- Completion of divestment of first major tranche in Bajaj Joint Ventures | Allianz Allianz.com
- Bajaj Finserv Increases Stake in Insurance Subsidiaries, Joint Venture Ends InvestyWise |
- Bajaj Finserv shares in focus as firm completes acquisition of 23% stake in insurance companies from Allianz SE Upstox
- Allianz Sells Indian Holdings for 2.1 Billion Euros MarketScreener
- Bajaj Finserv Ends Insurance JV With Allianz Group In Rs 21,400-Crore Deal NDTV Profit
Category: 3. Business
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Completion of divestment of first major tranche in Bajaj Joint Ventures | Allianz – Allianz.com
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Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder
WASHINGTON, Jan. 8, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received a decision letter from the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form. This letter stems from CDER’s agreed re-review of the jet lag application under the October 1 collaborative framework agreement.
The FDA acknowledged positive efficacy from Vanda’s controlled clinical trials, however, the FDA concluded that these data do not provide substantial evidence of effectiveness for jet lag disorder, primarily on the grounds that controlled phase advance protocols (5-hour and 8-hour bedtime shifts) are not sufficiently analogous to actual jet travel, which according to the FDA involves additional factors such as reduced oxygen pressure, physical constraints, noise, and lighting changes.
Vanda respectfully disagrees with this interpretation. Phase advance models are widely accepted in circadian rhythm research as valid and reliable surrogates for simulating the core circadian misalignment underlying eastward jet lag—the primary driver of the disorder’s hallmark symptoms per ICSD-3 criteria. These models reproducibly induce the essential features of jet lag without the confounders of variable travel conditions which are unrelated to jet lag. The convergent evidence from Vanda’s studies including simulated and actual transatlantic travel demonstrates tasimelteon’s meaningful benefits on sleep duration, latency to persistent sleep, and next-day alertness.
Tasimelteon’s safety profile is also well-established, with predominantly mild adverse events and a market experience of over 10 years in chronic approved indications. Vanda maintains that the submitted dataset meets the statutory standard for substantial evidence of effectiveness on clinically relevant endpoints, for jet lag disorder.
Procedural Status
As previously announced, in August 2025 the D.C. Circuit set aside a prior FDA refusal to approve HETLIOZ® for jet lag disorder, describing Vanda’s evidence as “specific, reasoned, and rooted in evidence” and the FDA’s prior review as “cursory,” while noting statistically significant improvements on primary endpoints across trials.
Following that ruling, Vanda and the FDA entered a collaborative framework agreement in October 2025, under which the FDA committed to an expedited re-review of the sNDA by January 7, 2026, including consideration of narrowed, sleep-focused indications.
Vanda appreciates the FDA’s engagement but believes the current decision does not fully reflect the collaborative spirit or address the Court’s concerns regarding meaningful engagement with the evidence. Vanda remains committed to working constructively with the FDA while pursuing all appropriate avenues to advance approval of HETLIOZ® for jet lag disorder and make this important therapy available to travelers.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About HETLIOZ®
HETLIOZ® is a melatonin‑receptor agonist, approved in the United States for the treatment of Non‑24‑Hour Sleep‑Wake Disorder and nighttime sleep disturbances associated with Smith‑Magenis Syndrome. For full U.S. Prescribing Information for HETLIOZ®, including indications and Important Safety Information, visit www.hetlioz.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding Vanda’s commitment to working with the FDA while pursuing appropriate avenues to advance approval of HETLIOZ® in jet lag disorder, and the potential commercial availability of HETLIOZ® for the treatment of jet lag disorder are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda’s forward-looking statements include, among others, the FDA’s willingness to work with Vanda and meaningfully engage with the evidence, the results of Vanda’s efforts to advance and obtain FDA approval of HETLIOZ® in jet lag disorder, and Vanda’s ability to successfully execute a commercial launch of HETLIOZ® for the treatment of jet lag disorder if approved. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda’s business and market, particularly those identified in the “Cautionary Note Regarding Forward-Looking Statements”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vanda’s most recent Annual Report on Form 10-K, as updated by Vanda’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
[email protected]SOURCE Vanda Pharmaceuticals Inc.
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North Solihull looks forward to the next Solihull Apprenticeship and Pathways Show
Apprenticeships and post-16 pathways such as BTEC and T Levels will be on display at the show later this month for young people to learn about local opportunities.
With over 40 employers and training providers signed up for the show, this event enables young people to learn about alternative routes after GCSE’s. They can speak to exhibitors and current apprentices who will be able to share their first-hand experience. The first hour is a quiet hour for young people with additional needs to find out more about Inclusive programmes such as Supported Internships.
Visitors will have the chance to speak to employers and training providers from hospitality, manufacturing, construction, engineering and public sectors. Exhibitors include JLR, National Gas, Severn Trent, the NEC Group, Everyone Active, Solihull College & University Centre, Reflections Training Academy, Creative Alliance and Solihull Council. It will take place at the North Solihull Sports Centre on Wednesday 28 January 2026 from 2:30pm to 7:00pm.
Councillor Heather Delaney, Portfolio Holder for Economy, Business & Skills, said: “The Solihull Apprenticeship and Pathways Show has always been well attended. We are excited for new exhibitors joining us this time such as National Gas and British Academy of Jewellery. We are always working to expand our network and reach so that visitors can learn about opportunities from more industries. Speaking directly with employers and current apprentices is the best way for young people to find out if a training programme or apprenticeship is for them.
“At the beginning of the year, it’s usually the time that young people start to think about what they’ll do after GCSE’s. It can be daunting for some, so we hope that an event like this would give young people the chance to get all the information they need to explore all the post-16 pathways available locally. Ultimately, it will help them take the best next steps. I’d encourage all young people, especially those in Year 10-13, to sign up for the show.”
Organised by Solihull Careers Hub which is part of the Council’s Employment and Skills Team, the Solihull Apprenticeship and Pathways Show is free to attend and it is advised to book in advance. Free parking is available on site. For more information or sign up, please visit this webpage.
Editor notes:
- The Solihull Apprenticeship and Pathways Show is funded by the UK Government through the UK Shared Prosperity Fund, West Midlands Combined Authority, The Careers and Enterprise Company and Solihull Metropolitan Borough Council.
- Solihull Careers Hub is funded by The Careers and Enterprise Company and Solihull Metropolitan Borough Council.
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Minister Calleary signs new contract with An Post for cash payments at post offices
- An Post will deliver approx. 25 million payments to welfare customers in 2026
- Pensions, jobseekers, child benefit and other payments can be collected at your local post office
Today, Minister for Social Protection, Dara Calleary announced that An Post has been awarded the contract for the Department of Social Protection’s new Cash Payment Services contract.
The Department’s Cash Payment Services contract provides for over-the-counter personal cash payments to welfare recipients. About 30% of payments made to the Department’s customers are made by cash.
The awarding of the contract to An Post follows a competitive tender process to secure the best-value and best-quality provision for customers and taxpayers.
The new Cash Payment Services contract began on the 1st of January 2026 and will expire in December 2028. After the initial three-year contract period is complete, the Department has the option to extend the contract for one additional year.
Welcoming the new contract, Minister Calleary said:
“An Post delivered almost 25 million welfare payments to our customers through the An Post Network in 2025. Now that this new contract is in place, my Department, in conjunction with An Post will continue to provide the important provision of cash payments to the Department’s customers who rely on this service across urban and rural communities.”
Debbie Byrne, Managing Director of An Post Retail said:
“An Post is pleased to continue delivering cash payment services to Department of Social Protection customers across Ireland.”
“Through investment in our unique network of 880 Post Offices, technology, training and our dedicated staff and Postmasters, we will continue to ensure customers’ access to secure, reliable cash payments, so essential to local communities.
Post Offices handled more than €7 billion in DSP payments last year, showing huge resilience during extreme weather events and other challenges to serve customers. We look forward to our continued close working relationship with the Department over the coming years”, she added.
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REMINDER: Swisscom 3G phase-out | CERN
Swisscom will switch off its 3G network at the end of 2025. This 3rd generation of mobile communications was introduced 20 years ago and has become inefficient in terms of energy requirements, spectrum usage and the resources required to maintain it, so operators are freeing up these resources for new technologies.
To continue using your mobile phone at CERN (in Switzerland and in CERN’s underground facilities) you’ll need a device that supports at least 4G and VoLTE (Voice over LTE). SMS (Short Message Service) services will be maintained via 4G.
You can check your device’s compatibility via Swisscom’s cockpit or by sending a free SMS to 444, using your CERN SIM card, with the keyword 3G. Please be aware that some models’ characteristics are not properly identified in Swisscom’s database. If this is the case, you should check that 4G/5G is shown on your phone as an option for data connectivity. You will also need a VoLTE-compatible phone to place/receive calls. If your device displays 4G but it disappears when you make a call (while connected to Swisscom), then VoLTE is not switched on or your device is not compatible.
If your phone is not compatible, you should replace it. 4G and VoLTE have been standard on mobile phones for the last 7 to 10 years, depending on the brand.
For further information, you can visit this link or contact the mobile service support team.
__________
This announcement was originally published in June 2025.
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Chinese shares close lower Thursday-Xinhua
BEIJING, Jan. 8 (Xinhua) — Chinese stocks closed lower on Thursday, with the benchmark Shanghai Composite Index down 0.07 percent to 4,082.98 points.
The Shenzhen Component Index closed 0.51 percent lower at 13,959.48 points.
The combined turnover of these two indices totaled 2.82 trillion yuan (about 402 billion U.S. dollars), down from 2.85 trillion yuan on the previous trading day.
Stocks related to the commercial aerospace sector as well as brain-computer interfaces and AI applications led the gains, while those related to insurance, securities companies, lithium mining and precious metals experienced declines.
The ChiNext Index, tracking China’s Nasdaq-style board of growth enterprises, fell 0.82 percent to close at 3,302.31 points.
However, the STAR Composite Index, which reflects the performance of stocks on China’s sci-tech innovation board, closed 1.14 percent higher at 1,766.57 points. ■
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CR Tested These Protein Powders. All Had Low Levels of Lead.
Before publication, CR contacted the manufacturers of all the products we tested and shared our results and methodology with them. We wanted to know whether they were using any unique sourcing or manufacturing processes that could explain their comparatively cleaner results, and what that might reveal about other manufacturers’ practices.
Premier Protein declined to comment. Representatives from Equate’s parent company, Walmart, and Clean Simple Eats didn’t respond to multiple requests for comment.
Truvani’s co-founder and co-CEO, Derek Halpern, said in an interview that what sets his company apart is the frequency with which it tests for heavy metals. “I’ve been told routinely by my manufacturers that the volume of tests that we ask for far outstrips anyone else they’ve ever worked with,” he said. “I just want a test result for every lot—that doesn’t seem that ridiculous to me.”
Truvani has tested its chocolate-flavored protein powder 162 times over the last 12 months, Halpern said. Every lot of Truvani products is tested for heavy metals and other contaminants, and ingredients that don’t meet internal standards are rejected. (Halpern declined to share the specific thresholds Truvani uses, but said that its lead standard is similar to the California Prop 65 limit that CR uses in its level of concern calculations.)
Halpern said he suspects less rigorous approaches are more common across the industry because they’re less costly and still technically meet FDA requirements. Some companies rely on spot-checks or certificates of analysis from ingredient suppliers instead of testing every finished lot, he said.
“It can be more expensive to ensure that every vat of your product is very low in lead,” says Cohen of Harvard Medical School. “And without a requirement that it be that way, it’s unlikely that the industry as a whole is going to move in that direction.”
Lindsay Dahl, chief impact officer at the supplement brand Ritual, says she thinks that “heavy metal testing transparency is feasible for the entire industry.” Ritual tests its ingredients and all finished goods for contamination, and uses California’s Prop 65 limit as a goalpost for most products, she says.
Ritual is unique in that it publishes detailed sourcing information for its products. “We openly share the final place of manufacturing and the names of our suppliers for the public to see,” says Dahl, who added that the company thinks that “ingredient traceability is the best way to help reduce contaminants.” She noted that the powder tested by CR was made with Puris-brand pea protein from North America and cocoa powder from several countries through Cocoa Horizons, a program that promotes sustainable and traceable farming.
“It took us three years of searching and testing different cocoa suppliers to finally launch a chocolate flavor version of Essential Protein,” says Dahl, who attributed the delay to Ritual’s heavy metal and human rights standards. “While we spend a tremendous amount of time working to find the highest quality suppliers, we also know it’s hard to have formulas that are entirely contaminant-free, which is where our product testing comes in.”
In a letter to Congress last year, Ritual’s CEO, Katerina Schneider, said that because plant-based protein powder is a “high-risk product,” the company publishes heavy metal test results for one recently released lot of each flavor of its Essential Protein powder on its website. In the letter, Schneider also took the rare step of advocating for greater industry regulation, calling on Congress to “empower the FDA to establish health-protective limits for heavy metals in supplements and protein powder.”
It’s a position also held by CR’s consumer advocates—and many others. A CR petition calling on the FDA to set strict standards for heavy metals in protein supplements has garnered over 43,000 signatures since October.
“The FDA is still lacking enforceable lead limits for protein powders and dietary supplements,” says Brian Ronholm, CR’s director of food policy. “Having these standards in place would push the industry to consistently make products with lower levels of lead, which our test results certainly demonstrate is possible for companies to do.”
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A year of action: More than 43,000 counterfeit products removed from Manchester’s streets in 2025
In 2025 Manchester City Council’s Trading Standards Team seized and destroyed nearly £4.5m of counterfeit goods.
Ranging from fake handbags, trainers, jewellery, electronic items, sportswear, to children’s toys and sunglasses there are few areas that the counterfeit goods industry does not reach.
However, through exemplary partnership work alongside Greater Manchester Police, and brand representatives this criminal industry has taken a substantial hit over the past 12 months.
Of the more than 43,500 counterfeit items which were seized it is estimated that the value lost to the industry was between £34m – £43m.*
In addition to counterfeit goods a substantial push was made throughout the year to crack down on the sale and distribution of illicit tobacco. Sold in packaging not compliant with UK law and often shipped in from oversees, it presents a substantial impediment to supporting Mancunians to quit smoking and move away from tobacco products.
As Manchester has some of the worst health outcomes in the country when it comes to smoking-related illnesses it is hugely important that steps are taken to curtail the sale of illicit tobacco.
In total, 316,625 cigarettes – equivalent to nearly 16,000 individual packs were seized. In addition, 258kg of hand rolling tobacco was seized, as well as more than 18,000 illegal vapes which do not comply with UK laws or regulations.
Councillor Lee-Ann Igbon, Executive Member for Vibrant Neighbourhoods, said: “I am incredibly proud of the results that our officers achieved throughout 2025. The counterfeit industry was substantially embedded in our communities, but through their diligence and the support of our valued partners we have driven away some of the worst offenders and are beginning the process of regenerating the areas of Manchester that were long blighted by this sort of crime.
“Through Operations Elswick and Machinize run in collaboration with GMP we have made a significant impact against criminal enterprises and we hope this sends a message that we will not tolerate this harmful trade.”
Detective Chief Inspector Melanie Johnson, lead coordinator over Operation Machinize for GMP, said: “Last year we collaborated with Manchester City Council’s Trading Standards to tackle businesses on our high streets that were being used as a front for criminality and putting our communities at risk.
“As a result of our operations, we managed to seize over £1 million worth of illegal items.
“The joint partnership operation has enabled GMP to gather further information and intelligence enhancing our understanding of criminality within these types of businesses.
“We take any information we receive very seriously and will continue to investigate all aspects of this criminality to protect our communities from the harms of illegal products.”
*Note on Lost Value
This is the estimated loss of money when comparing the price of a sold counterfeit item, vs the authentic product. Ie., if a pair of counterfeit Nike shoes were sold for £20, when the RRP was £90, the lost value would be £70.
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DMA Review contributions
Today, the European Commission published a summary and the individual contributions received in response to the consultation on the ongoing review of the Digital Markets Act (DMA).
The Commission welcomes the high level of participation, with over 450 contributions submitted by a broad range of interested parties, including small and medium-sized enterprises (SMEs), gatekeepers, civil society organisations, academics, and individual citizens. The contributions generally show respondents’ broad support for the DMA’s objectives and indicate that the regulation has already brought benefits. Some contributions ask to strengthen interoperability, data access and data portability, as well as support for SMEs. Some also ask to expand the DMA’s scope, particularly in relation to AI and cloud services. Gatekeepers on the other hand expressed criticisms such as regarding impact on user experience, as well as concerns about proportionality.
The assessment of these contributions will feed into the Commission’s review report to be presented by 3 May 2026 to the European Parliament, the Council, and the European Economic and Social Committee. The regular review of the DMA every three years is a legal requirement, mandated by the regulation itself, to ensure that the DMA meets its objectives and maintains its effectiveness in the evolving landscape of digital markets.
The public consultation, which was launched on 3 July 2025 as part of the ongoing review, was accompanied by a call for evidence and a dedicated questionnaire on Artificial Intelligence (AI), which were published on 26 August 2025. The contributions to the call for evidence are already public.
See the announcement also on Commission’s press corner.
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A deep learning and large language hybrid workflow for omics interpretation
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