FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge

20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...

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EMA publishes agenda for 20-23 June 2022 CHMP meeting

20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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HIRA reviews reimbursing antidiabetic combo therapies

15 June 2022 - HIRA has been analysing how new reimbursements for anti-diabetic combination therapies mixing oral SGLT-2 and DPP-4 ...

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Zeposia is included in the high-cost protection with limitation

17 June 2022 - Zeposia (ozanimod) is included in the high-cost protection with limited subsidy from 17 June 2022.  ...

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Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...

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Givlaari is included in the high-cost protection with limitation

17 June 2022 - Givlaari (givosiran) is included in the high-cost protection with limited subsidy to reduce attacks in patients with ...

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EFPIA and Vaccines Europe are deeply disappointed about the decision taken by World Trade Organization at the Ministerial Conference to endorse a TRIPS waiver for COVID-19 vaccines

17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...

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PHARMAC's latest breast cancer drug funding 'way short' - advocate

16 June 2022 - On Wednesday PHARMAC announced $190 million to fund cancer treatments and other medicines. ...

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IP waiver for COVID vaccines is a threat to future innovation

20 June 2022 - The decision to waive intellectual property protections for COVID-19 vaccines is fundamentally flawed and will have ...

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EU HTA regulation: international preparatory meeting in Cologne

17 June 2022 - At the invitation of IQWiG, 41 envoys from European HTA organisations and two from the EU ...

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Drug pricing debate in Washington is a headache for pharma

17 June 2022 - Last-ditch effort by Democrats to pass slimmed-down version of Build Back Better could include measures on drug ...

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Current issues in health technology assessment of cancer therapies: a survey of stakeholders and opinion leaders in Australia

17 June 2022 - The aim of this study was to find ways of bridging the gap in opinions concerning health ...

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Klobuchar, Porter call for FTC to investigate price hikes by Janssen, Bristol Myers Squibb

14 June 2022 - Two prominent Democratic lawmakers are requesting that the Federal Trade Commission investigate whether price hikes for ...

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Canadian regulator OKs Hugel's botulinum toxin product

16 June 2022 - Hugel said Thursday that it has obtained product approval from Health Canada for its botulinum toxin ...

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Canadian drug prices: new regulations could save billions of dollars

15 June 2022 - New drug price regulations set to come into effect next month could lower spending on patented ...

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