Bezos' Blue Origin company launches 13th human flight to space
Jeff Bezos' Blue Origin space company successfully launched its New Shepard crewed flight, NS-33, into space from a launch pad in western Texas less than a day after the company's founder married Lauren Sanchez in a star-studded wedding in Venice. Blue Origin's New Shepard program has flown more than 60 humans and 175 scientific payloads above the Kármán line, the internationally recognized boundary of space.
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CNN
an hour ago
- CNN
Trump admin will cut hurricane forecasters out of key satellite data in one month
The abrupt cutoff of satellite data crucial for hurricane forecasting is delayed by one month, until July 31, according to a message posted by the National Oceanic and Atmospheric Administration Monday. The impending data loss from a Department of Defense weather satellite system was announced on June 25 and slated to take place 'no later than' Monday, according to an earlier NOAA announcement. The Defense Department will still maintain the Defense Meteorological Satellite program, but announced last week it would cease sharing the imagery with NOAA and NASA. The decision, which was initiated by the Defense Department, caused an uproar among meteorologists, public officials and the media in the midst of hurricane season. The fear is that the missing information could degrade the accuracy of hurricane forecasts. The move comes in the wake of steep personnel cuts at the National Weather Service and other parts of NOAA. The data in question is from a microwave sounder data known as the Special Sensor Microwave Imager Sounder, or SSMIS. This tool is like a 3D X-ray of tropical storms and hurricanes, revealing where the strongest rain bands and winds are likely to be and how they are shifting. Such imagery provides forecasters with information about a storm's inner structure and is one of the limited ways they can discern how quickly and significantly a storm's intensity is changing, particularly at night and during periods when hurricane hunter aircraft are not flying in the storm. According to a former NOAA employee familiar with the matter, the Defense Department's actions caught the nation's weather and oceans agency off guard, along with NASA, whose scientists also use this satellite imagery. The delay, this source said, is the result of pressure from both NOAA and NASA officials. The new NOAA message supports this, stating: 'Late on Friday, June 27th, CNMOC received a request from Dr. Germain with NASA to postpone the removal and to continue processing and distributing DMSP data through July 31st.' 'An update service advisory will be sent and FNMOC now expects to decommission DMSP processing no later than July 31st,' the message states, referring to the Navy's Fleet Numerical Meteorology and Oceanography Center. The satellite status message references Karen M. St. Germain, the division director for NASA's Earth Science Division. This indicates the intervening of a high level official in this matter. The one month delay does not solve the issue since hurricane season peaks in August and September, and there currently is no plan in place for resuming the flow of this data, even when a new Defense Department weather satellite begins operations in October. Currently, NOAA is planning for that microwave imagery from that satellite will flow to the agency. According to media reports last week, the Defense Department's rationale for cutting off this data has to do with cybersecurity concerns stemming from the way the data is transmitted between agencies. NOAA has publicly maintained there are many other sources of data on hurricanes that will allow for accurate forecasts this season. The Atlantic hurricane season does not end until November 30, and this season is expected to be another unusually active one. This is a developing story and will be updated.
CNN
an hour ago
- CNN
Trump admin will cut hurricane forecasters out of key satellite data in one month
Hurricanes Storms Federal agenciesFacebookTweetLink Follow The abrupt cutoff of satellite data crucial for hurricane forecasting is delayed by one month, until July 31, according to a message posted by the National Oceanic and Atmospheric Administration Monday. The impending data loss from a Department of Defense weather satellite system was announced on June 25 and slated to take place 'no later than' Monday, according to an earlier NOAA announcement. The Defense Department will still maintain the Defense Meteorological Satellite program, but announced last week it would cease sharing the imagery with NOAA and NASA. The decision, which was initiated by the Defense Department, caused an uproar among meteorologists, public officials and the media in the midst of hurricane season. The fear is that the missing information could degrade the accuracy of hurricane forecasts. The move comes in the wake of steep personnel cuts at the National Weather Service and other parts of NOAA. The data in question is from a microwave sounder data known as the Special Sensor Microwave Imager Sounder, or SSMIS. This tool is like a 3D X-ray of tropical storms and hurricanes, revealing where the strongest rain bands and winds are likely to be and how they are shifting. Such imagery provides forecasters with information about a storm's inner structure and is one of the limited ways they can discern how quickly and significantly a storm's intensity is changing, particularly at night and during periods when hurricane hunter aircraft are not flying in the storm. According to a former NOAA employee familiar with the matter, the Defense Department's actions caught the nation's weather and oceans agency off guard, along with NASA, whose scientists also use this satellite imagery. The delay, this source said, is the result of pressure from both NOAA and NASA officials. The new NOAA message supports this, stating: 'Late on Friday, June 27th, CNMOC received a request from Dr. Germain with NASA to postpone the removal and to continue processing and distributing DMSP data through July 31st.' 'An update service advisory will be sent and FNMOC now expects to decommission DMSP processing no later than July 31st,' the message states, referring to the Navy's Fleet Numerical Meteorology and Oceanography Center. The satellite status message references Karen M. St. Germain, the division director for NASA's Earth Science Division. This indicates the intervening of a high level official in this matter. The one month delay does not solve the issue since hurricane season peaks in August and September, and there currently is no plan in place for resuming the flow of this data, even when a new Defense Department weather satellite begins operations in October. Currently, NOAA is planning for that microwave imagery from that satellite will flow to the agency. According to media reports last week, the Defense Department's rationale for cutting off this data has to do with cybersecurity concerns stemming from the way the data is transmitted between agencies. NOAA has publicly maintained there are many other sources of data on hurricanes that will allow for accurate forecasts this season. The Atlantic hurricane season does not end until November 30, and this season is expected to be another unusually active one. This is a developing story and will be updated.
Associated Press
2 hours ago
- Associated Press
Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy
CAMBRIDGE, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately 180 adults with PMN and expected to readout in 2029. PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure. Felzartamab is an anti-CD38 antibody that has been shown in clinical studies to selectively deplete CD38+ cells, including plasma cells, the source of autoantibodies that mistakenly attack the body's own tissues in a range of immune-mediated diseases. Importantly for felzartamab, it is estimated that up to 80% of PMN patients have autoantibodies against PLA2R (aPLA2R) generated by CD38-expressing plasma cells. Currently, there are no approved treatments for PMN and the standard of care includes treatments ranging from immunosuppressants to chemotherapy.2 'We are encouraged by the opportunity to advance a Phase 3 study for primary membranous nephropathy, a condition that carries a significant risk of kidney failure,' said Travis Murdoch, Head of the Biogen West Coast Hub. 'This is the third Phase 3 trial of felzartamab launched by Biogen this year, underscoring our ongoing commitment to developing potential novel treatment options for patients living with kidney disease.' PROMINENT is a 104-week, randomized, open-label, global multicenter Phase 3 trial ( NCT06962800 ) to evaluate the efficacy and safety of felzartamab compared with tacrolimus in moderate- to -high-risk participants with PMN, inclusive of newly diagnosed and relapsed patients, in achieving complete remission of proteinuria. Participants will be randomized to receive either felzartamab or tacrolimus with the primary endpoint being the percentage of participants who achieve complete remissions (CR) at week 104. The study will evaluate both anti-PLA2R (aPLA2R) autoantibody positive and negative patients, stratifying participants based on PLA2R levels. Key secondary endpoints include the impact of felzartamab on serum anti-phospholipase A2 receptor (PLA2R) antibodies and patient-reported outcomes. 'Primary membranous nephropathy remains an unaddressed area of nephrology, for which there are no approved treatments. Felzartamab's mechanism of action designed to deplete the cells that produce the pathogenic antibodies is exciting news for patients that are waiting for potential meaningful new treatment options,' said Mohamed El-Shahawy, M.D., MPH, MHA, Director of the Academic Research Institute in Los Angeles, Clinical Professor of Medicine at Keck-University of Southern California School of Medicine, and a principal investigator for the PROMINENT Phase 3 trial. 'I'm grateful that Biogen is advancing research in this rare kidney disease and am eager to see the continued progress in the study's enrollment.' Felzartamab was previously investigated in two Phase 2 studies, M-PLACE (n=31) and NewPLACE (n=24), which enrolled patients with aPLA2R-positive PMN. In the final analysis of M-PLACE, reductions in aPLA2R titers were observed in most patients as early as one week (median reduction of 45%), with responses (>50% reduction) in most patients at six months at end-of-treatment. In addition, improvements in proteinuria and serum albumin levels were observed with administration of felzartamab. Across both studies, the majority of treatment emergent adverse events (TEAEs) reported were mild to moderate and consistent with the known mechanism of action of felzartamab in the PMN population. The most common TEAE was infusion-related reactions on the first infusion that were mostly mild to moderate in intensity. In addition to beginning a Phase 3 study of felzartamab in PMN, Biogen also initiated two other Phase 3 studies of felzartamab this year, TRANSCEND ( NCT06685757 ) for late antibody-mediated rejection in adult kidney transplant recipients and PREVAIL ( NCT06935357 ) in IgA nephropathy. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established. About Primary Membranous Nephropathy (PMN) PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure, with an estimated prevalence of ~36k patients in the United States.1 Patients with nephrotic syndrome often present with very severe swelling and fatigue related to high-grade proteinuria, and they are also at an increased risk of infection. There are no approved treatments for PMN and the current standard of care includes treatments ranging from immunosuppressants to chemotherapy.2 Even with these strategies, approximately one third of patients do not achieve remission.2 About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This press release contains forward-looking statements, relating to: our strategy and plans; potential of, and expectations for the design, timing and results of the PROMINENT study, the ability of felzartamab to treat AMR, PMN or IgAN, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, our future financial and operating results. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References:
