BioSpace News Archive

Policy

Minoryx Therapeutics receives FDA Orphan Drug Designation for leriglitazone in Friedreich’s Ataxia

Minoryx Therapeutics announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA).

October 17, 2019
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4 min read
Finalists revealed for CPhI Worldwide’s eagerly anticipated 2019 Awards

CPhI Worldwide announces the finalists for the CPhI Pharma Awards.

October 17, 2019
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3 min read
Nomination Committee Appointed for the Annual General Meeting 2020 in Promore Pharma

Promore Pharma AB announced the composition of the Nomination Committee for the Annual General Meeting 2020, which will be held on Tuesday 26 May 2020.

October 17, 2019
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2 min read
Pharm Country

Uncovering the Mechanisms Behind Magnetogenetics Could Advance Biomanufacturing

Greater understanding of phenomena could enable unprecedented control over gene expression

October 17, 2019
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3 min read
FDA

FDA Announces Record Number of Generic Drug Approvals

For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.

October 17, 2019
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3 min read
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Mark Terry
Business

Stealth CEO Shares Excitement about Alexion Partnership and Potential of PMM Drug

Reenie McCarthy, chief executive officer of Stealth Biotherapeutics, has seen first-hand the negative impact of mitochondrial diseases, including watching an athlete decline from being an Olympic-level rower to becoming wheelchair-bound.

October 17, 2019
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4 min read
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Alex Keown
Biotech Beach

Bionano Genomics Announces Adoption of Its Saphyr® System by Clinical Cytogenetics Groups in Academia and Industry to Replace Traditional Methods for Clinical Testing

Successful validation of Saphyr to replace “gold standard” method of southern blotting for molecular diagnosis of FSHD supports broad utility of Saphyr

October 17, 2019
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6 min read
Business

HepaRegeniX GmbH Announces Management Changes

HepaRegeniX GmbH, a preclinical stage company developing a novel therapy for the treatment of acute and chronic liver diseases announced the appointment of seasoned biotech expert Dr. Michael Lutz as new CEO and Managing Director of the company..

October 17, 2019
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4 min read
Drug Development

SurgiMab recruits first US patient in pivotal Phase 3 trial evaluating SGM-101, a novel fluorescent tumor-specific antibody, for the improvement of surgical outcomes in colorectal cancer patients

SGM-101 is an investigational new imaging agent for fluorescence-guided surgery designed to enable surgeons to better visualize tumor tissues in real-time

October 17, 2019
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4 min read
Policy

Trailblazing scientific talent receive Singapore’s highest research and innovation accolades

Two teams and an individual have been awarded this year’s President’s Science and Technology Awards[1][1], the highest honours bestowed upon research scientists and engineers in Singapore whose work have resulted in significant scientific, technological or economic benefits for the country.

October 17, 2019
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6 min read