Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight.
Michael McCaughan
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The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
