Industry News

US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).

Impax Laboratories, Inc, a specialty pharmaceutical company, has received US Food and Drug Administration (FDA) approval for generic Mestinon Timespan tablets (pyridostigmine bromide extended release), 180 mg. The company is going for commercialisation of this product.

ERYTECH Pharma, the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, received a new patent in the United States.

Pfizer, a Rs. 1,800 crore plus Indian subsidiary of Pfizer Inc. USA, has entered into a business transfer agreement for the transfer of the company’s business at the Thane plant to Vidhi Research and Development LLP for Rs. 178 crore. Upon the conclusion of the BTA, all current workmen at the plant shall be transferred to the buyer so as to facilitate manufacturing operations.

GE Healthcare, the $18 billion healthcare technology division of GE, created a new business unit, Sustainable Healthcare Solutions (SHS), that will develop high-value, low-cost technologies and healthcare delivery solutions across multiple care settings.

Akorn, Inc., a leading specialty pharmaceutical company, has launched doxercalciferol injection solution, 4 mcg/2 ml in 2ml single-use vials. Akorn's product is therapeutically equivalent to Hectorol injection, marketed by Genzyme Corporation.

8K Miles Software Services Ltd, a leading provider of secure cloud solutions, acuire US-based NexAge Technologies, a leading regulatory compliance and technology solutions company in the life sciences sector. The agreement includes acquisition of intellectual property (IP), technical solutions, client contracts, and employees.

Jubilant Life Sciences Ltd, an integrated global pharmaceuticals company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (FDA) for zolmitriptan orally disintegrating tablets, 2.5 mg and 5 mg the generic version of Zomig-ZMT (AstraZeneca), which is used for acute treatment of migraine headaches in adults.

Sun Pharmaceutical Industries Ltd. and Strides Arcolab Ltd. have entered into a definitive agreement related to erstwhile Ranbaxy’s ‘Solus’ and ‘Solus Care’ divisions operating in the central nervous system (CNS) segment in India.