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Representation of Sanofi in connection with obtaining clearances from the European Commission and in China, Korea, Switzerland, Taiwan, Turkey and Ukraine for its collaboration with Google Life Sciences, Inc., now Verily, relating to diabetes management products and services.
Representation of AstraZeneca in relation to the creation of a $3.4 billion diabetes joint venture with BMS, and the subsequent acquisition of sole control over that venture; in its acquisition of the rights to Almirall’s respiratory franchise (for initial consideration of $875 million and up to $1.22 billion in development, launch and sales-related milestones); assisting in the acquisition of the Takeda respiratory portfolio; and in relation to the creation of an oncology joint venture with Fujifilm Kyowa Kirin Biologics (FKB).
Represented Salix Pharmaceuticals in antitrust issues related to its $2.6 billion acquisition of Santarus, Inc., another specialty pharmaceutical company focused on gastrointestinal treatments and in its $300 million acquisition of Oceana Therapeutics, LCC.
On behalf of the Pharmaceutical Research and Manufacturers of America, appeared before a hearing of a committee of the Duma on proposals to establish greater protection for innovative pharmaceutical products, including protection of patents and regulatory exclusivity periods.
Advised major international pharmaceutical companies on clinical trial rules in Russia.
December 8, 2016, Inside EU Life Sciences
The UK’s Competition and Markets Authority (the “CMA”) imposed a £84.2 million (€99.7 million) fine on Pfizer yesterday. In addition, the CMA also fined distributor Flynn Pharma £5.2 million (€6.1 million). The CMA found that Pfizer and Flynn Pharma abused their dominant positions by charging excessive and unfair prices for phenytoin sodium capsules, drugs used ...
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
November 30, 2016, Inside EU Life Sciences
On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017. Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars. In particular, Article 59(11) of the Draft Law provides that: two products enjoy a biosimilarity relationship only where this has … Continue ...
November 23, 2016
NEW YORK—Covington is advising Cantor Fitzgerald as financial advisor to Signal Genetics in connection with Signal’s merger transaction with miRagen Therapeutics.
Signal is a commercial stage, molecular diagnostic company that provides innovative diagnostic services that help physicians make better-informed decisions concerning the care of cancer patients. ...
October 21, 2016, Inside EU Life Sciences
In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on … Continue Reading
October 17, 2016, Inside EU Life Sciences
The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine ...
July 11, 2016, Inside EU Life Sciences
In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union … Continue Reading
February 12, 2016, Inside EU Life Sciences
The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK. The paroxetine patent was due to expire in 2001, and several companies including Generics UK Limited (“GUK”) ...
October 12, 2015, Inside EU Life Sciences
On Thursday the General Court (the “GC”) held the first two hearings in the Lundbeck case. Generics UK, now part of the Mylan group, and its former parent Merck KGaA (“Merck”) challenged the European Commission’s (the “Commission”) analysis, arguing that the Commission had wrongfully concluded that Generics UK’s settlement agreement with Danish originator ...
September 14, 2015, Inside EU Life Sciences
Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post. On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the ...
July 23, 2015, Inside EU Life Sciences
By Colin Warriner Since 1 July 2015, anyone in the UK selling medicines online to the general public must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and be on the MHRA’s list of UK registered online retail sellers. In addition, those retailers now need to display, on every relevant page of … Continue Reading
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS). EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need. … ...