Banish Burnout: New Programs Help Banish This Silent $Trillion Epidemic
RENO, Nev., May 23, 2025 /CNW/ -- Renowned business coach and social psychologist Dr. André Walton, founder of Plan4Change, has launched two one-on-one coaching programs designed to combat burnout using his innovative Spherical Thinking™ method. His Banish Burnout programs are helping professionals rewire their thinking to overcome anxiety, stress, and exhaustion, while also equipping them to identify early signs of burnout in others.
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Globe and Mail
25 minutes ago
- Globe and Mail
$750 Million Market Projected to Reach $3.35 Billion Globally in 2034 for Abbreviated New Drug Application Filed on Preservative-Free IV Ketamine: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
$NRXP Has $7.8 Million in Financing for Clinic Acquisitions and Purchase of Kadima Neuropsychiatry Institute as Treatment Model and Leading Investigative Site for Suicidal Depression / PTSD Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain. Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC). Abbreviated New Drug Application Filed for Preservative-Free IV Ketamine. Current Ketamine Market Estimated at $750 Million and Projected to Reach $3.35 Billion Globally in 2034. $7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with Universal Capital, LLC. Added to Previously Announced Term Sheet with a Strategic Investor, NRXP HOPE Funding of $10.3 Million is Planned in Near Term. Agreement to Purchase Kadima Neuropsychiatry Institute Expected to Serve as Clinical Model for Treatment Offerings Nationwide. Kadima is a Leading Investigative Site for CNS and Psychedelic Research, Having Served as the Lead Site in Nearly All Major Trials in This Space. Dr. David Feifel, Nationally Recognized Pioneer in Interventional Psychiatry to join as Chief Medical Innovation Officer. New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia. Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine. Patent expected to be Orange Book Listable. Waiver Exemption from Paying a $4.3 Million New Drug Application Fee Under Prescription Drug User Fee Act (PDUFA). Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties. Application to Uplist to NASDAQ Global Market from NASDAQ Capital Market NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100. In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine On June 5th NRXP announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management. NRXP anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of closely related benzalkonium chloride in current drug products. Preservatives were originally added to sterile injectable products in an era when a single vial of medication was used to treat multiple patients, a practice no longer allowed in US hospitals. NRXP has demonstrated that there is no need for such preservatives to maintain stability and sterility in ketamine presentations intended for single-patient use. Should the citizen's petition be granted, all formulations of ketamine sold in the US could face a regulatory requirement to be preservative free. $7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions On May 15th NRXP announced signing of a term sheet with Universal Capital, LLC to provide $7.8 million in acquisition capital to initiate subsidiary HOPE's planned national rollup of interventional psychiatry clinics, commencing with previously-announced acquisitions of Dura Medical, Kadima, and NeuroSpa. Together with proceeds of a previously announced strategic investment, this financing is anticipated to provide $10.3 million in acquisition capital. HOPE's three initial acquisitions represent best-in-class clinics that offer neuroplastic treatments including NRXP ketamine and transcranial magnetic stimulation (TMS) to treat patients with severe depression, PTSD, and related central nervous system conditions. Neuroplastic treatments represent a rapidly emerging class of interventions that cause the growth of new connections (synapses) between brain cells that have been shown in multiple clinical trials to relieve symptoms of depression and suicidality. The FDA has approved TMS devices for a number of indications and has approved a nasal form of ketamine for treatment resistant depression. HOPE's parent company, NRXP, is currently applying to the FDA for approval of intravenous preservative-free ketamine to treat suicidal depression. Agreement to Purchase Kadima Neuropsychiatry Institute; Foundational Acquisition for the NRXP HOPE Network of Interventional Psychiatry Clinics On May 13th NRXP announced signing of a definitive agreement to purchase the Kadima Neuropsychiatry Institute. Kadima is expected to serve as the clinical model for treatment offerings in NRXP HOPE-acquired clinics and is expected to continue its role as a leading investigative site for research into neuroplastic therapies including psychedelic medications, transcranial magnetic stimulation (TMS), and hyperbaric therapy. Kadima is one of California's flagship interventional psychiatry clinics and was among the first to bring ketamine treatment for central nervous system (CNS) disorders out of academic research settings and into clinical practice. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, transcranial magnetic stimulation ("TMS") as well as medication management. Further, Kadima and David Feifel, MD PhD, Founder and Medical Director of Kadima, have served as leaders in clinical trial work on emerging therapies in CNS for top companies in the industry. Importantly, the clinic is profitable and is forecast to continue growth going forward. Dr. Feifel will join NRXP HOPE as its first Chief Medical Innovation Officer upon closing of the acquisition. Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine On May 5th NRXP announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. This patent filing builds on the NRXP recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRXP advances its commercialization strategy. "We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRXP. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need." FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression On April 30th NRXP announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. NRXP anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025). Disclosure listed on the CorporateAds website Media Contact Company Name: NRx Pharmaceuticals, Inc. Contact Person: Matthew Duffy, Chief Business Officer Email: Send Email Phone: 484 254 6134 Address: 1201 Orange Street Suite 600 City: Miami State: Florida Country: United States Website:
CBC
35 minutes ago
- CBC
Carney and Trump are holding direct talks to drop tariffs: sources
Prime Minister Mark Carney and U.S. President Donald Trump are having direct discussions to reach a trade deal and lift tariffs, according to sources with knowledge of their talks. The two leaders agreed even before Canadians went to the polls this spring that they would chart a new economic and security deal, but the Canada-U.S. relationship appeared to hit a snag earlier this week when Trump doubled tariffs on all steel and aluminum imports. The tariffs, now at 50 per cent, are a further blow to the Canadian industries that are the U.S.'s biggest supplier of the metals. In response, Carney only said "intensive discussions" were ongoing and that his government was readying reprisals if negotiations with the United States failed. Sources, who spoke to CBC News and Radio-Canada on the condition they not be named, now say the two have been talking on the phone about reaching a deal. WATCH | Canadian exports to U.S. are dropping: Canadian exports to U.S. fell more than 15% in April as Trump tariffs hit 25 minutes ago Duration 4:05 There have been no public readouts of the calls. Carney and Trump met publicly last month at the White House, but no direct communication between the leaders had been confirmed since then. Earlier this week, Radio-Canada reported that Ottawa is hoping to reach an agreement with the Trump administration before the G7 summit — just 10 days from now in Alberta. Earlier this week, Trump's envoy to Canada, Ambassador Pete Hoekstra, told a crowd in Toronto the deal "is being settled at the highest levels of the U.S. government with the involvement of the highest elected officials."
CTV News
42 minutes ago
- CTV News
Trump and Musk's relationship flames out just as it started, intensely and publicly
Elon Musk speaks during a news conference with U.S. President Donald Trump in the Oval Office of the White House, Friday, May 30, 2025, in Washington. (AP Photo/Evan Vucci) WASHINGTON — The breakup between the president of the United States and the world's richest man is unfurling much like their relationship started — rapidly, intensely and very publicly. As U.S. President Donald Trump sat in the Oval Office on Thursday with Germany's leader at his side, he lamented his soured relationship with Elon Musk, his adviser-turned-social media antagonist. Trump said he was 'very disappointed' with Musk after the billionaire former backer lambasted the president's signature bill of tax cuts and spending plans. Trump suggested Musk, who left the government last month after spearheading the tumultuous Department of Government Efficiency, misses being in the White House and has 'Trump derangement syndrome.' 'He hasn't said bad about me personally, but I'm sure that will be next,' Trump said. 'But I'm very disappointed in Elon. I've helped Elon a lot.' Without me, Trump would have lost the election, Dems would control the House and the Republicans would be 51-49 in the Senate. — Elon Musk (@elonmusk) June 5, 2025 Observers had long wondered if the friendship between the two brash billionaires known for lobbing insults online would flame out in spectacular fashion. It did, in less than a year. 'Look, Elon and I had a great relationship. I don't know if we will anymore,' Trump said. He said that he had helped Musk a lot and brushed aside the billionaire's efforts to get him elected last year, claiming that he would have won closely contested Pennsylvania even without Musk's help, which included spending at least $250 million supporting his campaign. The Republican president's comments came as Musk has continued a storm of social media posts attacking Trump's 'Big Beautiful Bill' and warning it will increase the federal deficit. Musk has called Trump's big tax break bill a 'disgusting abomination.' As Trump spoke to reporters at the White House on Thursday, Musk was watching. 'False,' he fired back on his social media platform as the president continued speaking. 'This bill was never shown to me even once and was passed in the dead of night so fast that almost no one in Congress could even read it!' Trump said Musk, the CEO and founder of Tesla, 'only developed a problem' with the bill because it rolls back tax credits for electric vehicles. 'Whatever,' Musk snapped back in a post on X responding to a video clip of the moment. He went on and said Trump could keep the cuts but should 'ditch the MOUNTAIN of DISGUSTING PORK in the bill.' The bill would unleash trillions of dollars in tax cuts and slash spending but also spike deficits by $2.4 trillion over a decade and leave some 10.9 million more people without health insurance, according to an analysis by the Congressional Budget Office, which for decades has served as the official scorekeeper of legislation in Congress. Michelle L. Price, The Associated Press
