Latest news with #regulatoryapprovals
Yahoo
17 hours ago
- Business
- Yahoo
Vor Bio Appoints Qing Zuraw, M.D. as Chief Development Officer
Dr. Zuraw led clinical development of telitacicept across MG, Sjögren's, SLE, and RA at RemeGen, resulting in multiple regulatory approvals in China; brings deep U.S. and global development experience to support Vor Bio's new development focus and execution of late-stage programs CAMBRIDGE, Mass., July 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced the appointment of Qing Zuraw, M.D., M.P.H., M.B.A., as Chief Development Officer, effective immediately. Dr. Zuraw joins Vor Bio with over 25 years of experience leading complex global and U.S. clinical development programs across autoimmune, inflammatory, and immunologic diseases. Most recently, she served as Chief Development Officer and Head of Global Clinical Development for Autoimmune Diseases at RemeGen Co., Ltd., where she was one of the key leaders of successful development and execution of clinical trials for telitacicept across four key indications—systemic lupus erythematosus (SLE), Sjögren's syndrome, myasthenia gravis (MG), and rheumatoid arthritis (RA)—culminating in regulatory approvals in China for the treatment of SLE, generalized MG and RA. At RemeGen, Dr. Zuraw built and led a cross-functional global team that managed all aspects of telitacicept development, including clinical trial design, regulatory strategy, site engagement, and execution. She played a central role in regulatory interactions with the U.S. Food & Drug Administration, European Medicines Agency, and China's Center for Drug Evaluation, achieving Fast Track, Breakthrough Therapy, and Orphan Drug designations for telitacicept across multiple indications. 'We are delighted to welcome Qing to Vor Bio at a critical time for the company,' said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. 'Her deep and diverse clinical development expertise across autoimmune and immunological diseases and with telitacicept will be invaluable as we execute on our late-stage programs. Qing's ability to lead high-performing clinical organizations will be instrumental as we drive forward our global development programs, particularly in the U.S.' Dr. Zuraw has also previously held senior leadership roles at Janssen Research & Development, Teva Pharmaceutical Industries Ltd., Akebia Therapeutics, Inc., Biogen Inc., and Covance, Inc., where she led global clinical development programs across rheumatology, nephrology, respiratory, and immunology. She played a key role in the U.S. FDA approval of Guselkumab for psoriatic arthritis and contributed to multiple NDA and BLA submissions across therapeutic areas. Throughout her career, she has built and led high-performing teams to execute complex trials from early development through post-marketing. 'Vor Bio is uniquely positioned to become a leader in autoimmune therapeutics,' said Dr. Zuraw. 'Having been intimately involved in the development of telitacicept in China from early clinical stages through to multiple approvals, I'm thrilled to join the talented team at Vor Bio to bring telitacicept to patients globally.' About Vor BioVor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding Vor Bio's development plans for telitacicept, its ability to change the treatment landscape for patients with autoimmune conditions and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Media & Investor Contacts:Sarah Spencer+1 857-242-6076investors@ Carl Mauchinvestors@ in to access your portfolio
Travel Weekly
3 days ago
- Business
- Travel Weekly
Southwest will begin flying to St. Thomas in 2026
Southwest Airlines will begin serving St. Thomas in early 2026. The airline has yet to provide further details, including specific routes, or even how many routes it will fly to the U.S. Virgin Islands locale. A launch date has also not yet been set as the airline awaits regulatory approvals, but Southwest said tickets will be available for purchase soon. St. Thomas will be Southwest's first new destination since November 2021, when it launched what turned out to be short-lived service to Syracuse, N.Y. The airline is also teasing that it will announce two more new destinations over the course of the summer. In the Caribbean, Southwest currently flies to Aruba, the Bahamas, Cayman Islands, Cuba, Dominican Republic, Jamaica, Puerto Rico and Turks and Caicos.
Yahoo
10-07-2025
- Business
- Yahoo
Regulatory approvals received for the sale of MacGregor, closing expected on 31 July 2025
HIAB CORPORATION, STOCK EXCHANGE RELEASE, 10 JULY 2025 AT 09:30 AM (EEST) Regulatory approvals received for the sale of MacGregor, closing expected on 31 July 2025 Hiab (at the time Cargotec) announced on 14 November, 2024, that it had signed an agreement to sell its MacGregor business to funds managed by Triton (the 'Transaction'). On July 1, 2025, Hiab announced that all necessary regulatory approvals had been received, with the exception of approval from the Chinese State Administration for Market Regulation (SAMR). All regulatory approvals have now been secured, and the closing of the Transaction is expected on 31 July 2025. MacGregor has been reported as part of discontinued operations from the fourth quarter of 2024 onwards. Hiab CorporationFor further information, please contact: Mikko Puolakka, CFO, tel. +358 20 777 4000 Aki Vesikallio, Vice President, Investor Relations, tel. +358 40 729 1670Hiab (Nasdaq Helsinki: HIAB) is a leading provider of smart and sustainable on road loadhandling solutions, committed to delivering the best customer experience every day with the most engaged people and partners. Globally, Hiab is represented on every continent through its extensive network of 3,000 own and partner sales and service locations, enabling delivery to over 100 countries. The company's continuing operations sales in 2024 totalled approximately EUR 1.6 billion and it employs over 4,000 people.
CNA
10-07-2025
- Automotive
- CNA
Tesla to expand robotaxi service to San Francisco Bay Area within two months, Musk says
SAN FRANCISCO :Tesla will expand its robotaxi service to the San Francisco Bay Area "in a month or two", depending on regulatory approvals, CEO Elon Musk said on Wednesday. Tesla last month rolled out a test of the long-promised service in a limited area of Austin, Texas, with about a dozen vehicles and many restrictions, including a safety monitor in the front passenger seat. Tesla will expand the service to "a larger area in Austin this weekend," Musk said on his social media platform X in response to a post from another user about the lack of an update on expansion. When Tesla Owners Silicon Valley asked about expansion in the Bay Area, Musk said: "Waiting on regulatory approvals, but probably in a month or two."
Zawya
24-06-2025
- Business
- Zawya
Oman: Ahli Bank halts merger talks, revives $129mln capital plan
MUSCAT: Ahli Bank SAOG has announced the postponement of its proposed merger with Sohar International Bank SAOG due to a lack of necessary regulatory approvals, the lender disclosed in a market statement on Sunday. The Board of Directors of Ahli Bank resolved to suspend further discussions with Sohar International until further notice. The merger proposal, initially announced in April 2025, was part of a broader consolidation trend in Oman's banking sector aimed at improving operational scale and competitiveness. 'In light of this development,' the bank stated, 'and in alignment with the Bank's capital planning objectives, the Board has also resolved to proceed with a capital increase through a rights issue of OMR 50 million.' This capital raise, previously announced and later suspended due to the merger talks, is now being revived. Ahli Bank confirmed it will undertake all necessary steps to implement the rights issue, including seeking required regulatory approvals. The bank reiterated its commitment to transparency, stating: 'Ahli Bank will continue to disclose any material developments to the market in accordance with applicable laws and disclosure regulations.' 2022 © All right reserved for Oman Establishment for Press, Publication and Advertising (OEPPA) Provided by SyndiGate Media Inc. (
