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Generics Explore this Topic

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Alvogen Fails In Revlimid IPR Attempt

Alvogen’s inter partes review petition challenging a Revlimid patent in the US has been denied by the PTAB, following similar denials of petitions by Dr Reddy’s over three other Revlimid patents.

Intellectual Property United States

Saphris Asenapine Ruling Is Bounced Back By US Appeals Court

District court errors on failing to address potential motivation to develop sublingual formulations, as well as on claim construction for label carve-outs, have led the US Court of Appeals to vacate and remand a patent validity and infringement ruling on Allergan’s Saphris asenapine antipsychotic.
United States Intellectual Property

Canadian Body Welcomes Pharmacare Report

An interim report on implementing national pharmacare in Canada that highlights the importance of cost savings and access to medicines has been welcomed by local off-patent industry body the CGPA.

Market Intelligence Canada
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Biosimilars Explore this Topic

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Alvotech Starts European Trial For High-Concentration Adalimumab

Icelandic developer Alvotech is looking to set itself apart from the pack offering biosimilar rivals to Humira by conducting a Phase III clinical trial for an alternative to AbbVie’s high-concentration 100mg/ml version of adalimumab, the world’s best-selling drug.
Biosimilars Immune Disorders

UK’s CMA Will Not Take Action Over Remicade Discount Scheme

The UK’s competition regulator will not take action against MSD over a suspected anti-competitive discount scheme for Remicade (infliximab), despite an earlier provisional finding that MSD had a dominant market position and the scheme was in breach of competition law.

Legal Issues Biosimilars

Canadian Body Welcomes Pharmacare Report

An interim report on implementing national pharmacare in Canada that highlights the importance of cost savings and access to medicines has been welcomed by local off-patent industry body the CGPA.

Market Intelligence Canada
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Value-Added Medicines Explore this Topic

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Accord Agrees Leuprolide Deal as Part of Differentiation Strategy

Accord is furthering its push into added-value medicines by entering into a licensing agreement for Foresee’s injectable suspension leuprolide injectable.
Value-Added Medicines Deals

Celltrion’s Subcutaneous Infliximab Shows Promise

Data revealed by Korea’s Celltrion demonstrates that the firm’s subcutaneous infliximab is comparable to the intravenous formulation, with a study showing that auto-injection is a viable administrative method.

Biosimilars Strategy

TLC Seeks A Second Opinion On Doxolipad

After the CHMP last month refused to recommend granting approval for TLC’s doxorubicin hybrid, the firm has asked the committee within the EMA to revisit its opinion.

Europe Regulation
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