BioSpace News Archive

Policy

I-Mab Biopharma and MorphoSys Announce China IND Submission of TJ202/MOR202

On August 8, 2018 Beijing time I-Mab Biopharma and MorphoSys AG announced today that I-Mab has Submitted an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody directed against CD38 for the treatment of multiple myeloma.

August 7, 2018
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7 min read
Deals

ProLung Shareholder Group Led by Founder and Former CEO Steve Eror Files Preliminary Consent Materials for the Addition of 8 New Directors to the Board

Cautions the Board Against any Further Board Appointments or Governance Changes During the Pendency of the Consent Solicitation

August 7, 2018
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5 min read
Business

CORRECTING and REPLACING Synergy Pharmaceuticals Reports Second Quarter 2018 Financial Results and Business Update

CORRECTION...by Synergy Pharmaceuticals Inc.

August 7, 2018
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16 min read
Business

Akouos Raises $50 Million Series A to Advance Gene Therapy for Hearing Loss

Akouos, based in Boston, announced a Series A financing worth $50 million. The round was led by seed investors 5AM Ventures and New Enterprise Associates (NEA).

August 7, 2018
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2 min read
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Mark Terry
Drug Development

Spark’s Hemophilia A Gene Therapy Significantly Reduced Bleeding in Clinical Trial

An investigational gene therapy treatment for hemophilia A has seen a 97 percent response rate after one treatment for the 12 trial participants, Spark Therapeutics announced this morning.

August 7, 2018
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3 min read
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Alex Keown
BioMidwest

Mayo Clinic Finds Genes Associated with Triple-Negative Breast Cancer

Researchers at the Mayo Clinic, led by geneticist Fergus Couch, identified specific genes associated with triple-negative breast cancer. Triple-negative breast cancer is generally difficult to treat and has a lower five-year survival rate than other types of breast cancer.

August 7, 2018
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2 min read
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Mark Terry
Business

Walmsley Taps HSBC Veteran to Replace CFO Simon Dingemans

GlaxoSmithKline Chief Executive Officer Emma Walmsley has made another key appointment to her senior leadership team.

August 7, 2018
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2 min read
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Alex Keown
Policy

Recent Drug Scandals in China Spotlight Potential Global Supply Chain Issues

China is the largest supplier of active pharmaceutical ingredients (API) in the world, supplying 40 percent of APIs to global pharma companies. And a recent series of scandals and issues related to drug manufacturing in China has highlighted how many problems this could cause the global drug supply chain.

August 7, 2018
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3 min read
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Mark Terry
Business

FDA Issues New Draft Guidance to Promote Development of Medications to Treat Opioid Use Disorder

On Monday, the U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.

August 7, 2018
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2 min read
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Alex Keown
Drug Development

Bellerophon Therapeutics Plunges As Late-Stage PAH Trial Fails Following Interim Analysis

Shares of Bellerophon Therapeutics have plunged nearly 75 percent this morning after the company announced its Phase III pulmonary arterial hypertension failed to meet endpoints following a pre-specified interim analysis from a Data Monitoring Committee.

August 7, 2018
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2 min read
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Alex Keown