Glenmark reveals encouraging data from hay fever study

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 […]

Lupin launches testosterone solution in the US

Pharma major Lupin said it has launched a testosterone topical solution in the US for males suffering from the deficiency of the hormone. Lupin’s Testosterone Topical Solution is the generic equivalent of Eli Lilly and Company’s Axiron solution, Testosterone Topical Solution, 30 mg per actuation had annual sales of approximately $179 million in the US, […]

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

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. […]

Fortis Healthcare gets notice from Registrar of Companies

Hospital chain Fortis Healthcare said it received a notice from the Punjab and Chandigarh office of Registrar of Companies asking for information. The company did not clarify what the information was related to, but it is likely that it is related to the corporate affairs ministry’s inquiry into allegations that the promoters siphoned off money […]

Glenmark to market South Korean co’s drugs in the US

Glenmark Pharmaceuticals, a global pharmaceutical company based in India, said it has signed an exclusive agreement with a South Korean company to sell six eye-related generic drugs in the US market. The total U.S. brand sales for the six products was approximately $1.7 billion for calendar year 2017. Glenmark said it expects to file six […]

USFDA issues Form 483 on Biocon’s Malaysia manufacturing plant

The United States’ Food & Drug Administration has issued a Form 483 after inspecting Biocon’s Malaysia manufacturing plant, indicating that it found discrepancies during the inspection. Issue of Form 483 means that the plant has not been approved for production of medicines in its current shape, and must be modified under a ‘corrective and preventive […]

Suven gets patents in India, South Korea

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

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,” […]

Cipla, Strides Shasun launch HIV drug in the US after patent expires

Cipla and Strides Shasun, two Indian pharmaceutical companies, both said they have started shipping generic versions of Gilead Sciences’ HIV drug Viread after patent protection expired last week. Viread is among the bigger pharmaceutical drugs in the US and has sales of around $725 mln (Rs 4,650 cr) in the US every year. The patent […]

Panacea Biotech, Serum Institute in polio vaccine tie-up

Panacea Biotec said it signed two long-term agreements with the world’s largest vaccine manufacturer, Serum Institute of India Pvt. Ltd, for manufacturing polio vaccines with a potential market size of $1.25 bln per year. The vaccine will also protect against six other diseases — Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenza type B & Polio. […]

Ipca Laboratories acquires US pharma manufacturer for $9.65 mln

Ipca Laboratories Ltd said it is has acquired US-based drug manufacturer Pisgah Labs Inc. for US$ 9.65 millions free of debt. The acquisition is aimed at establishing the company’s foothold in the US market in the field of contract research and small-volume manufacturing of active pharmaceutical intermediaries. Pisgah Labs Inc., North Carolina, USA was originally […]

NIIT acquires US-based corporate training firm

NIIT Limited, which made a name for itself training millions of Indians with IT skills, said it acquired a US-based corporate training company. NIIT will incur a cost of $8.1 mln (Rs 51.50 cr) over the next five years for the acquisition, including assumed debt and goodwill costs. Eagle International Institute provides training programs for […]

OrbiMed Asia invests $7.5 mln more in Vivimed Labs unit

Vivimed Labs said it will receive $7.5mn investment from OrbiMed Asia into its API business as a follow on to the $42.5 mn invested in September 2017. At the time, Vivimed has said that the proceeds will be utilised for debt reduction at the parent entity level as well as for expanding the API business. […]

Lupin gets USFDA nod for scalp solution

Pharma Major Lupin announced that it has received final approval from the US Food & Drug Administration to market a generic version of Dovonex Scalp Solution from Leo Pharmaceutical Products Ltd. Calcipotriene Topical Solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. Lupin’s Calcipotriene Topical Solution, 0.005% (Scalp Solution) […]

Aurobindo Pharma gets USFDA nod for generic deep vein thrombosis drug

Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fondaparinux Sodium injection — a bioequivalent and therapeutic equivalent to Arixtra of Mylan Ireland. The product, used to prevent deep vein thrombosis (DVT), will be launched next month. “The approved product has an estimated market […]