LexBlog IP

AUGUST 16, 2023

The settlement permits marketing of FYB202 in the United States, subject to regulatory approval, no later than April 15, 2025. According to the press release, Formycon plans to submit a biologics license application later in 2023 to seek regulatory approval for FBY202. Economic terms of the settlement were not disclosed in the press release.

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LexBlog IP

AUGUST 30, 2023

market on March 7, 2025, if approved by FDA. J&J also recently filed a confidential settlement and license agreement to terminate a Samsung Bioepis challenge to all claims of U.S.

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LexBlog IP

JANUARY 16, 2023

The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. The European Commission’s aim is to adopt the EHDS by the end of its current mandate (October 31, 2024). The following identifies the three main areas covered by the EHDS proposal: 1.

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LexBlog IP

FEBRUARY 1, 2024

In October 2023, Accord settled with Janssen Biotech under confidential terms that would allow Accord to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending FDA approval. Accord, a global subsidiary of Intas Pharmaceuticals, will be responsible for U.S. commercialization.

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LexBlog IP

JULY 31, 2023

It’s important to note that data security and confidentiality aren’t taken lightly. Those pre-dating January 1, 2024, have a grace period until January 1, 2025, to submit their initial reports. Additionally, those who file to form or register an entity share the same disclosure obligations.

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The IPKat

SEPTEMBER 1, 2023

The UK government has launched a second consultation on proposed changes to allow the Intellectual Property Office to deliver better digital services. In July, the government concluded its first transformation consultation. The IPO actively encourages parties to mediate, as a quicker and less costly alternative to litigation.

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SpicyIP

APRIL 30, 2023

Nirtech – Analysing the Claim of Breach of Confidential Information Image from here. Ex-employees using confidential information acquired from the former employer! Nirtech on protecting confidential information. adds Belarus, Bulgaria to intellectual property watch list. Other posts Rochem v.

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