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Seegene Receives FDA Clearance for its Herpes Simp...

Gaithersburg, Maryland and SEOUL, Korea, February 17, 2015 – Seegene Inc. (096530.KQ), a leading developer of multiplex PCR technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for its TOCE™-based herpes simplex virus (HSV) types 1 and 2 assay. This is the first product that Seegene has taken through the FDA, and it opens the way for Seegene’s other...

Analyzing the Winners and Losers in the Growth of ...

Success of Delivery Device Developers in Solving Formulation Limitations a Key Factor according to Greystone Research Associates (Amherst, NH) – As patients live longer and the prevalence and incidence of chronic ailments increase across the general population, drug developers and their delivery device partners are adapting to address what will become a significant market opportunity. Chronic conditions require drug...

UCSF, Stanford and Johns Hopkins join FDA partners...

At a time when Big Pharma is increasingly tapping academic institutions for expertise in informatics and data-driven computer models for drug discovery, the FDA has selected Johns Hopkins University, Stanford University and the University of California, San Francisco (UCSF) for a new initiative aimed at streamlining the drug development and approval process. Under the FDA’s Centers of Excellence in Regulatory Science...

Cubist’s superbug drug clears FDA panel

Cubist’s latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer’s blockbuster Zyvox. The FDA’s Anti-Infective Drugs Advisory Committee voted 14-0 to recommend approval for Cubist’s tedizolid phosphate to treat acute bacterial skin infections, which are caused by drug-resistant pathogens including MRSA. The drug can be...

FDA Grants Breakthrough Status to Gene Therapy for...

Celladon became the first company to receive breakthrough status for a gene therapy treatment in development. The treatment, MYDICAR, is intended to reduce the risk of heart failure in patients with a deficiency of the enzyme SERCA2a. The FDA made its decision to grant breakthrough status to MYDICAR on the basis of Celladon’s Phase 1 trial of 39 systolic dysfunction patients. The study reported that subjects receiving...

New drug approvals plunge in 2013

The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27 OKs for new entities in 2013–a sharp plunge from 2012’s high of 39 that once again raises big questions about the productivity and sustainability of the world’s multibillion-dollar R&D business. After 2012...
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