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Optimism on Pfizer COVID vaccine is unwarranted

World of DTC Marketing

Biogen shot up when an initial review of their Alzheimer’s drug was positive, but then analysts torpedoed the company when another FDA panel said there wasn’t enough data. When a vaccine is available, you can also bet that people will form long lines to get vaccinated even though there is skepticism about vaccine safety.

Media 286
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Drug pricing increases are disgraceful

World of DTC Marketing

The online retailer spends about $20 billion a year on R&D, despite being renowned for both low prices and low profits. years to win FDA approval, at a median cost of $648 million. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million a drug.

Insurance 181
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US legislative update: takeaways for European pharma

European Pharmaceutical Review

For example, the US recently passed the Inflation Reduction Act, 1 which requires the Secretary of Health and Human Services (HHS) to negotiate prices for certain physician-administered and retail prescription drugs covered under Medicare Parts B and D. Citizen Petitions before the FDA. 5) monitoring access to biosimilars.

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. It’s not just the FDA,” he said. I think the pandemic sped that up a bit.

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How one pharma “family business” places patients first

pharmaphorum

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. It’s not just the FDA,” he said. I think the pandemic sped that up a bit.

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Biden Administration Requires Vaccination for Medicare and Medicaid Certified Providers/Suppliers by January 2022: CMS Issues its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule

Nixon Gwilt Law

Overview The Centers for Medicare and Medicaid Services (CMS) issued its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) on November 4, 2021, the same day the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS).