What is USFDA Purple Book? What it’s significance?
Posted on19 Nov 2019
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The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
USFDA approved Pfizer’s Abrilada, a biosimilar of Humira
Posted on19 Nov 2019
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The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrilada, a biosimilar of Humira. Pfizer said the FDA approved Abrilada (adalimumab-afzb) for the treatment of... Read More
Pfizer’s Upjohn and Mylan merged business entity will be namea as Viatris
The name of the new company to be formed by the merger of Mylan and Upjohn, a division of Pfizer, will be... Read More
Bayer and Dewpoint Therapeutics co-development deal for cardiovascular and gynecological diseases
Bayer and Dewpoint Therapeutics, a biotechnology company with sites in Boston and Dresden, Germany, today announced an option, research and license agreement... Read More
Sandoz to Acquire Japanese Biz of AGI
Posted on17 Nov 2019
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Sandoz has entered into an agreement to acquire the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary of Aspen... Read More
Selumetinib NDA Submission for Neurofibromatosis Type 1 (NF1) granted Priority Review
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration... Read More
Insignt on Roche’s Up-to-$1.4Billion Promedior Acquisition
Posted on17 Nov 2019
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Roche has agreed to acquire Promedior for up to $1.4 billion. Roche’s deal will give it full rights to Promedior’s entire portfolio... Read More
Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity
Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate),... Read More
What is the significance of Clinical Hold of investigational molecules?
A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an... Read More
US FDA places partial hold on Novartis’ AVXS-101 intrathecal study
USFDA placed a partial hold on clinical trials for intrathecal administration of AVXS-101. The announcement follows an AveXis communication to health authorities... Read More