Tag: DRUG DEVELOPMENT

Suven Life Sciences Announces Positive Results from Narcolepsy drug trial

| Trisha Thomas

Hyderabad-based Suven Life Sciences today announced positive topline results from a Phase 2 clinical trial evaluating its investigational drug samelisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. The randomized, placebo-controlled study met its primary endpoint, demonstrating that samelisant treatment resulted in a statistically significant and clinically meaningful reduction in […]

Zydus Cadila starts crucial trial for fatty liver drug

| Trisha Thomas

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 […]

Natco Pharma starts Ph III trial of new COVID drug molnupiravir

| Sreejiraj Eluvangal

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 JV’s new drug is first US FDA-approved NCE designed by Indians

| Trisha Thomas

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 […]

Zydus’ cytokine inhibitor moves into clinical trial

| Trisha Thomas

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), […]

COVID-19: Dr Reddy’s signs deal to make and sell favipiravir globally

| Trisha Thomas

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 reports progress in its eczema drug investigation

| Soumya Thomas

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 […]

Biocon, Mylan get approval for glargine insulin in Europe, Australia

| Trisha Thomas

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 […]

Lupin launches generic version of Bayer’s birth control pill Safyral

| Trisha Thomas

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 reveals encouraging data from hay fever study

| Trisha Thomas

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 […]

Strides Shasun launches OTC version of ulcer drug Ranitidine in the US

| Trisha Thomas

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. […]

Suven gets patents in India, South Korea

| Trisha Thomas

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 Pharma finds encouraging results from skin drug trial

| Trisha Thomas

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,” […]

Dr Reddy’s launches generic chemotherapy drug in the US

| Trisha Thomas

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 gets neuro drug patents in India, Canada

| Trisha Thomas

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 reports successful trial for nasal spray, to file NDA soon

| Trisha Thomas

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 […]

Crucial win for Biocon as FDA approves cancer biosimilar trastuzumab

| Trisha Thomas

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 […]