Showing posts from August, 2018

iCAD Announces AERB Approval of Xoft System in India

A global medical technology leader providing innovative cancer detection and therapy solutions, announced today that its  Xoft ®  Axxent ®  Electronic Brachytherapy (eBx ® ) System ®  has received an Atomic Energy Regulatory Board (AERB) Type Approval for use in India. The approval affirms that the system conforms to established safety standards and makes the full suite of the Company’s electronic brachytherapy products available to clinicians and patients across the country. The  Omega Hospitals – Hyderabad , part of the Hyderabad Institute of Oncology, is the first site to adopt the Xoft System in India. Omega Hospitals is a world-class, integrated healthcare delivery system providing more than 89,500 patient care visits annually. “AERB approval of the Xoft System represents an important milestone in our continued efforts to provide healthcare facilities worldwide with leading-edge technology offering clinically-proven treatment options for a range of cancers,” said Ken Ferry, CE

Panacea inks pact with Natco, Breckenridge for cancer drug

 Panacea Biotec today said it has inked a tripartite pact with Natco Pharma and Breckenridge Pharmaceutical Inc to manufacture and supply of Azacitidine injection, a chemotherapy drug, for the US market. As per the terms of agreement, Natco has provided the technology for manufacturing Azacitidine to Panacea Biotec’s Baddi facility. Panacea will be responsible for manufacture and supply of the product, which will be marketed, sold and distributed by Breckenridge in the US. In a regulatory filing, Panacea said its application (prior approval supplement) for qualifying its site has been filed with the United States Food and Drug Administration (USFDA) and the approval is expected in due course of time. “This collaboration will enable the company to grow its revenues and will also ensure increased capacity utilisation of our oncology plant at Baddi,” Panacea Biotec Managing Director Rajesh Jain said. Source:

China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer

Roche  (SIX: RO, ROG; OTCQX: RHHBY )   today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval follows priority review of Alecensa in China and has been granted just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals, respectively. "Today's approval marks a new era for ALK-positive lung cancer patients in China, who now have a treatment option that offers a meaningful, sustained benefit compared with the previous standard of care," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "It also represents a significant regulatory shift, with the approval received under unprecedented timelines. We are proud to be at the forefront of healthcare inno

Health matters: How machine learning is helping beat chemotherapy

While  machine  learning has already proven its worth in many fields, be it travel, logistics or online shopping, health care is emerging as a sector where it is expected to be a game chager.  OncoStem  Diagnostics, a Bengaluru-based start-up, is using this technology to a greater extent to ease the lives of patients suffering from cancer, especially breast  cancer. OncoStem  was founded in 2011 by Manjiri Bakre, a PhD in  Cell Biology  from the Indian Institute of Science (IISc), who realised not enough has been done to gauge the aggressiveness of the  cancer  tumour. She felt the necessity of using  machine  learning to solve this problem out of her personal experience, when she lost a friend who was just 30 to breast cancer, just two years after it was diagnosed. According to a Lancet report on oncology, breast  cancer  is the most common type of cancer in India, and continues to increase in incidence. About 150,000 women are diagnosed with  breast cancer  every year in the

Pfizer joins crowded field with EU approval for Herceptin biosimilar

The industry behemoth announced on Tuesday that it had receieved European approval to launch its first ever oncology biosimilar therapy, Trazimera (trastuzumab), joining the ranks of Samsung Bioepis, Amgen (Nasdaq: AMGN) and Celltrion (KRX: 068270) in the crowded field of Herceptin copycats. "The approval of Trazimera, Pfizer’s first oncology biosimilar, is another significant step  in our quest to introduce more treatment options for patients in Europe" The Genentech-developed breast cancer therapy was one of the  top-five highest selling  drugs  in 2017, but has faced a sudden flux of biosimilar competition in 2018. All four  copycats were launched in the first seven months of this calendar year. "Trazimera has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,” said Diana Lüftner, member of the Presidency of the German Society of Hematology

Biocon to focus on innovative therapy for Head & Neck cancer in India

Biocon Ltd., Asia's premier biopharmaceuticals company, organized a scientific session and a panel discussion on Creating a paradigm shift in patient outcomes in cancer treatment through innovative targeted therapies. A panel of leading Oncologists focused on the evolution of cancer care treatment in India and highlighted the role of Biosimilars and Biologics in driving newer standards of testing and care in the country. In particular, the discussion focused on targeted therapies in Head and Neck Cancer, including the usage of Biocon’s novel Biologic – BioMab EGFR (Nimotuzumab). The discussion saw an exchange of views from an august panel of senior specialists: Dr. G K Rath, Head, National Cancer Institute, AIIMS;  Dr. Harit Chaturvedi, Director of Surgical Oncology, Max Super Speciality Hospital, Saket; Dr. Kumar Prabash, Professor & Head Solid Unit, Medical Oncology, Tata Memorial Hospital; Dr Shyam Aggarwal, Senior Consultant, Medical Oncology, Sir Ganga Ram Hospital; Dr