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Policy and Regulation

Regulation Explore this Topic

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Industry Alliance Supports Commission On Environment

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Regulation Europe

Novitium’s Pyridostigmine Shows Six Appeal Of CGT Pathway

In granting its sixth approval for an ANDA with a Competitive Generic Therapy (CGT) designation, the FDA insists it is fostering competition in the US off-patent market.
Approvals Generic Drugs

CREATES Act Will Not Lead To Frivolous Lawsuits, Says AAM's Davis

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs
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Pricing Strategies; Reimbursement 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

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
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Intellectual Property 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

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
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Market Intelligence 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

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
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