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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 105
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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. The price is right. Raising questions. Reaching a compromise.

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

pharmaphorum

Arecor Therapeutics is planning to float on the London stock market, to raise funding and awareness for its developmental portfolio of biologic drugs, which are based on already-marketed drugs reformulated to provide extra benefits for patients. .

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

The Pharma Data

You won’t believe the marketing techniques of some food companies, who have convinced the public that certain foods are healthy when in fact they are just the opposite.We’ll expose the truth behind these food products and how you can replace them with far healthier and just as, if not more, delicious options.

Doctors 52
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A history of the pharmaceutical industry

pharmaphorum

Previously a centre of the trade in textiles and dyes, Swiss manufacturers gradually began to realise their dyestuffs had antiseptic and other properties and began to market them as pharmaceuticals, in contrast to the origin in pharmacies of other enterprises. Thalidomide and the development of drug safety regulation and monitoring.

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?