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Tomato recall affecting multiple states elevated to highest risk warning by FDA

Tomato recall affecting multiple states elevated to highest risk warning by FDA

CBS News04-06-2025

A tomato recall affecting three southern states has been upgraded to a Class I recall, the most severe warning by the Food and Drug Administration. The recall of the tomatoes was first announced in May over potential salmonella contamination.
Class I is the FDA's highest recall designation for health hazards, meaning there is "a reasonable probability" that the product will cause "serious adverse health consequences or death."
The tomatoes, from Williams Farms Repack, LLC, were shipped to Georgia, North Carolina and South Carolina. The impacted products include a 3 count package, 10 pound box, 25 pound box as well as a 60 count 2 layer box, the FDA says.
The FDA is urging consumers who purchased these products not to consume them, adding they can return them to the place of purchase for a full refund or discard them.
Williams Farms Repack LLC is recalling tomatoes sold to wholesalers in South Carolina, North Carolina and Georgia.
Food and Drug Administration
Salmonella can cause "serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems," the FDA wrote in its initial recall announcement.
Healthy people infected with the bacteria often experience a range of symptoms, including: fever, diarrhea, nausea, vomiting and abdominal pain.
According to the Centers for Disease Control and Prevention, symptoms usually start six hours to six days after consuming the bacteria.
Most people recover without treatment after four to seven days, but younger children, older adults and those with weakened immune systems "may experience more severe illnesses that require medical treatment or hospitalization," the CDC says.

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Accredited Investors: Navigating the Post-Pandemic Landscape
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Associated Press

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  • Associated Press

Accredited Investors: Navigating the Post-Pandemic Landscape

ATLANTA, June 30, 2025 (GLOBE NEWSWIRE) -- A new era of early-stage investing takes center stage this summer as Keiretsu Forum South-East, the Angel Capital Association (ACA), and Georgia Tech's Advanced Technology Development Center (ATDC) announce the Southeast Investor Conference, set for July 29–30, 2025, in Atlanta. The two-day program is designed to deliver candid insights, curated deal flow, and pragmatic strategies to navigate an investment landscape that has transformed dramatically in recent years. Attendees will explore evolving trends shaping portfolio management, early exits, and innovative funding models—while engaging with the entrepreneurs building the next generation of market solutions. The Southeast Investor Conference will feature a blend of educational programming and direct access to capital-ready startups. Notable sessions include: The conference also includes a curated Startup Showcase, featuring promising early-stage companies actively raising capital. Participating founders will present their ventures to an audience of active accredited investors, followed by structured Q&A and networking opportunities during the investor reception and conference dinner. Organizers welcome angel groups throughout the Southeast with exceptional deal flow to connect regarding participation in the showcase. The event aims to spotlight founders and investment opportunities demonstrating market traction, clear pathways to scale, and strong potential for timely exits. The Southeast Investor Conference is supported by Accorto Regulatory Solutions, whose sponsorship underscores their commitment to strengthening the innovation landscape. They are a boutique regulatory firm that helps domestic and international companies bring FDA-regulated product concepts to market. Accorto partners with entrepreneurs and investors to accelerate compliant commercialization of breakthrough technologies. 'The investment environment has never been more demanding,' said Barry Etra, Director of Entrepreneur Services, Keiretsu Forum. 'This conference was designed to provide both the clarity and the connections serious investors need to navigate these cycles with confidence.' Registration for the Southeast Investor Conference is open to accredited investors and investment professionals. Capacity is limited to preserve the highly interactive format of the sessions and networking components. Register at About Keiretsu Forum South-East Keiretsu Forum is the world's largest and most active accredited investor community, with over 2,000 members across 50+ chapters globally. Since its founding, Keiretsu members have invested over $1 billion in early-stage companies spanning technology, life sciences, consumer products, and beyond. About the Angel Capital Association The Angel Capital Association is a professional alliance of accredited angel investors in North America. Representing more than 15,000 angels and over 250 angel groups and platforms, ACA supports investor education, public policy, and industry standards. About Georgia Tech's ATDC The Advanced Technology Development Center (ATDC) at Georgia Tech is the state of Georgia's technology incubator, helping entrepreneurs build and scale technology companies that make an impact. For media inquiries or information about participation in the Startup Showcase, please contact: Cindi Sutera K4-MST Communications [email protected] 610-613-2773

INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease

Yahoo

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  • Yahoo

INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease

In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer's Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and biological endpoints. Treatment with XPro™ was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients. The most common adverse events (AE) were injection site reactions. Additional analyses will be presented at Alzheimer's Association International Conference (AAIC) in Toronto, Canada (July 27-31, 2025) and the Company will submit for Breakthrough Therapy designation with the FDA. Conference call today at 8AM ET, details below. Boca Raton, June 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), today announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro™, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population (mITT, n=200), predefined analyses demonstrated a cognitive benefit for XPro™ over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer's patients with two or more biomarkers of inflammation at baseline (n=100), marking a key milestone in the development of XPro™ for Early AD. The MINDFuL trial, a double-blind, placebo-controlled study, enrolled 208 participants with early-stage AD to assess XPro™'s potential in slowing cognitive decline by tackling neuroinflammation. Patients with at least one of four inflammatory biomarkers (elevated CRP, ESR, HbA1c, or at least one ApoE4 allele) were randomized 2:1 (XPro™:placebo) and treated over 24 weeks. The primary endpoint was change in cognition over 6 months on the Early Mild Alzheimer's Cognitive Composite (EMACC), a cognitive assessment designed specifically to measure change in early AD patients. While the primary endpoint was not met in the mITT group, key changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated with XPro™ over patients treated with placebo. These results identify a clear population of AD patients for which XPro™ might have therapeutic benefit. 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CJ Barnum, PhD, VP of CNS Drug Development, added, 'By targeting neuroinflammation, a key driver of Alzheimer's disease progression, XPro™ offers a novel mechanism to potentially slow disease progression and cognitive symptoms for persons living with Alzheimer's disease and inflammation. The continued development of this therapeutic, whether as a standalone treatment or in combination with other therapies, holds promise in addressing this critical and growing unmet medical need.' Additional analyses are underway and will be presented at AAIC in Toronto, Canada (July 27-31, 2025). Expert Commentary on Use of Effect Size in Clinical Trials 'In early-phase Alzheimer's disease trials, absolute effect sizes of 0.2 or greater are considered preliminary evidence of potential therapeutic efficacy and are informative for signal detection in early phase studies when sample sizes are small and the unknowns of a novel mechanism are significant,' said Dr. Judith Jaeger, a leading expert in cognitive assessment and consultant to INmune Bio on this trial. 'When a therapy consistently meets the 0.2 benchmark across multiple parameters (clinical and biological), confidence in the validity of the observed effects increases, indicating a therapy is worth advancing.' Next Steps INmune Bio will present additional analyses from the MINDFuL trial at AAIC® in Toronto, Canada (July 27-31, 2025). Based on the totality of the data, the company intends to: File for Breakthrough Therapy Designation with the FDA. 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By reducing neuroinflammation, XPro™ may offer significant benefits for patients with neurologic disorders, potentially enhancing cognitive function and supporting neuronal communication. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer's disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). 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Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595 (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. Company Contact: David Moss Chief Financial Officer (561) 710-0512info@ Daniel Carlson Head of Investor Relations (415) 509-4590dcarlson@ in to access your portfolio

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1

Business Wire

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  • Business Wire

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously. 1 'The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,' said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit. 'GAMMAGARD LIQUID ERC uses the same state-of-the-art manufacturing process as our other ready-to-use liquid immunoglobulin formulations and is aligned with our forward-looking strategy to prioritize reliable supply while offering a broad range of immunoglobulin therapies to address varied patient needs.' With this approval, Takeda continues to be the only manufacturer of IG therapy with low IgA content less than or equal to 2 µg/mL in a 10% solution. 1 It is anticipated that commercialization of GAMMAGARD LIQUID ERC will begin in the U.S. in 2026, followed by the European Union in 2027, where GAMMAGARD LIQUID ERC is approved by the European Medicines Agency (EMA) as DEQSIGA ®. 3 The timeline to commercial launch is consistent with the time it takes to ramp up manufacturing and supply for plasma-derived therapies. In parallel to this approval, and after thorough analysis, Takeda has decided to discontinue GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, the company's first-generation low IgA product. 2 As the only lyophilized (freeze-dried) preparation in Takeda's IG portfolio, GAMMAGARD S/D uses a different, older manufacturing process. For GAMMAGARD S/D, this process is no longer able to reliably meet the future needs of the patient community. Therefore, Takeda has informed the FDA and other health authorities that manufacturing of GAMMAGARD S/D will be discontinued at the end of December 2027. Beyond that date, Takeda intends to maintain GAMMAGARD S/D inventory until it is depleted or expired. 'We understand the impact that this news may have on patients who currently rely on GAMMAGARD S/D for their treatment,' said Kristina Allikmets. 'We are communicating this information now to allow time for patients to work closely with their health care teams to develop alternative treatment plans.' About GAMMAGARD LIQUID ERC GAMMAGARD LIQUID ERC is a ready-to-use liquid immunoglobulin therapy with an IgA content of less than or equal to 2 µg/mL in a 10% solution to be administered intravenously or subcutaneously. It is indicated in the United States as replacement therapy for primary immunodeficiency (PI) in people two years of age and older. 1 GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID [Immune Globulin Infusion (Human)], with the modification of parameters in a single process step to improve IgA reduction. This enhanced removal capability (ERC) results in a product with IgA less than or equal to 2 µg/mL in a 10% solution. 1 While GAMMAGARD LIQUID ERC is not indicated specifically for IgA sensitivity in people with primary immunodeficiency, it may be an appropriate option for them based on their physician's clinical judgment. GAMMAGARD LIQUID ERC is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to the product. It also carries warnings and precautions regarding the potential for severe hypersensitivity reactions, including in patients who have previously tolerated immune globulin products. Despite containing low levels of IgA (≤2 µg/mL in a 10% solution), the risk of anaphylaxis remains. 1 About GAMMAGARD S/D GAMMAGARD S/D is lyophilized (freeze-dried) immunoglobulin therapy with IgA content less than 1 µg/mL in a 5% solution for intravenous use only. It is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic immune thrombocytopenic purpura (ITP) to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. 2 About Primary Immunodeficiency (PI) Primary immunodeficiency (PI) is a group of more than 550 rare and chronic disorders, where a part of the body's immune system is missing or does not function the way it should. 4 These conditions result from genetic mutations, which are usually inherited. 5 The symptoms of PI vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists. 6 In the United States, PI affects about 1 in 1,200 people. 7 GAMMAGARD LIQUID ERC, GAMMAGARD LIQUID and GAMMAGARD S/D U.S. Important Safety Information WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. WARNING: RENAL DYSFUNCTION and ACUTE RENAL FAILURE Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D do not contain sucrose. Expand Contraindications GAMMAGARD LIQUID is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to human IG, and IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID. GAMMAGARD LIQUID ERC and GAMMAGARD S/D are contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Warnings and Precautions Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis. Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Acute renal failure has been reported in association with GAMMAGARD LIQUID and GAMMAGARD S/D. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events. Thrombosis: Has been reported to occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Aseptic Meningitis Syndrome: Has been reported with use of IG. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. The syndrome usually begins within several hours to two days following IG treatment Hemolysis: GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC, and GAMMAGARD S/D contain blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing. Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema has been reported with IV-administered IG, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support. Transmittable Infectious Agents: Because GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC, and GAMMAGARD S/D are made from human plasma, they may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID. Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Alterations in serum sodium levels (i.e., acute hypernatremia, pseudohyponatremia) may occur with GAMMAGARD S/D. In patients on a low sodium diet, calculate the amount of sodium from GAMMAGARD S/D when determining dietary sodium intake. Adverse Reactions GAMMAGARD LIQUID IV administration: The serious adverse reaction seen during IV clinical trials was aseptic meningitis. The most common adverse reactions observed in ≥5% of patients in clinical trials were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur. Subcutaneous administration: The most common adverse reactions observed in ≥5% of patients in clinical trials were infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity. GAMMAGARD LIQUID ERC The safety of GAMMAGARD LIQUID ERC in patients with primary humoral immunodeficiency (PI) is supported by two clinical studies conducted on GAMMAGARD LIQUID. No clinical studies have been conducted using GAMMAGARD LIQUID ERC. IV administration: The most common adverse reactions observed in ≥5% of patients in study 1 were headache, fatigue, pyrexia, chills, nausea, pain in extremity, diarrhea, migraine, vomiting, dizziness, urticaria, cough, asthma, oropharyngeal pain, infusion site extravasation, arthralgia, rash, myalgia, pruritis, and cardiac murmur. Subcutaneous administration: The most common adverse reactions observed in ≥5% of patients in study 2 were infusion site (local) event, headache, pyrexia, fatigue, heart rate increased, abdominal pain upper, vomiting, arthralgia, nausea, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous ulcer, migraine, oropharyngeal pain, and pain in extremity. GAMMAGARD S/D The most common adverse reactions observed in ≥5% of clinical trial patients during or within 48 hours of infusion were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis, and flushing. The most serious adverse reactions reported postmarketing include renal failure, thrombotic events (myocardial infarction, cerebrovascular accidents, and pulmonary embolism), anaphylactic shock, aseptic meningitis, and hemolysis. Drug Interactions Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could', 'anticipates', 'estimates', 'projects' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

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