Goodwin (JD Supra European Union)

95 results for Goodwin (JD Supra European Union)

  • Global Biosimilar Update

    The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical...

  • Navigating EU Data Transfers: Effects of Schrems II Start to Bite

    Risks of non-compliance with the GDPR keep increasing with data protection authorities (DPAs) now ordering suspension of transfers of personal data to the U.S. In March, the Bavarian DPA found there was an unlawful transfer of personal data from a German controller to the e-mail marketing service Mailchimp in the U.S. A month later, the Portuguese DPA ordered a public authority to suspend all...

  • New Horizons: European Commission Proposes Measures to Regulate AI

    On 21 April 2021, the European Commission unveiled a proposal for an EU Artificial Intelligence Regulation (“Proposal”). The Proposal recognizes that AI offers significant benefits and opportunities for the EU market, but also reveals the concern European regulators have long held regarding the potential for unregulated AI to adversely affect European fundamental rights. Influenced by the core EU

  • Late Breach Notice In Europe Leads To Nearly €500K Fine

    On 31 March 2021 the Dutch Data Protection Authority (DPA) announced that it fined the online reservation platform Booking.com €475,000 for failing to notify the DPA of a data breach within the timeline established in the GDPR. The decision signals European regulators’ growing scrutiny of how companies exercise discretion in incident response decisions. Recently, Goodwin reported on the Irish...

  • EDPB Clarifies Scientific Research GDPR Compliance, But Harmonisation Across Europe Remains Elusive

    Earlier this year, the European Data Protection Board (“EDPB”) issued additional guidance on the application of the General Data Protection Regulation (“GDPR”) in the area of scientific health research. In key takeaways from the guidance, the EDPB...

  • Brexit & Trademarks: Important Considerations For Maintaining UK Trademark Rights Post-Brexit

    With the United Kingdom’s withdrawal from the European Union, companies must reconsider the implications of doing business in the UK and the EU, including how Brexit affects the company’s intellectual property rights. Included below is a summary of the effects of Brexit on trademark rights held in the EU and the UK, and steps which may be taken to maintain coverage in the UK.

  • CHMP adopts positive opinions on two bevacizumab biosimilars

    At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung...

  • Post Schrems II Guidance: EU Regulators Raise Bar For Global Data Transfers

    On 15 January, 2021, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) adopted a joint opinion (“Joint Opinion”) on the draft new sets of Standard Contractual Clauses (“New SCCs”) for international transfers released by the European Commission in November 2020. The EDPB and the EDPS welcome the New SCCs but ask for clarity in some key areas,...

  • ESG And The Sustainable Finance Disclosure Regulation

    As part of the EU’s strategy on climate change following the Paris Agreement of 2015, a number of EU regulations have been enacted in the past 12 months. From the fund management industry’s point of view, the two most important are the “Sustainable Finance Disclosure Regulation” and the “Taxonomy Regulation.” The Taxonomy Regulation seeks to establish a classification system in relation to...

  • Emer Cooke takes office as first woman head of EMA

    Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical unit of the European Commission and EMA and was the Director responsible for all medical product-related regulatory activities at the WHO in Geneva from 2016 to November 2020

  • European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab)

    On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent.  The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies.

  • EMA issues positive opinion for PBP1510

    Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody. PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which there is not yet an approved targeted molecular therapy.

  • EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

    Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.

  • Centus Biotherapeutics Receives Positive Opinion for EQUIDACENT (Bevacizumab Biosimilar) in Europe

    On July 23, 2020, Centus Biotherapeutics received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for EQUIDACENT, a biosimilar to AVASTIN (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal...

  • Déjà Vu All Over Again: EU High Court Invalidates Privacy Shield For EU – U.S. Data Transfers

    Today (July 16) Europe’s highest court, the Court of Justice of the European Union (CJEU), in the case of Data Protection Commissioner v Facebook Ireland and Maximillian Schrems (Schrems II) invalidated the EU–U.S. Privacy Shield (Privacy Shield). The Court ruled that the Privacy Shield failed to offer adequate protections for EU personal data transferred to the U.S. The ruling is a stunning...

  • English Contracts under Stress in Times of Economic Disruption

    The current economic, environmental and political outlook globally is perhaps the most uncertain it has been in decades. Against this backdrop, contracts are likely to be analysed and tested in ways unlike before. With this in mind, understanding the approach that the English courts will take in interpreting contracts and the legal principles that may be available to parties looking for options...

  • Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

    Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical studies demonstrating bioequivalence to the...

  • Sanofi Receives Positive Opinion for Insulin Aspart Biosimilar in Europe

    On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of insulin aspart (NovoRapid, marketed by Novo Nordisk).

  • Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product

    Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the EU. The Xplore trial, which was started in 2019, is intended

  • EU and non-EU Managers of Luxembourg Funds: Weekly Updates for the CSSF

    Various measures have been implemented in Luxembourg to help Luxembourg funds tackle the impact of the COVID-19 outbreak... This is a fast-moving crisis and it is important to closely monitor the outbreak, its business impact and how it may affect the governance and performance of Luxembourg funds. As a result, the CSSF has taken the practical step to request any manager (whether or not...

  • Rituximab Biosimilar Updates from Europe

    We previously reported that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP). In particular, the EMA reported that these applications were withdrawn after the agency had evaluated the company’s responses to EMA’s questions.

  • Meeting Highlights from the Committee for Medicinal Products for Human Use

    The European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP) recently reported biosimilar updates from its March 2020 meeting. At the meeting, Mylan and Lupin’s NEPEXTO (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing...

  • Luxembourg Adopts Draft Bill Introducing Defensive Tax Measures for EU List of Non-Cooperative Jurisdictions

    On 25 March 2020, the Luxembourg Government adopted a draft bill introducing new defensive measures denying the tax deduction of interest and royalty payments made to a related entity located in a blacklisted jurisdiction. This draft bill comes at a time when the Cayman Islands was added in February to the EU list of non-cooperative jurisdictions for tax purposes. These upcoming measures could

  • Celltrion Applies for European Approval of Humira Biosimilar

    The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar.  According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.”

  • Long Live The Model Clauses?

    The Advocate General has issued an Opinion which states that the European Commission’s decision, enforcing the Standard Contractual Clauses (SCCs), is valid.

  • European Court of Justice Limits the "Right to be Forgotten" in Landmark Privacy Decision

    The European Court of Justice recently limited the “right to be forgotten” in a landmark decision for online privacy law. The decision arises from a dispute between Commission nationale de l'informatique et des libertés (CNIL) – the French data protection authority – and Google concerning the scope of the right to be forgotten. The right allows individuals to ask search engines to remove links...

  • Pfizer Receives European Approval For Avastin® (Bevacizumab) Biosimilar

    Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of...

  • Mundipharma Launches Pegfilgrastim Biosimilar in Europe

    On February 5, 2019, Mundipharma announced the European launch of Pelmeg® (pegfilgrastim), a biosimilar of Neulasta®. As we have previously reported, Mundipharma acquired Pelmeg® from Cinfa Biotech and it was approved by the European Commission in November 2018.

  • European Commission Releases Pharmaceutical Anti-Competition Report

    The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and that anti-competitive...

  • Luxembourg Register of Beneficial Owners

    The European Union's Directive 2015/849, better known as the 4th Anti-Money Laundering Directive, regulates prevention of the use of the financial system for the purposes of money laundering or terrorist financing. As such, Articles 30 and 31 of the 4th Anti-Money Laundering Directive introduce the requirement for each member state to establish beneficial ownership registers.

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