One more Indian Plant received USFDA observations: Alkem’s Daman Plant
Alkem Laboratories has received 13 observations from the US drug regulator for its manufacturing facility at Daman. This obervation comes as response... Read More
What is REMS? What is it’s significance?
In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It’s called the... Read More
FDA grants accelerated approval to Eteplirsen, first drug for Duchenne muscular dystrophy
Posted on23 Sep 2016
TagsDuchenne muscular dystrophy, Eteplirsen, Fast Track designation, orphan drug, orphan drug designation, priority review
Comments0
The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular... Read More
Indoco Remedies has acquired Baddi manufacturing facility of Micro Labs Ltd., Bangalore
Indoco Remedies has acquired the manufacturing facility located at Baddi of Micro Labs Ltd., (a Bangalore based company). The facility is spread... Read More
Himalaya’s streategy to launch pre and post natal care segment products under Himalaya For Moms
The Himalaya Drug Company will now expand its presence in Mother Care segment with the introduction of dedicated products for expecting and... Read More
Allergan to acquire California-based clinical-stage biopharma company, Tobira Therapeutics for $1.7 billion
Allergan plc, a leading global pharmaceutical company, and Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for... Read More
Allergan acquires biopharma company, Akarna Therapeutics
Allergan plc, a leading global pharmaceutical company, has acquired Akarna Therapeutics Ltd., a privately held biopharmaceutical company focused on developing novel small... Read More
Zydus partners Takeda to develop, market vaccine for chikungunya
Zydus Cadila has partnered with Japanese drug maker Takeda Pharmaceutical Co. Ltd to develop and commercialise a vaccine against chikungunya. The broad-based... Read More
Glenmark licensing deal with Particle Sciences to develop and commercialise generic Abraxane
Glenmark Pharmaceuticals, Inc., USA (Glenmark) has entered into a strategic development, license and commercialization agreement with Particle Sciences, Inc. to develop and... Read More
US FDA approves Aralez’s aspirin & omeprazole fixed dose combination
Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved once-daily Yosprala, the... Read More