Showing posts from September, 2021

BDR Pharma launches generic cancer drug in India

Drug firm BDR Pharmaceuticals on Tuesday said it has launched generic Cabozantinib, used for the treatment of various types of cancer , and will bring the product in India in the next few days. Cabozantinib is used for the treatment of metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma, BDR Pharma said in a statement. “Ensuring that all our patients have access to quality-produced, world-class treatment at a reasonable rate was the main reason for launching the drug in India,” BDR Pharmaceuticals, Business Development – Director, Raheel Shah said. The company, however, did not give any details about the cost of the drug. Cabozantinib is prescribed for treating patients with progressive, metastatic medullary thyroid cancer and as a second-line treatment for renal cell carcinoma apart from treating hepatocellular carcinoma, BDR Pharma said. The drug is available in the strengths of 20 mg, 40 mg and 60 mg, it added. Source:https://indianexpres

MSN Labs launches generic drug for renal cancer treatment

MSN Labs has launched Cabolong, a branded generic of Cabozantinib, for the treatment of renal cell carcinoma. Cabolong is available in 20mg/40mg/60mg strengths at a pricing of below ₹10,000 for monthly treatment regimen with the highest strength. In contrast, the same therapy cost runs into lakhs (of rupees) with imported brands currently available in the market, the company said in a release on Thursday. MSN Labs said it has set up a dedicated oncology division, whose focus is on presenting a comprehensive range of affordable high quality, bio-equivalent generic oncology medicines to benefit patients in India. “Given the rising cancer incidence in our country and overwhelming treatment costs, launch of our dedicated oncology division demonstrates our unwavering commitment to patients’ health and economic well-being,” it said. Cabolong is manufactured at MSN Labs facility approved by global regulatory authorities such as US FDA and EU GMP, the company said. Source:https://www.thehindu.

US FDA accepts for priority review Bristol Myers’s BLA for LAG-3-blocking antibody relatlimab & nivolumab FDC to treat unresectable or metastatic melanoma

  Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. “Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic

Boehringer Ingelhein acquires biopharma company, Abexxa Biologics

  Boehringer Ingelheim announced the acquisition of Abexxa Biologics, a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments. The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell, rather than those expressed on the cell membrane. This enlarges the pool of potential cancer antigen targets. In particular, Abexxa’s technology could lead to the development of cancer immunotherapies that are effective in a broader range of patients and cancer types. “The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully to en

Merck announces positive results from phase 3 KEYNOTE-355 trial of Keytruda in combo with chemotherapy to treat mTNBC whose tumors expressed PD-L1

  Merck announced the final overall survival (OS) results from the pivotal phase 3 KEYNOTE-355 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) for the first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). Keytruda is the first anti-PD-1 therapy in combination with chemotherapy to demonstrate a statistically significant and clinically meaningful improvement in OS for these patients. In this study, Keytruda plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093) in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] =10), as compared to chemotherapy alone. There was an increase of 6.9 months in median OS with Keytruda plus chemotherapy compared to chemotherapy alone (23.0 months [95% CI, 19.0-26.3] vs. 16.1 months [95% CI, 12.6-18.8], respectively). Although the trial was not powered to compare e

GSK to present new data in oncology pipeline and portfolio at ESMO Congress 2021

GlaxoSmithKline (GSK) plc will present new data across the company’s oncology pipeline and portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress 2021 (16-21 September), including new data on Jemperli (dostarlimab) and Zejula (niraparib), as well as early-stage research in immuno-oncology and oncology cell therapy. With 13 presentations at the meeting (12 GSK-sponsored and one GSK-supported), GSK will demonstrate its momentum in advancing dostarlimab and niraparib, and provide new insights into investigational therapies through early-stage research. The data being presented at ESMO reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variet