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In Pharmaceuticals & Biotech

United Arab Emirates: Enacts New Medical Products Law to Boost Innovation in Pharmaceuticals and Medical Devices

by , , and 5 Mins Read

On 1 October 2024, the UAE Government has issued a new Federal Decree-Law No. 38 of 2024 to regulate medical products, the pharmacy profession and pharmaceutical establishments (the “Law”). The Law replaces Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments including its later amendments (hereafter, “Federal Law of 2019”). However, its implementing regulations remain in effect to the extent they do not contradict with the Law. The Law was first published on the UAE government website…

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In Pharmaceuticals & Biotech

“What can we learn from 2024’s biotech IPOs?” –  Adam Farlow chats to Fierce Biotech

by 1 Min Read

Is there renewed enthusiasm on the public markets for biotech companies following the uptick in IPOs seen at the start of 2024 and in the late summer and autumn? What advice would you give to biotechs considering an IPO listing? Are there key traits that define successful biotech IPOs, or red flags that signal less successful ones? How do biotech IPO trends fit in the broader IPO market context, and what can we expect to…

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In Medical Devices

The French Political Crisis Leads the Pharmaceutical and Medical Device Industries Towards A Leap Into the Unknown for 2025

by , and 2 Mins Read

On 5 December 2024, the French Government was forced to resign following the vote of non-confidence by the French National Assembly towards the Social Security Financing Bill (“PLFSS”). A new Government was then appointed on 23 December 2024. As a result, 2024 ended without a PLFSS for 2025, leaving the Pharma and MedTech industries in uncertainty, particularly regarding the safeguard clause mechanism.   A Special Law To Prevent From Any Shutdown The PLFSS is debated…

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In Pharmaceuticals & Biotech

Extended Producer Responsibility for Pharmaceutical and Cosmetics Companies: Adoption of the Recast Urban Wastewater Treatment Directive

by and 5 Mins Read

On 5 November 2024 the Council of the European Union adopted the recast Urban Wastewater Treatment Directive, following the European Parliament’s approval of the text earlier this year. Of particular relevance to pharmaceutical and cosmetic companies, the recast Directive will introduce new extended producer responsibility (“EPR”) [1] obligations in respect of micropollutants from their products that end up in the urban wastewater stream. Background The EU’s previous Urban Wastewater Treatment Directive has been in place since…

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In Pharmaceuticals & Biotech

ECJ Ruling: Pharma Payments to State Health Insurers Are Rebates, Not Taxes

by , and 2 Mins Read

Pharmaceutical companies can breathe a sigh of relief following the European Court of Justice’s recent ruling in the Novo Nordisk A/S case (C-248/23 ). This decision marks the third time the ECJ has softened the rules around deducting pharmaceutical subsidies from the VAT base. Previously, in the German and Hungarian Boehringer cases (C-462/16 and C-717/19), the ECJ allowed subsidies to be deducted if paid to private insurers and later extended this to public insurers under…

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In Pharmaceuticals & Biotech

Guest Feature: India Pharma Focus – 4 Key Industry Developments to Track

by and 4 Mins Read

The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch: 1. Patent (Amendment) Rules 2024: Beware shorter…

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In Pharmaceuticals & Biotech

Has the European Parliament Missed the Chance to Boost Orphan Drug Development?

by , , and 1 Min Read

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…

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In Pharmaceuticals & Biotech

The BIOSECURE Act: Potential Implications for Biotechnology Collaborations with Chinese Companies

by , , , , , and 1 Min Read

Bipartisan legislation advancing in the U.S. Senate and the U.S. House of Representatives known as the “BIOSECURE Act” (“the Act”) has the potential to restrict the ability of biotechnology companies to collaborate with certain Chinese companies without losing the ability to contract with the U.S. government. Following the same model that was used to target Chinese telecommunications companies in the late 2010s, the Act would prohibit federal “executive agencies” from contracting with or extending loans…

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In Pharmaceuticals & Biotech

Extended Producer Responsibility for Pharmaceutical and Cosmetics Companies: the Recast Urban Wastewater Treatment Directive

by and 5 Mins Read

On 5 November 2024 the Council of the European Union adopted the recast Urban Wastewater Treatment Directive, following the European Parliament’s approval of the text earlier this year.  Of particular relevance to pharmaceutical and cosmetic companies, the recast Directive will introduce new extended producer responsibility (“EPR”)[1] obligations in respect of micropollutants from their products that end up in the urban wastewater stream. Background The EU’s previous Urban Wastewater Treatment Directive has been in place since 1991…

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In Pharmaceuticals & Biotech

UK Guidance introduces new requirements on parallel distributors in Great Britain and Northern Ireland

by , and 2 Mins Read

As the pharmaceutical industry adjusts to the further changes the Windsor Framework will bring, there are important changes ahead for parallel import licensing across the UK. The transition from Parallel Distribution Notices (PDNs) to Parallel Import Licences (PLPIs) has introduced new requirements that will impact parallel distributors in Great Britain and Northern Ireland. In Great Britain, PDNs have already been replaced by PLPIs, allowing products to be marketed exclusively within the region. However, with the…

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