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Korea Herald
2 days ago
- Business
- Korea Herald
[Bio USA] Global biotech leaders call for stronger, smarter supply chains
BOSTON — A special panel discussion held Wednesday at the 2025 Bio USA brought together several global biotechnology leaders to tackle one of the sector's most pressing issues: how to build more resilient supply chains amid ongoing global instability. The session "Building Resilient Global and National Supply Chains" addressed the complexity and vulnerabilities of current systems, especially in light of recent global disruptions such as the COVID-19 pandemic and rising geopolitical tensions. Panelists unanimously agreed that the pandemic laid bare serious weaknesses in global biotech supply chains. "The pandemic was really what first started companies thinking about the supply chains. It disrupted a lot of the work that innovative pharma companies were doing," said Rory Mullen, head of Biopharma and Food at Industrial Development Agency Ireland. Since then, many companies have been reassessing internal operations and external partnerships, placing greater focus on regional resilience, supply redundancy and long-term risk management. However, new challenges continue to emerge, as told by panelists. 'Today, geopolitical tensions and the threat of tariffs add more layers of uncertainty,' Mullen added. 'As companies prepare for future shocks, they are constantly trying to assess what these uncertainties could imply.' Jurie Hwang, director general at the Korea Biotechnology Industry Organization, spotlighted South Korea's significant dependency on foreign sources for materials and active pharmaceutical ingredients, especially from China and India. "We rely on them for 97 percent of our materials. In other words, we cannot survive without them in the drug-making process," Hwang said. She also identified a shortage of human resources as another critical vulnerability for Korea's biotech industry. Hilary Stiss, senior director of International Affairs at the Biotechnology Innovation Organization, highlighted a fundamental gap in government understanding of the biotech supply chain's intricacies. "The lack of understanding of what the supply chain is, that's partly a failure on our part as an industry to explain," she said, calling for more proactive engagement with policymakers. Stiss also emphasized the need for expanded training and retraining programs at the state and national levels to support a stronger, more agile workforce. The session ended with the message that strengthening biotech supply chains takes more than quick fixes and requires ongoing collaboration, careful long-term planning and the ability to adapt in order to handle both current and future disruptions.
Business Wire
3 days ago
- Business
- Business Wire
JCR Pharmaceuticals Announces Launch of Mucopolysaccharidosis (MPS) Type II Disease Awareness Film Featured in
HYOGO, Japan--(BUSINESS WIRE)-- JCR Pharmaceuticals Co., Ltd. (TSE 4552; 'JCR'), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, announced the launch of a film featured in The Next Frontier, a global branded film series presented by the Biotechnology Innovation Organization (BIO) and produced by BBC StoryWorks Commercial Productions. The Next Frontier series explores how biotechnology can be used effectively to address urgent challenges the world faces. As part of the series, the JCR-sponsored film tells the story of a family affected by mucopolysaccharidosis type II (MPS II, or Hunter syndrome), a rare, progressive, life-threatening lysosomal storage disorder. 'This film demonstrates the hardships and challenges that people living with MPS II face on a daily basis from the perspective of a family affected by this devastating and life-limiting disease,' said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. 'We are honored to participate in this important video series to shine a spotlight on MPS II and increase awareness worldwide about this debilitating rare disease for which patients desperately need new treatment options. This impactful story is a great illustration of how collaborating with patient communities drives progress. We are committed to supporting the MPS II patient community, and we look forward to advancing our investigational therapy for people living with MPS II.' The Next Frontier series highlights biotechnology's potential to help create a healthier and more sustainable future for all. The series delves into how powerful storytelling can turn complexity into clarity and breakthrough science into emotional connection. The series debuted at the BIO International Convention, taking place from June 16-19, 2025. Watch the JCR film here, and view the full The Next Frontier series here. About The Next Frontier Series The Next Frontier is a global branded film series presented by Biotechnology Innovation Organization (BIO) and produced by BBC StoryWorks Commercial Productions, and it explores how biotechnology can be used effectively to address urgent challenges the world faces. The series highlights biotechnology's potential to help create a healthier and more sustainable future for all. The series delves into how powerful storytelling can turn complexity into clarity and breakthrough science into emotional connection and features the tools that help the public not just understand biotech but believe in its potential. If the future depends on science, it also depends on the stories we tell. About Biotechnology Innovation Organization (BIO) BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services, worldwide. BIO members are at the forefront of researching and developing innovative biotechnologies across healthcare, agriculture, industry, and the environment. Corporate members range from entrepreneurial companies developing a first product to Fortune 500 multinationals. BIO is helping to drive a revolution that aims to cure patients, protect our climate, and nourish humanity. About Mucopolysaccharidosis Type II (Hunter Syndrome) Mucopolysaccharidosis type II (MPS II, or Hunter syndrome) is an X-linked recessive lysosomal storage disorder caused by a deficiency of iduronate-2-sulfatase, an enzyme that breaks down complex carbohydrates called glycosaminoglycans (GAGs, also known as mucopolysaccharides) in the body. Hunter syndrome, which affects an estimated 2,000-3,000 individuals worldwide (according to JCR research), gives rise to a wide range of somatic and neurological symptoms. The current standard of care for Hunter syndrome is enzyme replacement therapy. Central nervous system symptoms related to MPS II have been unmet medical needs so far. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world's most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients' lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including employees, partners, and patients. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit the global website:
Yahoo
3 days ago
- Business
- Yahoo
JCR Pharmaceuticals Announces Launch of Mucopolysaccharidosis (MPS) Type II Disease Awareness Film Featured in The Next Frontier Series
- Story Highlights Severity and Impact of MPS II, a Rare, Life-Threatening Lysosomal Storage Disorder - HYOGO, Japan, June 18, 2025--(BUSINESS WIRE)--JCR Pharmaceuticals Co., Ltd. (TSE 4552; "JCR"), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, announced the launch of a film featured in The Next Frontier, a global branded film series presented by the Biotechnology Innovation Organization (BIO) and produced by BBC StoryWorks Commercial Productions. The Next Frontier series explores how biotechnology can be used effectively to address urgent challenges the world faces. As part of the series, the JCR-sponsored film tells the story of a family affected by mucopolysaccharidosis type II (MPS II, or Hunter syndrome), a rare, progressive, life-threatening lysosomal storage disorder. "This film demonstrates the hardships and challenges that people living with MPS II face on a daily basis from the perspective of a family affected by this devastating and life-limiting disease," said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. "We are honored to participate in this important video series to shine a spotlight on MPS II and increase awareness worldwide about this debilitating rare disease for which patients desperately need new treatment options. This impactful story is a great illustration of how collaborating with patient communities drives progress. We are committed to supporting the MPS II patient community, and we look forward to advancing our investigational therapy for people living with MPS II." The Next Frontier series highlights biotechnology's potential to help create a healthier and more sustainable future for all. The series delves into how powerful storytelling can turn complexity into clarity and breakthrough science into emotional connection. The series debuted at the BIO International Convention, taking place from June 16-19, 2025. Watch the JCR film here, and view the full The Next Frontier series here. About The Next Frontier SeriesThe Next Frontier is a global branded film series presented by Biotechnology Innovation Organization (BIO) and produced by BBC StoryWorks Commercial Productions, and it explores how biotechnology can be used effectively to address urgent challenges the world faces. The series highlights biotechnology's potential to help create a healthier and more sustainable future for all. The series delves into how powerful storytelling can turn complexity into clarity and breakthrough science into emotional connection and features the tools that help the public not just understand biotech but believe in its potential. If the future depends on science, it also depends on the stories we tell. About Biotechnology Innovation Organization (BIO)BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services, worldwide. BIO members are at the forefront of researching and developing innovative biotechnologies across healthcare, agriculture, industry, and the environment. Corporate members range from entrepreneurial companies developing a first product to Fortune 500 multinationals. BIO is helping to drive a revolution that aims to cure patients, protect our climate, and nourish humanity. About Mucopolysaccharidosis Type II (Hunter Syndrome)Mucopolysaccharidosis type II (MPS II, or Hunter syndrome) is an X-linked recessive lysosomal storage disorder caused by a deficiency of iduronate-2-sulfatase, an enzyme that breaks down complex carbohydrates called glycosaminoglycans (GAGs, also known as mucopolysaccharides) in the body. Hunter syndrome, which affects an estimated 2,000-3,000 individuals worldwide (according to JCR research), gives rise to a wide range of somatic and neurological symptoms. The current standard of care for Hunter syndrome is enzyme replacement therapy. Central nervous system symptoms related to MPS II have been unmet medical needs so far. About JCR Pharmaceuticals Co., Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world's most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients' lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including employees, partners, and patients. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit the global website: View source version on Contacts Investors & Media:JCR Pharmaceuticals Co., Communicationsir-info@
Politico
4 days ago
- Business
- Politico
BIO chair: U.S. has a ‘crisis' on drug costs
Driving The Day NEW BIO CHAIR'S POLICY TAKE — The biotech industry faces a mix of longstanding and novel political challenges amid President Donald Trump's second term. One of its chief lobbying arms is gearing up to take them on. Ahead of the Biotechnology Innovation Organization's annual convention this week in Boston, Genentech's Fritz Bittenbender — who was elected Monday as the group's board chair — chatted with Lauren about BIO's priority issues, distrust in science and medical institutions and its approach to geopolitical engagement. Pros can read the full Q&A, but here are some highlights and outtakes: An 'existential policy crisis': Bittenbender used the term to refer to debates around 'intellectual property, how do you pay for medicines, what kind of investments are we going to make at early-stage research' — all of which bring to mind Trump administration priorities like the most-favored-nation approach to bringing down drug prices and limiting National Institutes of Health spending on indirect costs in university research. 'We have a lot of sound-bite policy happening right now, and [most-favored-nation is] a great example of that,' he said, adding that the U.S. health system works much differently from those in allied European countries, often held up as examples of cheaper markets. How industry can combat distrust in science: Biotechs need to do a better job of communicating the benefits they bring to patients, and they need policymakers' help, Bittenbender said. 'Working with policymakers, and … bringing as much transparency to our industry as we possibly can — using real-world data and digital analytics more effectively to understand postmarketing studies of products on the market and being transparent about that,' he said. Federal job cuts: Regulatory uncertainty is an 'existential threat' to the industry amid the massive downsizing and restructuring of the Department of Health and Human Services, Bittenbender said. 'If it's going to take 10 or 15 years to bring a product to the market and $1 [billion] to $2 billion to do that, that's a significant investment over a long-term period. And for investors to want to do that, they have to know that there's a certain regulatory environment,' he said. 'They have to know that regulatory timelines are going to be met or exceeded.' The tariff threat: 'Our industry is a national security imperative for the country, and that means having essential medicines that patients really need manufactured here,' Bittenbender said. 'Hopefully, we won't see tariffs on the pharmaceutical industry, and we work in other ways to get manufacturing into the United States and to ensure that essential medicines that we need in times of emergency or pandemic are sourced from a place that we trust and that we know we can get them,' he added. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. NPR reports on how music therapy can help cancer patients manage their stress and symptoms. Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA SECOND DMD DRUG DEATH — A second patient with Duchenne muscular dystrophy has died after taking Sarepta Therapeutics' Elevidys gene therapy, the company said, prompting a reevaluation of the drug's treatment protocol. The death occurred in a 15-year-old nonambulatory individual enrolled in the company's randomized, placebo-controlled trial intended to confirm the drug's benefit in patients who can't walk under the FDA's accelerated approval pathway. A company official said the latest death shares 'some similarities to the previous' death of a teenage boy earlier this year; both fatalities were due to acute liver failure, a known side effect of the viral vector gene therapy used in Elevidys. Sarepta said the signal has emerged only in patients who can't walk, which they consider a surrogate for disease progression. Sarepta President and CEO Douglas Ingram said the company wants to meet with the FDA 'as rapidly as possible' to establish a new immunosuppressive regimen for nonambulatory patients. Until that's implemented, the company has paused drug shipments for that population, as well as dosing for its clinical trial, it said. Response: HHS spokesperson Emily Hilliard said the FDA is treating the death 'with the highest level of concern' and 'will take all appropriate regulatory actions to protect patients during our review of gene therapy products.' The FDA is reviewing a cell therapy candidate from Capricor Therapeutics to treat DMD. The target date for a decision is Aug. 31. PDUFA PROBLEMS? KalVista Pharmaceuticals raised some eyebrows late last week after announcing that the FDA had disclosed it would miss its Tuesday PDUFA target for the drug sebetralstat, which is used as therapy for hereditary angioedema, 'due to heavy workload and limited resources.' The rare disorder causes episodes of swelling in various parts of the body and can sometimes be fatal. FDA Commissioner Marty Makary has repeatedly said medical product reviews would continue apace despite thousands of job cuts at the agency, and reviewers were not among the terminated workers. But employees charged with supporting review staff by booking travel and securing supplies were impacted, and drug companies remain concerned about attrition in the remaining workforce. HHS did not comment. In Congress EXPANDED ORPHAN EXEMPTION OUT — The Senate Finance Committee's reconciliation bill strips an effort by the House to expand a Medicare drug price negotiations exemption for orphan drugs to include medicines that treat multiple rare diseases or conditions. The Congressional Budget Office estimated the policy in the House bill would cost the federal government nearly $5 billion over 10 years, a figure groups like AARP and Patients For Affordable Drugs Now used to urge senators to keep the measure out of the Senate bill. But pharmaceutical companies argue the provision would incentivize additional investment in rare-disease drug development as the IRA exemption currently applies to orphan drugs that treat a single rare disease. SANDERS WANTS ACIP INVESTIGATION — Senate HELP ranking member Bernie Sanders (I-Vt.) wants his counterpart to open a bipartisan investigation into the removal of 17 members of the CDC's outside vaccine committee. In his letter to Sen. Bill Cassidy (R-La.), chair of the Health, Education, Labor and Pensions Committee, Sanders asked for 'serious oversight' of HHS Secretary Robert F. Kennedy Jr.'s actions regarding the Advisory Committee for Immunization Practices. 'Secretary Kennedy's reckless decision to fire these non-partisan scientific experts and replace them with ideologues with limited expertise and a history of undermining vaccines will not only endanger the lives of Americans of all ages, it directly contradicts a commitment he made to you before he was confirmed that he would not make any significant changes to this important Committee,' Sanders wrote to Cassidy. A spokesperson for Cassidy did not immediately respond to a request for comment. In the courts PURDUE SETTLEMENT 2.0 — All 50 states and several U.S. territories have agreed to sign onto a $7.4 billion settlement with Purdue Pharma and its principal owners, the Sackler family, that will resolve state and local government claims. 'The local government sign-on and voting solicitation process for this settlement moving forward will be contingent on bankruptcy court approval,' California Attorney General Rob Bonta's office said in a news release. 'A hearing is scheduled on that matter in the coming days.' The settlement ends the Sackler family's control of Purdue and prevents them from selling opioids in the country. Document Drawer The FDA's Psychopharmacologic Drugs Advisory Committee will meet on July 18 to discuss Otsuka Pharmaceutical's supplemental new drug application to approve Rexulti to treat adults with post-traumatic stress disorder in combination with sertraline. The FDA published final guidance outlining recommendations for generic drugmakers on how to submit a pre-submission facility correspondence that can be used to help the agency begin site assessments in advance of submitting an abbreviated new drug application. WHAT WE'RE READING The 17 dismissed members of the CDC's vaccine advisory panel published an op-ed in JAMA, saying their abrupt dismissal last week 'undermines the committee's capacity to operate effectively and efficiently, aside from raising questions about competence.' HHS awarded an Arizona law firm $150,000 for its expertise on the Vaccine Injury Compensation Program, NOTUS' Margaret Manto reports, suggesting it's considering policy changes to the 40-year-old system.
Yahoo
10-06-2025
- Business
- Yahoo
MAIA Biotechnology to Present at BIO International Convention 2025
CHICAGO, June 10, 2025--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its participation in the upcoming BIO (Biotechnology Innovation Organization) International Convention 2025 taking place June 16-19, 2025, in Boston, Massachusetts. MAIA Chairman and CEO Vlad Vitoc, MD, MBA will deliver a presentation featuring the latest findings from the Company's THIO-101 Phase 2 clinical trial evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC). Ateganosine is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment. MAIA recently announced the design for the expansion of the THIO-101 trial, which will further assess the efficacy of treatment in third-line NSCLC patients. Presentation DetailsSession date and time: June 18 at 11:30 AM EDTPresenter: Vlad Vitoc, MD, MBA Registered participants may request a meeting with MAIA management via the BIO Partnering™ platform on the BIO 2025 website. About BIO BIO (Biotechnology Innovation Organization) is the world's largest advocacy association representing biotechnology companies, academic and research institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. About Ateganosine Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2'-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. About THIO-101, a Phase 2 Clinical Trial THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine's anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using overall response rate (ORR) as the primary clinical endpoint. The expansion of the study will assess ORR in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase 2 trial, please visit using the identifier NCT05208944. About MAIA Biotechnology, Inc. MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit Forward Looking Statements MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as "may," "might," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, "MAIA," "Company," "we," "our," and "us" refers to MAIA Biotechnology, Inc. and its subsidiaries. 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