27 Jun 2022 FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility By Bethany Hills Hilary Hoffman After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
24 May 2022 Raw material shortage and its impact on the pharma industry By Sonia de Kondserovsky Marion Abecassis Marion de Galembert The COVID-19 pandemic, followed by the Ukraine war, has led to an economic crisis that has resulted in supply difficulties and a sharp...
17 May 2022 Digital Health Transformation: The new Brazilian law on digital drugs leaflets By Bruna Rocha Juliana Marcondes Victoria Cristofaro Yesterday morning (12), the Brazilian Federal Government approved Law n. 14,338/22, which results from a bill of the Chamber of Deputies...
17 May 2022 Patent term extensions and infringement proceedings in Australia, and the standing of an exclusive licensee By Nicholas Tyacke Alexandra de Zwart Sarah McKenzie For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
19 Apr 2022 Access by Spanish patients to authorised medicines in Europe By Andrea Fernandez Paula Gonzalez de Castejón Llano-Ponte The annual report "Indicators of Access to Innovative Therapies in Europe (W.A.I.T. Indicator)", prepared by the consultancy firm Iqvia...
08 Apr 2022 Ukraine conflict: Impact on clinical trials By Mariana Ricardo Ana Rita Santos Both the Clinical Trials Coordination Group (CTCG) and the Portuguese National Authority of Medicines and Health Products (INFARMED) have...
06 Apr 2022 New rules on the cultivation of medicinal cannabis in Poland By Amelia Prawda Jolanta Dabrowicz On 29 March 2022, the Polish President signed the Act of 24 March 2022 amending the Act on Counteracting Drug Addiction (the "Act"). The...
04 Apr 2022 MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases By Taryn Jones Teresa Hitchcock The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
16 Mar 2022 UK ABPI calls for standardised international approach to university-industry collaborations By Richard Taylor Anna Wrench The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
04 Mar 2022 Medicine promotion in Italy: Medicines Agency confirms increased 7% contribution due by 30 April 2022 By Nicola Landolfi In a note published on 2 March 2022, the Italian Medicines Agency (AIFA) confirmed that all pharmaceutical companies must, by no later...
08 Feb 2022 An analysis of the effect of drug pricing provisions in the Build Back Better Act on pharmaceutical innovation By Kirsten Axelsen Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
26 Jan 2022 Initiative launched to accelerate EU clinical trials (ACT EU) By Lyndsey Hudson Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical...
17 Jan 2022 Legislative initiative on off-label prescription By Vadim Barbu Off-label use of medication is currently not regulated in Romania. Rather, it is up to the doctors to decide on the off-label use of a...
03 Dec 2021 Portugal establishes new rules on the revision of the prices for medicinal products By Mariana Ricardo Ordinance no. 280/2021, dated 3 December (entering into force on December 4, 2021) creates an exceptional criterion to be used in the...
23 Nov 2021 Is the UK the right home for life sciences startups? By Lyndsey Hudson I saw this recent article highlighting the need for the UK to create a much more supportive and sustainable environment for life sciences...
17 Nov 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...