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May 11, 2017
Shadowed by nearly $30B in debt, Valeant's $50M guidance raise looks pretty paltry Faced with a crippling pile of debt, Valeant on Tuesday slightly increased its 2017 earnings guidance, one small positive development as it works to rebound from its noted downfall. The Canadian drugmaker reported first-quarter reven...
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May 09, 2017
Lilly moves forward with biologics plant expansion in Ireland Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. The construction might begin in coming months and commissioning will begin in 2019. The expansion is expected to add...
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May 02, 2017
FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinas...
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Apr 25, 2017
Samsung biosim nod sets J&J's Remicade up for tough fight Samsung Bioepis won FDA approval late Friday for its Remicade substitute, Renflexis (infliximab-abda), becoming the the second biosimilar to threaten that brand in the U.S. Not an unexpected event, and the launch isn’t expected until October because of bi...
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Apr 12, 2017
Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical ...
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Apr 07, 2017
Hemophilia is the most common inherited bleeding disorder which leads to spontaneous bleeding as the blood does not clot properly. Hemophilia, characterized by the spontaneous bleeding and swollen joints due to bleeding into the joints, is of several different types- such as Hemophilia A, Hemophilia B, and...
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Apr 06, 2017
Valeant's asset-sale woes continue as Stada, Mundipharma lowball iNova bids Embattled Valeant has promised its investors $8 billion in asset sales—but as the company’s latest deal struggles continue to demonstrate, getting there may not be so easy. The bids rolling in for Valeant’s Australian iNova subsidiary aren’t...
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Apr 04, 2017
Biogen triumphs in latest Tecfidera patent dispute Biogen has prevailed in a patent squabble with Denmark’s Forward Pharma over multiple sclerosis med Tecfidera—but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward cou...
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Mar 30, 2017
Mylan closing Illinois plant, cutting 90 jobs as part of slim-down after Meda buyout Mylan has been in the midst of cutting about 3,500 jobs to decrease costs and refocus after its $7 billion buyout last year of Meda Pharmaceuticals. About 90 of those cuts will come with the closure of a plant in Illinois.The drugma...
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Mar 28, 2017
Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...
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Roche’s HER2-Positive Breast Cancer Treatment Franchise
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Transforming Multiple Myeloma Treatment: The Promise of Novel Drug Classes
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