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Latest From AstraZeneca PLC

FDA Plans 2-Day Meeting On Skin Cancer Detection Tools

The advisory panel will discuss ways to ensure the safety of skin lesion analysis systems, and consider the potential down-classification of two computer-aided melanoma detection devices. 

Regulation Advisory Committees

EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen

Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy. 

European Performance Tracker Review Pathway

Amneal Makes It Three With Pegfilgrastim Approval

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Biosimilars Approvals

India FY22 Earnings: Everyone’s Talking Of Big Spikes In Input, Logistics Costs

The sharp escalation in prices of raw materials, solvents, excipients and logistics in a volatile operating environment charged by geopolitical tensions and supply chain challenges was one of the key talking points at the fiscal fourth quarter earnings discussions of leading Indian firms. With little hope for respite any time soon, companies are devising strategies to cope.

Commercial India
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Company Information

  • Industry
  • Pharmaceuticals
  • Other Names / Subsidiaries
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    • Almirall Sofotec
    • AlphaCore Pharma
    • Amplimmune, Inc.
    • Ardea Biosciences, Inc.
    • Arrow Therapeutics
    • Aviron
    • Cellective Therapeutics, Inc.
    • Definiens
    • IntraBiotics Pharmaceuticals, Inc.
    • KuDOS Pharmaceuticals Ltd.
    • Medimmune
    • Novexel
    • Omthera Pharmaceuticals
    • Pearl Therapeutics
    • Spirogen Ltd.
    • U.S. Bioscience
    • Acerta Pharma
    • ZS Pharma
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