Sun Pharmaceutical Industries Ltd said the US FDA has accepted a New Drug Application (NDA) for its OTX-101 dry eye drug. The application will now be processed for approval. Dry eye is a condition in which the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate […]
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 […]
Ahmedabad-based Lincoln Pharmaceuticals said it developed a painless form of malaria injection and has also received a patent in India for the same. It said it expects to increase its exports of anti-malarial treatments by 70-80% thanks to the invention. At present, the Arteether anti-malarial injection available in market are in 3 ml and 2 […]
Pharma Major Lupin said it got the approval of the US Food and Drug Administration to launch a generic version of Bayer’s oral contraceptive Safyral. The branded version has annual sales of around $23 mln in the US. Lupin’s product will be called Tydemy. The combination is indicated for use by women to prevent pregnancy […]
Torrent Pharmaceuticals said it completed its previously announced acquisition of the branded formulation business of Unichem Laboratories for India and Nepal, including its Sikkim manufacturing facility. The deal was signed on 3rd November, 2017. With this, Torrent has entered the list of top pharma firms in the Indian market. “From today, Torrent begins the Integration […]
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 […]
Pharma manufacturer Neuland Laboratories said it acquired a manufacturing plant located near Hyderabad from Arch Pharma Labs Limited. The facility is spread across 12 acres and has a capacity of about 197 KL, the company said. The plant was inspected by the USFDA in 2015, it added. “These were much needed to provide flexibility to […]
The Delhi government has suspended the license of the Max Hospital in Shalimar Bagh after it was implicated in wrongly declaring a newbord dead. “They cannot take any new patients, but they can continue to treat the existing patients,” Delhi’s health minister Satyendar Jain said. The move comes even as the Haryana Government on Thursday […]
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 […]
An official inquiry by the Haryana government has found the Gurgaon Fortis hospital guilty of overcharging and several other violations of law, media outlets reported. Quoting the official copy of the report, Mirror Now said that the inquiry committee found the hospital guilty of negligence, lapses, unethical and unlawful acts on the part of the team […]
Pharma company Eris LifeSciences said it has completed its purchase of the India branded generics of Strides Shasun for Rs 500 cr in cash. “We now wish to confirm that the transaction ahs achieved closure,” said Eris Lifesciences. Last month, Strides Shasun said it was selling the India branded business as part of its portfolio […]
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 […]
Mukesh Ambani, India’s richest man, said telecom was the first of his big bet, and he will now use his resources to solve problems in three other difficult areas — agriculture, education and healthcare. Speaking at the HT Leadership Summit, Ambani said his primary motivation was not to make money. “Money has never meant much […]
Glenmark Pharmaceuticals said it has registered its Seretide Accuhaler product in the Nordic region of Europe, including Sweden, Denmark, Norway, Finland and Iceland. “The commercialization of the product would depend on national approval as well as substitution and pricing approvals,” the company said. The product was registered under the decentralized process. The decentralized process is […]
Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions. The applications were resubmitted last month after being pulled in August in response to audit observations relating to one of Biocon’s drug facilities. At the […]
Pharma major Dr Reddy’s Laboratories said European Union authorities have again allowed it to produce drugs for sale in the EU region at its Duvvada factory in Andhra Pradesh. In its inspection conducted in September, the Regulatory Authority of Germany (Regierun von Oberbayern) had made six major observations on the formulations manufacturing facility near Vishakapattanam. […]
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. […]
Government of India-funded Indian Council of Medical Research (ICMR) and private sector player Zydus have announced the launch of new diagnostic kits that can help in detecting Japanese Encephalitis Virus in mosquitoes and the Crimean-Congo Haemorrhagic Fever in sheep, goat and cattle. The kits are the result of the research and development conducted by ICMR […]
Pharma major Dr Reddy’s Laboratories said it has been served with a class action lawsuit, originally announced in August, related to public disclosures made about regulatory action against the company. “Further to our intimation dated August 28, 2017 with regard to US Securities Class Action Lawsuit, we would like to inform you that the US […]
