NMPA Grants Priority Review to NDA for Glycerol Phenylbutyrate

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Stockholm, September 28, 2022 Immedica Pharma AB is pleased to announce that RAVICTI® (glycerol phenylbutyrate), has been accepted and granted Priority Review for the New Drug Application (NDA) in China. This has been presented earlier by our partner WinHealth (see full press release below). In April, another submission for RAVICTI® Market Authorisation Approval was accepted […]

Immedica welcomes Linda Holmström as Head of Communication

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It is with great pleasure we today can welcome Linda Holmström, who is an experienced stock exchange- and corporate brand communicator. Linda will take the role as Head of Communication and be responsible for both our external corporate branding including ESG and sustainability communication as well as being tightly involved in our European launches, with focus on […]

Immedica Pharma and Innovative Medicines announces ANMAT (Argentina) and INVIMA (Colombia) filing acceptance of RAVICTI® (glycerol phenylbutyrate), a adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs)

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Immedica Pharma and Innovative Medicines announces ANMAT (Argentina) and INVIMA (Colombia) filing acceptance of RAVICTI® (glycerol phenylbutyrate), a adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) Immedica Pharma AB, and Innovative Medicines SA, announces two submissions of marketing authorization applications to: The National Agency of Medicines, Food and Medical Technology (ANMAT) […]

Immedica Pharma AB submits Marketing Authorisation Application to the European Medicines Agency seeking approval of pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D).

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Stockholm, August 18, 2022 Immedica Pharma AB announced today that the company’s Marketing Authorisation Application for pegzilarginase has been successfully validated by the European Medicines Agency (EMA) for the treatment of patients with Arginase 1 Deficiency (ARG1-D). The application is supported by positive results from the international phase 3 study (CAEB1102-300A, also named PEACE), investigating […]

Zepzelca® (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency)

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Immedica Pharma AB is pleased to announce that Zepzelca® (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency), presented earlier by our valued partner PharmaMar (see full press release below). Anders Edvell, CEO says: “To be awarded an Innovation Passport under the new Innovative Licensing […]

How to ensure medical supply in a global crisis

How to ensure medical supply in a global crisis Orphan drugs are vital, sometimes life-saving. How can you ensure that medicine reaches the patients during a crisis? How do you manage reduced access to essential ingredients, closed transport routes, and other unexpected events?  Mikael Näslund, Head of Supply at Immedica Pharma, shares his insights. Mikael […]

Do you want a career in rare diseases?

Do you want a career in rare diseases? Check if you have the capabilities needed. Immedica Pharma provides pharmaceuticals to patients with rare diseases and their caregivers. Working with rare diseases and orphan drugs is extremely gratifying as treatment is of utter importance for the patients’ health and life quality. Gunilla Mickelsson, Head of Northern […]

Immedica and OrphanPacific enter agreement giving OrphanPacific rights to Ravicti® (glycerol phenylbutyrate) in Japan

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Stockholm, May 31, 2022 – Immedica Pharma AB (“Immedica”) and Japanese company OrphanPacific, Inc. (“OrphanPacific”) are happy to announce that they on May 2, 2022, entered an agreement under which OrphanPacific gains the exclusive rights to Ravicti® in Japan. The pharmaceutical drug product Ravicti® is approved in Europe and North America for treatment of urea […]

Actinium Pharmaceuticals, Inc. and Immedica Announce Commercialization Agreement for Iomab-B (131I apamistamab) in Europe, the Middle East and North Africa

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  Potential for up to $452 million in milestone payments with royalties in the mid-twenty percent range   Actinium receives $35 million upfront payment   Immedica obtains exclusive rights to Iomab-B in Europe, the Middle East and North Africa   NEW YORK, NY and Stockholm – April [12], 2022 – Actinium Pharmaceuticals, Inc.  (NYSE AMERICAN: […]