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Category Archives: FDA
It's Blind Leading the Blind on Companion Diagnostics
A new report from the Tufts Center for Study of Drug Development (CSDD), confirms that companion diagnostics are an important factor for pharma companies to consider when seeking reimbursement of their drugs. But companies still have a ways to go in allaying the concerns of investors, regulators and payors alike, and fixing this will require [...]
Also posted in Orphan Drugs, R&D, Regulatory, Strategy, Technology Tagged companion diagnostics Leave a comment
UN Pact Scuttles Anti-Vaccine Provision
A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, [...]
Also posted in Emerging Markets, Global, Legal, Market Access, Patient Communication, Safety, healthcare Tagged autism, developing countries, patient advocates, patient groups, thimerosol, vaccines, WHO 1 Comment
Will "Robust Pipeline" Yield More New Drugs?
Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in [...]
Also posted in Biotech, R&D, Regulatory, leadership Tagged drug approvals, FDA, John Lechleiter, NME, PhRMA, pipeline, R&D Leave a comment
The Orphan Drug Act at 30 Years: What's Next?
30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the beginning of a journey where medicines for rare diseases have gained a foothold in the portfolios of drug companies large and [...]
Also posted in Biotech, IP, Orphan Drugs, Regulatory, Strategy Tagged BioMarin, FDASIA, NORD, ODA, Orphan Drugs, PDUFA, Ultra Orphan Leave a comment
Amid Flu Epidemic a Focus on Vaccine Innovation