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Jul 11, 2017
Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had a...
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May 30, 2017
Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmak...
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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 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 21, 2017
Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics Novartis has been mining a pivotal study of Entresto, its heart-failure med, for more insights ever since it was first published in 2014. Now, a new analysis shows that Entresto beat an older med at reducing blood sugar levels in heart failure...
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Mar 14, 2017
Pfizer faces first 2017 patent loss as Pristiq generics arrive Pfizer faces a challenging year on the patent loss front, starting with the generics of its antidepressant Pristiq now hitting the market. Mylan today said it had launched its copycat of desvenlafaxine extended-release tablets, in 50 mg and 100 mg doses....
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Mar 02, 2017
Clinigen and Eisai partner to offer Halaven for metastatic breast cancer in South Africa Eisai has partnered with Clinigen Group to distribute Halaven (eribulin) in South Africa for the treatment of women with metastatic breast cancer. Discovered and developed by Eisai, Eribulin is a synthetic variant of microtubule...
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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
Jul 24, 2024
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