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CSL Behring’s Kcentra Shows Superiority to Plasma in Late-Stage Study

Results from CSL Behring’s late-stage study showing Kcentra’s superiority to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, warfarin) therapy in adult patients needing an urgent surgery or invasive procedure were published in The Lancet. CSL’s Kcentra is the first and …

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Respiratory Biotech Pulmatrix to Merge with Ruthigen

Respiratory biotech Pulmatrix announced an agreement to merge with publicly traded, biopharmaceutical company Ruthigen. The companies have entered into a definitive merger agreement, under which Pulmatrix will become a wholly-owned subsidiary of Ruthigen – which would take the Pulmatrix name and continue Pulmatrix’s work of advancing a new generation of …

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European Commission Approves Novartis’ Jakavi for Treatment of Patients with a Rare Blood Cancer

Today, Novartis announced that the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients with a rare blood cancer. The company said that the drug is now approved in Europe for the treatment of adults with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. …

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Biosimilars 20/20: A Market Analysis of the Growth and Implications of Biosimilars Over the Next Five Years

TAMPA, FL, March 16, 2015 — The biosimilars event of the year – Biosimilars 20/20 – is scheduled for June 3-4, 2015 at The Hub in Philadelphia, PA. The event promises to provide an in-depth look into the future of the biosimilars market and address challenges of implementation. Biosimilars 20/20 …

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Samsung Submits Application to the EMA for its Remicade Biosimilar Candidate, SB2

South Korea’s Samsung Bioepis Co., Ltd. recently announced that it has submitted a marketing authorization application (MAA) for SB2, its Remicade (infliximab) biosimilar candidate to European health regulators. The company said that it has submitted the MAA to the European Medicines Agency (EMA). The MAA for SB2 is the second …

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Valeant Raises its Offer to Acquire Salix

After Endo International offered a rival bid, Valeant Pharmaceuticals International announced that it has raised its offer for gastrointestinal drugmaker Salix Pharmaceuticals. The companies announced that they have entered into an amendment to their agreement and plan merger. Valeant has increased its offer price to acquire all the outstanding common …

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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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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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CMS Expands Telemedicine Services Coverage through New ACO Model

The Centers for Medicare & Medicaid Services (CMS) is launching a Next Generation Accountable Care Organization (ACO) Model of payment and care delivery, an initiative that will extend coverage for telemedicine services to millions of Medicare beneficiaries. Telemedicine is defined as clinicians encountering patients remotely in real time through audio …

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