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Teva Gets EU Backing For OTC Desloratadine

Teva subsidiary Ratiopharm has secured EMA backing for the EU-wide switch of allergy drug desloratadine.

Generic Drugs OTC Drugs

Awards Offers Two Weeks Of Online Networking

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

Generic Drugs Biosimilars

Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

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Awards Offers Two Weeks Of Online Networking

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

Generic Drugs Biosimilars

Podcast: The UK's New Biosimilars Licensing Pathway

In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.

Biosimilars Regulation

Roche’s Biosimilar Losses Could Be Closer To CHF5bn

Roche entered the year with a projected hit to revenues from multi-source biosimilar competition to its three leading biologics. However, the number was increased at the half-year mark and could be set to ratchet up further, according to management.

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Awards Offers Two Weeks Of Online Networking

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

Generic Drugs Biosimilars

Industry Urges Medicare Rethink On 505(b)(2) Policy

Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.

Value-Added Medicines Reimbursement

Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.

Value-Added Medicines Complete Response Letters
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