Showing posts from December, 2017

Dr Reddy’s launches generic chemotherapy drug in the US

Pharma manufacturer Dr. Reddy’s Laboratories said it launched a generic version of chemotherapy drug drug Alkeran. The drug is used for palliative — or relief-oriented — treatment of multiple myeloma and epithelial carcinoma of the ovary. The Alkeran brand and generic had U.S. sales of approximately $107 million MAT for the most recent twelve months ending in October 2017, Dr Reddy’s said. The product, Melphalan Hydrochloride Injection, is a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for injection in the United States. It will be sold in a carton containing one singledose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent, it said Source:

Epygen Biotech eying Indian biosimilar market with 5 drugs under pipeline

With an eye on India's biosimilar market which is estimated to grow to US$ 5 billion by 2022, Epygen Biotech, an international biotechnology group headquartered at the Dubai Science Park, is coming up with a manufacturing plant at Patalganga in Raigad MIDC belt, Maharashtra with five biosimilars in pipeline. Spread over 60,000 square feet, the manufacturing facility will be operational by the end of 2018 and will commercialize five biosimilars which are being developed at our own technology incubation center at Navi Mumbai in Maharashtra. Besides India, we also have laboratories and facilities in USA and Dubai. Around  Rs.  175 crore have been earmarked by the company for research and development of five biosimilar drugs which will be launched by 2022, said Debayan Ghosh, founder & president, Epygen Biotech. Currently, the preclinical trials are happening based on Patalganga plant and CTs are lined up. The first biosimilar drug, recombinant streptokinase (rSK) will be launched

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna. “Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluatio

European Commission approves Roches Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer

ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either Alecensa or crizotinib. The primary endpoint of the ALEX study is PFS as assessed by the investigator, and secondary endpoints include: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (as defined by RECIST criteria), duration of response, overall survival, health-related quality of life and safety. The multicentre study was conducted in 303 people across 161 sites in 31 countries. Overall survival (OS) data are currently considered immature with only about a quarter of events being reported. 7   Grade 3-5 adverse events (AEs

DNA fragment length can be cancer marker

Scientists at the  Institute of Bioinformatics  and  Applied Biotechnology  ( IBAB ), Bengaluru, in collaboration with city-based  Megha-Gen Bioscience Pvt Ltd , are studying the lengths of DNA fragments of normal healthy individuals and cancer patients to check if asymptomatic cancer could be detected through a mere blood test. Researchers say DNA fragments are shorter for normal individuals, while it is several times longer for those with cancer. Normal DNA is 150 base pairs (units) long, while that of primary cancer tissue is much longer — going up to 1,000 base pairs in some cases. "Cancer can be screened using a measure called DNA Integrity, which is the ratio of amounts of large DNA fragments versus short ones," said Dr Subhashini Srinivasan, faculty scientist, IBAB who is spearheading the research. "We are working on creating the age and disease baseline that could be used as a standard parameter for length of DNA-Integrity fragments." In case of cancer pati

Cancer Genetics Receives New York State Approval for FDA-Approved Oncomine Dx Target Test by Thermo Fisher Scientific

Cancer Genetics, Inc. (Nasdaq: CGIX ), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced it has received approval for Thermo Fisher Scientific’s Oncomine Dx Target Test from the New York State Department of Health. The first FDA-approved test of its kind, the Oncomine Dx Target Test is playing an increasingly important role in lung cancer diagnostics, a market that is projected to reach $3.65 billion by 2024 i . The Oncomine Dx Target Test is a next-generation sequencing (NGS)-based companion diagnostic (CDx) that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC), including the combined therapy of dabrafenib and trametinib, crizotinib, or gefitinib. “We applaud CGI’s focused efforts in making available and now gaining approval from the New York State Department of Health for Oncomine Dx Target Test,” said Joydeep Goswami, presiden

Pharma firm Roche's drug cocktail doubles chance of holding lung cancer at bay

Adding Roche's immunotherapy Tecentriq to older drugs doubled the percentage of lung cancer patients who survived a year without their disease advancing, an outcome some experts labeled unprecedented. Thirty-seven percent of patients in a closely watched clinical trial who got Tecentriq, Avastin and chemotherapy reached the one-year mark without their cancer progressing (PFS), according to data released on Thursday. For patients getting only Avastin and chemotherapy, that fell to 18%. Roche's November announcement that its Impower 150 trial had broadly succeeded in first-line lung cancer patients helped spur a one-day, $12 billion rally in the Basel-based drugmaker's market capitalization. Thursday's release of specific numbers at a European Society for Medical Oncology meeting in Geneva could further fan investor optimism the Swiss drug maker is gaining on rivals Merck & Co and Bristol-Myers Squibb. Roche Chief Executive Severin Schwan sees an opportuni

Glenmark starts trials of blood cancer drug

Glenmark Pharmaceuticals said it has started the clinical trial of its blood cancer drug GBR 1342 with the dosing of the first patient. “In just the last year, three of the Company’s biologics, two of which are immuno-oncology agents, have begun clinical trials, which is a testament to the outstanding progress made by the global R&D workforce,” said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. GBR 1342 works by targeting CD38 and the CD3 T-cell co-receptor. CD38 is an antigen target implicated in multiple myeloma and other malignancies of hematopoietic (blood stem cell) origin, as well as a variety of solid tumors. “This first-in-human, open-label study’s primary objective is to assess the safety and tolerability of increasing doses of GBR 1342 in multiple myeloma patients until a maximum tolerated dose is reached,” Glenmark Pharma said. The study will also test biomarkers, immunogenicity and additional measures of anti-tumor act

Mylan, Biocon's biosimilar of cancer drug Herceptin gets USFDA nod

Biotechnology major   Biocon   has said the US health regulator has approved   Mylan   NV's biosimilar Ogivri, co-developed with it, for the treatment of certain breast and stomach cancers. Ogivri is the first United States Food and Drug Administration (USFDA) approved biosimilar to   Herceptin   and the first biosimilar from   Mylan   and Biocons joint portfolio approved in the US, the two   companies   said in a joint statement. Mylan  anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of its ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year, it added. Mylan  CEO Heather Bresch said: "The approval of Ogivri represents a monumental achievement for  Mylan  to increase patient access to biosimilars and deliver significant savings to the US healthcare system." As one of the nations leading suppliers of  cancer  medicines,  Mylan  is excited to add to its portfolio a pr

Panacea Biotec gets US nod for generic version of cancer drug Abraxane

Panacea Biotec said it got the regulatory nod in the US for launching a generic version of big-selling cancer drug Abraxane. The drug will be sold with the help of Canadian pharmaceutical distributor Apotex. The annual sale of Abraxane worldwide is approximately US$973.4 million and approximately USS633.8 million in the US, the Indian company said. The drug will be used for the treatment of Metastatic Breast Cancer, Non-Small Cell Lung  Cancer and Adenocarcinoma of the Pancreas in the US. The approved drug is Paclitaxel Protein Bound Particles in vials of 100mg. Panacea Biotec has already commercialized this product in India and emerging markets like Sri Lanka, Turkey etc. under the trademark – PacliALL. “The company looks forward to commercializing this product in US and several other markets  worldwide in collaboration with Apotex,” it said “The FDA’s acceptance of our ANDA filing is an important milestone for our ‘Best-few’ products development prog