The ‘sunset clause’ for marketing authorisations of pharmaceuticals
This clause comes under European Drug Regulatory Affairs. Under the ‘sunset clause’ of Article 24(4) to (6) of Directive 2001/83/EC, any marketing... Read More
Insignt on Takeda and Biological E. Ltd (BE) licensing agreements for vaccines
Takeda Pharmaceutical Company (Takeda) and Biological E. Ltd (BE) have entered into a collaboration whereby two licensing agreements to expedite the development... Read More
Sanofi and Regeneron got EC approval of Kevzara® (sarilumab) in combo with MTX to treat adult patients with moderately to severely active RA
Posted on28 Jun 2017
TagsMAB, Regeneron, Sanofi, sarilumab, US FDA accepts Sanofi and Regeneron's sarilumab BLA for review
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Sanofi and Regeneron Pharmaceuticals announced that the European Commission (EC) has granted marketing authorization for Kevzara (sarilumab) in combination with methotrexate (MTX)... Read More
USFDA Approval of Genentech’s RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology
Posted on25 Jun 2017
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Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration (FDA)... Read More
Case Analysis: US FDA approval of Shire’s Mydayis
Shire has announced that the US Food and Drug Administration (FDA) has approved Mydayis (mixed salts of a single-entity amphetamine product), a... Read More
A close look into AstraZeneca’s DCGI marketing approval for Symbicort 320 for asthma and COPD
What is meant by DCGI approval? Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization is responsible for... Read More
Case Study: Sandoz’s EU approval for Rixathon
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) has approved Rixathon... Read More
Daiichi Sankyo launched Narurapid & Narusus tablets for cancer pain treatment
Daiichi Sankyo Company has has launched Narurapid tablets 1 mg, 2 mg, 4 mg (immediate release formulation) and Narusus tablets 2 mg,... Read More
Novartis’s CSR campaign on hypertension in low-income urban communities
On World Hypertension Day 2017, the Novartis Foundation and its partners, including Intel Corporation, the NCD Alliance, city governments and local partners,... Read More
Ethicon receives FDA approval for surgicel powder absorbable hemostat
Uncontrolled bleeding during surgery can adversely affect patient outcomes, hospital costs and resources. Primary methods of hemostasis alone may be ineffective or... Read More