Latest news with #geneEditing
South China Morning Post
4 days ago
- Business
- South China Morning Post
PLA ‘warns off' US ship near Scarborough Shoal, China property woes: SCMP daily highlights
Catch up on some of SCMP's biggest China stories of the day. If you would like to see more of our reporting, please consider subscribing A US destroyer has entered disputed waters in the South China Sea, less than two days after an apparent collision involving a Chinese coastguard vessel and a PLA Navy ship while the former was pursuing a Philippine coastguard vessel in the area. Chinese scientists have boosted the speed of new hybrid crop development fivefold with a combined strategy of 'robot-friendly' gene editing and artificial intelligence-driven robotics. Illustration: Reuters China decided on Wednesday to sanction two European banks as a countermeasure against previous financial sanctions from the 27-member bloc.
RNZ News
08-08-2025
- Politics
- RNZ News
More detail on gene tech regulations to come, as industry mulls opportunities
The Gene Technology Bill seeks to overhaul current law that restricts the use of gene technologies in New Zealand. Photo: 123RF The Gene Technology Bill was discussed at length at the second annual Plant Breeders' Forum in Ōtautahi Christchurch on Thursday, hosted by the New Zealand Plant Breeders and Research Association (NZPBRA). The bill sought to overhaul current legislation that restricted the use of gene technologies in New Zealand, the Hazardous Substances and New Organisms Act (HSNO) from 1996. The risks, opportunities and challenges of gene technologies were debated by hundreds during the select committee process, which drew 15,000 submissions. Many scientists said the effective near 30-year ban on the use of gene technologies like gene editing, transgenic breeding or other new breeding techniques used outside the laboratory held them back from progress, leaving them with the slower traditional breeding techniques. However critics - including conventional and organic farming and anti-genetic engineering (GE) movements - raised concerns about the co-existence of genetically-modified (GM) and non-GM crops on farms, market access, human and environmental health concerns from GM foods and via animal feed, and the controls and requirements for the use of these technologies outside the laboratory. Read more about the Gene Technology Bill: Biological chemist Professor Emily Parker chaired the Ministry for Business, Innovation and Employment's gene technology technical advisory group. Speaking at the Plant Breeders' Forum, she said there had been significant scientific and technological advances since 1996 when the HSNO Act first came into force, and the current regulatory system was seen as a "significant barrier" to getting approval for genetic technology projects. "Primary legislation which is what is before the House at the moment, is the scaffold" she said. "But it will be underpinned by secondary legislation. This is regulations, notices, standards, things that are issued under secondary legislation. "That has a lot of detail about exactly how different activities are managed and there's a lot of technical detail in that, but I know that there will be a lot of interest by this community in that secondary legislation." Parker said the regulations, that were expected in the fourth quarter of the year, would go out for full public consultation. "It sets up a stand-alone regulatory regime; it creates what we call an authorisation framework to manage the risks of gene tech and enable their safe use," Parker said. "And we have international obligations, such as we're signatories to the Cartagena Protocol that we need to make sure we manage within that legislation." In 2000, New Zealand signed the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, an international treaty which aimed to protect biological diversity and human health from the possible risks of importing or exporting living modified organism, including GMOs. Food Safety Minister Andrew Hoggard and his Australian counterparts have agreed to update the definitions for GM food in Australia and New Zealand. Photo: Cosmo Kentish-Barnes Parker said the new approach was modelled very closely to Australia's Gene Technology Act (2002) that was now under its third review. She said requirements for the use of new breeding techniques like gene editing would be specified, and whether they would be notified or non-notified with the public, based on where they fell in risk categories. "What will not be regulated is some organisms and gene technologies can be exempted under the regulations and there will be a set of non-regulated organisms and technology." Parker said she was unable to answer questions asked by a GE-Free New Zealand spokesperson at the forum, if activities exempted from the regulations would be required to feature on a public register, cover liability, or feature on the label . Last month, Food Safety Minister Andrew Hoggard and his Australian counterparts agreed to update the definitions for GM food in Australia and New Zealand, which saw food made with the addition of new or novel DNA no longer being required to state that on the food label. Parker said the public would be able to have their say on the upcoming details. "There will be a lot more opportunity to comment and to have feedback on how the scheme is being used, how this framework is going to be populated, and whether that appropriately manages to be suitable for human health and for the environment." The roll-out of the legislation, if it was accepted by Cabinet, will be a multi-government agency effort. The Ministry for Business and Innovation was the lead government agency, the Environmental Protection Authority will be the regulator, and the Ministry for Primary Industries will be the enforcer. The gene-editing technique CRISPR, was launched by the forestry institute Scion in May last year. Photo: 123RF One technique of interest that arose among many scientists at the event was gene-editing technique CRISPR, that forestry institute Scion launched in May last year. Geneticist Sai Arojju of the Radiata Pine Breeding Company - the only one in New Zealand - said CRISPR and RNA techniques were of interest to the industry - that started using genomic selection in 2022. "In terms of accelerated genetic gain, we feel like adopting new technologies is the way to go," he said at the forum. "Genomics is one example that I've shown you and the remote sensing is the other way that we can sort of accelerate those genetic gains in our breeding programme. "We are keeping an eye on the new technologies as well, for example, CRISPR, how does it fit into our breeding programme, and RNA is the other technology which can be used as a disease control, basically." However, the Forest Stewardship Council (FSC) Board abandoned discussions around genetic engineering in forestry in 2023, and decided not to investigate GM trees. "The decision considered the different views in FSC's membership around the learning process, the division this brings to FSC as well as the potential risk to FSC's mission and reputation. The decision was made by consensus, with two board members expressing reservations about the process," it said in a statement in March 2023. Null segregants descended from genetically modified organisms (GMO) that were considered transgenes, but do not contain those modifications anymore, were no longer considered GMO. Jazz apples took around 15 years to come to market, using traditional breeding techniques cross-breeding Braeburn and Royal Gala cultivars. Photo: CC 1.0 BY-SA / Daderot Molecular biologist Dr Revel Drummond of Plant and Food Research - now the Bioeconomy Institute - said conventional breeding was done in multi-year stages for apples, which took a "a very long time". He said using null segregants could accelerate one stage of the breeding process, from around five years for apples, to just one. "A null segregant is simply something that used to be transgenic and no longer is, so we've taken the transgenic part out of the equation by crossing it away," he said. He said the method was useful, like a "trick" where instead of waiting four or five years for an apple through traditional breeding, it could be cut down to one year. "Now you could do a breeding cycle per year in a fruit tree," he said. "Annual breeding makes a lot of sense here." Jazz apples, for example, were considered one of New Zealand's relatively faster genetic developments taking around 15 years to come to market, using traditional breeding techniques cross-breeding Braeburn and Royal Gala cultivars. Forage breeding was a significant sector that contributed hugely to agricultural success, and had been developed in Aotearoa for the past century. Germplasm - or genetic resources such as seeds, tissues or DNA sequences - was described as "the lifeblood of our industry," by Dr Derek Woodfield, the now retired general manager at PGG Wrightson Seeds. Woodfield said ryegrass and associated endophytes made up around 60-70 percent of the overall forage breeding effort in New Zealand, driven by the need to increase livestock production. "Animals cannot compensate by eating more poor quality forage, they will just grow slower and so the aim of forage breeding is to have high quality forage and high amounts of it to drive animal performance." He said consolidation and rationalisation of the sector had concentrated breeding efforts, listing three of the four main forage breeders as internationally-owned. CropMark, the event sponsor, was the only one that remained New Zealand-owned, he said. "I think we have a huge risk in our forage industry from overseas ownership of our core breeding programmes," Woodfield said. "We are susceptible to overseas investors deciding we are not profitable enough or they're reducing their investment or changing the way in which we do it. "Now they'll only do that for sensible reasons, economic reasons, we hope. But you know we do have to work out what that means long-term for New Zealand." The Health Select Committee declined to comment on how the 15,000 Gene Technology Bill submissions were split in terms of support or opposition, ahead of the release of its report to Cabinet due on 22 August. The second and third reading of the bill was expected later this year, before the Office of the Gene Technology Regulator was tipped to go live in 2026. Sign up for Ngā Pitopito Kōrero , a daily newsletter curated by our editors and delivered straight to your inbox every weekday.
Yahoo
20-06-2025
- Business
- Yahoo
Eli Lilly (NYSE:LLY) Faces $7 Billion Lawsuit While Partnering With Innovative Biotech
Eli Lilly has been in the spotlight recently with a 3.96% share price increase over the past month. The selection of RyboDyn Inc. to join Lilly Gateway Labs stands out among recent developments, signaling strengthened research capabilities in precision immunotherapies and potentially bolstering investor confidence. Additionally, the company's legal entanglement with the lawsuit concerning Actos, following a class certification affirmation, highlights ongoing challenges in the pharmaceutical sector. The company's ongoing talks to acquire Verve Therapeutics also show its commitment to growing its gene-editing capabilities. These events have added weight to the broader market's trends. We've identified 2 warning signs for Eli Lilly (1 can't be ignored) that you should be aware of. The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 27 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. Recent developments at Eli Lilly, such as the RyboDyn Inc. collaboration, have potential implications for its strategic growth, particularly in precision immunotherapies. This aligns with the company's narrative of expanding capabilities in oncology and immunology, indicating possible enhancements in revenue and earnings forecasts over the long term. Additionally, as Eli Lilly progresses with Phase III trials, including those for orforglipron, the anticipated product approvals could bolster revenue avenues by tapping into high-demand markets like diabetes and obesity treatments. Over the past five years, Eli Lilly's total shareholder return was a very large 430.14%, demonstrating substantial long-term growth despite recent underperformance against the US Pharmaceuticals industry, which saw a 8.9% drop over the past year. This impressive five-year return provides context to the company's current position, underscoring a history of robust shareholder value creation. Given the ongoing acquisition talks with Verve Therapeutics and Eli Lilly's significant investment in both manufacturing and R&D, the outlook for future revenue and earnings remains optimistic. However, potential regulatory hurdles and pricing pressures, particularly in the U.S. market, highlight possible challenges. The shares, with a current price of US$775.12, are 21.0% below the analyst consensus target of US$981.63. This discount suggests room for growth, should the company meet or exceed the analyst expectations on revenue and earnings. Learn about Eli Lilly's future growth trajectory here. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:LLY. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
15-06-2025
- Business
- Yahoo
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global Phase 3 HAELO trial of lonvo-z has concluded screening ahead of schedule with more than half screened from U.S. sites; Intellia to provide an update on enrollment in the future CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom. 'Today's results underscore the promising potential of Intellia's approach to gene editing therapy – a one-time treatment that was well tolerated and offered a highly differentiated, durable effect for patients suffering from a serious disease,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'Seeing all 10 patients in the Phase 1 portion of this study free from both HAE attacks and chronic therapy at nearly two years of median follow-up is incredibly encouraging. These data fuel our optimism for the outcomes of our ongoing Phase 3 HAELO study, which we expect to report in the first half of 2026, and highlight the strong value we believe it will offer patients, physicians and payers.' 'People living with HAE often report a reduced quality of life because they worry about the likelihood of their next attack, either because they still experience attacks or are reminded of it by their use of chronic therapy,' said Dr. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc. 'Based on the data, it is reasonable to expect lonvo-z could offer patients the potential to be free from both physical HAE attacks and the burden of managing chronic HAE treatment.' In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12 data cutoff, patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Safety Across all three dose levels, lonvo-z has been well tolerated and continues to demonstrate a favorable safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to 3 years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Clinical Development PlansIntellia's global Phase 3, randomized, double-blind, placebo-controlled HAELO trial is ongoing to assess the safety and efficacy of lonvo-z at the 50 mg dosage. The Company announced today the HAELO trial has successfully completed screening ahead of schedule, with over half of the patients being screened in the United States. The study is no longer recruiting and Intellia will provide an update on enrollment in the future. New and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is planned to be presented in the second half of 2025. Intellia expects to submit a biologics license application (BLA) in 2026 to support the Company's plans for a U.S. launch in 2027. For more information on HAELO (NCT06634420), please visit About the Lonvoguran Ziclumeran (lonvo-z, also known as NTLA-2002) Clinical ProgramIntellia's ongoing Phase 1/2 study is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion of the study is an international, open-label study designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the study. Enrollment in both portions of the Phase 1/2 study is complete. Intellia dosed the first patient in the global Phase 3, randomized, double-blind, placebo-controlled HAELO trial in January of 2025. Visit (NCT05120830) for more details. About Lonvo-zBased on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy designed to prevent HAE attacks by inactivating the kallikrein B1 (KLKB1) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Intellia TherapeuticsIntellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for hereditary angioedema ('HAE'), including the ability to successfully complete its global Phase 3 HAELO study; its expectation to present additional data regarding lonvo-z, including reporting outcomes of the Phase 3 HAELO study in the first half of 2026 and presenting new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study of lonvo-z in the second half of 2025; and its expectation to be able to support a biologics license application for lonvo-z for the treatment of HAE by 2026 for a U.S. launch in 2027. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE; the risk that any one or more of Intellia's product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia's other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by ChavesSenior Manager, Investor Media:Matt CrensonTen Bridge Communicationsmcrenson@
