What is USFDA Accelerated Approval Program of new molecular entities?
Posted on30 May 2016
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The FDA devised the Accelerated Approval Program to allow earlier approval of drugs that treat serious conditions, and that fill an unmet... Read More
USFDA Accelerated Approval of OCALIVA
Molecule: obeticholic acid Brand Name: Ocaliva Type of Approval: New Drug Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization... Read More
USFDA rejected AstraZeneca’s potential blockbuster hyperkalemia drug ZS-9
AstraZeneca acquired ZS Pharma in Nov 2015 for its potential blockbuster hyperkalemia drug ZS-9. ZS Pharma is focused on the development and... Read More
DRL acquired 6 OTC brands from Ducere Pharma in US
Dr. Reddy’s Laboratories Ltd has acquired a portfolio of half a dozen over-the-counter (OTC) drug brands from American drugmaker Ducere Pharma to... Read More
Is HEPA filters required to install for air supply in areas used for the manufacture of non-sterile dosage forms?
No, HEPA filters does not specifically require manufacturing facilities for non-sterile drugs to maintain HEPA filtered air. The Regulations do require the... Read More
What is PIC/S?
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S... Read More
$62bn bids by Bayer for GM seed giant Monsanto
German drug and chemicals group Bayer has offered to buy the American GM seed pioneer Monsanto for $62bn (£43bn) in a deal... Read More
Recipharm acquired Cirrus Pharmaceuticals Inc.
Recipharma completes the acquisition formatlities of Cirrus Pharmaceuticals Inc., with operations in the US, with services including development of inhalation, liquid, semi-solid,... Read More
Novartis strategic rejig – Created 2 SBU for effective control
Novartis is splitting its pharmaceuticals division into two business units. SBU 1 will take care of cancer drugs and SBU 2 will... Read More
Mundipharma, Purdue Pharma’s development and commercialization deal for sigma-1 antagonist
Mundipharma Medical Company Limited and the independent associated company, Purdue Pharma L.P., announced that, following completion of phase II studies, they have... Read More