Latest news with #PBM
Korea Herald
12 hours ago
- Business
- Korea Herald
Embed Financial Group Holdings (EFGH) is pleased to announce a pivotal addition to the EFGH leadership team
SINGAPORE, July 17, 2025 /PRNewswire/ -- Embed Financial Group Holdings (EFGH) welcomes Eldwin Wong as its new Chief Executive Officer, Asia. Eldwin is a seasoned leader in the financial technology sector. As the founder and CEO of IN Financial Technologies (INFT), he successfully built a leading fintech group in Singapore, providing essential financial services and securing key regulatory licenses from the Monetary Authority of Singapore (MAS). His extensive experience in scaling tech-driven businesses and his deep understanding of the financial landscape in Asia will be invaluable as we continue to expand our embedded finance solutions. Beyond his business acumen, Eldwin's commitment to public service—for which he was awarded the Pingat Bakti Masyarakat (PBM)—resonates deeply with EFGH's mission to drive financial inclusion and create lasting value for communities across the region. Please join EFGH in giving Eldwin a warm welcome. EFGH is confident that his leadership will be instrumental in accelerating its growth and strengthening its partnerships throughout Asia.
Business Wire
07-07-2025
- Business
- Business Wire
Alcon to Acquire LumiThera and Its Photobiomodulation Device for the Treatment of Early and Intermediate Dry Age-Related Macular Degeneration (AMD)
GENEVA--(BUSINESS WIRE)--Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced its intention to acquire LumiThera, Inc., a leader in light-based innovations for ophthalmology, and its PBM device for the treatment of early and intermediate dry AMD. 1 LumiThera's PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD. 2,* Dry AMD is a progressive disease typically treated in late stage, with limited treatment options. 2 'For more than 25 years, Alcon has been a leader in vitreoretinal surgery, and we are excited to expand our offerings into the clinic, to help millions of people living with dry AMD gain vision,' said Sean Clark, Vice President and General Manager, Global Surgical Franchise, Alcon. 'Dry AMD is an area of significant unmet need, and PBM is an efficacious, non-invasive light therapy that can provide visual improvement for patients with early and intermediate disease. With Alcon's global commercial and clinical expertise, we have the potential to make this therapy more broadly available to Eye Care Professionals and their patients, while continuing to strengthen its body of clinical evidence.' In dry AMD, vision loss results from the dysfunction and break down of retinal cells within the macula—the part of the retina that allows for sharpness and fine detail in seeing what's directly in front of the viewer. 4 In the early stages, central vision becomes distorted and may ultimately progress to a complete loss, making everyday activities difficult, like reading, driving and even recognizing faces. 5 The retina is rich in mitochondria, and mitochondrial dysfunction is a known cause of vision loss in dry AMD. 6 PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses three specific, science-backed wavelengths—delivering non-phototoxic light therapy (not laser therapy). 7,8 The non-invasive treatments are administered while the patient is sitting comfortably in a clinic setting. Data from the LIGHTSITE I, II, and III clinical trials consistently showed that PBM treatments provide visual acuity improvement with no treatment-related serious adverse events reported. 2 The pivotal LIGHTSITE III study was conducted at 10 sites across the U.S. and evaluated two years of PBM treatment versus a control light therapy. The results showed: Patients with PBM-treated eyes on average experienced visual acuity improvement—gaining one line of visual acuity (ETDRS) from Baseline at Months 13, 21 and maintained at Month 24 9 About 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 24 9 Nearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement—gaining at least one line of visual acuity (ETDRS) from Baseline at Month 24 9 More than 97% of patients reported no pain or discomfort 2,9 More than 80% of patients stayed on therapy for two years—the recommended course of treatment 2,9 'At LumiThera, we have been committed to developing novel light therapy technologies that address dry AMD,' said Clark Tedford, Ph.D., President and CEO of LumiThera. 'Our PBM device provides a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss. We are thrilled that Alcon agrees in the potential that this device has to change the lives of millions living with dry AMD, and we are confident that Alcon has the capabilities to broadly commercialize it.' PBM received FDA de novo market authorization in November 2024 and received CE Mark in November 2018. PBM is currently available in Europe, Latin America, Singapore, the U.K. and the U.S. The transaction does not include the acquisition of AdaptDx and Nova/Diopsys diagnostic devices, which will be separated and spun-off to LumiThera's shareholders prior to Alcon's acquisition and will continue to be marketed and sold by the LumiThera spin-off. Subject to customary closing conditions and a LumiThera shareholder vote, Alcon and LumiThera anticipate the acquisition to be completed in the third quarter of 2025. Forward-looking Statements This press release contains, and our officers and representatives may from time to time make, certain 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as 'anticipate,' 'intend,' 'commitment,' 'look forward,' 'maintain,' 'plan,' 'goal,' 'seek,' 'target,' 'assume,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will' and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential transaction and the expected timing, impacts and benefits thereof. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict such as: (i) the proposed merger may not be completed in a timely manner or at all; (ii) the failure to realize the anticipated benefits of the proposed merger; and (iii) there may be liabilities related to the merger that are not known, probable or estimable at this time or unexpected costs, charges or expenses. Additional factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at About LumiThera LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, specifically dry AMD. LumiThera is the leader in ophthalmic PBM innovation; for more information visit About PBM The photobiomodulation (PBM) device (a.k.a. Valeda) multiwavelength treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of the PBM device treatment for dry AMD patients to improve vision. *It is possible that treatment benefit may not persist significantly after treatment is stopped. Important Product Information Indications for Use The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by: The presence of at least 3 medium drusen (> 63 μm and = 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, AND The absence of neovascular maculopathy or central-involving geographic atrophy After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment. Contraindications for Use As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician. Precautions It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye. References U.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at LumiThera, Inc. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2(2):e106–e116. DOI: 10.1016/S2214-109X(13)70145-170145-1. Centers for Disease Control and Prevention. About Common Eye Disorders and Diseases. Accessed in June 2025 at Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. The Lancet. 2018;392(10153):1147–1159. DOI: 10.1016/S0140-6736(18)31550-2. Eells JT. Mitochondrial dysfunction in the aging retina. Biology (Basel). 2019;8(2):31. DOI: 10.3390/biology8020031. Wong-Riley MTT, Liang HL, Eells JT, Chance B. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. J Biol Chem. 2005;280(6):4761–4771. DOI: 10.1074/jbc.M409650200. Ball KA, Castello PR, Poyton RO. Low intensity light stimulates nitrite-dependent nitric oxide synthesis but not oxygen consumption by cytochrome c oxidase: Implications for phototherapy. Biochim Biophys Acta. 2011;1807(7):964–970. DOI: 10.1016/ Valeda ® Light Delivery System User Manual (LBL-0001-01 REV C).
Belfast Telegraph
05-07-2025
- Automotive
- Belfast Telegraph
Andrew Irwin reveals his target for a successful weekend as he looks to get British Superbike season back on track
Irwin admits his 2025 season has proved challenging so far, with the 30-year-old leaving Snetterton empty-handed two weeks. The Carrickfergus man crashed twice and was outside the points in the Sprint race, finishing 19th. Irwin, currently 16th in the championship, was 12th in the combined free times yesterday at Knockhill on a wet track. He is now looking ahead to today's opening race (4.00pm) and is focused on putting some points on the board at a circuit he enjoys. 'I'm looking forward to Knockhill, it's a track that I've always enjoyed,' said Irwin. 'The start of my season hasn't gone exactly to plan but we were fast at Donington and I think that will translate into how we run this weekend. 'Three solid races is the plan, from which we can really change the shape of our season from this point onwards. 'I've got good memories of Knockhill; last year, we ran well and I was quick in the wet, which may be a factor this year. 'It feels like sort of a home round; the Scottish fans are really welcoming and the circuit is truly unique. 'Certainly, it's a big change from Snetterton last time out, and the variety of tracks that we get to race on in BSB is part of what makes the series so good.' His older brother, Glenn, is out of action this weekend through injury following a crash in practice at Snetterton. The Hager PBM Ducati rider underwent surgery on his sacrum after suffering hip and pelvis fractures in a high-side. The 35-year-old was fortunate to avoid being struck by brother Andrew and Scotsman Rory Skinner in the aftermath, who did not see him lying prone at the side of the track because of a cloud of dust kicked up by Irwin's crash. The two-time title runner-up has been replaced in the PBM team by former champion Scott Redding, who was 13th fastest yesterday on his return to the series. 'It's exciting for me to be back racing in front of the BSB crowd this weekend at Knockhill,' said the 2019 champion. 'Obviously, I have some really great memories with the team from when we won the title back in 2019 and as always I want to do the best job I possibly can for myself, our sponsors and the team. 'I want to put on the best performance I can with this opportunity and I also want to wish Glenn a speedy recovery from his injuries.' No official timeframe has been given for Irwin's return but the Ulster rider pledged to be back in the saddle during the current campaign, while Jordan Bird, co-owner of the PBM squad, said his recovery was 'going well'. Storm Stacey (Bathams AJN BMW) was fastest yesterday from Danny Kent (McAMS Yamaha), Josh Brookes (DAO Racing Honda) and championship leader Bradley Ray (Raceways Yamaha).
Free Malaysia Today
03-07-2025
- Politics
- Free Malaysia Today
Bersatu man files report on alleged death threat
Bersatu Youth executive council member Na'im Brundage did not dismiss the possibility that the threats were politically motivated. (Facebook pic) PETALING JAYA : A Bersatu Youth leader filed a police report yesterday after allegedly receiving a death threat from an unknown person. Bersatu Youth executive council member Na'im Brundage said the person also threatened to splash acid on him, although no reason was disclosed. Na'im said he did not dismiss the possibility that the threats were politically motivated since he was active in politics and in airing his views on social media. 'Such threats will not hamper me from continuing to speak up for the people. I want to stress that I will never bow to any form of threat, pressure, or intimidation. 'I urge all Malaysians to unite and reject the culture of violent politics, and to instead defend the practice of mature politics,' he said in a statement. FMT has reached out to the Dang Wangi police for comment. Na'im left Bersatu for Parti Bangsa Malaysia (PBM) in 2022, joining former minister Zuraida Kamaruddin. He rejoined Bersatu in November after being sacked from PBM along with 12 others, including Zuraida.
Politico
01-07-2025
- Business
- Politico
State PBM regulation hits a SCOTUS roadblock
Programming note: We'll be off this Friday but will be back in your inboxes next Monday. Driving the Day STATES DEALT A PBM BLOW — The Supreme Court declined Monday to consider an appellate court's 2023 decision overturning portions of an Oklahoma law regulating pharmacy benefit managers, raising questions about the implications for state actions to rein in the companies' business practices. The 10th Circuit appeals court ruled that federal laws regulating private employer-sponsored health plans and Medicare's drug benefit preempt the 2019 state law's provisions that aimed to bolster independent pharmacies' bargaining power with PBMs, which help negotiate retail drug prices between drugmakers and payers. Community pharmacies have long panned the middlemen — which are responsible for 80 percent of the market — for steering customers toward pharmacy chains they own. Nearly three dozen states and Washington, D.C., plus several pharmacy organizations, joined the case as 'friends of the court' on the side of Oklahoma, illustrating state-level interest in overseeing how PBM practices affect where patients pick up their prescriptions. Several states have considered PBM bills in recent years as congressional efforts to police the industry have floundered. Reaction: 'We are disappointed, but hopeful that the Court will take up this issue in the near future and clarify that States can indeed regulate PBMs in the way envisioned by Oklahoma's laws in question,' Leslie Berger, a spokesperson for Oklahoma Attorney General Gentner Drummond, said in a statement. B. Douglas Hoey, CEO of the National Community Pharmacists Association, said the group is 'very disappointed' the Supreme Court didn't act to 'reinforce' a unanimous 2020 decision upholding Arkansas' regulation of PBM reimbursement practices — a ruling widely seen as giving states more leeway to act amid Congress' silence. 'Now the lower courts are divided, and the states are confused about what they can do to protect patients and small-business pharmacies from the unfair, anticompetitive practices of the PBMs, higher drug costs and from PBMs overruling doctors' prescribing decisions,' he said. PBMs celebrate: The PBMs' lobbying group, which challenged Oklahoma's law, applauded the high court's denial of Mulready v. Pharmaceutical Care Management Association and suggested it portends a similar fate for similar laws in other states. 'In recent months, various businesses and unions have joined to challenge state restrictions on health benefit in Iowa, Minnesota, Arkansas, and Tennessee,' PCMA general counsel Jack Linehan said in a statement. 'These cases and the Mulready decision send a powerful reminder that overbroad state laws are not only illegal, but they boost healthcare costs for businesses and their workers.' NCPA said the 10th Circuit's decision likely stands for now, but only for the six states covered by that court. 'States contemplating PBM reform should not be dissuaded,' it said. PBMs have taken Arkansas back to court — this time over a new law that would prevent them from owning pharmacies like CVS in the state. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. No more excess humidity in D.C. would be great. Send tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). In the courts MORE DENIALS — Federal courts have rebuffed two attempts by anti-vaccine activists to challenge past losses. The Supreme Court also denied on Monday a bid by Children's Health Defense — the group founded by Health Secretary Robert F. Kennedy Jr. — to have its censorship case against social media giant Meta heard. The group alleged that the owner of Facebook and Instagram colluded with the federal government to deplatform its content. And the U.S. Court of Federal Claims denied CHD attorney Rolf Hazlehurst's motion to reopen his son's case claiming that childhood vaccines caused his autism. Judge Edward H. Meyers signed the order Thursday, according to the court docket, but the document is not yet public due to court rules that embargo the release of decisions until parties decide whether to request the redaction of any medical or otherwise private information. Mary Holland, CHD's president and CEO, said the group is disappointed by both decisions. 'It is our understanding that Mr. Hazlehurst is already evaluating the next steps,' she said in a statement. Separately, she said 'the problem' the organization presented in its Meta case 'has lessened' — seemingly a nod to Kennedy's ascension to power within the federal government. 'The censorship-industrial complex agreements of the past seem to have gone by the wayside, at least for now, and for that I am grateful,' she said. In Congress A BBB ORPHAN DRUG WIN? Drugmakers notched a win in the GOP megabill Monday, David writes. Senate Parliamentarian Elizabeth MacDonough allowed an expansion of Medicare's drug-price negotiation exemption for orphan drugs to include medicines that treat multiple rare diseases to remain in the package. She initially ruled that it violated the so-called Byrd rule — which limits what can pass with a simple majority during the reconciliation process — over the weekend. The decision means the policy remains in the underlying GOP reconciliation package being debated by the Senate. Pharma Moves Parexel, a clinical trial consulting company, has hired two FDA alums — Dr. Lola Fashoyin-Aje as senior vice president and head of regulatory oncology, cell and gene therapies and Tala Fakhouri as vice president of consulting for artificial intelligence and digital policy. Fashoyin-Aje was director of the Office of Clinical Evaluation within the FDA's Center for Biologics Evaluation and Research, while Fakhouri was associate director for data science and AI in the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research. Anindita 'Annie' Saha will take on the lead AI policy role at the FDA's drug division, according to an internal email reviewed by POLITICO. Saha is a 20-year agency veteran who will also keep her role as associate director for strategic initiatives at the Digital Health Center of Excellence within the FDA's device center. Saha replaces Fakhouri. Shara Selonick has joined the Senior Care Pharmacy Coalition, which advocates for long-term care pharmacies, as vice president of strategy and government affairs. She most recently was a public health adviser at the FDA. Document Drawer The Government Accountability Office published a report on its forum on 'reducing spending and enhancing value in the U.S. health care system. AbbVie is scheduled to meet with the White House Office of Information and Regulatory Affairs on Tuesday to discuss the Health Resources and Services Administration's 340B rebate guidance. AHIP is scheduled to meet with OIRA on Wednesday to discuss the policy. WHAT WE'RE READING The Supreme Court's decision upholding the Affordable Care Act's coverage mandate for preventive services may now shift the legal landscape toward defining what constitutes 'evidence' underpinning federal recommendations, Lauren writes. Kennedy's influence over federal health regulation under a Republican president is being seen in a once-unlikely area — psychedelics as sanctioned mental health treatments, POLITICO's Erin Schumaker reports. A federal judge ruled last week that the Health Resources and Services Administration didn't violate the law by requiring Johnson & Johnson to get its approval before changing how it reimburses providers participating in a drug discount program, Stat's Ed Silverman writes.
