BioSpace News Archive

Business

Clinigen Extends Agreement With Eisai to Supply Halaven, Fycompa and Lenvima Into 10 African Countries

Clinigen Group has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven, Fycompa and Lenvima into 10 African countries.

January 3, 2018
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2 min read
Biotech Bay

Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris

Seven patients successfully treated using next generation image-guided atherectomy device for treatment of peripheral artery disease.

January 3, 2018
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5 min read
Biotech Bay

Pharmaleads to Present at Biotech Showcase 2018 in San Francisco

Pharmaleads today announces its participation at the upcoming 10th Annual Biotech Showcase Conference to be held in San Francisco on January 8 - 10, 2018.

January 3, 2018
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1 min read
Biotech Bay

Zosano Pharma Announces Notice of Allowance for a U.S. Patent Application Covering M207 as an Acute Treatment for Migraine

Issuance will extend patent life of M207 to 2037.

January 3, 2018
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4 min read
Drug Development

Enteris BioPharma Announces Positive Results From Phase IIa Clinical Trial of Ovarest (oral leuprolide tablet) for Endometriosis

Data from the study indicated that Ovarest enabled significant suppression of estradiol, demonstrating a measurable pharmacodynamic effect that is tightly correlated with efficacy in endometriosis.

January 3, 2018
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5 min read
Policy

Statement From FDA Commissioner Scott Gottlieb, M.D. on New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices

The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan.

January 3, 2018
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6 min read
Pharm Country

VenatoRx Pharmaceuticals Receives FDA’s QIDP and Fast Track Designations for Development of Its Lead Antibiotic Program

The designations were granted for both complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

January 3, 2018
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3 min read
Drug Development

Rasna Therapeutics, Inc., Announces Follow Up Phase II Clinical Data Confirming Efficacy of Actinomycin D in Patients with NPM1-Mutated Acute Myeloid Leukemia

Rasna Therapeutics today announced follow up Phase II clinical data showing that 4 out of 9 (44%) evaluable AML patients carrying the NPM1 gene mutation treated with actinomycin D (“Act D”), achieved complete remission (CR).

January 3, 2018
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5 min read
Business

Symbiotix Biotherapies Announces Process Development & Manufacturing Agreement with Paragon Bioservices

According to the agreement, Paragon will continue its work on Symbiotix’s lead program to complete the optimization of the downstream production process for SYMB-104 in preparation for production of clinical material at scale.

January 3, 2018
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3 min read
Business

Anthera Pharmaceuticals Announces Appointment of Patrick Murphy as Senior Vice President, Manufacturing

In his new role, Patrick will oversee the manufacturing commercial scale-up of Sollpura.

January 3, 2018
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2 min read