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Heidelberg Pharma AG

http://heidelberg-pharma.com/en/

Latest From Heidelberg Pharma AG

US FDA’s Drugs Center Wins Round One In Makena Dispute With Covis On Document Production

Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Review Pathway Post Market Regulation & Studies

Advanz Appoints Stada Europe Head As New CEO

Stada’s head of Europe, Steffen Wagner, is set to become the new CEO of Advanz early next year, while current CEO Graeme Duncan will step down and take a new role as special advisor to the board. Advanz is also appointing a new chief financial officer, with Merck Healthcare’s Andreas Stickler set to succeed Adeel Ahmad in January.

Executive Changes Leadership

US FDA Chief Scientist Hinton’s Departure Leaves Vacancy Atop Makena Decision Tree

Jacqueline O’Shaughnessy takes over as acting chief scientist following Denise Hinton’s move to the surgeon general’s office; Hinton previously had been tapped by acting commissioner Janet Woodcock to make a final decision on the accelerated approval status of Covis' preterm birth prevention drug Makena.

FDA Review Pathway

AstraZeneca Rejigs Respiratory Franchise With Fresh Covis Deal

Having got hold of two COPD drugs from Spain's Almirall in 2014, AstraZeneca has passed Eklira and Duaklir onto old partner Covis Pharma as it focuses on more targeted respiratory therapies.

Respiratory Business Strategies
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Company Information

  • Industry
  • Pharmaceuticals
    • Radiopharmaceuticals, Contrast Agents
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • Heidelberg Pharma Research GmbH
    • Wilex AG
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