Latest news with #Bevacizumab
Business Wire
11 hours ago
- Business
- Business Wire
Trially AI Taps Serial Entrepreneur Christian Smith as CRO to Expand AI Clinical Trial Enrollment Across U.S.
KANSAS CITY, Mo.--(BUSINESS WIRE)-- Trially®, a breakthrough AI clinical trial recruitment technology to unlock faster qualified patient enrollment, today announced the appointment of as Chief Revenue Officer. A serial entrepreneur and proven operator, Smith brings a track record of scaling quality service for healthcare organizations and will lead efforts to accelerate trial enrollment for U.S. site networks, healthcare systems, and sponsors with Trially's AI tools. When my mom passed away of breast cancer in 2005, we had no clue there were 28 studies running within driving distance, including studies for Trastuzumab and Bevacizumab which represent some of the top treatments on the market today. Smith joins Trially at a pivotal moment. As clinical research sites face mounting enrollment pressure and shrinking pipelines, Trially has emerged as a category-defining technology. In a landscape where 68% of sites miss enrollment targets and screen failure rates continue to rise, Trially AI is enabling sites to predictably prescreen and qualify patients for trials — with or without an EHR integration — helping teams multiply enrollment for even the most complex protocols in record time. 'In my late teens, I found how difficult it is to navigate medical care when standard treatment paths do not yield results,' said Smith. 'When my mom passed away of breast cancer in 2005, we had no clue there were 28 studies running within driving distance, including studies for Trastuzumab and Bevacizumab which represent some of the top treatments on the market today. It is an honor to join Trially to serve the physician networks and sites by matching patients with novel drug therapies to improve health outcomes and the standard of care.' Prior to Trially, Smith co-founded TrackR, where he helped create the Bluetooth tracking category and grew revenue to over $50 million. During the COVID-19 pandemic, he led direct-to-consumer operations at Dascena, opening 44 testing sites across 26 cities. Most recently, he co-founded Forta, where he pioneered a family centric autism therapy model powered by AI. His expertise in direct-to-patient recruitment, AI-driven care models, and scaling operational quality — are critical to best support Trially partners. 'Christian brings the exact mindset we value at Trially: efficiency, transparency, empathy,' said Trevor Welch, Co-founder and Chief Product Officer of Trially. "He understands what it means to scale with purpose, and he's passionate about empowering research teams to help patients get access to life-saving therapies. His arrival marks a new chapter in our mission to unlock faster qualified patient enrollment across the industry.' About Trially Trially® is shaping the future of clinical trial recruitment with its proprietary AI matching technology that safely unlocks rich clinical data to enroll qualified patients faster. Proven to multiply enrollment rates by 200%, dramatically reduce screen failures and improve site efficiency, Trially's site-based software rapidly integrates with any EHR or CTMS system while maintaining full compliance with HIPAA, SOC 2, FDA 21 CFR Part 11 and ISO 27001 regulations. Designed to meet the needs of physicians, research sites and pharmaceutical sponsors, Trially empowers you to achieve outstanding results in clinical research. For more information visit
Business Standard
16 hours ago
- Health
- Business Standard
Biocon Biologics partners with National Cancer Society of Malaysia
To launch a Patient Assistance Program (PAP) in Malaysia Biocon Biologics has partnered with the National Cancer Society of Malaysia (NCSM), a prominent not-for-profit cancer organization, to launch a Patient Assistance Program (PAP) in Malaysia aimed at improving access to affordable, high-quality biosimilars for underserved cancer patients in Malaysia. Biocon Biologics will provide quality-assured biosimilars from its oncology portfolio, including Trastuzumab, Pegfilgrastim and Bevacizumab, to NCSM, which will manage patient enrolment and medicine supply as part of its healthcare services. This collaboration combines Biocon's expertise in biosimilars with NCSM's community outreach to enhance cancer care accessibility and affordability in Malaysia. The program will start with providing bTrastuzumab to cancer patients facing treatment delays due to budget constraints. The MoU was signed during the National Cancer Congress Malaysia 2025 event, emphasizing a commitment to improving patient-centric healthcare.
BusinessToday
17 hours ago
- Health
- BusinessToday
National Cancer Malaysia Partners Biocon In Offering Affordable Cancer Care For The Underserved
Biocon Biologics Limited, has partnered with the National Cancer Society of Malaysia to launch a Patient Assistance Program (PAP) in Malaysia aimed at improving access to affordable, high-quality biosimilars for underserved cancer patients in Malaysia. The partnership will see Biocon Biologics providing quality-assured biosimilars from its oncology portfolio, including Trastuzumab, Pegfilgrastim and Bevacizumab, to NCSM, which will manage patient enrolment and medicine supply as part of its healthcare services. This collaboration combines Biocon's expertise in biosimilars with NCSM's community outreach to enhance cancer care accessibility and affordability in Malaysia. The program will start with providing Trastuzumab to cancer patients facing treatment delays due to budget constraints. Ratish Trehan, Head of Commercial – Emerging Markets, Biocon Biologics, said, 'Together, we hope to positively impact thousands of lives and strengthen Malaysia's efforts to deliver inclusive, patient-centric healthcare.' Biocon Biologics aims to build on its previous success in expanding access to diabetes care in Malaysia, having served over 345,000 patients, and is now focusing on oncology through strategic partnerships like this. Related
Business Upturn
18 hours ago
- Business
- Business Upturn
Biocon Biologics partners with NCSM to launch Cancer Patient Assistance Program in Malaysia
By Aman Shukla Published on June 24, 2025, 08:56 IST Biocon Biologics Limited, a global biosimilars company and a subsidiary of Biocon Ltd., has joined hands with the National Cancer Society of Malaysia (NCSM) to launch a new Patient Assistance Program (PAP). This initiative aims to improve access to affordable, high-quality cancer treatments for underserved patients in Malaysia. Through this partnership, Biocon Biologics will supply biosimilar medicines from its oncology portfolio, including Trastuzumab, Pegfilgrastim, and Bevacizumab, to support cancer treatment in the country. The program will be managed by NCSM, which will oversee patient enrollment and the distribution of medicines as part of its broader healthcare services. The initiative will begin with the distribution of bTrastuzumab to breast cancer patients who are currently facing treatment delays due to budget limitations. The Memorandum of Understanding (MoU) was officially signed during the National Cancer Congress Malaysia 2025 , underscoring both organizations' commitment to advancing patient-centric healthcare and strengthening cancer care infrastructure in Malaysia. Biocon Biologics brings its global expertise in biosimilars to the partnership, while NCSM contributes its extensive experience in community outreach and patient support. Together, they aim to reduce the treatment burden for patients and make life-saving therapies more accessible. This program builds on Biocon Biologics' earlier success in Malaysia, where it provided insulin therapy and support to over 345,000 diabetes patients. The company is now extending its focus to oncology, using strategic collaborations to expand its impact on public health. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Associated Press
10-04-2025
- Business
- Associated Press
Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio
BRIDGEWATER, N.J. and BENGALURU, India, April 10, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: 'The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.' In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many 'firsts' in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment.* Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.* Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. Recurrent glioblastoma in adults. Metastatic renal cell carcinoma in combination with interferon alfa. Persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by JOBEVNE as a single agent, for stage III or IV disease following initial surgical resection in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by JOBEVNE as a single agent, for platinum-sensitive recurrent disease * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. WARNINGS AND PRECAUTIONS: Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any organ Surgery and Wound Healing Complications: In patients who experience wound healing complications during JOBEVNE treatment, withhold JOBEVNE until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer JOBEVNE for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis. Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage. Arterial Thromboembolic Events (ATE): Discontinue for severe ATE. Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE. Hypertension: Monitor blood pressure and treat hypertension. Withhold until medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy. Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue. Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine. Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception. Ovarian Failure: Advise females of the potential risk. Congestive Heart Failure (CHF): Discontinue JOBEVNE in patients who develop CHF. Please refer to full Prescribing Information for Jobevne™ (bevacizumab-nwgd) for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics' analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It's pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.
