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Ed Silverman

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Latest From Ed Silverman

Regulators Seek Solutions To Manufacturing Woes

Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.

Manufacturing Market Intelligence

Understanding The Evolving Medical Cannabis Market

In case you have not noticed, a new gold rush appears to be under way. Buoyed by surging interest in medical cannabis, big and small companies from around the world are racing to take advantage of the potential for the marijuana plant to cure numerous diseases and take its place in the pantheon of pharmaceutical products.

Growth Research & Development

Surrogate Endpoints: Benefits, Issues And The Future

On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.

Clinical Trials Research and Development Strategies

Surrogate Endpoints: Benefits, Issues And The Future

On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.

Clinical Trials Innovation

Proving The Value Of Value-Based Deals

As controversy continues over pharmaceutical pricing, more drugmakers are eyeing deals that peg health plan cost to outcomes to boost volume and win formulary placement. But these deals are challenging to construct and to date there is little evidence that they reduce costs for patients.

BioPharmaceutical Pricing Strategies

States Fight For Drug Price Transparency

California's Proposition 61 and a number of other state-led measures to control drug prices failed to gain traction in 2016. But states are likely to remain a battleground in the war against costs in a pharma-friendly Trump administration.

BioPharmaceutical Market Access
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