BioSpace News Archive

Business

Kewaunee Scientific Declares Quarterly Dividend

Kewaunee Scientific Corporation announced today its Board of Directors declared a quarterly cash dividend of seventeen cents per outstanding share, payable on December 18, 2017 to stockholders of record at the close of business on December 4, 2017.

November 21, 2017

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1 min read

Policy

Starpharma: NDA Submission for VivaGel BV in the U.S.

VivaGel BV has been granted Fast Track status and Qualified Infectious Disease Product designation, which allows for rolling submission of the NDA and ensures priority regulatory review by the FDA.

November 21, 2017

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2 min read

Therapix Biosciences Spotlighted in Financial and Trade Media Outlets

Therapix has received positive media coverage in a variety of financial and trade media outlets.

November 21, 2017

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4 min read

Drug Development

Janssen Submits Application to U.S. FDA to Expand Indication for DARZALEX (daratumumab) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma who are Transplant Ineligible

Janssen Biotech today announced that it has submitted a supplemental sBLA to the FDA for DARZALEX (daratumumab).

November 21, 2017

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17 min read

Biotech Beach

Avelas Biosciences to Present at Piper Jaffray Healthcare Conference

Avelas BioSciences today announced that Carmine N. Stengone, president and CEO, will present at the 29th Annual Piper Jaffray Healthcare Conference on Tuesday, November 28, 2017, at 4:50 p.m. EST in New York City.

November 21, 2017

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1 min read

AC Immune to Host Key Opinion Leader Meeting on Tau as a Therapeutic and Diagnostic Target in Alzheimer’s and other Neurodegenerative Diseases

The event will be held on December 1, 2017 from 12.00pm - 1.45pm ET at the St. Regis Hotel, 2 E. 55th Street in New York, NY.

November 21, 2017

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6 min read

FDA

Teligent Announces FDA Approval of Erythromycin Topical Solution USP, 2%

This is Teligent’s eighth approval for 2017.

November 21, 2017

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2 min read

Drug Development

Catalyst Pharmaceuticals Announces Phase II Study of Firdapse in Ambulatory Patients With Spinal Muscular Atrophy (SMA)

The study will be conducted by a team of researchers led by Lorenzo Maggi, MD, and Giovanni Baranello, MD, of the Fondazione Istituto Neurologico Carlo Besta in Milan, Italy, a major referral center for SMA patients.

November 21, 2017

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7 min read

Business

Genmab Announces Submission of Supplemental Biologics License Application to FDA for Daratumumab in Front Line Multiple Myeloma

In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

November 21, 2017

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7 min read

Drug Development

Data from Phase III ALCYONE Study of Daratumumab Accepted for Oral Presentation at Annual Meeting of the American Society of Hematology

The abstract is published online on the ASH website: www.hematology.org.

November 21, 2017

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7 min read