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FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. It’s much needed. It’s a hot area.” trillion Consolidated Appropriations Act.

Drugs 130
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How the patient voice is becoming vital for drug approval

pharmaphorum

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

Drugs 98
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Orphan drugs’ financial success raises questions

pharmaphorum

This is why the action by the US in 1983 and subsequently the European Commission Regulation No. 141/2000 (the Orphan Regulation), that both acted to encourage development in the area, are regarded as crucial for changing the landscape in rare disease R&D. It is estimated that between 3.5 The price is right. Reaching a compromise.

Drugs 52
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Diabetes Smarts – Helping Men & Women To Prevent & Fight Diabetes Symptoms

The Pharma Data

First, most are on the payroll of the big pharma companies earning lucrative commissions for pushing their drugs…. Yes, it’s important to get rid of unproductive carbohydrates, refined sugars and processed foods… …If you don’t you’ll suffer more insulin resistance and unstable blood readings.

Doctors 52
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Arecor heads for London Stock Exchange with drug reformulation strategy

pharmaphorum

Based in Cambridge, Arecor has proprietary formulation technology and plans to enter development partnerships and licence out drugs to big pharma companies, looking for milestone payments and royalties as they progress through the development process and on commercialisation.

Insulin 52
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A history of the pharmaceutical industry

pharmaphorum

The period between 1918 and 1939 was marked by two breakthroughs that presaged the arrival of the pharma industry as we know it today. The first was insulin – Frederick Banting and colleagues managed to isolate insulin that could treat diabetes, up until that point a fatal condition. George Merck on the cover of Time magazine.

Medicine 145
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Pricing, Profits and Progress: Pharma’s Post-COVID Priorities

pharmaphorum

The fundamental misconception among the public, the media and even some lawmakers is that higher drug list prices are the result of drug manufacturers being in a monopolistic position to endlessly raise prices on critical drugs like insulin and then rake in big profits. What’s Next: How Should Pharma Companies Respond?