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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
Pharma major Strides Shasun said it agreed to sell its India branded generics business to Eris LifeSciences Limited for Rs 500 cr in cash. “This transaction is the outcome of the company’s portfolio reprioritization, to focus more sharply on larger regulated markets,” it said. The India branded generics business being divested by Strides had sales […]
Pharma major Zydus Cadila said it received final approval from the USFDA to market an anti-inflammatory injection Ethacrynate Sodium in the US. The drug is used to decrease the Swelling (edema) caused by various disease conditions such as liver disease, kidney disease, congestive heart failure, cancer etc. and will be produced at the group’s formulations […]
Pharma giant Cipla Ltd said it received final approval for launching a generic version of Astrazeneca’s Pulmicort inhalation suspension for pediatric asthma in the US. The product is available for shipping immediately, Cipla said. Pulmicort Respules and generic equivalents had U.S. sales of approximately $825M for the 12- month period ending September 2017, making them […]
Pharma company Suven Life Sciences Ltd said it received new patents in India, USA and Hong Kong for neurological drugs. The patents — one each in Hong Kong and the US and a couple in India — are valid through 2032, 2030 and 2034. “The granted claims of the patents include the class of selective […]
Pharma giant Zydus Cadila reported excellent numbers for the September quarter, led by rising US revenue that lifted its margins and profits. For the second quarter ended September 30, 2017, Zydus Cadila reported Earnings before Interest, Depreciation and Tax (EBIDTA) of Rs. 857 crores, up by 68% y-o-y. Net profit was up 33% to Rs. […]
Alembic Pharmaceuticals said it bought New Jersey-based generic drug developer Orit Laboratories LLC, which will bring seven approved generics and four applications with it. Orbit has “a team of eight highly experienced scientists,” Alembic said, adding that the firm focuses on developing and filing oral solid and liquid products. “We Welcome Dr. Satish Patel, Founder […]
Pharma major Lupin reported an 8% fall in Q2 revenue to Rs. 3,952 cr. Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) for the quarter fell by 13% to 927 cr. Net profit was also down by 31.3% at Rs 455 cr in in the September quarter. The profit was higher than the mean analyst […]
Pharma giant Cipla said it received final approval to market a generic version of Genzyme’s kidney drug Renvela Tablets in the US. Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health. The approval is for Sevelamer Carbonate Tablets, 800 mg, which is an AB-rated […]
Suven Life Sciences Ltd said it was granted a patent by New Zealand authorities for “a class of selective 5-HT4 compounds” that are being developed to treat neurodegenerative diseases. The compounds are being explored for use in cases of Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia, it said. The new […]
