CognitrexCancerDigest

Innovent Biologics, a world-class biopharmaceutical company that develops and commercialises high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, jointly announced with Eli Lilly and Company that the innovative PD-1 inhibitor Tyvyt (sintilimab injection), co-developed by both companies, is the only PD-1 inhibitor that has been included in the new Catalogue of National Reimbursement Drug List (NRDL) according to the latest announcement from the National Healthcare Security Administration (NHSA). The inclusion of Tyvyt (sintilimab injection) to the NRDL demonstrates that the NHSA has recognised its clinical value, patients benefit and novelty among other factors. This will also allow more patients to be able to afford the new immunotherapy drugs to improve their lives. Dr. Michael Yu, founder, chairman and chief executive officer of Innovent, said: "In recent years, the country's healthcare system reform has been systematically p...

SINGAPORE: A drug routinely used to treat women suffering from ovarian and breast cancers, has shown promising results when administered to men in whom prostate cancer had spread to other organs too (metastatic cancer). Olaparib , (brand name Lynparza) produced by Anglo-Swedish pharmaceutical major AstraZeneca, recently underwent clinical trials and was found efficacious in treating prostate cancer patients, according to initial results of the clinical trials presented at European Society for Medical Oncology (ESMO) Asia Congress 2019, under way at Singapore from November 22-24. Prostate cancer is the sixth leading cause of cancer deaths worldwide among men with a burden of 3.6 lakh men dying annually, as per the Global Cancer registry 2018. Indian prevalence of prostate cancer is 4.5 in one lakh population. It's seen among men of the age group 50-60 years. Olaparib, is a pharmacological inhibitor of the enzyme PARP (poly ADP Ribose polymerase or PARP) which is required for cance...

The number of cancer cases in India has seen a steady rise in recent years with all states reporting a jump in number of patients afflicted with various types of the disease, the junior minister for health said in a reply tabled last week in Lok Sabha. As to steps being taken to combat the spread of cancer, minister Ashwini Kumar Choubey said the government is focusing on three types of cancers: breast, cervical and oral which, along with  lung cancer , together account for 41% of the country’s cancer burden, according to  Indian Council of Medical Research  (ICMR) data. A look at the data shared in Parliament. Source: https://health.economictimes.indiatimes.com/news/industry/mizoram-tops-in-cancer-prevalence-kerala-saw-fastest-growth-in-2-yrs/72233406

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Calquence (acalabrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Calquence, which is a next-generation selective inhibitor of Bruton’s tyrosine kinase (BTK), binds covalently to BTK to inhibit its activity. The FDA approval was based on data from the interim analyses of two phase III clinical trials, including Elevate-TN in patients with previously untreated CLL and Ascend in patients with relapsed or refractory CLL. According to the company, both studies demonstrated that Calquence in combination with obinutuzumab or as monotherapy significantly minimised the relative risk of disease progression or death against the comparator arms in both first-line and relapsed or refractory CLL. Elevate-TN is a randomised, multicentre and open-label Phase III study designed to assess the safety and efficacy of Calquence in combination with obinutuzu...

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has exempted Sun Pharmaceutical Industries’ gemcitabine hydrochloride injection from price control in its last meeting on 30 October, according to minutes of the meeting. The approval for the ready-to-use infusion bags of gemcitabine hydrochloride injection, which exhibits anti-tumor activity and is used to treat various kinds of cancer. Under paragraph 32 of the Drug (Price Control) Order, 2013, the NPPA can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research. Sun Pharma got the approval for gemcitabine hydrochloride injection of 10mg/ml strength in ready to use infusion bags of 120ml, 140ml and 160 ml. While the Standing National Committee on Medicines raised concerns that there was no clinical study to suggest that the product offered significant therapeutic advantage and increased efficacy as compared to other forms of the drugs, the NPPA poi...

BENGALURU: The Centre for Devices and Radiological Health (CDRH) of the US Food and Drug Administration ( USFDA ) has designated Cytotron —a device invented in India by a Bengaluru scientist—as a “Breakthrough Device” in the treatment of liver, pancreas and breast cancers. Cytotron aids in tissue engineering of cancer cells to alter or modify how specific proteins are regulated to cause cancer cells to stop multiplying and spreading. Cytotron was invented in India by Rajah Vijay Kumar at the Centre for Advanced Research and Development (CARD) after nearly 30 years of research in understanding cellular pathways and interactions with specifically modulated fast radio bursts. “It is been a great feeling that after so many years of hard work against all odds, a prestigious institution like the USFDA is designating our work as a “breakthrough” in the treatment of three notorious cancers,” Kumar said in a statement. He told TOI that the recognition—which comes his way because there haven’...

Sun Pharmaceutical Industries announced that it has entered into a licensing agreement with AstraZeneca UK (AstraZeneca) to introduce certain novel ready-to- use (RTU) infusion oncology products in China. The agreement will help to bring cost effective and quality drugs to patients in China. As per the terms of the agreement, Sun Pharma will be responsible for development, regulatory filings and manufacturing the products covered in the agreement while AstraZeneca will exclusively promote and distribute these products in China. The initial tenure of the agreement is 10 years from the first commercial sale of the said products in China. The financial terms of the agreement are confidential. Source: https://www.business-standard.com/article/news-cm/sun-pharma-enters-into-licensing-agreement-with-astrazeneca-for-oncology-products-in-china-119110600195_1.html