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Robin Blaney is a partner in the firm’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions. Mr. Blaney writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.
- Advised Salix Pharmaceuticals in the acquisition of Oceana Therapeutics, a medical device business.
- Provided EU and UK regulatory advice to a number of the major national and multinational pharmaceutical companies and biotechnology, diagnostic, medical device, and consumer product manufacturers.
- Represented Intercell AG in connection with its acquisition of Cytos Biotechnology Ltd’s platform technology for monoclonal antibody discovery.
- Participated in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, manufacturing, distribution, clinical trials, and pharmacovigilance rules.
- Counselled clients on product classification issues, including the borderlines between medicines, medical devices, cosmetics and combination products.
January 10, 2019, Covington Alert
On January 7, 2019, EU Regulation 2019/5 was published in the Official Journal of the European Union. The Regulation is part of a package that makes numerous significant amendments to the EU’s regime for veterinary medicines and medicated feed, and it also made some key changes to the EU financial penalties regime.
October 15, 2018, Covington Alert
On August 23, 2018, the UK Government published several technical guidance notices relating to the regulation of medicines and medical devices in the event of a “no deal” or “hard” Brexit, i.e., a scenario where the EU and UK fail to conclude a withdrawal agreement and an associated transitional period and where the UK becomes a “third country” from midnight CET ...
April 20, 2018
LONDON—Covington advised BenevolentAI on an £80 million equity investment by new and existing investors, including Woodford Investment Management, at a pre-money valuation of £1.4 billion. The firm also recently advised BenevolentAI on its acquisition of Proximagen Limited, a Cambridge, UK-based drug discovery and development company, for an undisclosed ...
June 1, 2017, MLex
Robin Blaney is quoted in an MLex article regarding pleas from the EMA urging UK drugmakers to relicense their products in another EU country before Brexit. According to Blaney, the transfer of authorizations is "primarily an administrative exercise," and there is no legal obstacle to using a shell company in the European Economic Area to hold marketing ...
EU Excessive Pricing Cases in the EU - More to Come?
January 17, 2017, Webinar
October 6, 2016, Inside Medical Devices
The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health. The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity...… Continue ...
May 12, 2016, Inside Medical Devices
Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners. As it sets a new course, France is now at the European forefront of ...
EU Law and Life Sciences - Cosmetics: Managing Online Sales to Protect Your Brand
May 12, 2016, Webinar
Fate of EU drugs agency hangs in Brexit balance
February 17, 2016, Politico
Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...
December 17, 2015
LONDON, 17 December, 2015 — Covington advised AstraZeneca on its acquisition of Takeda’s respiratory business. Under the terms of the agreement, AstraZeneca will make a payment of $575 million, and approximately 200 staff will transfer to AstraZeneca upon completion. The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the ...
September 30, 2015
NEW YORK - Covington advised the underwriters in the $106.1 million initial public offering by Austrian-based Nabriva Therapeutics AG of 10,350,000 million American Depositary Shares, representing 1,035,000 shares of Nabriva’s common stock. This was the first U.S. initial public offering by an Austrian company. The ADSs are now listed on the NASDAQ Global Market ...
June 2015, Intellectual Property & Technology Journal
Covington Advises Allergy Therapeutics on Alerpharma Acquisition and £20 Million Placing
June 24, 2015
LONDON, June 24, 2015 — Covington advised Allergy Therapeutics plc, the AIM-listed specialty pharmaceutical company, on its recently announced acquisition of Alerpharma, S.A. a Spanish-based allergy immunotherapy company which previously spun out from Spanish biopharmaceutical company, Zeltia S.A. Alerpharma’s principal operating subsidiary, Inmunal, markets ...
June 18, 2015
WASHINGTON, DC, June 18, 2015 — Covington advised Allergan plc in its acquisition of KYTHERA Biopharmaceuticals, Inc. for consideration having a fixed value of $75 per KYTHERA share, or approximately $2.1 billion, which will be paid 80 percent in cash and 20 percent in Allergan shares issued to KYTHERA shareholders. KYTHERA is a biopharmaceutical company ...
June 11, 2015
BRUSSELS, June 11, 2015 — Covington has received 20 leading practice group rankings in the 2015 editions of Chambers Europe and Legal 500 EMEA. The legal guides have recognised the firm’s expertise in the following areas: CHAMBERS EUROPE Europe-wide - Regulatory - Agro/Food Europe-wide - Regulatory - Environment Europe-wide - Regulatory - ...
The Pfizer Saga - Discussing the Implications of the Pfizer/Xalatan Case in the EU
February 24, 2015, Webinar
Washington-area appointments and promotions for Oct. 20
October 20, 2014, The Washington Post
"Covington & Burling of the District appointed Ashley Bass, Robin Blaney, Krista Carver, Jeffrey Davidson, Nicole Duclos, Shankar Duraiswamy, Scott Freling, David Garr, Jason Goldberg, Andrew Lazerow, Michael Lechliter, Anne Lee, Scott Schrader, Nathan Shafroth and Ranganath Sudarshan partners."
Covington Promotes 15 Lawyers to Partnership
October 1, 2014
WASHINGTON, DC, October 1, 2014 — Covington & Burling is pleased to announce that it has elected 15 lawyers to its partnership effective today. “Our new partners come from six firm offices and practice in a variety of areas that are of great importance to the firm’s clients,” said Timothy Hester, chair of Covington’s management committee. “These are all superb ...
October 7, 2014
LONDON, 7 October, 2014 — Covington & Burling advised Horizon Discovery Group plc, an AIM listed international life science company supplying research tools and services to organizations engaged in genomics research and the development of personalized medicines, on the acquisition of Sage Labs Inc. for a total of approximately $48 million (£29 million), ...
Transparency Requirements Faced by Pharmaceutical Companies Following the Recent Legal Developments in Europe
May 22, 2014, EFPIA & Local Disclosure Requirements: How to Implement an International IT System
Covington Advises MedImmune in Acquisition of Amplimmune
August 26, 2013
NEW YORK, August 26, 2013 — Covington & Burling is advising MedImmune, AstraZeneca’s global biologics research and development arm, on the acquisition of Amplimmune, a privately held biologics company focused on developing novel therapeutics in cancer immunology. Under the terms of the merger agreement, MedImmune will acquire Amplimmune shares for an initial ...
December 21, 2012, Inside Medical Devices
The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU rules, laboratory-developed tests ...
December 21, 2012, Inside EU Life Sciences
This post originally appeared on our sister blog, InsideMedicalDevices. The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. ...
Data Privacy and Clinical Trials
December 5, 2012, Clinical Trials Conference 2012
November 30, 2012, Inside Medical Devices
On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs), will be replaced by ...
November 30, 2012, Inside EU Life Sciences
This post originally appeared on our sister blog, InsideMedicalDevices. On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive ...
Key Issues in Contract Manufacturing Agreements
June 15, 2012, Drafting Commercial Contracts for the Pharmaceutical Industry
Data Privacy and Drug Safety
June 15, 2012, Pharmacovigilance Conference 2012
March 5, 2012, Inside EU Life Sciences
Article originally published in PLC Life Sciences Handbook 2012 M&A in the life sciences sector has remained robust, driven by factors such as: The need to replenish shrinking product pipelines. The need to maintain revenues as patents on top-selling products expire. The strategic diversification of business lines. Expansion into emerging ...
2012, PLC Life Sciences Handbook 2012
Key Issues in Contract Manufacturing Agreements
November 15, 2011, Drafting Commercial Contracts for the Pharmaceutical Industry
November 10, 2011
WASHINGTON, DC, November 10, 2011 — Covington & Burling represented Salix Pharmaceuticals, Ltd. in its agreement to acquire Oceana Therapeutics, Inc., a privately held global provider of gastroenterology and urology therapeutics, for $300 million in cash. “The acquisition of Oceana expands our product portfolio of innovative products, furthers the ...
Legal Perspective on medical devices labelling: Understanding and overcoming challenges
October 19, 2011, 5th Annual Labelling and Packaging Compliance for Medical Devices & IVDs Conference
Examining the EU Falsified Medicines directive
October 19, 2011, 1st Annual Pharmaceutical Packaging and Artwork Conference
Implementing Appropriate Language in IIT Contracts
September 5, 2011, European Investigator Initiated Studies
June 15, 2011, Inside EU Life Sciences
Originally published as Covington E-Alert on June 15, 2011 The U.K. Department for Business, Innovation and Skills (BIS) has recently issued the final version of its guidance on the Agency Workers Regulations 2010, which implement Directive 2008/104/EC. The Regulations come into force on 1 October 2011, and will entitle agency workers (or “temps”) to the...… ...
June 15, 2011, Covington E-Alert
Legal Consequences for Temperature Excursions
October 20, 2010, Temperature Controlled Pharmaceutical Distribution Conference
Covington Advises J&J on Acquisition of RespiVert
June 1, 2010
NEW YORK, June 1, 2010 — Centocor Ortho Biotech Inc., a subsidiary of Johnson & Johnson, announced today that it has acquired UK-based RespiVert. Covington & Burling LLP advised Johnson & Johnson on the deal. Johnson & Johnson embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Johnson ...
5/6/2010
LONDON, 6 May, 2010 — Intercell AG today announced that it has signed an agreement with Cytos Biotechnology Ltd. to acquire Cytos’ platform technology for monoclonal antibody discovery. The technology is based on expression cloning of monoclonal antibodies from human B-cells and enables the identification of anti-infective antibodies to prevent and treat ...
EU Devices Regulation: The Framework
March 1, 2010, Principles of European Medical Technology Regulatory Affairs
January 15, 2010, Inside EU Life Sciences
Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010 I. Introduction This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner ...
The Interplay Between Legal and Regulatory Challenges of PMS and Vigilance
February 26, 2009, 4th Annual Post-Market Surveillance and Vigilance Conference
European Community
2009, Global Pharmacovigilance Laws & Regulations: The Essential Reference
EC Pharmacovigilance Regulation
January 1, 2009, Consummateurs, Médicaments et Industrie Pharmaceutique
Device Vigilance: Legal and Regulatory Challenges
September 23, 2008, Medical Device Law and Compliance Forum
March 15, 2008, Inside EU Life Sciences
Article originally published in EURALex, issue 192, in March 2008 The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. ...
March 2008, EURALex
The Interplay Between Legal and Regulatory Challenges of PMS and Vigilance
February 19, 2008, 3rd Annual Post-Market Surveillance and Vigilance Seminar
July 2005, World Data Protection Report
- Legal 500 UK, Product Liability (2016)
- Legal 500 EMEA, Healthcare and Life Sciences (2015-2016)