Eurofins Discovery Announces Collaboration with a Swiss-based Biotech Company Amphilix AG

Eurofins Discovery | November 04, 2020

Eurofins Discovery, the leading provider of services and products to the drug discovery industry, announced a new collaboration with Amphilix AG, a Swiss-based biotech company, to support a program aimed at identifying a treatment modulating key disease mechanisms. Amphilix AG will take advantage of Eurofins Discovery's DiscoveryOne™ offering, an integrated drug discovery platform providing expert support to progress programs to preclinical development and beyond. Amphilix will engage Eurofins Discovery to prosecute the biology, pharmacology, ADME, and safety pharmacology aspects of the program, working in collaboration with the accomplished team at Eurofins Discovery to progress to a development candidate. The two organizations expect this to be the first of multiple programs in which they collaborate to discover new treatments for unmet medical needs.

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A Chinese scientist claims to have created the world’s first genetically-engineered babies. He used CRISPR, a revolutionary gene-editing technology, to deactivate a gene in their DNA linked to HIV infection. Editing human DNA in this way could save lives, but many researchers fear unintended consequences.

Spotlight

A Chinese scientist claims to have created the world’s first genetically-engineered babies. He used CRISPR, a revolutionary gene-editing technology, to deactivate a gene in their DNA linked to HIV infection. Editing human DNA in this way could save lives, but many researchers fear unintended consequences.

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Stemcyte Submitted its Application for A Biologics License (BLA) For Its Product "HPC-Cord Blood" To The US FDA

Stemcyte | March 23, 2022

On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process. The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorders an appropriate preparative regimen for hematopoietic and immunologic reconstitution. There have been over 40,000 successful umbilical cord blood transplants globally to treat disorders of the hematological and immunological systems and genetic metabolic diseases since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988. StemCyte has donated more than 2,200 cord blood units for transplantation to 1 in every 20 patients with umbilical cord blood transplants globally during the last 20 years. In addition, at least 350 transplant centers around the world, including well-known medical centers such as UCLA Medical Center, Duke University Hospital, Taiwan Chang Gung Memorial Hospital, and National Taiwan University Hospital, consistently meet the quality standards of international accrediting bodies and are recognized and trusted as safe and effective by StemCyte's products.

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Sartorius Stedim Biotech Closes Acquisition of Slovenian Purification Specialist BIA Separations

Sartorius | November 03, 2020

Sartorius Stedim Biotech (SSB), a leading partner of the biopharma industry, successfully closed the acquisition of the Slovenian purification specialist BIA Separations. The transaction was completed on November 2, 2020, after receiving the required approvals. "BIA's portfolio is highly complementary to Sartorius Stedim Biotech. We are thus creating an excellent offering for the manufacturing of gene therapies and other advanced therapies, and are pleased to welcome 120 new employees," said Dr. Joachim Kreuzburg, Chairman of the Board and CEO of Sartorius Stedim Biotech. The total purchase price of the transaction is 360 million euros of which 240 million euros were paid in cash and 120 million euros in SSB shares. Both parties have further agreed on three tranches of earn-out payments based on performance over the next five financial years. SSB has been preparing to integrate BIA Separations so this can now be initiated despite the special conditions prevailing during the pandemic. BIA Separations develops and manufactures market-leading products for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are used in cell and gene therapies and other advanced therapies. BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics, and the company also has a strong presence with such novel drug candidates in the clinical pipeline. Expecting continued very strong double-digit sales growth over the next few years, BIA is forecasted to earn sales revenue of approx. 25 million euros in 2020 at profit margins that will be accretive to the underlying EBITDA margin of the Sartorius Stedim Biotech Group. The transaction is not expected to have any material impact on Sartorius Stedim Biotech's 2020 results.

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Acticor Biotech Announces the Success of the First Phase of its ACTIMIS study with Glenzocimab In Patients with Acute Ischemic Stroke

Acticor Biotech | October 05, 2020

Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including acute ischemic stroke, today announced the completion of its ACTIMIS Dose Escalation Phase of Glenzocimab Study as add-on to standard of care in Patients with acute ischemic stroke. This Dose Escalation Phase was successfully completed with 60 patients enrolled from 6 European countries (France, Belgium, Germany, Spain, Switzerland and Italy). 5 cohorts of patients presenting with an acute ischemic stroke episode of moderate to severe intensity were enrolled in this study and randomly received glenzocimab at one of 4 ascending doses or a placebo, in a blind fashion as a 6-hour single-dose infusion. Patients were evaluated continuously for 24 hours, then 7 and 90 days after the episode. Approximately 50% were also treated with the thrombolytic agent rtPA (ACTILYSE®), and the other 50% received rtPA and underwent a mechanical thrombectomy. The DSMB met on 5 occasions in between each cohort and at the end of the last administration, and they analyzed the safety data with a particular focus on the advent of intra-cerebral hemorrhages and other bleeding related events. The last analysis performed after the target dose of 1000mg had been administered to 12 patients confirmed both the absence of increased bleeding when glenzocimab is added to rtPA and to rtPA and thrombectomy, and the absence of any dose-related trend in the number and nature of adverse events recorded.

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