ABPI response to Government Statutory Scheme rise

2 March 2023 - The Government has confirmed plans to raise the revenue clawback rate paid by pharmaceutical firms subject ...

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FDA and FTC collaborate to advance competition in the biologic marketplace

2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...

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A review of patient reported outcome considerations in Oncologic Drugs Advisory Committee meetings (2016-2021)

28 February 2023 - The purpose of this project was to gain insight into the role of patient reported outcome data ...

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The drug prices review board was once a solution. It’s now a problem.

1 March 2023 - Anti-drug company activists are repeating ill-informed myths about controlling drug prices in Canada. ...

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Drugs likely subject to Medicare negotiation (2026-2028)

28 February 2023 - In 2026-2028, we estimate that Medicare will negotiate prices for 38 Medicare Part D drugs and 2 ...

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Areteia Therapeutics granted ILAP designation from UK MHRA for oral dexpramipexole for eosinophilic asthma

23 February 2023 - Areteia Therapeutics today announced that the UK’s MHRA has granted an Innovation Passport under the Innovative Licensing ...

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For Cytokinetics, an FDA rejection of its heart drug would help, not hinder

27 February 2023 - Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval.  ...

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AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...

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Member of Canada’s drug pricing regulator quits over ‘lack of support’ for medicine cost reforms

23 February 2023 - A member of the Patented Medicine Prices Review Board, Canada’s drug pricing regulator, has resigned over ...

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FDA continues important work to advance medical products for patients with rare diseases

23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...

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$130,000 a year for medicine is outrageous. But I blame the Government, not drug makers.

21 February 2023 - I don't blame President Biden for pursuing price controls. They are popular. Yet popularity does not ...

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The FDA returns to its bad habits

20 February 2023 - The agency may nix a new treatment for a debilitating orphan disease. ...

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Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA

20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...

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US to select 10 costliest drugs for Medicare pricing negotiation

18 February 2023 - The US Government will select the 10 costliest prescription medicines to Medicare for negotiating prices with ...

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Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn

17 February 2023 - In the aftermath of the FDA’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another ...

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