News & Analysis as of

Biopharmaceutical European Union

Rothwell, Figg, Ernst & Manbeck, P.C.

The New Exclusive European Licensee of Cenobamate: Angelini Pharma Acquires Emerging Swiss Biotech Company Arvelle Therapeutics

The Italian pharmaceutical company Angelini Pharma announced on January 4, 2021, that it will acquire emerging Swiss biotech company Arvelle Therapeutics for a total aggregate valuation of up to $960 million. Angelini Pharma...more

Knobbe Martens

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

Knobbe Martens on

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Hogan Lovells

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified...more

Hogan Lovells

EMA on optimising the development of advanced therapies

Hogan Lovells on

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

Knobbe Martens

Polymer for Celiac Disease is Confirmed as Class IIb Medical Device in European Union

Knobbe Martens on

According to a press release from the Israeli company BioLineRx, their novel polymer for treating Celiac Disease has been confirmed as a Class IIb medical device in the European Union (EU).  According to the company, the...more

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