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MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the opening of a new €25 million BioReliance® testing facility

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

MilliporeSigma Announces Opening of BioReliance® Testing Facility in Darmstadt, Germany to Support Drug Product Release in Europe

Thu, 16 Jul 2026 08:11:00 -0400

Burlington, Massachusetts, July 16, 2026 (GLOBE NEWSWIRE) --

New 2,000-square-meter facility expands the company’s global testing network with commercial drug substance and drug product release testing and GMP-compliant stability studies
Strategic location near major clinical trial hubs strengthens support for biopharmaceutical companies bringing therapies to European markets
Darmstadt site joins the company’s global BioReliance® testing network, enhancing end-to-end analytical and biosafety testing services

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

EMD Serono, the U.S. and Canada healthcare unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations.

Enpatoran is an investigational oral selective inhibitor of toll-like receptors 7 and 8 (TLR7/8), which are involved in immune pathways linked to lupus. The drug has not been approved for any use anywhere in the world.

The FDA's decision was based on results from the Phase 2 WILLOW study, a multicenter, randomized, double-blind, placebo-controlled trial that included patients with both Cutaneous Lupus Erythematosus (CLE) and

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

FDA grants breakthrough designation to EMD Serono's lupus drug enpatoran

Wed, 08 Jul 2026 08:00:39 -0400

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and

EMD Serono Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients with Active Skin Manifestations

Wed, 08 Jul 2026 08:00:00 -0400

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies
FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations
Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug development and review

Not intended for media outside the U.S. or Canada

BOSTON--(BUSINESS WIRE)-- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the US Food and