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Atara Biotherapeutics' Ebvallo® (tabelecleucel) Receives European Commission Approval as First Ever Therapy for Adults and Children with EBV+ PTLD

Retrieved on: 
Monday, December 19, 2022

THOUSAND OAKS, Calif. and CASTRES, France, Dec. 19, 2022 /PRNewswire/ -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), and Pierre Fabre today announced that the European Commission (EC) has granted marketing authorization for Ebvallo® (tabelecleucel) as a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Key Points: 
  • "The approval of Ebvallo® in Europe represents a medical breakthrough for patients with significant unmet need," said Pascal Touchon, President and Chief Executive Officer of Atara.
  • "As the first allogeneic, or donor-derived, T-cell immunotherapy to receive approval from any regulatory agency in the world, this represents a historic moment for Atara, our European partner, Pierre Fabre, and for the broader cell therapy field."
  • EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient's T-cell immune response is compromised by immunosuppression.
  • Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need.

Urovant Sciences and Pierre Fabre Médicament Enter into Exclusive License Agreement to Commercialize Vibegron for the Treatment of Overactive Bladder in the European Economic Area, UK, and Switzerland

Retrieved on: 
Tuesday, July 5, 2022

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe.

Key Points: 
  • Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe.
  • As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
  • 2011;108(7):1132-1138. doi:10.1111/j.1464-410X.2010.09993.x
    UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.
  • PIERRE FABRE, the PIERRE FABRE logo are trademarks of Pierre Fabre Medicament SAS, registered in the U.S and in other countries.

Pierre Fabre and the EspeRare Foundation administer investigational treatment to first patient in EDELIFE clinical trial for rare genetic disease, XLHED

Retrieved on: 
Friday, July 1, 2022

GENEVA and Castres, France, July 1, 2022 /PRNewswire/ --The EspeRare Foundation and the Pierre Fabre group announced today that the first patient in the EDELIFE clinical trial has received the three rounds of injection as planned. The pivotal trial is the first-of-its-kind, as the treatment is given to the XLHED (X-linked Hypohidrotic Ectodermal Dysplasia)-affected baby while inside his mother's womb. The trial intends to confirm the efficacy and safety of ER004 given as a pre-natal treatment to XLHED-affected boys.  

Key Points: 
  • The pivotal trial is the first-of-its-kind, as the treatment is given to the XLHED (X-linked Hypohidrotic Ectodermal Dysplasia)-affected baby while inside his mother's womb.
  • The trial intends to confirm the efficacy and safety of ER004 given as a pre-natal treatment to XLHED-affected boys.
  • "We need the support of the XLHED community to ensure that those who may benefit from this unique treatment are aware of the EDELIFE trial."
  • Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognised public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.

Pierre Fabre and the EspeRare Foundation administer investigational treatment to first patient in EDELIFE clinical trial for rare genetic disease, XLHED

Retrieved on: 
Friday, July 1, 2022

GENEVA and Castres, France, July 1, 2022 /PRNewswire/ --The EspeRare Foundation and the Pierre Fabre group announced today that the first patient in the EDELIFE clinical trial has received the three rounds of injection as planned. The pivotal trial is the first-of-its-kind, as the treatment is given to the XLHED (X-linked Hypohidrotic Ectodermal Dysplasia)-affected baby while inside his mother's womb. The trial intends to confirm the efficacy and safety of ER004 given as a pre-natal treatment to XLHED-affected boys.  

Key Points: 
  • The pivotal trial is the first-of-its-kind, as the treatment is given to the XLHED (X-linked Hypohidrotic Ectodermal Dysplasia)-affected baby while inside his mother's womb.
  • The trial intends to confirm the efficacy and safety of ER004 given as a pre-natal treatment to XLHED-affected boys.
  • "We need the support of the XLHED community to ensure that those who may benefit from this unique treatment are aware of the EDELIFE trial."
  • Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognised public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.

Talem Therapeutics Announces Multi-Target Antibody Discovery Research Collaboration With Pierre Fabre

Retrieved on: 
Thursday, October 7, 2021

IMMUNOPRECISE ANTIBODIES LTD. (the Company or IPA) (NASDAQ: IPA) (TSX VENTURE: IPA) and the Pierre Fabre pharmaceutical group announced today that IPAs subsidiary, Talem Therapeutics LLC (Talem), and Pierre Fabre have entered a multi-year, multi-target research collaboration with the goal to discover and develop therapeutics antibodies for up to nine targets.

Key Points: 
  • IMMUNOPRECISE ANTIBODIES LTD. (the Company or IPA) (NASDAQ: IPA) (TSX VENTURE: IPA) and the Pierre Fabre pharmaceutical group announced today that IPAs subsidiary, Talem Therapeutics LLC (Talem), and Pierre Fabre have entered a multi-year, multi-target research collaboration with the goal to discover and develop therapeutics antibodies for up to nine targets.
  • Its portfolio ranges across several medical franchises and international brands, including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avne, Klorane, Ducray, Ren Furterer, A-Derma, Naturactive and Pierre Fabre Oral Care.
  • Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
  • Forward-looking information contained in this news release include, but are not limited to, statements regarding the potential of the research collaboration with Pierre Fabre and our expectations with respect to that research collaboration and, any license that may be entered into with Pierre Fabre as a result of that research collaboration, and the potential of our other programs or services.