BioSpace News Archive

Deals

Cibus Announces Launch of Initial Public Offering

Cibus Global, Ltd. today announced the launch of its underwritten initial public offering of 6,666,667 shares of its Class A common stock pursuant to a registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission.

February 4, 2019

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3 min read

Drug Development

Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis

Eli Lilly and Company and Incyte Corporation announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis.

February 4, 2019

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13 min read

Policy

European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Recommendation Based on Significant Overall Survival Benefit Demonstrated with KEYTRUDA in Combination with Chemotherapy in Pivotal KEYNOTE-407 Trial

February 4, 2019

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28 min read

FDA

BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer

BioLineRx Ltd. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer.

February 4, 2019

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6 min read

Business

The Stepping Stones Group Partners With The Perfect Playground

The Stepping Stones Group today announced its partnership with The Perfect Playground OT, PT, & SLP, PLLC (The Perfect Playground), a New York based therapy company.

February 4, 2019

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4 min read

Policy

VLP Therapeutics to Initiate First Clinical Trial of VLPM01 Malaria Vaccine

VLP Therapeutics today announced that the U.S. Food and Drug Administration has cleared an investigational new drug application for a clinical trial of the Company’s VLPM01 malaria vaccine.

February 4, 2019

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2 min read

Crescita Therapeutics Inc.™ and Tetra Natural Health Collaborate to Enhance Transdermal Delivery of Beta-Caryophyllene in Tetra’s Dermatology Product Portfolio

Crescita Therapeutics Inc. today announced an agreement to develop an enhanced version of Tetra’s dermatology portfolio using Crescita’s patented transdermal delivery technologies: Multiplexed Molecular Penetration Enhancer (“MMPE™") and DuraPeel™.

February 4, 2019

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7 min read

Takeda to Highlight Advancements in Rare Lysosomal Storage Disorders at Global Scientific Meeting

12 presentations will be presented across 3 lysosomal storage disorders, underscoring Takeda’s commitment to patients with rare diseases

February 4, 2019

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10 min read

Genetown

Curis, Inc. to Present at the 2019 BIO CEO & Investor Conference

Curis, Inc. today announced that James Dentzer, President and Chief Executive Officer, will present at the 2019 BIO CEO & Investor Conference on Tuesday, February 12th, at 10:30 a.m. EST in the Hudson/Empire Room at the Marriott Marquis in New York City.

February 4, 2019

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1 min read

Pharm Country

NanoViricides Has Initiated IND-Enabling Safety/Toxicology Studies for Its First Drug Candidate Moving towards Human Clinical Trials

NanoViricides, Inc. announces that its first drug candidate has now entered IND-enabling Safety/Toxicology studies moving towards human clinical trials.

February 4, 2019

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9 min read