Latest news with #BIOSECUREAct
Business Standard
13-05-2025
- Business
- Business Standard
India Solidifies Position as Most Attractive Global CDMO Destination: LoEstro Report
VMPL New Delhi [India], May 13: India is poised to lead the global biopharma outsourcing landscape, leveraging recent regulatory shifts to cement its status as the most attractive destination for CDMO services. According to a new report by LoEstro Advisors, the country's Contract Development and Manufacturing Organisation (CDMO) industry is projected to reach USD 14 billion by FY28, growing at a rapid 14% CAGR. This positions India not just as a major player, but also as a global front-runner in drug development and manufacturing services. The report highlights India's unique strengths. These include significant cost advantages, a skilled scientific workforce, and a strong regulatory track record. The research says India is home to 585 FDA-approved plants, second only to the United States. Every year, over 200,000 pharmacy graduates join the workforce. The country also offers affordable land and labour, allowing companies to scale faster and at lower costs. Commenting on the findings, Rakesh Gupta, Managing Partner at LoEstro Advisors, said, "At LoEstro Advisors, we are committed to delivering actionable insights to empower decision-makers in the pharmaceutical and healthcare sectors. We trust this report will serve as a valuable resource for executives, investors, and industry leaders aiming to capitalize on the opportunities within the CDMO space." Crucially, geopolitical and policy shifts are influencing global outsourcing strategies. In the United States, the proposed BIOSECURE Act, which seeks to limit federal contracts with firms that partner with certain Chinese biotech companies, has already started reshaping outsourcing patterns. While the legislation is still under debate, it has gained bipartisan support and is seen as likely to pass. Anticipating this, several US-based companies have begun actively exploring alternatives outside of China. India, with its strong regulatory reputation and manufacturing capacity, is emerging as a natural and strategic alternative. The CDMO industry is also shifting toward next-generation therapies, including cell and gene treatments, mRNA platforms, and antibody-drug conjugates (ADCS). These require advanced capabilities and high specialisation. Indian CDMOS are responding by investing in cutting-edge infrastructure, digital technologies, and integrated service models. With increasing geopolitical uncertainties, ESG regulations, and volatile costs in traditional markets, global pharma companies are rethinking their supply chains. Many are moving operations closer to home or to trusted partners. India, with its proven reliability and regulatory compliance, is emerging as a stable, strategic choice. PE Platforms like Cohance, Viyash, and Sekhmet are consolidating the Indian CDMO space. This wave of integration is reshaping the industry. For mid-sized players, it presents both a challenge and a golden opportunity to scale, specialise, and stand out.
Yahoo
17-03-2025
- Business
- Yahoo
Scinai to Connect with Investors, Showcase its Innovative I&I pipeline and its Boutique cGMP Biologics CDMO during BIO-Europe Spring 2025
JERUSALEM, March 17, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and in providing CDMO services through its Scinai Bioservices unit, today announced that it will be meeting with investors, showcasing its innovative I&I product pipeline in partnership meetings and exhibiting its CDMO boutique services at the BIO-Europe Spring 2025 conference, taking place March 17-19 in Milan, Italy. Scinai's CEO, Mr. Amir Reichman, CTO, Dr. Dalit Weinstein-Fischer and Business Development Director, Mr. Solomon Gahtan will be holding meetings during the conference days with: Potential pharma partners in the field of I&I and dermatology interested in co-developing or in-licensing one of Scinai's innovative NanoAbs. Prospective clients of the company's end-to-end biologics CDMO services. Institutional and private investors interested in Scinai's value proposition. Additional interested parties are encouraged to schedule a meeting through the conference partnering platform or to email Scinai at bd@ to schedule a meeting. Throughout the conference, Scinai will also be available at exhibitor booth #22 to showcase its CDMO services. About Scinai Bioservices CDMOIn 2024, Scinai launched its CDMO business unit, branded as Scinai Bioservices, operating from the Company's site in Jerusalem, Israel. This facility includes 1,850 square meters (approximately 20,000 square feet) of clean rooms and laboratories, all operating under cGMP conditions in compliance with European Medicines Agency (EMA) and FDA requirements. Since its inception, the CDMO unit has executed drug development projects for multiple biotech companies. These activities have included upstream and downstream process development, scale-up, analytical methods development and drug manufacturing for pre-clinical and clinical trials. Additionally, the Company has partnered with Ayana Pharma to provide liposomal encapsulated drug development services. Scinai's U.S. subsidiary, Scinai Bioservices Inc., aims to serve U.S. based early-stage biotech companies by providing the required CDMO services that are currently in short supply. Scinai Bioservices Inc. allows early-stage biotech startups, supported by U.S. government grant funding, to use their grant money, avoiding any concerns related to the BIOSECURE Act. About Scinai ImmunotherapeuticsScinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique Biologics CDMO providing biological drug development, analytical methods development, clinical GMP manufacturing, and pre-clinical and clinical trial design and execution services to early stage biotech companies. Company website: Company ContactsInvestor Relations | +972 8 930 2529 | ir@ and Partnering | +972 8 930 2529 | bd@ Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that we won't raise any capital under SEPA or that we will not otherwise benefit from the SEPA as currently anticipated; lower than anticipated revenues of Scinai's CDMO business; the risk that Scinai's expanded presence in the U.S. will not significantly enhance the prospects of its CDMO unit; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Photo - View original content to download multimedia: SOURCE Scinai Immunotherapeutics Ltd.
Yahoo
31-01-2025
- Health
- Yahoo
RFK Jr. thrusts domestic manufacturing agenda on Day 2 of confirmation hearings
Robert F. Kennedy Jr. (RFK Jr) has claimed that 'China will be able to ransom medical health' in America due to its hold on drug manufacturing during his high-profile confirmation hearing. During the Senate Health, Education, Labor, and Pensions (HELP) Committee meeting held on Thursday (30 January), the nominee for the United States Secretary of Health and Human Services (HHS) under the Trump administration said that it was vital for the US to take back control of drug manufacturing. Kennedy said: 'This is a huge priority for President Trump. It is perhaps our greatest national security vulnerability and over the past few years so much of our critical medicine production and supply chains have been moved to China. This is a crisis in our country. If there is a pandemic, if there is a war or any conflict, China will now be able to ransom American health and that is not a good situation. We need to bring that production home and President Trump is committed to doing just that.' This comes soon after the BIOSECURE Act, widely seen as a law that targets China-based pharma manufacturers like Wuxi Biologics, Wuxi AppTec and more, was excluded from the National Defense Authorization Act (NDAA) for fiscal year 2025 that was put forth for Senate approval in early December. The BIOSECURE act was expected to be a part of the NDAA after it was passed by the House of Representatives in September 2024. The act seeks to prohibit federal agencies from contracting with or providing funding to any company working with a 'biotechnology company of concern'. Senators grilled Kennedy on several topics as part of the nomination hearings, including his stance on vaccines, which was also raised yesterday (29 January). Kennedy stated he is not 'anti-vaccine' in yesterday's session, and added today that he would continue to evaluate safety and efficacy of all vaccines. Addressing Kennedy in today's hearing, Republican Senator Bill Cassidy said: "Your past of undermining confidence in vaccines with unfounded or misleading arguments concerns me. I have constituents who partly credit you for their decision to not vaccinate their have cast doubt on some of these vaccines, but the data has been there for a long time.' Another concern raised in today's committee was Kennedy's 'lack of knowledge' about Medicare and Medicaid, both of which would come under the aegis of the Department of the Health and Human Services, which Kennedy has been nominated to lead. Kennedy incorrectly stated Medicare Part A is 'mainly for primary care or physicians,' while it covers seniors' inpatient hospital care. On Medicare Part B, Kennedy said 'it's for physicians and doctors,' but Democratic Senator Maggie Hassan clarified it is for outpatient care and home health. On Medicare Part C, Kennedy said it's for 'the full menu of all the services A, B, C and D' but Hassan corrected him that it is for Medicare Advantage, which includes Medicare Part A and Part B. Kennedy also shared his views on glucagon-like peptide 1 agonists (GLP-1RAs) at the hearing. He said: "The GLP class of drugs are miracle drugs, but I do not think they should be the first front line intervention for six-year-old kids. That is the standard of practice now" Novo Nordisk's Wegovy (semaglutide) has been approved by the US Food and Drug Administration (FDA) for the treatment of obesity in children 12 years of age or older. It has not been approved anywhere globally for children under the age of 12. Eli Lilly's Zepbound is not approved in children of any age. "RFK Jr. thrusts domestic manufacturing agenda on Day 2 of confirmation hearings" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
