- Bristol Myers buys Orbital Therapeutics for $1.5 billion in cell therapy push Reuters
- Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics Business Wire
- BMS inks $1.5B in vivo CAR-T buyout to pull Orbital into its sphere of influence Fierce Biotech
- BMS Makes $1.5B Cell Therapy Play With Orbital Takeover BioSpace
- Bristol Myers to buy startup Orbital Therapeutics, building out cell therapy pipeline statnews.com
Category: 3. Business
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Bristol Myers buys Orbital Therapeutics for $1.5 billion in cell therapy push – Reuters
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‘Brazen shoplifting’ forces Liverpool butcher to shut down
A butcher has said the level of shoplifting at his business was one of the reasons for closing down.
Westcott Factory Meats in Liverpool also said the increasing cost of business rates, national insurance and electricity had played a part in the decision.
Its owner and director, Carl Hayes, said thieves had been “brazenly” stealing products, including legs of lamb and steaks, on a weekly basis.
Mr Hayes, who has been in the meat and butchery business for over 30 years, said the level of crime was “now the worst it’s ever been”.
Mr Hayes said: “We had one the other week where a guy took a big bag of legs of lamb. It was a Saturday morning, we were busy, loads going on, but he just walked out.
“We used to have a security guard a couple of days a week, but again, that comes at a cost that you’ve got to put into the business.
“But it’s worse now. In the last six, nine months, it’s the worst it’s ever been.”
The business started as a stall at Stanley Meat Market in Old Swan in 2012 before moving to its current premises on Smithdown Road in 2017.
It closed its doors for the last time on 8 October and had to lay off 12 members of staff.
“We’re just one of thousands of businesses that are suffering in the same way,” he said.
In a post on Facebook, a business representative, who also cited the rise of meat prices as an issue, said it was “with deep regret” the shop was closing after eight “fabulous years”.
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Reminder: Program for the publication of Yara International ASA third quarter results 2025
Yara International ASA third quarter 2025 results will be published on Friday, 17 October 2025 at 08:00 CEST.
You can follow the third-quarter results presentation online at 12:00 CEST. The presentation will be held in English.
The report, presentation and webcast will be available at the above mentioned times at https://yara.com/investor-relations/latest-quarterly-report
There will also be a conference call at 13:00 CEST the same day with an opportunity to ask questions to Yara’s management. Please use the link to register for this session:
https://registrations.events/direct/Q4I4815792Registered conference call participants will receive a confirmation with a full list of available international dial-in numbers and a unique passcode. If you do not see the email in a few minutes after completed registration, please check the “junk mail” folder or “spam” folder in your email client. Please join the call 5-10 minutes prior to scheduled start time.
Alternatively, it is possible to use the dial-in numbers listed below on the day of the conference to register through an operator:
Norway: +47 57 98 94 27
UK: +44 20 8610 3526
USA: +1 646 307 1951
India: +91 2250323379When prompted, provide the conference ID: 48157.
Contact
Maria Gabrielsen
Head of Investor Relations
M: +47 920 900 93
E: maria.gabrielsen@yara.comAbout Yara
Yara’s mission is to responsibly feed the world and protect the planet. We pursue a strategy of sustainable value growth through reducing emissions from crop nutrition production and developing low-emission energy solutions. Yara’s ambition is focused on growing a nature-positive food future that creates value for our customers, shareholders and society at large and delivers a more sustainable food value chain.
To drive the green shift in fertilizer production, shipping, and other energy intensive industries, Yara will produce ammonia with significantly lower emissions. We provide digital tools for precision farming and work closely with partners at all levels of the food value chain to share knowledge and promote more efficient and sustainable solutions.
Founded in 1905 to solve the emerging famine in Europe, Yara has established a unique position as the industry’s only global crop nutrition company. With 17,000 employees and operations in more than 60 countries, sustainability is an integral part of our business model. In 2024, Yara reported revenues of USD 13.9 billion.
www.yara.com
This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act
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OpenAI video app Sora hits 1 million downloads faster than ChatGPT
OpenAI says the latest version of its text-to-video artificial intelligence (AI) tool Sora was downloaded over a million times in less than five days – hitting the milestone faster than ChatGPT did at launch.
The app, which has topped the Apple App Store charts in the US, generates ten second long realistic-looking videos from simple text prompts.
The figures were announced in an X post from Sora boss Bill Peebles, who said the “surging growth” came even though the app was only available to people in North America who had received an invite.
But its handling of copyright material – and the images of dead public figures – has attracted significant criticism online despite the growth.
The Sora app – which makes it easy for users to post videos they have created to social media – has resulted in a deluge of videos on social feeds.
Some have included depictions of deceased celebrities such as musicians Michael Jackson and Tupac Shakur.
Three days ago, Zelda Williams, the daughter of Robin Williams, asked people to stop sending her AI-generated videos of her father, the celebrated US actor and comic who died in 2014.
A plea that press reports have linked to the popularity of Sora.
An OpenAI spokesperson told US news site Axios in an email there were “strong free speech interests” in allowing the depiction of historical figures.
But the spokesperson said, for public figures who were “recently deceased”, authorized persons could request their likenesses aren’t used – though it did not specify what counted as “recent”.
Videos also frequently feature depictions of characters from films, TV and games.
In one Sora deepfake of Sam Altman, the OpenAI boss is shown with several Pokémon characters saying “I hope Nintendo doesn’t sue us”, CNBC reported.
In another viral deepfake video he grills and eats the game’s infamous Pikachu mascot.
Nintendo has not revealed any plans to take legal action, but several companies behind popular generative AI systems, including OpenAI, are currently locked in legal battles with the creators and rights holders of creative works.
The potential cost of these battles is high.
AI firm Anthropic agreed to pay $1.5bn (£1.11bn) to settle a class action lawsuit filed by authors who said the company stole their work to train its AI models.
OpenAI says it is adapting its approach to these issues.
On 4 October, Mr Altman blogged that the firm had been “learning quickly from how people are using Sora and taking feedback from users, rights holders, and other interested groups”.
He said the firm would “give rights holders more granular control over generation of characters”.
And he said there were plans for some form of revenue-sharing in the future.
But it remains to be seen if rights holders will agree Sora videos are a new kind of “interactive fan fiction” as Mr Altman suggested – or whether it will force the firm to face a grilling in the civil courts.
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Resource, economic, and carbon benefits of end-of-life trucks’ urban mining in China
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How Old Companies Can Ignite New Growth
As companies mature, their growth tends to slow. Research has shown that stagnation is a normal part of the corporate life cycle—but it is not destiny. Some firms defy the trend, achieving and sustaining what we call breakout growth: they increase their sales at least twice as fast as their peers for five years, and then sustain above-industry growth for five subsequent years. In a global study of 848 companies that experienced stagnation—defined as five years of below-industry revenue growth—we identified 99 companies that beat the odds over the subsequent 10 years.
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S&P Global and CME Group Complete Sale of OSTTRA to KKR
NEW YORK, October 10, 2025 — S&P Global (NYSE: SPGI) and CME Group today announced that they have completed the sale of OSTTRA to KKR, a leading global investment firm. The terms of the deal for OSTTRA equaled total enterprise value at $3.1 billion, which will be divided evenly between S&P Global and CME Group pursuant to their 50/50 joint venture.
Established in 2021 as a joint venture between CME Group and S&P Global, OSTTRA serves the global financial ecosystem with a comprehensive suite of critical post-trade offerings across interest rates, FX, credit and equity asset classes. OSTTRA provides end-to-end connectivity and workflow solutions to banks, broker-dealers, asset managers, and other market participants across trade processing, trade lifecycle, and optimization.
Barclays and Davis Polk served as financial and legal advisors, respectively, to S&P Global. Citi and Skadden served as financial and legal advisors, respectively, to CME Group.
About S&P Global
S&P Global (NYSE: SPGI) provides essential intelligence. We enable governments, businesses and individuals with the right data, expertise and connected technology so that they can make decisions with conviction. From helping our customers assess new investments to guiding them through sustainability and energy transition across supply chains, we unlock new opportunities, solve challenges and accelerate progress for the world.We are widely sought after by many of the world’s leading organizations to provide credit ratings, benchmarks, analytics and workflow solutions in the global capital, commodity and automotive markets. With every one of our offerings, we help the world’s leading organizations plan for tomorrow, today.
About CME Group
As the world’s leading derivatives marketplace, CME Group (www.cmegroup.com) enables clients to trade futures, options, cash and OTC markets, optimize portfolios, and analyze data – empowering market participants worldwide to efficiently manage risk and capture opportunities. CME Group exchanges offer the widest range of global benchmark products across all major asset classes based on interest rates, equity indexes, foreign exchange, energy, agricultural products and metals. The company offers futures and options on futures trading through the CME Globex platform, fixed income trading via BrokerTec and foreign exchange trading on the EBS platform. In addition, it operates one of the world’s leading central counterparty clearing providers, CME Clearing.CME Group, the Globe logo, CME, Chicago Mercantile Exchange, Globex, and E-mini are trademarks of Chicago Mercantile Exchange Inc. CBOT and Chicago Board of Trade are trademarks of Board of Trade of the City of Chicago, Inc. NYMEX, New York Mercantile Exchange and ClearPort are trademarks of New York Mercantile Exchange, Inc. COMEX is a trademark of Commodity Exchange, Inc. BrokerTec is a trademark of BrokerTec Americas LLC and EBS is a trademark of EBS Group LTD. The S&P 500 Index is a product of S&P Dow Jones Indices LLC (“S&P DJI”). “S&P®”, “S&P 500®”, “SPY®”, “SPX®”, US 500 and The 500 are trademarks of Standard & Poor’s Financial Services LLC; Dow Jones®, DJIA® and Dow Jones Industrial Average are service and/or trademarks of Dow Jones Trademark Holdings LLC. These trademarks have been licensed for use by Chicago Mercantile Exchange Inc. Futures contracts based on the S&P 500 Index are not sponsored, endorsed, marketed, or promoted by S&P DJI, and S&P DJI makes no representation regarding the advisability of investing in such products. All other trademarks are the property of their respective owners.
Media Contacts:
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Farhan Husain
farhan.husain@spglobal.comInvestor Relations
mark.grant@spglobal.comCME Group
Laurie Bischel
laurie.bischel@cmegroup.comInvestor Relations
investors@cmegroup.comCME-G
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Bombardier Set to Impress at NBAA-BACE 2025 with Global and Challenger Jets on Display
- Bombardier will participate in NBAA-BACE from October 14–16 in Las Vegas
- Bombardier Global 7500, Global 6500, and Challenger 3500 aircraft will be featured on static display
- Media representatives are invited to two exclusive Bombardier events at NBAA-BACE in Las Vegas, including a special unveiling at Henderson Executive Airport on Tuesday, October 14 at 2:00 p.m.
Bombardier announced today its participation in the 2025 edition of the NBAA Business Aviation Convention & Exhibition (NBAA-BACE), taking place October 14–16 at Henderson Executive Airport in Las Vegas. As a global leader in business aviation, Bombardier will showcase three of its most iconic aircraft on static display – the Global 7500, Global 6500, and Challenger 3500 – and will also highlight its top-ranked, comprehensive service offering on site.
“Our aircraft are designed to inspire, and they stand out as some of the most compelling examples of innovation and craftsmanship at this year’s show, complemented by our extensive service offering that ensures an exceptional ownership experience,” said Éric Martel, President and Chief Executive Officer, Bombardier. “The Bombardier Global 7500, Global 6500, and Challenger 3500 each bring something exceptional to the table, and with the Global 8000 on the horizon as the fastest business jet in the world, we continue to redefine what’s possible in business aviation.”
Visitors to the static display will have the opportunity to explore the spacious and refined interiors of each jet—including the record-setting Bombardier Global 7500, renowned for its industry-leading speed and landing capabilities; the Global 6500, offering outstanding versatility and long-range performance; and the Challenger 3500, which delivers impressive speed and efficiency. All three aircraft are engineered to provide Bombardier’s signature smooth ride, ensuring exceptional comfort on every mission.
Media representatives are invited to attend two Bombardier events at NBAA-BACE in Las Vegas for exclusive access to the company’s latest announcements. The first media event will be held on Monday, October 13 at 11:00 a.m. (Pacific Time). A second event—a special unveiling celebration—will take place at Bombardier’s static display at Henderson Executive Airport on Tuesday, October 14 at 2:00 p.m. (Pacific Time).
For media inquiries or to schedule aircraft tours, please contact Bombardier’s Public Relations team.
About Bombardier
At Bombardier (BBD-B.TO), we design, build, modify and maintain the world’s best-performing aircraft for the world’s most discerning people and businesses, governments and militaries. That means not simply exceeding standards, but understanding customers well enough to anticipate their unspoken needs.
For them, we are committed to pioneering the future of aviation—innovating to make flying more reliable, efficient and sustainable. And we are passionate about delivering unrivaled craftsmanship and care, giving our customers greater confidence and the elevated experience they deserve and expect. Because people who shape the world will always need the most productive and responsible ways to move through it.
Bombardier customers operate a fleet of more than 5,100 aircraft, supported by a vast network of Bombardier team members worldwide and 10 service facilities across six countries. Bombardier’s performance-leading jets are proudly manufactured in aerostructure, assembly and completion facilities in Canada, the United States and Mexico. In 2024, Bombardier was honoured with the prestigious “Red Dot: Best of the Best” award for Brands and Communication Design.
For Information
For corporate news and information, including Bombardier’s Sustainability report, as well as the company’s initiative to cover all its flight operations with a Sustainable Aviation Fuel (SAF) blend utilizing the Book-and-Claim system visit
bombardier.com.Learn more about Bombardier’s industry-leading products and customer service network at bombardier.com. Follow us on X @Bombardier.
Media Contacts
General media contact webform
Christina Lemyre McCraw
+1-514-497-4928
christina.lemyremccraw@aero.bombardier.comBombardier, Global, Global 8000, Global 7500, Global 6500 and Challenger 3500 are registered or unregistered trademarks of Bombardier Inc. or its subsidiaries.
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Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress
TITUSVILLE, N.J. (October 10, 2025) — Johnson & Johnson (NYSE: JNJ) announced today that 17 abstracts featuring new clinical and real-world data will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands. Presentations include the latest research from across the Company’s neuropsychiatry portfolio, including major depressive disorder (MDD), treatment-resistant depression (TRD), and schizophrenia.
“MDD is a complex disorder that can manifest in different ways for each individual, and the traditional one-size-fits-all treatment approach often results in mixed patient outcomes,” said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine.1,2 “At Johnson & Johnson, we are committed to advancing innovative and differentiated therapies through a targeted and patient-first approach, and our data at ECNP strongly reflects our relentless focus on this commitment.”
Key presentations include:
- New analysis of Phase 3 data evaluating the impact of investigational adjunctive CAPLYTA® (lumateperone) on sexual function in patients with MDD (Poster PS04-3102).3
- An oral presentation highlighting findings from a sub-group analysis of Phase 3 data evaluating the efficacy of adjunctive seltorexant, an investigational first-in-class therapy, compared with adjunctive quetiapine extended release (XR) in European Union and United Kingdom patients with MDD with insomnia symptoms.4
- Findings from a post-hoc analysis of the ESCAPE-TRD study examining the association between baseline patient characteristics and reaching remission with SPRAVATO® (esketamine) CIII nasal spray versus quetiapine XR in patients with TRD (Poster PS02-1219).5
- Real-world safety data from the French ELLIPSE study of SPRAVATO® (PS02-1111).6
- Results from a Delphi research study outlining expert consensus recommendations of European psychiatrists on key decision-making factors for continuation of SPRAVATO® treatment in patients with TRD (Poster PS04-3215).7
Johnson & Johnson will present the following posters at ECNP Congress on October 12 from 8:00 – 8:30 a.m. CET (e-posters), October 13 from 12:35 – 2:00 p.m. CET, and October 14 from 12:35 – 2:00 p.m. CET.
Poster # Title Major Depressive Disorder EP03-0245 Adjunctive Lumateperone 42 mg Treatment in Major Depressive Disorder: Efficacy in Anhedonia and Across Broad Range of Depressive Symptoms PS03-2109 Efficacy of Adjunctive Lumateperone 42 mg Treatment Across Depression and Anhedonia Symptoms in Major Depressive Disorder PS04-3102 Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder EP03-0243 Long-Term Adjunctive Lumateperone Treatment in Major Depressive Disorder: Results From a Six-Month Open-Label Extension Study PS03-2108 Beyond Inflammation: Unveiling Novel Molecular Mechanisms in Major Depressive Disorder and Antidepressant Response in a Cohort Stratified by Inflammatory Status PS02-1123 Seltorexant: A Safe and Well-Tolerated Adjunctive Treatment for Adolescent Major Depressive Disorder With Comparable Pharmacokinetics to Adults PS03-2143 Factors Associated With Long-Term Hypnotics Use in Depression Oral Presentation Developments in Adjunctive Treatment: Seltorexant Versus Quetiapine in Managing Major Depressive Disorder With Insomnia Symptoms Treatment-Resistant Depression PS02-1220 Efficacy and Safety of 4 Months of Treatment With Esketamine Nasal Spray Monotherapy in Adult Patients With Treatment-Resistant Depression PS01-0124 Early Dose Management and Up-Titration of Esketamine in the Double-Blind Induction Phase of the Randomized, Active-Controlled, Phase 3 TRANSFORM-2 Study PS04-3215 Expert Consensus on Decision-Making Factors for Continuation of Esketamine Nasal Spray in Treatment-Resistant Depression: A Delphi Method PS02-1216 ECHO: Study Design and Baseline Characteristics of a Non-Interventional Cohort Study of Esketamine Nasal Spray in Treatment-Resistant Depression PS02-1219 Patient Characteristics Associated With Relative Benefit of Esketamine Nasal Spray Versus Quetiapine Extended Release on Achieving Remission in ESCAPE-TRD Study PS02-1111 Evolution of Clinical Dimensions and Safety in Patients With Major Depressive Disorder Treated by Esketamine: The French Real-World ELLIPSE Study PS01-0076 Prevalence, Incidence, and Therapy of (Treatment-Resistant) Depression in Germany: A Sickness Funds Analysis Schizophrenia PS01-0220 Impact of Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables on Clinical and Psychosocial Outcomes in Rwandan Patients With Schizophrenia PS04-3104 Lumateperone For The Prevention of Relapse in Patients with Schizophrenia: Results From a Double-Blind, Placebo-Controlled, Randomized Withdrawal, Phase 3 Trial ABOUT MAJOR DEPRESSIVE DISORDER (MDD)
MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people – or about 4 percent of the population.8,9 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.10 While depression is typically treated with a “one-size-fits-all” approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations.1,2 As a result, responses to treatment vary widely. With current standard-of-care oral antidepressants, 2 in 3 people living with MDD continue to experience residual or persistent symptoms.11 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.12Insomnia is one of the most common symptoms of MDD, affecting more than 80 percent of people living with MDD.13 Disturbed sleep and insomnia symptoms have a significant impact on a patient’s quality of life and exacerbate the risk of depressive relapse and suicide.14,15
Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration.16,17 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.17 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.18 Based on the STAR*d study, after trying their third oral antidepressant, approximately 86 percent of patients do not achieve remission.18
ABOUT CAPLYTA®
CAPLYTA® (lumateperone) 42 mg is an oral, once daily atypical antipsychotic approved for the treatment of adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate.While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses.
A supplemental new drug application (sNDA) for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder is currently under U.S. Food and Drug Administration review.
ABOUT SELTOREXANT
Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms and restoring sleep without next-day sedation in patients with depression.19 When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression and insomnia.20,21 Seltorexant is the only investigational therapy being studied in MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby addressing the underlying biology that contributes to depression and causes insomnia symptoms.ABOUT SPRAVATO®
SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration alone or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in 79 markets and administered to more than 150,000 patients worldwide.ABOUT SCHIZOPHRENIA
Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the U.S. yet remains widely misunderstood and insufficiently treated.22 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common.23 Evidence shows that the first three to five years after diagnosis – “the critical period” – from symptom onset are key for a patient’s treatment, as this is when the condition progresses most rapidly.24,25 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.26ABOUT JOHNSON & JOHNSON’S SCHIZOPHRENIA PORTFOLIO
Johnson & Johnson’s portfolio of schizophrenia therapies offers the broadest range of oral and long-acting injectable treatment options to support each patient’s individual treatment journey. The Company’s long-acting injectable treatments for adults with schizophrenia provides the most varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available, including INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional.23,24CAPLYTA® is a once-daily oral therapy approved to treat adults with schizophrenia. A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was recently
submitted to the U.S. Food and Drug Administration.CAPLYTA® IMPORTANT SAFETY INFORMATION
CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Important Safety Information
Boxed Warnings:
· Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
· Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
- Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.
CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.
Please click here to see full Prescribing Information including Boxed Warnings.
SPRAVATO® IMPORTANT SAFETY INFORMATION
What is SPRAVATO® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine used:
- with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD)
- with an antidepressant taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?SPRAVATO® can cause serious side effects, including:
- Sedation, dissociation, and respiratory depression. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), breathing problems (respiratory depression and respiratory arrest)
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
- Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO®, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program.
- Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children.
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
- How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
o Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
o Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
· thoughts about suicide or dying
· new or worse depression
· feeling very agitated or restless
· trouble sleeping (insomnia)
· acting aggressive, being angry or violent
· an extreme increase in activity and talking (mania)· suicide attempts
· new or worse anxiety
· panic attacks
· new or worse irritability
· acting on dangerous impulses
· other unusual changes in behavior or moodDo not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
- have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
- are pregnant or plan to become pregnant. SPRAVATO® may harm your unborn baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at
https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
See “What is the most important information I should know about SPRAVATO®?”
Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® include:
· feeling disconnected from yourself, your thoughts, feelings and things around you · dizziness
· nausea
· feeling sleepy
· spinning sensation
· decreased feeling of sensitivity (numbness)
· feeling anxious · lack of energy
· increased blood pressure
· vomiting
· feeling drunk
· headache
· feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088.
Please see full
Prescribing Information, including Boxed WARNINGS, and
Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.cp-170363v4
INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® IMPORTANT SAFETY INFORMATION
INDICATIONS
INVEGA HAFYERA® (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA® is used in adults who have been treated with either:
- INVEGA SUSTENNA® (paliperidone palmitate) a 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months
- INVEGA TRINZA® (paliperidone palmitate) a 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months
INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months.
INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional.
INVEGA SUSTENNA® is used to treat schizophrenia in adults.
INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® IMPORTANT SAFETY INFORMATION
What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®?INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:
- Increased risk of death in elderly people with dementia-related psychosis.
INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® are not for the treatment of people with dementia-related psychosis.
Do not receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients.
Before you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your blood
- have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have Parkinson’s disease or a type of dementia called Lewy Body Dementia
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being treated for high blood pressure
- have or have had seizures or epilepsy
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby
- If you become pregnant while taking INVEGA HAFYERA®, INVEGA TRINZA® or
INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. - Infants born to women who are treated with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
- If you become pregnant while taking INVEGA HAFYERA®, INVEGA TRINZA® or
- are breastfeeding or plan to breastfeed. INVEGA HAFYERA®, INVEGA TRINZA® or
INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® works.
Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
How will I receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®?
- Follow your treatment schedule exactly as your healthcare provider tells you to.
- Your healthcare provider will tell you how much you will receive and when you will receive it.
What should I avoid while receiving INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®?
- INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA®, INVEGA TRINZA® or
INVEGA SUSTENNA® affects you.
- Avoid getting overheated or dehydrated.
INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:
- See “What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®?”
- stroke in elderly people (cerebrovascular problems) that can lead to death
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure.
- problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats.
- uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain.
- low blood pressure and fainting
- changes in your blood cell counts
- high level of prolactin in your blood (hyperprolactinemia). INVEGA HAFYERA®,
INVEGA TRINZA® or INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
- problems thinking clearly and moving your body
- difficulty swallowing that can cause food or liquid to get into your lungs
- prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
- problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration.
The most common side effects of INVEGA HAFYERA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.
The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.
The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.
Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.
Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals.
For more information, go to
www.invegahafyera.com,
www.invegatrinza.com or
www.invegasustenna.com or call
1-800-526-7736.Please click to read the full Prescribing Information, including Boxed WARNING, for
INVEGA HAFYERA®,
INVEGA TRINZA® and
INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.cp-256259v4
https://www.intracellulartherapies.com/docs/caplyta_pi.pdf
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at
http://www.jnj.com or at
www.innovativemedicine.jnj.com. Follow us at
@JNJInnovMed.Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to CAPLYTA®, Seltorexant, SPRAVATO®, INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products, and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.Footnotes:
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- Pandya M, et al. Where in the Brain Is Depression? Curr Psychiatry Rep. 2012;14:634–642. doi: 10.1007/s11920-012-0322-7
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- Young AH, Fagiolini A, Perry R, et al. Expert Consensus on Decision-Making Factors for Continuation of Esketamine Nasal Spray in Treatment-Resistant Depression: A Delphi Method. ECNP 2025; October 11-14, 2025. Poster PS04-3215.
- World Health Organization. Mental disorders. Accessed October 2025. https://www.who.int/news-room/fact-sheets/detail/mental-disorders
- National Alliance on Mental Health. Mental health by the numbers. Accessed October 2025. https://www.nami.org/about-mental-illness/mental-health-by-the-numbers/#:~:text=Millions%20of%20people%20are%20affected,represents%201%20in%205%20adults
- Key substance use and mental health indicators in the United States: results from the 2023 national survey on drug use and health. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Published July 2024. Accessed October 2025. https://www.samhsa.gov/data/report/2023-nsduh-annual-national-report
- Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.
- Arnaud AM, Brister TS, Duckworth K, et al. Impact of major depressive disorder on comorbidities: a systematic literature review. J Clin Psychiatry. 2022;83(6):21r14328.
- Nutt D, Wilson S, Paterson L. Sleep disorders are core symptoms of depression. Dialogues Clin Neurosci. 2008 Sep; 10(3): 329–336.
- Taddei-Allen P. Economic Burden and Managed Care Considerations for the Treatment of Insomnia. AJMC. Updated April 12, 2020. Accessed October 2025. https://www.ajmc.com/view/economic-burden-and-managed-care-considerations-for-the-treatment-of-insomnia
- Ağargün MY, Kara H, Solmaz M. Sleep disturbances and suicidal behavior in patients with major depression. J Clin Psychiatry. 1997;58(6):249-51.
- National Institute of Mental Health. Major Depression. Accessed October 2025. https://www.nimh.nih.gov/health/statistics/major-depression
- Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699. doi: 10.4088/JCP.20m13699
- Sanacora G, Zarate C, Krystal J, et al. Targeting the glutamatergic system to develop novel, improved therapeutics for mood disorders. Nat Rev Drug Discov. 2008;7(5):426-437. doi:10.1038/nrd2462
- Recourt K, de Boer P, Zuiker R, et al. The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder [published correction appears in Transl Psychiatry. 2019 Oct 2;9(1):240. doi: 10.1038/s41398-019-0585-4].
- Nollet M, Leman S. Role of orexin in the pathophysiology of depression: potential for pharmacological intervention. CNS Drugs. 2013;27(6):411-422. doi:10.1007/s40263-013-0064-z
- Brooks S, Jacobs GE, de Boer P, et al. The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia. J Psychopharmacol. 2019;33(2):202-209. doi:10.1177/0269881118822258
- Treatment Advocacy Center. Schizophrenia Fact Sheet. Accessed October 2025. www.tac.org/reports_publications/schizophrenia-fact-sheet/.
- Tandon, Rajiv et al. “The schizophrenia syndrome, circa 2024: What we know and how that informs its nature.” Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015
- Birchwood, M. “Early intervention and sustaining the management of vulnerability.” The Australian and New Zealand Journal of Psychiatry. vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241
- National Alliance on Mental Illness. Understanding Schizophrenia. Accessed October 2025. Understanding Schizophrenia | NAMI: National Alliance on Mental Illness. Accessed October 2025. https://www.nami.org/early-onset-schizophrenia/understanding-schizophrenia/
- Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125
© Johnson & Johnson 2025. All rights reserved.
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