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Latest From medac GmbH

US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Review Pathway Drug Review

COVID-19 Vaccines: Ocugen’s EUA Request For Covaxin In Kids Faces Steep Climb At US FDA

Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.

Coronavirus COVID-19 Vaccines

Dr Reddy’s Gears For Sputnik Pediatric Shot, Molnupiravir Upside

Dr Reddy’s indicates it is close to break-even between “the investment made and what we gained” for Russian COVID-19 vaccine Sputnik V in India, with Sputnik Light, boosters and pediatric shots seen as the new growth drivers. The company’s fully vertically integrated operations also puts it in prime position for supplies of antiviral molnupiravir.

Coronavirus COVID-19 Vaccines

Coronavirus Notebook: WHO OKs Bharat’s Covaxin, AZ Pulls Swiss Vaxzevria Filing

The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.

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Company Information

  • Industry
  • In Vitro Diagnostics
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
    • Generic Drugs
  • Other Names / Subsidiaries
    • medac Gesellschaft für klinische Spezialpräparate mbH
    • medac GmbH Sp. z o.o.
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