EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease
Roche announced that the European Medicines Agency (EMA) has granted Prime (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known... Read More
Insight on Bayer’s EU approval of new treatment regimen for Eylea
Bayer has received European Commission approval of a new treatment approach for Eylea to enable clinicians to combine proactive treatment with early... Read More
What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
Posted on31 Jul 2018
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FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new drug applications... Read More
EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC
Posted on31 Jul 2018
TagsCHMP, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, KEYTRUDA
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Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of... Read More
Hyrimoz Sandoz’s biosimilar got European marketing approval
Posted on31 Jul 2018
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Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization... Read More
Is COPP and FSC is same?
Posted on30 Jul 2018
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COPP stands for certificate of pharmaceutical products and FSC stands for free sale certificate. Certificate of a Pharmaceutical Product (COPP) The COPP... Read More
Nabriva acurie Zavante to stregthen antibiotic pipeline
Nabriva Therapeutics has acquired Zavante Therapeutics. Under the deal terms announced after the market close Tuesday, San Diego-based Zavante received an upfront... Read More
US FDA committee recommends approval malaria drug, Tafenoquine
60 Degrees Pharmaceuticals (60P) has announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA)... Read More
What is EMA’s PRIME designation?
The PRIME programme was launched by the EMA in 2016 to provide early and enhanced support to optimize the development of eligible... Read More
Sun Pharma launches generic Glumetza tablets in US
Sun Pharmaceutical Industries Ltd announced that one of its wholly owned subsidiaries has launched the generic versions of Glumetza (metformin hydrochloride) extended... Read More