News & Analysis as of

Marketing Pharmaceutical Industry European Union

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from...

Goodwin on

Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment in Possible Future Generic Marketing Excludes Legitimate Basis for Pharma Settlement, Suggests EU Advocate General

In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more

Hogan Lovells

Brexit: the impact on supplementary protection certificates (SPCs)

Hogan Lovells on

On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or...more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Hogan Lovells on

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Hogan Lovells

New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

Hogan Lovells on

On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. ...more

K&L Gates LLP

CJEU Confirms: Supplemental Protection Certificate Application Requires Issued Marketing Authorization

K&L Gates LLP on

A recent decision of the CJEU in Europe raises concerns for pharmaceutical companies who wish to supplement the protection of their products with SPCs. With its decision C 567/16 the court follows a strict approach and...more

Hogan Lovells

EMA released new procedural guide for Multinational Assessment Teams

Hogan Lovells on

The European Medicines Agency (“EMA”) has released a procedural guideline for rapporteurs and coordinators participating in Multinational Assessment Teams (“MNAT”)....more

Jones Day

Ten Years of Conditional Marketing Authorizations

Jones Day on

The European Medicines Agency ("EMA") published a report ("EMA report") concerning the data collected over 10 years—between July 2006 and June 2016—on the so-called "conditional marketing authorizations" ("CMAs")....more

Hogan Lovells

Extension to the EMA's Multinational Assessment Team Initiative as of April 2017

Hogan Lovells on

Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national...more

Searcy Denney Scarola Barnhart & Shipley

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: UK High Court Considers quia timet Injunctions

The UK High Court recently gave its judgment in the case of Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva)...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Court of Appeal Refers Questions on Specific Mechanism to Court of Justice of European Union

Merck Canada Inc and Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc - Prior to their accession to the European Patent Convention, several states did not allow patent protection for pharmaceutical products. To...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide