Specialty Pharmacy

Bristol-Myers Squibb’s Resubmitted Application for its Hepatitis C Drug Accepted by the FDA

The US Food and Drug Administration (FDA) has accepted for review Bristol-Myers Squibb’s (BMS) resubmitted application for its investigational hepatitis C drug. The company said that the agency accepted its New Drug Application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, for use in combination with Gilead’s sofosbuvir for …

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Baxter’s Investigational Hemophilia Drug Succeeds in Phase 3 Study

Today, Baxter International Inc. announced positive results from its late-stage trial evaluating its investigational treatment for patients with hemophilia A or B. The company said that its BAX 817, an investigational recombinant factor VIIa (rFVIIa), demonstrated positive safety and efficacy results in its Phase III clinical trial in patients with …

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FDNA to Launch Online Forum for the Genetics Expert Community

Pioneer in computer-aided dysmorphology analysis, FDNA, announced that it will launch an online forum for the genetics expert community for undiagnosed and challenging cases. The company said that it will unveil the “Unknown Forum” at the Annual Clinical Genetics Meeting ACMG 2015 in Salt Lake City, UT on March 26, …

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Study Finds An 80% Colorectal Cancer Screening Rate by 2018 Could Prevent 20,000 Deaths Per Year

Early detection of cancer is critical and can significantly improve survival for most cancer types. Therefore, it is important to utilize screening tools when available. A new study found that increasing colorectal cancer (CRC) screening rates to 80 percent by 2018 would prevent an additional 21,000 colorectal cancer deaths per …

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Neuralstem’s ALS Drug May be Effective for a Subset of Patients

Today, Neuralstem, Inc. announced top-line data from a mid-stage trial evaluating its investigational amyotrophic lateral sclerosis (ALS) treatment, saying that the drug met its primary safety endpoints. The company said that data from the Phase II trial of NSI-556 spinal cord-derived neural stem cells, under development for the treatment of …

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Genetic Test Maker 23andMe Hires Biotech Executive to Lead its Drug Development Effort

Google-backed genetic-testing company 23andMe is launching its own drug development unit, and bringing on former Genentech executive to become its chief scientist and lead the company’s research and development efforts. 23andMe has collected genetic information from more than 850,000 customers worldwide from its $99 DNA spit test and more than …

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Concordia Pays $1.2 Billion for Covis Pharma Assets

Rare disease specialist Concordia Healthcare Corp. recently announced that it will purchase assets of Covis Pharma’s pharma and injectables units for $1.2 billion in cash. Concordia said that it has entered into a definitive agreement to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and …

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Merck Serono Partners with Illumina to Develop a University NGS-Based Oncology Diagnostic

Illumina announced that it is partnering with Merck Serono to develop a universal oncology diagnostic that uses next-generation sequencing (NGS). The companies will collaborate to develop a universal NGS-based oncology diagnostic for clinical trials of targeted cancer therapies, with the goal of a more comprehensive tool for precision medicine. The …

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FDA Approves United Therapeutics’ Rare Pediatric Cancer Drug and Gives the Company a Priority Review Voucher

US health regulators approved the first drug to treat pediatric patients with high-risk neuroblastoma, a rare cancer that develops on immature nerve cells. United Therapeutics Corporation announced that the US Food and Drug Administration (FDA) has approved Unituxin (dinutuximab) Injection, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and …

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