BioSpace News Archive

FDA

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA

For LENVIMA plus KEYTRUDA Combination Treatment as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment

July 23, 2019
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4 min read
Drug Development

ViiV’s Investigational HIV Drug Finds Success in Hard-to-Treat Patient Population

At 96 weeks, 60% of the heavily pretreated HIV patients dosed with ViiV’s experimental treatment achieved virologic suppression.

July 23, 2019
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3 min read
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Alex Keown
Drug Development

Myovant to Seek FDA Approval for Uterine Fibroid Treatment Following Successful Trial

With the positive results from this trial, as well as an earlier Phase III trial, Myovant Sciences plans to seek regulatory approval later this year.

July 23, 2019
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3 min read
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Alex Keown
Business

Civica Rx Inks 5-Year Generic Drug Deal with Hikma Pharmaceuticals

Today, Civica Rx announced a five-year deal with London, UK-based Hikma Pharmaceuticals to manufacture and supply Civica’s members with 14 sterile injectable drugs as a private label distributor.

July 23, 2019
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2 min read
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Mark Terry
Drug Development

Acadia’s Nuplazid Fails to Prove Effectiveness in Schizophrenia Trial

In the trial, 396 patients with moderate-to-severe psychotic symptoms related to adult schizophrenia received either Nuplazid or placebo added to their current antipsychotic treatment. The patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical significance on the primary endpoint.

July 23, 2019
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3 min read
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Mark Terry
Research Shows Exosomes Potentially Capable of Repairing Damaged Brain Cells

Research recently published by researchers from The Scripps Research Institute in the Proceedings of the National Academy of Sciences found that exosomes play an integral role in the development of neurons and neural circuits. In addition, they are able to fix brain cells damaged by developmental disease.

July 23, 2019
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2 min read
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Mark Terry
Business

Sanofi Strikes Deal for U.S. Over-the-Counter Rights to Roche’s Tamiflu

Sanofi will be responsible for leading the clinical program and funding all studies needed to support the over-the-counter switch in the United States and will also be responsible for the regulatory submissions.

July 23, 2019
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2 min read
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Alex Keown
Excellent Preclinical Efficacy Data of Apogenix’ HERA-GITRL Published in Journal for ImmunoTherapy of Cancer

HERA-GITRL Shows Strong Single-Agent Anti-Tumor Activity in Vitro and in Vivo and is Superior to Bivalent Clinical Benchmark Antibody

July 23, 2019
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4 min read
Business

Opiant Pharmaceuticals Expands Partnership with Sanofi, Signs Agreement for Manufacturing OPNT004 for Treatment of Acute Cannabinoid Overdose

Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company developing medicines for addictions and drug overdose, announced that it has signed an agreement with Sanofi to manufacture Opiant’s investigational agent OPNTOO4 for the treatment of Acute Cannabinoid Overdose.

July 23, 2019
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3 min read
Dutch Hospital First to Use Multiple Myeloma Diagnostic Test

The academic hematology department of Erasmus Medical Center is globally the first hospital to offer every multiple myeloma patient an innovative diagnostic service that predicts the aggressiveness of the disease by measuring 92 genes in the cancer cells

July 23, 2019
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2 min read