Cadila Healthcare, also known as Zydus Cadila, said it has started enrolling patients in a trial that can potentially yield the first FDA approved treatment for NASH or non-alcoholic fatty liver disease with inflammation. Fatty liver disease, caused by the deposition of fat in the liver, is divided into alcohol-related and non-alcohol related. Within non-alcoholic […]
Less than a month after it approved for clinical trial approval, Hyderabad-based Natco Pharma said it has begun dosing patients in its phase III clinical trial for molnupiravir, a promising candidate for treating COVID-19 that is being studied across the world. Phase III trial data can be submitted to regulatory agencies for seeking approval of […]
Alembic Pharmaceuticals said a new chemical developed by one of its joint ventures has become the first new chemical entity designed by Indian scientists to win approval from the US Food & Drug Administration. Umbralisib, created by its 50% JV Rhizen Pharma, is an anti-cancer drug that works by inhibiting phosphoinositide 3 kinase (PI3K) delta […]
Pharmaceutical manufacturer Zydus Cadila said it received permission to initiate clinical trials for ZYIL1, an oral small molecule NLRP3 inhibitor, as an anti-inflammatory agent. The molecule is being explored for treating a variety of inflammation-related conditions, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, gastro-intestinal diseases (inflammatory bowel disease), […]
Dr. Reddy’s Laboratories, one of India’s biggest pharmaceuticals manufacturers, said it has signed a licensing agreement with Japan-based FUJIFILM to manufacture anti-viral drug favipiravir. Favipiravir is traditionally used to treat infuenza, and is also being tested in COVID-19 patients. Dr Reddy’s said the tie-up is part of the Japanese company’s efforts to ramp up the […]
Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema. The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug […]
Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in Europe. Biosimilars are drugs that mimic or imitate the actions of natural proteins or enzymes in the body, such as insulin. Glargine insulin, which is […]
Pharma major Lupin said it launched a generic version of Bayer’s birth control drug Safyral tablets in the US. The company had received FDA approval for the launch in December. The tablets has annual sales of approximately USD 22 million in the US. Lupin’s product will be called Tydemy. The combination is indicated for use […]
Glenmark Pharmaceuticals reported encouraging clinical trial data from the study of its drug Ryaltris for hay fever or seasonal allergic rhinits. “Results of these robust studies demonstrates that consistent, significant relief from symptoms may be rapidly achieved and sustained with Ryaltris,” said Frank Hampel, Principal Investigator, Central Texas Health Research. “These findings, combined with prior […]
Pharma major Strides Shasun said it has decided to launch the ‘over the counter’ version of ulcer drug Ranitidine in 150 mg dosage in the US markets immediately. Strides Shasun is already a key player in the US Ranitidine market with 32% market share through its prescription version in 150 mg and 300 mg doses. […]
Pharma major Lupin said it has launched the generic version of Allergan’s Alzheimer’s drug Namenda XR in the US. The medicine has annual sales of approximately USD 936 million in the US, making it almost a billion-dollar drug. The launch was done in dosages of 7mg, 14mg, 21mg and 28mg of Memantine Hydrochloride. The drug […]
Drug maker Suven Life Sciences Ltd said it secured more patents in India and South Korea for its drugs designed for treating neurodegenerative diseases. The India product patent is valid through 2029, while the Korean one is good for up to 2033, the company that focuses on neurological diseases said. “The granted claims of the […]
Glenmark Pharmaceuticals reported encouraging results from its Phase 2 clinical trial for GBR 830, a drug that it is testing as a potential treatment for a skin disease known as atopic dermatitis. “A clinical improvement in Eczema Area and Severity Index (EASI) scores was observed in 17 out of 23 patients treated with GBR 830,” […]
Pharma company Lupin said it has launched a generic version of Pfizer Inc.’s antibiotic Vibra-Tab. The drug has annual sales of around $144 million in the US, the Indian company said. The AB-rated generic was approved by the United States Food and Drug Administration (FDA) earlier. Doxycycline Hyclate Tablets 100 mg is indicated for the […]
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 […]
Suven Life Sciences Ltd said it has been granted one patent each in Canada and India for drugs for treating Neurodegenerative diseases. The Canadian patent 2932428 is valid through 2034 and the Indian patent 289123 is valid through 2028. The chemical entities are considered useful in the treatment of cognitive impairment associated with neurodegenerative disorders […]
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that its nasal spray Ryaltris met safety and efficacy goals in a Phase 3 clinical study in treating perennial allergic rhinitis. With the positive results, the company said it plans to submit an application to the USFDA for treating seasonal allergic rhinitis in the first quarter of […]
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 […]
Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab. “Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier […]
Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India. The biosimilar — or a drug that mimics a natural protein — is useful in treating metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers. It will be priced at […]
