BioSpace News Archive

FDA

Updated: Merck Scores FDA Approval for Two New HIV Treatments

Nearly two months ahead of the planned PDUFA date, the U.S. Food and Drug Administration approved two new HIV-1 treatments developed by Merck. The FDA gave the go ahead for Delstrigo, a once-per day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor.

August 31, 2018
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4 min read
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Alex Keown
Deals

Arvinas to Launch IPO to Raise $100 Million

New Haven, Connecticut-based Arvinas, only a few months since raising $55 million in a Series C financing, filed for an initial public offering (IPO). The company hopes to raise $100 million.

August 31, 2018
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2 min read
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Mark Terry
Business

Eli Lilly Taps Anne White to Take Over Oncology Division

Eli Lilly Oncology will have a new president at the helm of the division. Industry veteran Anne White has been tapped to lead the division beginning Sept. 1. She replaced Sue Mahoney whose last day with the company is today.

August 31, 2018
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2 min read
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Alex Keown
Drug Development

AstraZeneca’s Lupus Drug Flunks Phase III Clinical Trial

AstraZeneca and MedImmune announced top-line results from its TULIP 1 Phase III clinical trial of anifrolumab in adults with moderate-to-severe systemic lupus erythematosus (SLE). Unfortunately, the drug didn’t meet the trials primary endpoint of statistically-significant reduction in disease activity.

August 31, 2018
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2 min read
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Mark Terry
FDA

FDA Approves Eight Novel Drugs in August

The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.

August 31, 2018
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3 min read
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Alex Keown
Drug Development

Researchers Use CRISPR to Treat Duchenne Muscular Dystrophy in Dogs

Researchers at the University of Texas Southwestern Medical Center used CRISPR gene editing to treat Duchenne muscular dystrophy (DMD) in dogs. Their work was published in the journal Science.

August 31, 2018
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3 min read
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Mark Terry
Business

EMD Serono Taps Rehan Verjee as New President

EMD Serono is shaking up its leadership. The biopharmaceutical arm of Germany-based Merck KGaA named Rehan Verjee as the new president of EMD Serono and global head of innovative medicine franchises at the parent company.

August 31, 2018
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2 min read
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Alex Keown
Business

Aflac Announces Formation of Advisory Council for the Aflac Childhood Cancer Campaign

Aflac, the leader in voluntary insurance sales at the worksite in the United States, today announced the creation of an advisory council of highly respected authorities in childhood cancer and related fields, as well as individuals directly impacted by pediatric cancer.

August 31, 2018
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4 min read
Deals

Access Healthcare acquires revenue cycle services provider Pacific BPO

Access Healthcare, a leading provider of healthcare business process outsourcing services, announced that it has acquired Pacific BPO, a premier provider of revenue cycle management services.

August 31, 2018
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4 min read
Business

Amneal Announces Partnership with American Regent on Generic Makena® and Progress on its Business Plan with Additional ANDA Approvals and Launches

Amneal Pharmaceuticals, Inc. today announced a 5-year supply and distribution agreement with American Regent for the only preservative-free generic alternative to Makena®

August 31, 2018
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9 min read