India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln. AbbVie, which has patents valid up to 2020 on the […]
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 […]
Suven Life Sciences Ltd said it was granted one patent each from Norway, South Korea and Singapore for drugs for the treatment of neurodegenerative diseases. The company said the patents relate to selective 5-HT 6 and 5HT 4 compounds, which are being developed as therapeutic agents for major depressive disorders and for the treatment of […]
Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat. Form 483 is issued to firm management at the conclusion of an inspection when an investigators observes conditions that in their […]
Pharma major Cipla dismissed concerns about adverse observations by the US Food and Drug Administration on one of its manufacturing plants in Goa. The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the company’s trade with the US, media reports had said. The company’s stock fell […]
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 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, […]
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 […]
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 […]
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 […]
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 major Lupin said it has launched a generic version of Roche’s big-selling flu drug Tamiflu in the US. The drug, known as Oseltamivir Phosphate, had annual tablet sales of approximately USD 518 million in the US, making it one of the biggest generics in the market. The dosages that have been launched are 30 […]
Pharma major Lupin said it has launched a generic version of Concordia’s ADHD drug Kapway in the US. Kapvay tablets has annual sales of approximately USD 66 million in the US. It was in November last year that Lupin and Ajanta Pharma said they’d both got approval to launch Clonidine Hydrochloride tablets from the US […]
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 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 $1.25 bln per year. The vaccine will also protect against six other diseases — Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenza type B & Polio. […]
Ipca Laboratories Ltd said it is has acquired US-based drug manufacturer Pisgah Labs Inc. for US$ 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 […]
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. […]
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) […]
