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ClinChoice Expanding its Global Footprint into Southeast Asia

ClinChoice, a leading global Contract Research Organization (CRO), announced expanding its global footprint with the acquisition of CSI Medical Research (CSI). CSI is a regional clinical CRO with professional staff and partners located across Southeast Asia (SEA), Australia and New Zealand (ANZ), to provide innovative and cost-effective clinical solutions. Through this strategic acquisition, ClinChoice further broadens its global footprint and full-service capabilities in more than 30 countries throughout Asia, Europe and North America around the world. In recent years, the overall environment and infrastructure to support clinical research in Southeast Asia have been significantly improved. With large population, improving economy, maturing regulatory processes and healthcare systems, the SEA has attracted increasing number of biotech and pharmaceutical companies to conduct clinical research and drug development trials in the region. CSI, incorporated in 2017, has quickly grown into a prominent regional CRO with proven track record of executing clinical trials in Southeast Asia. The management team at CSI consists of seasoned clinical research professionals that had worked in some of the biggest names in the industry before establishing CSI. The Company has managed a wide range of clinical trials with their extensive knowledge of local practice, requirements and regulations. ClinChoice, as a global CRO, is dedicated to providing full-service and functional solutions across the entire development lifecycle for pharmaceutical, biotechnology, medical device, and consumer product companies locally and globally. With over 4,000 professionals worldwide, ClinChoice has established deep regulatory know-how, clinical trial execution and data management capability across all major markets and regions around the world. With the history dating back to 1995, ClinChoice has completed over 1,500 full-service clinical studies across all clinical trial phases and covering all major therapeutic areas. "This is an exciting time for ClinChoice, and we are thrilled to welcome the talented CSI team to the ClinChoice family." said Mr. Ling Zhen, Global Chairman and CEO of ClinChoice, "With their wide-range of highly valuable service offering and seasoned professional team, the acquisition of CSI will further expand our presence in SEA and ANZ, and enhance our capability to well fulfill our clients' need locally and globally." "Joining with ClinChoice is the ideal next chapter in CSI growth story. We are excited to leverage on our familiarity with the SEA and ANZ regulations as well as the clinical sites within a region we called home, to assist more customers to navigate through the challenges with great speed and better cost efficiencies." said Mr. Nelson Wong, Founder and CEO of CSI Medical Research, "CSI's vision and mission in the approach to manage clinical trials are very much aligned with ClinChoice, and the company's high-quality, efficiency and teamwork culture will be fantastic for our talented employees and clients alike. We are very looking forward to what we can achieve together."

Healthcare startup CureBay to hire over 200 professionals in india

Bhubaneshwar-based healthcare startup CureBay, focused on solving primary healthcare in remote locations through an innovative hybrid model, has successfully raised approx Rs 62 crore in a Series A1 funding round. The round was led by Elevar Equity, their existing investor and saw participation from CureBay founders and some of the leadership team members. The newly raised funding will enable the health-tech innovator to continue creating access to high quality and affordable healthcare in medically underserved locations, build an intelligent and robust health data platform and hire the best tech and healthcare talent in the industry. As part of its growth strategy, the company aims to focus on driving profitability and data monetisation by investing in recurring revenue streams such as its membership program and building its data practice - both in technology and on the go-to-market front. The funding amount will further be used to hire over 200 professionals including data scientists, healthcare experts, specifically in diagnostics and pharmacy and to build their membership program that strongly drives their longitudinal data and affordability initiatives. Underscoring its commitment to enhancing primary healthcare access in rural India, the fresh funding will also be instrumental in driving CureBay's ambitious expansion plans over the next 6-12 months, raising its count of clinics - from the existing 90+ - to over 200 across Odisha, Chhattisgarh and entering a new market - Jharkhand.

BIOS Health to establish international medicine center in US, bringing quality jobs

BIOS Health announced it is partnering with the City of Bakersfield, Kern County, and Kern Venture Group (KVG) to establish a state-of-the-art precision medicine center in Bakersfield, California. BIOS Health is pioneering the technology to read and interpret neural signals in real-time with AI, giving crucial insights previously inaccessible to clinicians, and pharmaceutical and medical device companies. A major challenge in the healthcare industry today is a lack of any clear data and usable insights around the nervous system’s response to novel medicines and medical devices. This leads to high failure rates in clinical trials, costing the industry billions a year, and prevents potentially life-saving treatments from reaching patients - both of which the center aims to address. BIOS has developed adaptive dosing technology, using neural biomarkers and AI, to observe and adjust in real-time, the effects of drugs and stimulations on patients’ nervous systems. For example, during implantation of neural stimulation devices, clinicians and their patients can now access real-time measurements of the effectiveness of their treatment, optimizing the dosing in under 10 minutes compared to what normally takes 12 months or more of trial and error. BIOS will establish its West Coast hub to serve as the premier center for neural clinical trials and R&D, and to accelerate its broader commercialization in the US market. By setting up a center dedicated to real-time neural research for clinical trials, BIOS aims not only to scale up operations and reach more patients faster, but to also create an ecosystem of clinicians, pharmaceutical and medical device companies, and clinical trial partners around this new capability in accessing and understanding neural data. It will also enable BIOS to partner with leaders in clinics, more rapidly commercialize its technology in the clinical environment, and better serve pharmaceutical, biotechnology, and healthcare partners in the United States. BIOS chose Bakersfield for its proximity to large customers, access to talent, efficient operational costs, and its existing network of innovation and medical research. In particular, KVG, a partner and existing investor in BIOS, is attracting leading deep tech companies to the area to establish the industries of the future, and has extensive experience in accelerating their growth there. KVG, Kern County, and the City will also bring together their existing networks of local research organizations and large healthcare systems to facilitate the work of the center. Emil Hewage, CEO of BIOS Health, said: “We are excited to be creating the infrastructure, alongside our regional, clinical and commercial partners, to deliver a new future for precision medicine development. This investment is in reaction to the massive and unmet demand for more effective and affordable clinical trials. Our adaptive dosing technology can offer a new type of clinical trial in which we observe and interpret the neural response of patients in real-time. Soon, treatment decisions that used to take months, or even prove to be impossible, will be available to clinicians and patients at their fingertips.” David Higdon, Co-founder and Managing Partner of Kern Venture Group, said: “BIOS Health is leading us into a new era of precision neural insight, much like how reading DNA transformed medicine, and continues to do so. We see the potential to transform Bakersfield and the Central Valley with BIOS by establishing a critical mass of researchers, trials, and experts in the area. The potential really is unbounded for impact and for growth.” Jenni Byers, Interim Director, City of Bakersfield’s Economic & Community Development Department: “BIOS’s work is unique and has the potential to transform modern medicine as we know it today. Bakersfield is a prime West Coast location with an abundant labor force, robust job training programs, and has the resources to support BIOS's growth. We are confident that our support of BIOS will be an important investment in Bakersfield’s and BIOS’s future.” Jim Damian, Chief Economic Development Officer in Kern County, said: “Kern County is thrilled to partner with the City of Bakersfield and Kern Venture Group to welcome BIOS Health Ltd’s West Coast Hub to Kern County. This new business will not only generate quality jobs within our growing biotech and artificial intelligence sectors, but will support our region’s ambition of being the best place in California to start and grow a business.” Lord David Prior, former Chair of NHS England and investor in BIOS, said: “There is a huge backlog in clinical trials in part because they do not have the insight needed into how their therapies are affecting patients’ nervous systems or the means to adjust the dosing to reduce side effects. BIOS Health’s technology is a game-changer that will be able to reduce that backlog and accelerate better therapies through to clinical trial success so more patients are able to benefit faster.”

WuXi Biologics to Increase Manufacturing Capacity, creates 200 new jobs

WuXi Biologics a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it will increase the total manufacturing capacity of its facility in Worcester, Massachusetts to 36,000 liters. In response to global clients' increasing demand for contract manufacturing services, the Worcester facility, known as MFG11, will add 12,000 liters of commercial drug substance capacity, up from a planned 24,000 liters. Construction of the 189,500-square-foot facility is underway and recently achieved weather tight status. The facility anticipates being operational in 2025 with GMP release in 2026. WuXi Biologics currently employs over 400 people in the U.S., and the Worcester facility will create an additional 200 new jobs when fully operational. Dr. Chris Chen, CEO of WuXi Biologics, noted, "The new commercial capacity in Worcester, Massachusetts represents a key part of our global biomanufacturing network, reflecting our commitment to continuously strengthen our capabilities in line with anticipated market and client needs. We look forward to providing more efficient and cost-effective manufacturing processes and enabling our clients to bring new biologics to patients." Last year, WuXi Biologics launched its first Boston Research Service Center, marking its fourth site in the U.S. after its clinical manufacturing facility in New Jersey and process development and characterization laboratories in Pennsylvania. Upon the Worcester facility construction work going at full speed and operational by 2025, the company is well set to provide full-spectrum integrated services in the U.S., encompassing biologics discovery and development as well as clinical and commercial manufacturing.

Novartis expands its advanced radioligand therapy manufacturing facility in Indianapolis

Novartis announced that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States. The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world. The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future. “The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come. We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach.” The Indianapolis facility, centrally located within the US, is purpose-built from the ground up to manufacture RLTs now and into the future and includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry. The new site will supply the growing demand for patients in the US and eventually in Canada, upon approval, together with the company’s Millburn, New Jersey location. The site in Ivrea, Italy will continue to supply patients in and outside the US while the facility in Zaragoza, Spain will solely provide RLTs for patients outside the US. Novartis recently announced that supply of Pluvicto is unconstrained. Having doubled weekly production, Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly. Novartis is committed to improving access to its RLTs, Pluvicto and Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) by adding more treatment sites in closer proximity to patients over the coming months. With four active manufacturing facilities, and a RLT production capacity of 250,000 doses in 2024 and beyond, Novartis continues to expand its worldwide RLT manufacturing network as ongoing clinical trials may present the potential to bring Pluvicto and Lutathera to more patients in earlier lines of treatment.

IIL invests Rs 700 Cr in new vaccine manufacturing plant, adding 750+ jobs

Indian Immunologicals Limited (IIL) has started construction of its new greenfield veterinary vaccine facility to manufacture the Foot and Mouth Disease Vaccine (FMD-Vac) as well as Foot and Mouth Disease + Haemorrhagic Septicaemia Vaccine (FMD+HS-Vac) in Hyderabad’s Genome valley. This brand-new unit will have a BSL3 facility for the manufacture of drug substances and a fill-finish capability for the production of both drug products FMD vaccine and the FMD+HS vaccine. Telangana State Industrial Infrastructure Corporation Ltd (TSIIC), a Government of Telangana undertaking, had allotted the land to IIL at Biotech Park, Phase III, Karkapatla, Siddipet district in Telangana. The proposed facility has a capacity of 150 million doses/annum of FMD vaccine or FMD+HS vaccine each. With an investment of approximately Rs 700 crore, the proposed facility is expected to create more than 750 direct and indirect jobs. Dr K Anand Kumar, Managing Director, IIL said, “We are the largest supplier of FMD vaccine to Government of India’s prestigious Livestock Health Disease Control Programme (LHDCP). We are in an exponential growth phase and expected to grow 40% this year alone. In order to sustain the momentum, IIL is seriously considering making additional investments in building infrastructure within India and in other emerging geographies including Africa in a manner to develop tools that will help in control and eradication of diseases.”

Emcure’s new manufacturing plant to create additional job opportunities in India

Emcure Pharmaceuticals has inaugurated its recently commissioned facility at Mehsana in Gujarat. The inauguration was done by Rushikeshbhai Patel, Minister of Health and Family Welfare, Gujarat. The new plant manufactures injectables for sale in India as well as for export to global markets. Emcure's manufacturing operations have been established for decades, and are spread across 13 sites in India. The company currently has an oral formulations manufacturing line at Mehsana and the new unit commissioned in August, 2023 is now ready for commercial supplies to domestic and international markets. With dedicated manufacturing facilities for different platforms and packaging formats, Emcure’s manufacturing facilities across the country are capable of producing pharmaceutical and biopharmaceutical products across a wide range of dosage forms, including oral solids, oral liquids, injectables, including liposomal and lyophilised injectables, biotherapeutics and complex APIs. With approvals and accreditations from various regulatory authorities such as EDQM, Health Canada, USFDA, ANVISA Brazil, and more, the company ensures that it remains in compliance with the relevant regulations and is able to supply products in regulated and other markets. Emcure’s new manufacturing plant will aim at creating additional job opportunities in the local market.

Roche named among top three most sustainable healthcare companies

Roche has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). Roche ranked third, Chugai Pharmaceuticals, a member of the Roche Group, ranked second. “We are extremely proud that our deep commitment to sustainability in all our business practices has been recognised again,” said Roche CEO Thomas Schinecker. “It is a fantastic achievement that Chugai and Roche came in second and third, respectively. This double recognition reflects the innovation the Roche Group brings to society, and our commitment to continually embed sustainable practices in our strategy and culture.” For the past 15 consecutive years, Roche has maintained its leading ranking, which is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices serves as a benchmark for investors who integrate sustainability considerations into their portfolios. Sustainability at RocheFor over 125 years, sustainability has been an integral part of Roche’s business. Roche follows a holistic approach to sustainability and integrates the three dimensions of sustainability: Society: how we contribute to a better tomorrow for all Environment: how we minimise our impact on nature Economy: how we invest in medical advances, create jobs and ensure livelihoods Roche makes its biggest contribution to society by improving healthcare provision. It does so by developing innovative treatments across major disease areas and medical assays, digital solutions and services helping people live healthier lives.

AGC Inc to expand its biopharmaceutical CDMO capability in Japan

AGC Inc, Japan-headquartered manufacturer of glass, chemicals, and high-tech materials, has decided to expand its biopharmaceutical CDMO (contract development and manufacturing organisation) capability at the AGC Yokohama Technical Center. The total investment for the expansion is expected to be approximately 50 billion Japanese yen. Development services for gene and cell therapies is planned to begin first in 2025, followed by development and manufacturing services for mRNA pharmaceuticals, biopharmaceuticals made using mammalian cell cultures and gene and cell therapies in 2026. This expansion has been selected by the Japanese Ministry of Economy, Trade and Industry (METI) as part of its 'Developing biopharmaceutical manufacturing sites to strengthen vaccine production project'. AGC will introduce dual-use facilities that can be applied to manufacturing of vaccines in the event of a pandemic. In addition to mammalian cell culture bioreactors which have one of the largest capacity as a CDMO in Japan, the expansion will also include facilities for leading-edge field of mRNA pharmaceuticals and gene and cell therapies. This will greatly contribute to the domestic development and manufacturing capabilities for biopharmaceuticals, which are currently highly reliant on overseas CDMOs. Furthermore, fully operational, it is expected to employ approximately 400 employees and contribute to the advancement of the society and biotech industry.

SCHOTT Pharma invests in a new production facility ,creating 100 jobs in Serbia

Amid growing market demand, SCHOTT Pharma continues expanding its global manufacturing network and has decided to invest a double-digit million euro amount in a new production site for pharma drug containment solutions and delivery systems in Jagodina in central Serbia. "With this move, we are strengthening our presence in Europe, improving our competitiveness, and increasing our manufacturing flexibility to meet the needs of our customers in the region," explains Andreas Reisse, CEO of SCHOTT Pharma. The ramp-up for the manufacturing of ampoules for the pharmaceutical industry is expected to start in the course of 2024. The production site in Jagodina, a town of 35,000 inhabitants and the administrative center of the Pomoravlje County, is well on schedule: the groundbreaking ceremony will take place at the end of December. In the first phase, SCHOTT Pharma will create 130 new jobs, and 350 are planned for the expansion phase.

Health & Biotech