International regulators’ recommendations on COVID-19 vaccines and the Omicron variant

21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...

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The wild west of checkpoint inhibitor development

15 December 2021 - Although immunotherapy development has improved overall survival among patients with common cancers and has led to important ...

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Patient reported endpoints underrepresented in product information on new drugs

15 December 2021 - An IQWiG team analysed the extent to which patient reported outcomes, which were recorded as endpoints ...

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International regulators stress continued need for COVID-19 therapeutics

11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...

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FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products

9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...

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Don’t destroy future drug development

8 December 2021 - With support faltering for the massive big-government blowout Congress is trying to jam through by Christmas, ...

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FDA takes new steps aimed at advancing development of individualised medicines to treat genetic diseases

7 December 2021 - Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualised ...

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FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products

29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...

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FDA touts success and challenges in biosimilar development

10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...

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Why does the FDA want to stop improving medicines via patent ‘areas of concern’?

8 November 2021 - It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch ...

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Funding hole makes cracking COVID-19 vaccine code a tougher ask

4 November 2021 - Australia has the expertise to crack the code in the biggest challenge facing the COVID-19 vaccination ...

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Repurposing of authorised medicines: pilot to support not for profit organisations and academia

28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...

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Novartis aims to beat rivals to novel $10 billion cancer treatment market

22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...

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International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines

16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...

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Update of EU recommendations for 2021–2022 seasonal flu vaccine composition

28 June 2021 - EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine ...

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