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Latest From Recordati SpA

EMA Backs EU Approval For Ztalmy & Pylclari; Roches Withdraws EU Filing For AMD Implant

Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

Europe Approvals

Longer Exclusivity Periods For EU Centralized Rx-To-OTC Switches? Commission Says No

One way to revitalize interest in the EU's centralized switch procedure would be to introduce longer data exclusivity periods or market exclusivity for successful applicants, concluded an AESGP expert switch panel presenting at the association's 59th Annual Meeting in Paris, France. However, a European Commission representative told another panel that this was not under consideration as part of the EU pharmaceutical legislation revision.

Europe Health

Pear Bankruptcy Filing Highlights Difficult Challenges Facing Digital Therapeutics

Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.

Digital Health Business Strategies

AESGP Annual Meeting: OTC Antifungals, Antivirals Could Become Rx In EU

The European Commission shocked participants at this year's AESGP Annual Meeting by warning that OTC antifungals, like treatments for athlete’s foot, and OTC antivirals, like cold sore creams, could soon become prescription-only within the region, under proposed revisions to the EU pharma legislation. There is hope, however. The proposals are still open to feedback from industry, the AESGP points out, and even if this proposal becomes law, member states can waive this prescription requirement under certain conditions.

Europe Health
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Company Information

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  • Pharmaceuticals
    • OTC, Consumer
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  • Other Names / Subsidiaries
    • Bouchara Recordati
    • Dr. F. Frik Ilaç A.S.
    • Opalia Pharma S.A.
    • Orphan Europe
    • Recordati Pharmaceuticals Ltd.
    • Laboratorios Casen Fleet
    • Italchimici S.p.A.
    • Pro Farma AG
    • Recordati S.A. Chemical and Pharmaceutical Company
    • Recordati Rare Diseases Canada Inc.
    • Natural Point S.r.l.
    • Tonipharm S.A.S.
    • FIMEI S.p.A
    • Rossini Investimenti S.p.A
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