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GPhA Backing Biosimilar Substitute Legislation

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Generic Pharmaceutical Association president Ralph Neas says the association is backing compromise legislation to be considered in...

Drug Patent Expiries to Cost Owners $65 bil.: Report

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GlobalData says that upcoming patent expirations for several central nervous system drugs will cost their companies $65 billion in...

Engage Patients, Others with Specific Conditions: Pfizer

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Stakeholders suggest better ways to engage patients and others in drug development and regulatory decision-making.

FDA Grants Immunovaccine Fast Track for Cancer Vaccine

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FDA grants Immunovaccine a fast track designation for its lead cancer vaccine candidate, DPX-Survivac, for maintenance therapy in ...

House Omnibus Spending Bill Gives FDA a $37 Million Boost

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The House Appropriations Committee unveils a fiscal year 2015 Omnibus Appropriations bill that would fund FDA at $2.589 billion, a...

FDA Grants IDE Conditional OK for Scleroderma Trial

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FDA has granted conditional approval to Cytori Therapeutics for an Investigational Device Exemption to evaluate the Cytori Cell Th...

FDA Approves Expanded Use of Mercks Gardasil 9

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FDA approves a BLA supplement for Mercks Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for preventing certain di...

Drug Makers Explore New Digital Marketing Ideas

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Bloomberg News says that some drug companies are experimenting with a digital marketing technique that allows it to identify group...

FDA Guidance on Patient Counseling Info Section in Drug Labels

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FDA posts a final guidance on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Produc...

Judge Allows Generic Cubicin in 2016

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A Delaware federal district judge says Hospira can sell a generic form of Cubists Cubicin after one upheld patent expires in 2016....