911717/cormedix-receives-complete-response-letter-from-fda-for-defencath-catheter-lock-solution alt=CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution>Full story available on Benzinga.com</a></p> CRMD Health Care Press Releases Mon, 01 Mar 2021 13:30:00 +0000 Globe Newswire 19911717 at https://www.benzinga.com Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) https://www.benzinga.com/pressreleases/21/03/g19911715/veru-receives-fda-agreement-to-advance-veru-111-into-phase-3-study-in-hospitalized-covid-19-patien <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="center"><strong>– Veru completes expedited end of Phase 2 trial meeting with FDA –</strong></p> <p align="center"><strong>– FDA agrees that Phase 2 clinical findings suggest a clinically meaningful benefit for the use of VERU-111 in hospitalized COVID-19 patients at high risk for ARDS –</strong></p> <p align="center"><strong>– FDA agrees to advance VERU-111 into Phase 3 clinical study in hospitalized high risk COVID-19 patients to confirm the potential benefit and risk –</strong></p> <p align="center"><strong>– Phase 3 clinical study expected to begin in April 2021 with clinical results expected in calendar Q4 2021 – </strong><br /></p> <p>MIAMI, March 01, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERU#NASDAQ" rel="nofollow">VERU</a>), an oncology biopharmaceutical company, today announced that the FDA agreed in an End of Phase 2 meeting, to advance VERU-111 into a Phase 3 registration clinical study based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized COVID-19 patients at high risk for ARDS. The Phase 2 trial demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 has the potential for two-pronged action against COVID-19 as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results.</p> <p>"We are very pleased with the outcome of the FDA meeting. FDA was extremely collaborative and thought that the clinical data from the Phase 2 were promising and suggest a potential clinically meaningful benefit for the use of VERU-111 in hospitalized high risk COVID-19 patients. Also, the FDA agreed that VERU-111 warrants further development in a Phase 3 program," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Due to the urgency of the global pandemic and need for more effective treatment options for patients, we remain duty-bound to pursue this indication, even though it has not been the primary focus of Veru. We have the resources to conduct a Phase 3 trial without impacting our cancer drugs&#039; clinical development."</p> <p>We have met with and will seek funding from The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) as well as other agencies to fund the estimated amount of commercial drug to supply the needs of the US population, assuming confirmatory positive Phase 3 clinical results and FDA approval.</p> <p><strong>Phase 3 Clinical Trial Design:</strong></p> <p>With a similar trial design to the completed positive Phase 2 study, the Phase 3 clinical registration trial design will evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients alive at Day 29. It is expected that the Phase 3 clinical trial will be conducted in approximately 400 hospitalized patients who have SARS-CoV-2 virus infection and are at high risk for ARDS at a 2:1 ratio between the VERU-111 (approximately 267 patients) and placebo (approximately 133 patients) treated groups.</p> <p>The Company has enough clinical drug supply on hand to complete the Phase 3 clinical study. The Phase 3 clinical trial is expected to commence in April 2021 and clinical results are expected by the fourth quarter of calendar year 2021.</p> <p><strong>About the Phase 2 COVID-19 Clinical Trial:</strong></p> <p>Veru conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. The trial was conducted in five sites across the United States. Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled. Subjects received an 18mg dose of VERU-111 or placebo, as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients alive without respiratory failure at Day 29.</p> <p><em>Clinical Efficacy and Safety Results:</em></p> <p>For the primary endpoint in a modified intent-to-treat (MITT) population, VERU-111 treatment compared to placebo had a statistically significant and clinically meaningful reduction in the proportion of patients who are treatment failures (dead or alive with respiratory failure) with a 30% treatment failure rate in the placebo group (n=20) compared to 5.6% in the VERU-111 treated group (n=18) at Day 29. This represents an 81% relative reduction in the VERU-111 treatment failures and showed statistical significance with p=0.05.</p> <p>For secondary endpoints: in the Intent to Treat (ITT) population, VERU-111 reduced the proportion of patients who died on study from 30% (6/20) in the placebo group to 5.3% (1/19) in the VERU-111 treated group (p=0.044). This is an 82% relative reduction in mortality in the VERU-111 treated group. In an MITT population, VERU-111 showed a statistically significant and clinically meaningful reduction in days in ICU (VERU-111 patients at 3.00 ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19911715/veru-receives-fda-agreement-to-advance-veru-111-into-phase-3-study-in-hospitalized-covid-19-patien alt=Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)>Full story available on Benzinga.com</a></p> VERU Health Care Press Releases General Mon, 01 Mar 2021 13:30:00 +0000 Globe Newswire 19911715 at https://www.benzinga.com Ricky Sitomer, CEO of Star Jets International, Inc. (JETR) Announces Record 2020 Revenue of $9,581,799, a Year-Over-Year Increase in Revenue of 80% https://www.benzinga.com/pressreleases/21/03/g19911711/ricky-sitomer-ceo-of-star-jets-international-inc-jetr-announces-record-2020-revenue-of-9-581-799-a <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="left">NEW YORK, March 01, 2021 (GLOBE NEWSWIRE) -- Ricky Sitomer, CEO Star Jets International, Inc. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/JETR#OTC" rel="nofollow">JETR</a>), a leading <a href="https://www.globenewswire.com/Tracker?data=kOVKjTxxjzurjW4ft6GbvSl7-7uDDJU4MWrQbq45Ah_9ubwzmMJ4zw8z0mNRaLoYoLkexxi20FHwdQnsNeigp66pufAUggu1Uz_92CuPC86v5M16II9RseAhJML9j-OB" rel="nofollow" target="_blank" rel="nofollow"><u>Private Jet Charter Company</u></a>, announces an all-time revenue record of $9,581,799 million for the year ended December 31, 2020, a year-over-year increase of 80%.  JETR recorded $2.2 million in the fourth quarter of 2020, an increase of 100% year-over-year.  As predicted, the Company&#039;s tremendous growth continues as the demand for private air travel increases, and not showing any signs of slowing down.  </p> <p align="start">The Company expects to continue its growth pattern throughout the first quarter of 2021. Health concerns related to COVID-19 remains a primary reason for the uptick in private travel demand.  As many first-time passengers discovered and enjoyed their new-found benefits of private jet travel, repeat customer bookings increased throughout 2020.</p> <p align="start">Ricky Sitomer, CEO of JETR stated, "We are proud to announce our all-time-record revenue in 2020, and our continued growth in the private jet industry. The demand for private jets has been tremendous and we expect that the demand will clearly continue.  We look forward to working hard to grow our client base and we are primed and ready to serve our clients with all of their ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19911711/ricky-sitomer-ceo-of-star-jets-international-inc-jetr-announces-record-2020-revenue-of-9-581-799-a alt=Ricky Sitomer, CEO of Star Jets International, Inc. (JETR) Announces Record 2020 Revenue of $9,581,799, a Year-Over-Year Increase in Revenue of 80%>Full story available on Benzinga.com</a></p> JETR Health Care Press Releases Mon, 01 Mar 2021 13:30:00 +0000 Globe Newswire 19911711 at https://www.benzinga.com Merck's Cough Drug Gefapixant Application Accepted For US Review https://www.benzinga.com/general/biotech/21/03/19908728/mercks-cough-drug-gefapixant-application-accepted-for-us-review <p>The FDA has accepted&nbsp;<strong>Merck &amp; Co Inc&#39;s</strong>&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mrk#NYSE" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">MRK</a>) marketing application seeking approval for gefapixant,&nbsp;<a class="editor-rtfLink" href="http://www.benzinga.com/pressreleases/21/03/b19907676/u-s-fda-accepts-mercks-gefapixant-new-drug-application-for-review" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">for review</a>.</p> <ul> <li>The selective P2X3 receptor antagonist is being developed to treat refractory chronic cough ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19908728/mercks-cough-drug-gefapixant-application-accepted-for-us-review alt=Merck&#039;s Cough Drug Gefapixant Application Accepted For US Review>Full story available on Benzinga.com</a></p> Biotech chronic cough MRK News Health Care FDA General MRK US58933Y1055 News Biotech Health Care FDA General Benzinga Mon, 01 Mar 2021 13:12:54 +0000 Vandana Singh 19908728 at https://www.benzinga.com Perrigo Divests Generic Pharma Business For $1.55B To Altaris Capital https://www.benzinga.com/general/biotech/21/03/19909048/perrigo-divests-generic-pharma-business-for-1-55b-to-altaris-capital <p><strong>Perrigo Company Plc&nbsp;</strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/prgo#NYSE">PRGO</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/03/n19908207/perrigo-announces-agreement-to-sell-generic-rx-business-for-1-55-billion-in-total-consideration" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">agreed to sell its Generic Rx Pharmaceuticals business</a>&nbsp;to Altaris Capital Partners for $1.55 billion.&nbsp;</p> <ul> <li>The price included a $1.5 billion payment in cash. Altaris will also assume more than $50 million in potential R&amp;D milestone payments and contingent purchase obligations with third-party partners.</li> <li>Perrigo CEO and President ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/03/19909048/perrigo-divests-generic-pharma-business-for-1-55b-to-altaris-capital alt=Perrigo Divests Generic Pharma Business For $1.55B To Altaris Capital>Full story available on Benzinga.com</a></p> Biotech M&A News PRGO Health Care Asset Sales General PRGO US7142901039 News M&A Biotech Health Care Asset Sales General Benzinga Mon, 01 Mar 2021 13:08:39 +0000 Vandana Singh 19909048 at https://www.benzinga.com Type 1 Diabetes Market Size is Projected to Reach USD 2,800 Million by 2026, Globally: Facts & Factors https://www.benzinga.com/pressreleases/21/03/g19911183/type-1-diabetes-market-size-is-projected-to-reach-usd-2-800-million-by-2026-globally-facts-factors <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p>New York, NY, March 01, 2021 (GLOBE NEWSWIRE) -- Facts and Factors have published a new research report titled <b>"Type 1 Diabetes Market By Insulin Analog (Rapid-Acting Insulin Analogs, Long-Acting Insulin Analogs, and Premix Insulin Analogs): Global Industry Outlook, Market Size, Business Intelligence, Consumer Preferences, Statistical Surveys, Comprehensive Analysis, Historical Developments, Current Trends, and Forecasts, 2020–2026"</b>.</p> <p><i>"According to the research study, the global </i><a href="https://www.globenewswire.com/Tracker?data=1-iFdoED_5SDBJGg-9QFYpKlQSH77aYVIg2J0uYzfqjxHZgj2sPGNux8qOAVdICsjAkI5BcJ2ryMCRVe8FiWgqQI7XfI5DVo_Tyj1Eol3pbZhlbAUP5BUteo18kHWwP0RAwHi40mEEl1p-oQjqX4Y0gtmQH_Qj9LVYUabDZ6zuI=" rel="nofollow" target="_blank" rel="nofollow"><i><u>Type 1 Diabetes Market</u></i></a><i> was estimated at USD 2,000 Million in 2019 and is expected to reach USD 2,800 Million by 2026. The global Type 1 Diabetes Market is expected to grow at a compound annual growth rate (CAGR) of 5% from 2019 to 2026".</i></p> <p>Type 1 diabetes is a type of diabetes where an autoimmune response towards insulin-making beta cells of the pancreas leads to the early destruction of the pancreas. Type 1 diabetes mellitus is idiopathic but has a strong association with genes such as HLA-DR4 and HLA-DR3. Type 1 diabetes symptoms are increase thrust, extreme weight loss stomach upset, increase frequency of urination, fatigue, delayed healing, etc. One of the key remedies against type 1 diabetes is insulin therapy. Parents and the child should have proper knowledge of the condition. The primary goal in the case of type 1 diabetes is to keep the insulin level as close to normal. The treatment prescribed to the patient involves monitoring the blood sugar level within limit via diet, exercise, and insulin therapy. If left untreated, the type 1 diabetic patient experiences loss of consciousness. Uncontrolled diet and insulin may cause high blood sugar (hyperglycemia), increased ketones in urine, hypoglycemia, etc.</p> <p><b>Request Your Free Sample Report of Type 1 Diabetes Market @ </b><a href="https://www.globenewswire.com/Tracker?data=3e8sF6-C5G0B5HgbSgfygM8MSMIx7heikLfL-wnHQZBh1h3Na4NQR_9IxJSJ6cxrdr0hHw9E8i6qdyQSBSxTfDt2arj2QXBCU1VigKm-G02KKLZPZ-4-Lqy2GEmSIohYZGcUVI9Fu7YV-0VMpmkRzF48U1hoZKgVAhY1k6OdTfQJI47qJ2q4iVBe8XyiBhM4_9ELbbgE8JqMWI23VmBYyzY04oNH-S28lauAjo2S_akBu2eJlJ5jiNy4-PcpkmsEdJ_0F1iK11jH2gANIBC_xw==" rel="nofollow" target="_blank" rel="nofollow"><u>https://www.fnfresearch.com/sample/type-1-diabetes-market-by-insulin-analog-rapid-1256</u></a><b>                      </b> <b>           </b></p> <p><b><i>(The free sample of this report is readily available on request).</i></b></p> <p><b><i>Our Free Sample Report Includes:             </i></b></p> <ul> <li><i>2020 Updated </i><i>Report Introduction, Overview, and In-depth industry analysis</i></li> <li><i>COVID-19 Pandemic Outbreak Impact Analysis Included</i></li> <li><i>190+ Pages Research Report (Inclusion of Updated Research)</i></li> <li><i>Provide Chapter-wise guidance on Request</i></li> <li><i>2020 Updated Regional Analysis with Graphical Representation of Size, Share &amp; Trends</i></li> <li><i>Includes Updated List of table &amp; figures</i></li> <li><i>Updated Report Includes Top Market Players with their Business Strategy, Sales Volume, and Revenue Analysis</i></li> <li><i>Facts and Factors research methodology</i></li> </ul> <p><b>(Note: The sample of this report is updated with COVID-19 impact analysis before delivery)</b></p> <p><b>Key Questions Answered in this Report</b></p> <p>1) What was the impact of COVID-19 on the Type 1 Diabetes Market?</p> <p>2) What is the market size, share of the Type 1 Diabetes Market?</p> <p>3) Who are the top market players in the Type 1 Diabetes Market?</p> <p>4) What will be the future market of Type 1 Diabetes Market?</p> <p><b>Key Offerings:</b></p> <ul> <li>Market Size &amp; Forecast by Revenue &#x7C; 2020−2026</li> <li>Market Dynamics – Leading trends, growth drivers, restraints, and investment opportunities</li> <li>Market Segmentation – A detailed analysis by product, by types, end-user, applications, segments, and geography</li> <li>Competitive Landscape – Top key vendors and other prominent vendors</li> </ul> <p><b>Inquire more about this report before purchase @ </b><a href="https://www.globenewswire.com/Tracker?data=3e8sF6-C5G0B5HgbSgfygM8MSMIx7heikLfL-wnHQZCYmnqAD6aEijgWUAnRcZWqnBTkk3Q5VCFyTEBNjvajFsyqp1C0cIdZLKujIU0marHpnHlqweGmN-_Zs-TGNqkxbCDbbmq6dPUaoWqhzNKORlBt7asm5YJhjgtGilzVXA2sAijFeZizR1_vH_7MddFm4CNa3J9EovqBL991QDfNnX2Do_Gn6iKTpsDDUGpW4q8LYSn_lmf4KLFGxEE9Np4PPrm49C4x6EFRqZ3PebLZtg==" rel="nofollow" target="_blank" rel="nofollow"><u>https://www.fnfresearch.com/inquiry/type-1-diabetes-market-by-insulin-analog-rapid-1256</u></a>                                                  <br />        <br /><b>(You may enquire a report quote OR available discount offers to our sales team before purchase.)</b></p> <p><b>Impact Analysis of COVID-19 Pandemic on Businesses: Know Short Term and Long Term Impact</b></p> <p>Most of the businesses are facing a growing litany of business-critical concerns related to the coronavirus outbreak, including supply chain disruptions, a risk of a recession, and a potential drop in consumer spending. All these scenarios will ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19911183/type-1-diabetes-market-size-is-projected-to-reach-usd-2-800-million-by-2026-globally-facts-factors alt=Type 1 Diabetes Market Size is Projected to Reach USD 2,800 Million by 2026, Globally: Facts &amp; Factors>Full story available on Benzinga.com</a></p> Health Care Economics Analyst Ratings Press Releases Mon, 01 Mar 2021 13:07:13 +0000 Globe Newswire 19911183 at https://www.benzinga.com Onconova Therapeutics to Participate in Three Investment Conferences During the Month of March https://www.benzinga.com/pressreleases/21/03/g19909786/onconova-therapeutics-to-participate-in-three-investment-conferences-during-the-month-of-march <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="justify">NEWTOWN, PA., March 01, 2021 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONTX#NASDAQ" rel="nofollow">ONTX</a>) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President and Chief Executive Officer, will participate in three virtual investment conferences during the month of March, as follows:<br /></p> <ul type="disc"> <li style="text-align:justify;">The H.C. Wainwright Global Life Sciences Virtual Conference with one-on-one meetings being held March 9-10, 2021</li> <li style="text-align:justify;">The Virtual 33rd Annual Roth Conference with one-on-one meetings being held March 15-17, 2021</li> <li style="text-align:justify;">The Maxim Group Emerging Growth Virtual Conference being held March 17-18, 2021 with one-on-one meetings scheduled after the event<br /></li> </ul> <p align="justify">The Roth Capital Partners presentation will be prerecorded and available in the Investors &amp; Media section of the Company&#039;s website beginning today. Institutional and other investors interested in scheduling a one-on-one meeting with Onconova during any of these conferences should contact their sales representative at the sponsoring investment bank.</p> <p align="justify"><strong>About Onconova Therapeutics, Inc. </strong><br />Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer. The ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19909786/onconova-therapeutics-to-participate-in-three-investment-conferences-during-the-month-of-march alt=Onconova Therapeutics to Participate in Three Investment Conferences During the Month of March>Full story available on Benzinga.com</a></p> Biotech News ONTX Health Care Retail Sales Press Releases General Mon, 01 Mar 2021 13:00:00 +0000 Globe Newswire 19909786 at https://www.benzinga.com VYNE Therapeutics Announces Development Program for FMX114 Combination Topical Gel for Mild-to-Moderate Atopic Dermatitis https://www.benzinga.com/pressreleases/21/03/g19909768/vyne-therapeutics-announces-development-program-for-fmx114-combination-topical-gel-for-mild-to-mod <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="center">Announces promising preclinical data on FMX114<br /></p> <p align="center">Phase 2a clinical study in AD expected to begin in 3Q 2021 with top-line results by year end</p> <p align="center">Further details on FMX114, including clinical development plans, will be discussed on VYNE&#039;s year end 2020 earnings call at 8:30am ET March 4</p> <p>BRIDGEWATER, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VYNE#NASDAQ" rel="nofollow">VYNE</a>) ("VYNE" or the "Company") today announced development plans for FMX114, a fixed combination of pan-JAK inhibitor tofacitinib and sphingosine 1-phosphate receptor modulator fingolimod in a topical gel for the potential treatment of mild-to-moderate atopic dermatitis (AD). FMX114, VYNE&#039;s first product candidate designed to target AD, will be evaluated in a Phase 2a proof of concept study expected to begin in 3Q 2021.</p> <p>"We are excited to announce VYNE&#039;s newest therapeutic candidate FMX114," said David Domzalski, Chief Executive Officer of VYNE. "FMX114 is a non-steroidal topical treatment that is designed to address the multi-factorial nature of AD by offering a fixed combination multimodal solution to disease management. Advancement of FMX114 supports our strategic objective of building a diversified pipeline of products to address unmet needs of patients. We look forward to initiating the planned Phase 2a clinical trial in Q3 this year with anticipated top-line results by year end."</p> <p><strong>Proof of Concept Demonstrated in an Animal Model of AD</strong></p> <p>FMX114 was evaluated in a well-known nonclinical model in which dorsal depilated BALB-C mice are dosed with 100µl topical dinitrochlorobenzene (DNCB) solution to induce a type 2 inflammatory response in the skin with AD-like pathology. There was a 32-day induction phase followed by 7 days of both DNCB and investigational drug concomitant treatment. Two doses of FMX114 (0.6% tofacitinib + 0.01% fingolimod and 0.3% tofacitinib + 0.02% fingolimod) were compared with tofacitinib monotherapy, fingolimod monotherapy, triamcinolone (steroid) 0.1%, and DNCB control.</p> <p>Key findings from the study:</p> <ul type="disc"> <li style="margin-bottom:6pt;">Treatment with FMX114 0.6% tofacitinib + 0.01% fingolimod combination gel resulted in an 89% reduction in the modified atopic dermatitis index score (mADI) relative to the DNCB control group at day 7.</li> <li style="margin-bottom:6pt;">Both FMX114 doses had comparable efficacy to triamcinolone 0.1% cream, a product widely used in the treatment of AD.</li> <li style="margin-bottom:6pt;">Animal body weight was also evaluated to help determine tolerance to treatment. At day 7:<br /> <ul type="disc"> <li style="margin-bottom:6pt;">In both FMX114 treatment groups, the animals experienced body weight gains comparable to DNCB negative control and vehicle-treated healthy control animal groups.</li> <li>Animals treated with triamcinolone 0.1% cream lost approximately 21% of their body weight compared to the animals treated with FMX114.<br /></li> </ul> </li> </ul> <p><strong>Conference Call and Live Webcast</strong><br />VYNE management will host a conference call and live webcast with slides on Thursday, March 4, 2021, at 8:30 am Eastern Time to discuss the Company&#039;s financial results for the year ended December 31, 2020 and provide a business update. Dr. Iain Stuart, Chief ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19909768/vyne-therapeutics-announces-development-program-for-fmx114-combination-topical-gel-for-mild-to-mod alt=VYNE Therapeutics Announces Development Program for FMX114 Combination Topical Gel for Mild-to-Moderate Atopic Dermatitis>Full story available on Benzinga.com</a></p> VYNE Health Care Press Releases General Mon, 01 Mar 2021 13:00:00 +0000 Globe Newswire 19909768 at https://www.benzinga.com Cue Biopharma to Present at the Cowen 41st Annual Health Care Conference https://www.benzinga.com/pressreleases/21/03/g19909735/cue-biopharma-to-present-at-the-cowen-41st-annual-health-care-conference <link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="left">CAMBRIDGE, Mass., March 01, 2021 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=iyZc6mlWq_i3xSQJqFlxd7-I_DsdKNWGWBT-de57J_kQe4twYa-z2eGaD4i-Tk2B39zw2P4JNySXnLdBPhPlgLY9UPX128fvZAN5Xk5Losk=" rel="nofollow" target="_blank" rel="nofollow">Cue Biopharma, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CUE#NASDAQ" rel="nofollow">CUE</a>), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient&#039;s body, announced today that it will present at the Cowen 41st Annual Health Care Conference being held virtually from March 1-4, 2021.<br /></p> <p>At the conference, Cue Biopharma will provide an overview highlighting recent developments of the Immuno-STAT&#x2122; <em>(Selective Targeting and Alteration of T cells)</em> platform, its expanding pipeline and anticipated milestones. The presentation will also include an update on the Company&#039;s ongoing Phase 1 ...</p><p><a href=https://www.benzinga.com/pressreleases/21/03/g19909735/cue-biopharma-to-present-at-the-cowen-41st-annual-health-care-conference alt=Cue Biopharma to Present at the Cowen 41st Annual Health Care Conference>Full story available on Benzinga.com</a></p> CUE News Health Care Press Releases Mon, 01 Mar 2021 13:00:00 +0000 Globe Newswire 19909735 at https://www.benzinga.com