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Monthly Archives: June 2015

Merck Announces Positive Late-Stage Results for its Biosimilar Versions of Enbrel and Remicade

Today, Merck and Samsung Bioepis Co. announced that their biosimilar versions of the blockbuster anti-inflammatory drugs Enbrel and Remicade met their primary endpoints in late-stage studies. The companies said that Phase III studies of SB4, an investigational biosimilar of Enbrel (etanercept), and SB2, an investigational biosimilar of Remicade (infliximab), met …

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BioMarin Files for Approval of its Duchenne Muscular Dystrophy Drug in Europe

BioMarin Pharmaceutical Inc. has filed for European approval of its investigational drug for a rare, genetic disorder that causes progressive muscle wasting. The company said that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for drisapersen, an investigational antisense oligonucleotide drug candidate for the …

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Ten Breakthrough Drugs will Cost the US Nearly $50 Billion Over Ten Years

There has been heavy debate over the high cost of prescription drugs, and an analysis by Avalere Health estimates that the federal government will spend nearly $50 billion over the next decade on ten breakthrough drugs. The US Food and Drug Administration’s (FDA) new Breakthrough Therapy program is designed to …

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Celgene Enters $105 Million Cancer Immunotherapy Collaboration with Lycera

Celgene has entered into a new cancer immunotherapy deal that could provide privately-held Lycera Corp. up to $105 million-plus. Lycera announced the formation of an exclusive global collaboration with Celgene to advance Lycera’s proprietary pipeline for cancer and immune-mediated diseases. Lycera said that Celgene will license its portfolio of RORgamma …

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Vertex and Parion Sciences Sign Up to $1.17 Billion Cystic Fibrosis Deal

Vertex Pharmaceuticals and Parion Sciences have teamed up to develop new drugs for treatment of cystic fibrosis (CF) and other pulmonary diseases. The companies have initiated a collaboration worth up to $1.17 billion, under which Vertex and Parion will work together to develop investigational epithelial sodium channel (ENaC) inhibitors for …

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Breakthrough Status Granted to Genzyme’s Rare Enzyme Replacement Drug

Genzyme, a Sanofi company, recently announced that its investigational enzyme-replacement therapy was granted Breakthrough Therapy designation from US health regulators. The company said that the agency granted the status to its olipudase alfa for the treatment of patients with nonneurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick …

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AbbVie to Use Halozyme’s Technology in New Collaboration and Licensing Agreement

Halozyme Therapeutics Inc. has entered a potential $1.19 billion collaboration and licensing agreement with AbbVie Inc. surrounding Halozyme’s drug-delivery technology. The company announced a global collaboration and license agreement with AbbVie to develop and commercialize products combining proprietary AbbVie compounds with Halozyme’s Enhanze platform, the company’s drug delivery platform based …

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Cardinal Health to Acquire Generics Distributor Harvard Drug Group

Dublin, Ohio-based Cardinal Health recently announced its plans to buy generic drug distributor, The Harvard Drug Group (THDG), for $1.115 billion. Cardinal Health said that it plans to acquire THDG, a distributor of generic pharmaceuticals, over-the-counter medications and related products to retail, institutional and alternate care customers, currently owned by …

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Staying With the Patient

Medication adherence issues account for a significant portion of avoidable health care costs each year, through drug waste, treatment failure, and medical complications. Identifying ways to improve adherence ripples out positively throughout the health care system – benefiting the patient, payers, and all other key players. The pharmacy model at …

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Brazil Approves Hospira’s Remsima, a Biosimilar Version of Remicade

The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country. Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by …

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