Latest news with #drugdelivery
Irish Times
4 days ago
- Business
- Irish Times
German drug-maker Aenova to create 10 jobs with expansion of Kerry facility
German drugmaker Aenova is to create 10 jobs with a significant expansion of its facility in Killorglin, Co Kerry. The company, which trades as Temmler Ireland here, said the development would enable it to develop 'innovative drug delivery systems' in the future. It said the development will place the Killorglin site at the centre of its development capabilities in particle engineering, focusing on spray-dried amorphous solid dispersions and inhalation powders. The investment aims to improve bioavailability of poorly soluble drugs, which constitute about 80 per cent of compounds in global research pipelines. READ MORE Temmler Pharma took over the Killorglin site in 2007 and was acquired itself by Aenova Group five years later. The group currently employs 68 people at the facility. The expansion in Killorglin will create about 10 new roles in the areas of research and development, pharmaceutical technology, and analytics. David McWilliams on how 'big incentives' to build could save Dublin city Listen | 36:51 Florent Bordet, chief scientific officer at Aenova, said the company helps its customers speed up the drugmaking process. 'As an end-to-end contract development and manufacturing organisation, Aenova supports its customers throughout the entire drug product life cycle, from pre-formulation and development to commercial manufacturing,' he said. 'Bioavailability is crucial for new pharmaceutical active ingredients. Our new spray drying technology in Killorglin can help to address this issue and aid our customers bring their products to market faster.' Aidan Spillane, managing director at the Killorglin site, said the facility collaborates closely with scientific researchers at University College Cork and University of Limerick. IDA Ireland chief executive Michael Lohan said the facility has 'continually fostered opportunities, investment, and employment' in Killorglin. Minister for Enterprise Peter Burke said: 'I warmly congratulate Aenova on this exciting expansion of its Killorglin facility, which not only strengthens Ireland's position in advanced pharmaceutical development but also brings high value employment to Co Kerry. 'This investment is a strong vote of confidence in the southwest region's skilled workforce, world-class research partnerships, and thriving life sciences ecosystem.'
Entrepreneur
15-07-2025
- Business
- Entrepreneur
Breathe, Then Build
Opinions expressed by Entrepreneur contributors are their own. You're reading Entrepreneur United Kingdom, an international franchise of Entrepreneur Media. David Harris never set out to be a founder. For more than 30 years, he worked behind the scenes of the respiratory drug delivery industry, quietly growing frustrated with its obsession with imitation over innovation. Inhalers were treated as afterthoughts - mere packaging for the drug - and time after time, projects failed not due to lack of funding, but due to a lack of understanding of the physics that actually governs how patients breathe. In founding CHI, a Cambridge based healthcare technology company, Harris made a bold bet: that true change comes not from copying what exists, but from finally solving what doesn't. And to do that, he had to strike out on his own. Entrepreneur UK finds out more.... What inspired you to start your business? I've worked in the respiratory drug delivery industry for over 30 years, and my frustration has accumulated over this time as the industry has simply tried to copy existing tech - rather than addressing the real need. There is a huge sector set up around copying existing technology on the market. For example, I worked at a number of product and technology development consultancies and the vast majority of project work was focused on developing generic 'me-too' devices that didn't offer any improvement whatsoever for the patient. Pharmaceutical companies develop drugs - and treat the inhaler as packaging - and if it is easier to just copy something that is already proven, they aren't going to try and improve things. Copying existing devices isn't easy or cheap, so it is a false economy. Almost all of these projects fail, and never reach the market, or the patient. I didn't start my career dreaming of starting my own business. I've focused on inhalers because I want to improve patient outcomes. Over time I came to realise that this is what needs to be done for the industry to see real change, and as the consultancies I worked at were limited to do what was asked of them, starting a company to really innovate in this area seemed to be the most logical choice." What was the biggest challenge you faced in the early stages? Money. We nearly went under a few times, and that is hard especially when you have bills to pay. Developing technology takes time, licensing it takes time, and then getting through regulatory hurdles takes time, and there aren't many VC companies out there who have the patience for such long exit times. As a result, we've had to keep a tight control on costs while at the same time taking a lot of risks. Technically there are challenges too. The equipment that you need to acquire data is very expensive, so we had to invent cost-effective ways of testing the technology to prove out concepts, test our assumptions and to be able to confidently show potential customers and partners. There is also a significant lack of understanding within the pharmaceutical companies, and in fact generally, about respiratory physics. In a laboratory setting you can set up an experiment to mimic a patient inhaling in a very controlled manner - but in the real world it is a dynamic, transient, and complex event. Trying to work out what actually goes on has historically been difficult to do precisely, which is why clinical trials often just don't go as expected. That shows that the underlying physics are just not understood. How has the UK's economic environment impacted your business decisions? Ten years ago, it was possible to apply for grants, but there are fewer grants available and much stronger competition now. We've tried to stay clear of VCs as much as we can because we need people who understand the long timescales that are necessary for medical products, and the challenges of innovation. Instead, we've looked to partner with larger companies (like Aptar Pharma) in the industry who can bring expertise and commercial reach that we don't have. It was a model born out of necessity, but it is a very promising approach as it gives us a clear route to scalability, and that is important to our customers. How do you stay ahead of industry trends and innovate within your field? We listen and we try to understand the future barriers and challenges that the industry will face. For example, patients have very different inhalation capabilities, which can be affected by the condition that you are trying to treat. This lack of consistency among patients and in clinical trials is an issue, so we developed a platform called Aeolus, which has an in-built amplifier. This means that the formulation inside the inhaler doesn't know if it is being inhaled by an old person with poor lung function or an Olympic swimmer - they'd get very similar doses. Another example is that we also heard from the industry that new generations of large molecules (like biologics) will require larger masses of drug to be delivered. Rather than expecting a patient to use a traditional inhaler multiple times, we set about developing Quattrii, which is a platform specifically for large fill masses. There are many other trends that we've identified that impact on the decisions we make. But sometimes, inspiration comes from left field. When it comes to 'how' we innovate, that requires hiring the right people and creating the right culture. What steps do you take to build a strong company culture? We hire the right people. Being based in Cambridge gives us access to incredibly creative people, but we need people with integrity and who are open, honest and trustworthy. We empower everybody to contribute towards solving problems and, importantly, give them permission to fail. The reality is that we fail more than we succeed, but if we take the time to understand and challenge our failures, we can learn and improve. If you hire good, honest people and offer them a safe space, then they will feel able to take responsibility and have the freedom to explore solutions. What advice would you give to someone thinking about starting a business in the UK today? Don't let your ego get in the way. Pursue your ideas but don't become blinkered. Challenge your ideas and biases or find people who can. It's also important to be prepared for the financial risk, which can be difficult as you get older. I was in my late 40s when I started CHI, which meant that I had a good amount of industry experience and a large network, but at the same time I have children and a mortgage. At times, these financial pressures have felt overwhelming, especially in the early stages.
Yahoo
14-07-2025
- Business
- Yahoo
Defence's Accum Technology with ADC and Radiopharmaceutical Programs Target Cancer
Montreal, Quebec--(Newsfile Corp. - July 14, 2025) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a leading biotechnology company specializing in drug delivery technologies, is pleased to announce that its highly impactful programs on ADC and Radiopharma programs, which includes collaborations and preclinical studies on cancer therapies with Accum® are ongoing. Defence's Accum®-based ADCs have demonstrated enhanced intracellular delivery and cytotoxic activity in multiple preclinical cancer models compared to conventional ADCs. Defence continues to advance studies that validate additional Accum®-based ADCs, including optimization to increase the value and to attract Pharmaceuticals and Biotech companies for potential licensing deals and co-development opportunities. In addition, collaborations and preclinical studies with ADCs companies are ongoing to validate and confirm the significant efficacy improvement when Defence's Accum® technology is added to their respective ADC. Defence's Radiopharma focused program continues to enhance the optimization of Accum® radiolabelling with studies performed by the Canadian Nuclear Laboratories ("CNL") under notably the CNRI-H program that Defence was granted. The complete study is being performed, including biodistribution, pharmacokinetic profile and therapeutic potency, using radiolabelled Accum® with selected antibodies. Defence's scientific team is confident that the addition of the Accum® technology being applied in the radiopharmaceuticals industry may be transformative. The global antibody drug conjugate (ADC) market size is projected to grow from USD 13.51 billion in 2025 to USD 29.9 billion by 2034, at a compound annual growth rate (CAGR) of 9.23% from 2024 to 2034. The global radiopharmaceutical market is projected to reach $16.87-billion (U.S.) by 2033, growing at a CAGR of 9.9% during the forecast period (2025-2033). Defence's Accum® technology optimization is also currently ongoing, with more detail to be released upon completion of all the studies related. The Company will announce key results when they become available and completed as well as details on partnerships when and if deals and licensing occurred. Defence continues to work on studies in Canada, mainly at Defence's laboratory located in Montreal, Canada and in parallel the Company continues pursuing its plan to expand its presence to the US. About Defence: Defence Therapeutics is a publicly-traded clinical-stage biotechnology company developing and engineering the next generation of ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against cancer. For further information:Sebastien Plouffe, Founder, President, CEO and DirectorP: (514) 947-2272Splouffe@ Cautionary Statement Regarding "Forward-Looking" Information This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release. To view the source version of this press release, please visit Sign in to access your portfolio
Yahoo
11-07-2025
- Business
- Yahoo
Daré Bioscience Receives $6 Million Non-Dilutive Grant Installment; $37.8M to Date of up to $49M Commitment Supporting Smart Drug Delivery Device for Contraception; Platform has Broader Application Potential in Obesity and Metabolic Disorders
Exploring Strategic Partnerships to Expand Platform Beyond Reproductive Health SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today announced the receipt of a $6 million non-dilutive funding installment under its multi-year grant agreement to support development of DARE-LARC1, the contraception-focused use case of Daré's intelligent drug delivery system (DARE-IDDS) platform. This brings the total received to approximately $37.8 million of up to approximately $49 million in committed grant funding for nonclinical development, IND-enabling studies, and preparation for submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). DARE-LARC1 is a preclinical-stage investigational, long-acting reversible contraceptive (LARC) utilizing a next-generation programmable drug delivery device to administer levonorgestrel, the active pharmaceutical ingredient in a number of FDA-approved birth control methods, for an extended period without requiring day-to-day effort. The underlying DARE-IDDS platform has broader potential across multibillion-dollar markets, including obesity, diabetes, and other chronic conditions that require precise, programmable, and/or long-term dosing. Daré is currently exploring strategic partnering discussions to expand evaluation of the platform's use beyond reproductive health. 'This funding milestone will help advance what we believe is one of the most promising smart drug delivery technologies in development today,' said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. 'With non-dilutive capital covering early development, we are not only progressing a novel contraceptive, but also laying the foundation for a versatile, programmable drug delivery device platform across high-value therapeutic areas.' DARE-IDDS: A Next-Generation Drug Delivery Platform1 Originally developed at the Massachusetts Institute of Technology by renowned inventors Dr. Robert Langer and Dr. Michael Cima, clinical proof of concept was validated with an earlier prototype in a prior human study in osteoporosis patients, establishing the feasibility of long-term, programmable drug release via an implantable device.2 Since acquiring the technology, Daré has advanced the design by enhancing electronics, battery performance, and precision dosing, guided by therapeutic use cases and user feedback. The result is a programmable, wirelessly controlled device capable of delivering up to hundreds of individualized doses over months or years, without recharging or surgical replacement. Key Platform Features: Precision Dosing: Controlled release via programmable micro-reservoirs Extended Duration: Monthly to multi-year dosing capability from a single device No External Power Required: Implant-grade battery designed to last up to 20 years Remote Programmability: Schedules and dosing parameters adjustable wirelessly in real time Smartphone Integration: Custom mobile apps for user and clinician interface Upgradable Firmware: Software updates extend lifecycle without device removal Broad Market Potential While the initial focus is DARE-LARC1 for contraception, the flexible DARE-IDDS platform supports integration with GLP-1 analogs, anti-obesity medications, hormone therapies for areas such as diabetes, breast cancer, and infertility, and neurologic disease treatments such as for Parkinson's disease. 'Beyond reproductive health, this platform has the potential to dramatically improve patient adherence, reduce treatment burden, and lower healthcare system costs in areas that today rely on frequent injections or daily oral dosing,' added Johnson. Looking Ahead Daré is eligible for continued non-dilutive funding installments of up to approximately $11.2 million, contingent on achieving technical and other milestones specified in the grant agreement, and is actively exploring strategic collaborations to expand the investigation of the DARE-IDDS platform into additional therapeutic categories. The company expects to continue to provide updates on program progress and partnership activity. 1 DARE-IDDS is an investigational device in preclinical development. It has not been approved or cleared for clinical investigation in humans or for any use in humans. The platform features described in this press release are based on the results of technological proof-of-concept studies. 2 Farra et al., Science Translational Medicine, 22 Feb 2012, Vol 4, Issue 122. Available at: About Daré Bioscience Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Daré believes that innovation does not have to start from scratch. The company's goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women's health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner. The first FDA-approved product to emerge from Daré's portfolio of women's health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit for information about XACIATO. Daré's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil citrate, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré's full portfolio of women's health product candidates and mission to deliver differentiated therapies for women, please visit Daré Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma and Daré's CEO has been honored as one of Fierce Pharma's Most Influential People in Biopharma for Daré's contributions to innovation and advocacy in the women's health space. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website ( SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré's website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'design,' 'intend,' 'expect,' 'could,' 'plan,' 'potential,' 'predict,' 'seek,' 'should,' 'would,' 'contemplate,' 'project,' 'target,' 'objective,' 'on track,' or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-LARC1's potential to demonstrate safety and effectiveness as a long-acting reversible contraceptive product, the potential utilization of the DARE-IDDS platform in future products for the treatment of a broad range of diseases and conditions, the therapeutic and market potential of products utilizing the DARE-IDDS platform, if approved, the potential for Daré to enter into strategic collaborations relating to the DARE-IDDS platform, and the potential for Daré to receive additional payments under the grant agreement relating to DARE-LARC1. As used in this press release, 'first-in-category' is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women's health that is not being met by existing U.S. Food and Drug Administration (FDA)-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré's ability to achieve the technical and other milestones required to receive additional payments under the grant agreement relating to DARE-LARC1; the potential that no definitive agreements result from discussions regarding potential strategic collaborations for the DARE-IDDS platform; DARE-LARC1 is in preclinical development and results from preclinical studies or early clinical trials are not necessarily predictive of future clinical results; Daré's ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; the risk of delisting of Daré's common stock from Nasdaq; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré's ability to raise additional capital or on Daré's operations, financial results and condition, and ability to achieve current plans and objectives; Daré's ability to enter into and maintain third-party collaborations to facilitate access to the solutions Daré intends to bring to market as compounded drugs or consumer health products and Daré's reliance on those third parties; the performance of Section 503B-registered outsourcing facilities and other third parties on which Daré will rely to execute its expanded business strategy; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market; the degree of market demand and acceptance for the products Daré brings to market; Daré's reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future products, if any; the risk that the current regulatory pathway known as the FDA's 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré's ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the potential for termination of the subaward and grant agreements before Daré receives additional payments; the limits on Daré's ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; Daré's ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré's ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré's dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré's interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the risk that developments by competitors make Daré's product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré's product or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Daré's ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré's ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré's product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré's products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; and disputes or other developments concerning Daré's intellectual property rights. Daré's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relationsinnovations@ Source: Daré Bioscience, Inc.
Zawya
09-07-2025
- Business
- Zawya
BioSapien extends pre-Series A funding round to $8mln
UAE – BioSapien has extended its pre-Series A round to over $8 million, adding Globivest to its list of backers, alongside Global Ventures, Golden Gate Ventures, and Dara Holdings. Globivest is the first women-led, gender lens venture capital fund from the MENA region, according to a press release. The healthtech platform also announces the acquisition of world-class talent with 12 new appointments, including Zhiyu Xia PhD as Senior Manufacturing Engineer, Gaurav Vij MBA as Business Officer, and Nancy Sperling MS MS as the QC Lead. Founded in 2018, BioSapien offers a flagship product, MediChip™, which is a drug delivery, 3D-printed, slow-release delivery platform attachable to any tissue with minimal systemic side effects. Khatija Ali, CEO of BioSapien, said: 'Two of the greatest challenges for young, fast-growing companies are establishing a strong balance sheet and attracting high-quality talent. Therefore, I am delighted to announce an extension of BioSapien's pre-Series A funding round.' She added: 'A business is only as good as its people - so it is thrilling to be joined by such high-quality, diverse talent. Together, we will shape a future where precision medicine is both globally impactful and locally accessible.' In January 2025, BioSapien extended its pre-Series A funding round to $7 million to tackle escalating cancer rates by leveraging advanced 3D printing technology. During December 2024, the biotech company secured a $5.50 million pre-Series A funding round. All Rights Reserved - Mubasher Info © 2005 - 2022 Provided by SyndiGate Media Inc. (
