BioSpace News Archive

Policy

FDA Action Alert: Blueprint, Indivior and Lexicon

Blueprint Medicines, Indivior PLC and Lexicon Pharmaceuticals are all awaiting FDA decisions this week.

May 19, 2023
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4 min read
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Tristan Manalac
FDA

FDA Approves Bausch + Lomb, Novaliq Dry Eye Disease Drug

The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.

May 19, 2023
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2 min read
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Tristan Manalac
FDA

AbbVie Adds Crohn’s Disease to Rinvoq’s Growing List of Indications

Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.

May 19, 2023
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2 min read
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Tristan Manalac
BioMidwest

Humanetics Biomed expands its outsourced manufacturing capabilities to new markets

Humanetics Biomed is a Contract Development Manufacturing Organisation that combines the best biomedical technologies from Humanetics; with the technical engineering expertise for research and development of precision lasered components and subcomponents for medical devices.

May 19, 2023
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3 min read
Genetown

Tessera Therapeutics Presents New Data Demonstrating the Potential of Gene Writing™ Technology at the American Society of Gene and Cell Therapy 26th Annual Meeting

Tessera Therapeutics presented progress across multiple platforms and preclinical programs including increased efficiency in correcting the SCD mutation in preclinical models, increased efficiency in correcting the most common mutation in PKU in mouse and NHP models, and a first-time demonstration of efficient in vivo rewriting in AATD.

May 19, 2023
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6 min read
Pharm Country

Rocket Pharmaceuticals Presents Positive Data from LV Hematology and AAV Cardiovascular Gene Therapy Programs at the 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT)

Rocket Pharmaceuticals, Inc. announced positive data from the Pyruvate Kinase Deficiency, Fanconi Anemia, Severe Leukocyte Adhesion Deficiency-I and Danon Disease clinical programs and PKP2-arrhythmogenic cardiomyopathy preclinical program presented at the 26th Annual Meeting of the American Society of Gene and Cell Therapy in Los Angeles, California.

May 19, 2023
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19 min read
Deals

Intercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Intercept Pharmaceuticals, Inc. today announced that NASDAQ has halted trading of the company’s common stock.

May 19, 2023
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2 min read
Pharm Country

TELA Bio Invests in Surgeon Training and Education with Upcoming Cadaver LabCompany prioritizes education with a variety of in-person and virtual training programs

TELA Bio, Inc today announced it will be hosting its next cadaver lab on May 19 in Tampa, Florida.

May 19, 2023
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4 min read
Genetown

Bluejay Diagnostics Updates Symphony IL-6 Regulatory Strategy

Bluejay Diagnostics, Inc. today announced an updated clinical and regulatory strategy for the Symphony IL-6 biomarker test to measure acuity in sepsis patients.

May 19, 2023
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5 min read
Drug Development

HanAll Biopharma Announces Results from Phase III randomized, double-masked active treatment-controlled VELOS-3 Trial Evaluating Tanfanercept 0.25% for Treatment of Dry Eye Disease

HanAll Biopharma Co., Ltd. announced results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept, a novel, topical anti-inflammatory treatment being studied for the treatment of dry eye disease (DED) in subjects diagnosed with moderate to severe DED.

May 19, 2023
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7 min read