BioSpace News Archive

Drug Development

With FDA Target Action Date this Month for Zolgensma, AveXis Releases Even More Positive Data

SMA is a severe neuromuscular disease caused by a mutation in the SMN1 gene, which codes for SMN, a protein necessary for motor neuron function.

May 6, 2019
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3 min read
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Mark Terry
FDA

Pfizer’s Tafamidis Approved in First for Rare Heart Disease

The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.

May 6, 2019
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3 min read
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Alex Keown
FDA

Genentech’s Kadcyla Wins Second FDA Approval for HER2-Positive Breast Cancer

The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.

May 6, 2019
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2 min read
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Alex Keown
Adrenomed AG takes part in three upcoming conferences

Adrenomed AG, the vascular integrity company, announced its participation at three upcoming conferences in Europe and the USA.

May 6, 2019
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1 min read
Pharm Country

Biotech Support Group to exhibit at the 67th ASMS Conference on Mass Spectrometry & Allied Topics

Biotech Support Group will exhibit at the annual ASMS Conference, June 2-6, 2019 in Atlanta, GA.

May 6, 2019
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3 min read
Drug Development

Neurocrine’s Opicapone Plus Levodopa Improves Parkinson’s Symptoms

San Diego-based Neurocrine Biosciences presented data from two Phase III clinical trials of opicapone, a once-daily, oral catechol-O-methyltransferase (COMT) inhibitor for Parkinson’s disease.

May 6, 2019
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3 min read
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Mark Terry
Policy

Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review

Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver

May 6, 2019
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8 min read
Deals

Banco Sabadell Gives ADL Bionatur Solutions An Upside Potential Of 78%

Sales estimated to double in 2019 and exceed EUR 50 million

May 6, 2019
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2 min read
Drug Development

6 Companies Report Positive Data in Phase III Clinical Trials

Quite a few companies recently released results from late-stage clinical trials. Here’s a look at some of the top stories, from AveXis, Urovant, Lilly, and more.

May 6, 2019
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5 min read
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Mark Terry
Deals

Invitrocue Releases March 2019 Quarterly And Appoints New Advisor

Invitrocue Limited is pleased to provide its Appendix 4C cash flow statement for the quarter ended March 31, 2019 and to announce the appointment of Dr Sharifuddin Abdul Wahab as Global Insurance Advisor.

May 6, 2019
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1 min read