BioSpace News Archive

Ultomiris has been approved by FDA for commerciali

Lynparza Hits the Mark Again in a Late-Stage Trial, This Time in Prostate Cancer

AstraZeneca and Merck plan on seeking regulatory approval for Lynparza as a treatment for a subset of prostate cancer patients based on the Phase III PROfound data.

August 7, 2019

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3 min read

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Alex Keown

“Biopsy Without a Knife": A New Cancer Imaging Technique

To identify tumors or to determine if they’re malignant, surgical biopsies or the use of imaging techniques that rely on contrast dyes, are most commonly used. Researchers have now developed a high-powered imaging technique that doesn’t use dyes.

August 7, 2019

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2 min read

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Mark Terry

Policy

FDA Says Some Preclinical Data was Manipulated for Novartis’ $2.1 Million Gene Therapy Drug

Despite the data concerns, the U.S. Food and Drug Administration said it believes the gene therapy should remain on the market. Novartis said it stands behind the safety and efficacy of the therapy.

August 7, 2019

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3 min read

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Alex Keown

Deals

Permira Snaps Up Cambrex in Deal Valued at $2.4 Billion

Permira initiated the transaction after Cambrex flexed its own M&A muscle and acquired Avista and Halo.

August 7, 2019

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2 min read

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Alex Keown

BioSpace Global Roundup, Aug. 8

Biopharma companies from across the globe share business and development updates.

August 7, 2019

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5 min read

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Alex Keown

Business

Retrophin Reports Second Quarter 2019 Financial Results

Retrophin, Inc. reported its second quarter 2019 financial results and provided a corporate update.

August 7, 2019

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15 min read

Deals

Sir Gregory Winter FRS to Chair Orion Biotechnology’s Scientific Advisory Board

Orion Biotechnology Canada Ltd. announced that Sir Gregory Winter FRS has agreed to chair the Orion Biotechnology Scientific Advisory Board (SAB).

August 7, 2019

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3 min read

Policy

MorphoSys Announces Intention to Submit Marketing Authorization Application for Tafasitamab to European Medicines Agency

MorphoSys AG announced its intention to submit a Marketing Authorization Application to the European Medicines Agency based on its phase 2 L-MIND study of tafasitamab and lenalidomide in relapsed or refractory diffuse large B cell lymphoma.

August 7, 2019

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4 min read

Deals

Pharma study: How mature processes only last until the next audit

Big Data falls short - the consulting company MAIN5 presents study “Pharma Insights 2019"

August 7, 2019

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3 min read

Deals

NOXXON Announces A Capital Increase Of €1 Million Through A Private Placement Of Shares Without Warrants

NOXXON Pharma N.V. announced that following discussions with investors it has received letters of intent and binding commitments for long-term investment of €1 million through a private placement plus additional commitment for a future private placement.

August 7, 2019

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3 min read