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Genentech gets FDA approval for Esbriet to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
Genentech, Roche's subsidiary, has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat patients with idiopathic pulmonary fibrosis (IPF).
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Infinity reports topline data from phase 2a exploratory study of duvelisib in asthma patients
Infinity Pharmaceuticals has announced encouraging topline data from its Phase 2a exploratory study of duvelisib (IPI-145), its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with mild, allergic asthma.
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Sucampo extends license, collaboration agreement with Takeda for Amitiza
By PBR Staff Writer
US-based Sucampo Pharmaceuticals has signed an amendment to the existing collaboration and license agreement with Takeda Pharmaceutical Company (Takeda) covering the US and Canada for Amitiza (lubiprostone).
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FDA grants priority review designation for Eisai's Lenvatinib to treat advanced thyroid cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Eisai's new drug application (NDA) and has granted Priority Review status for its in-house developed agent lenvatinib mesylate (lenvatinib) to treat progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC).
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Breckenridge launches Mefenamic acid 250mg capsules
By PBR Staff Writer
US-based Breckenridge Pharmaceutical has launched Mefenamic Acid 250mg Capsules after securing final approval for its abbreviated new drug application (ANDA) from the US Food and Drug Administration (FDA).
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Axxess Pharma launches new TapouT Turbo Blend protein powder
By PBR Staff Writer
Axxess Pharma through its subsidiary AllStar Health Brands has launched a new TapouT Turbo Blend Protein Powder.
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Encore Consumer Capital announces sale of Isopure to Glanbia
Encore Consumer Capital, a private equity firm that invests exclusively in leading consumer products companies, has completed the sale of The Isopure Company, to Glanbia, the Ireland-based global performance nutrition and ingredients company, for $153m.
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Macular Health announces release of MacuStrip
Macular Health, a recognized leader in the ophthalmic nutraceutical industry, is poised to introduce a breakthrough product to the marketplace: fast-dissolving, easy to use oral strips.
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MissionPoint Health Partners and Second Harvest Food Bank of middle tennessee create partnership
MissionPoint Health Partners, a subsidiary of Ascension Health, the nation’s largest non-profit healthcare system, has created a partnership with Second Harvest Food Bank of Middle Tennessee to study the impact of nutrition on the healthcare organization’s food-insecure patients with hypertension or congestive heart failure (CHF), officials announced.
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New Ebola cases may reach 10,000 per week by year end: WHO
By PBR Staff Writer
The World Health Organization (WHO) has reported that the number of people being infected with the deadly Ebola virus disease in West Africa could reach up to 10,000 a week by the end of the December.
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Vaxart’s tablet vaccine for H1N1 influenza generates protective immunity equivalent to injectable in Phase I clinical study
Vaxart, a privately held, clinical-stage company developing recombinant vaccines that are administered by tablet rather than by injection, has announced clinical results demonstrating that its H1N1 tablet vaccine generates protective immunity comparable to currently licensed influenza vaccines, as measured by hemagglutinin inhibition assay (HAI), the established correlate of protection.
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INC Research to perform FDA due diligence audit of regulatory documents for Provectus
Provectus Biopharmaceuticals, a development-stage oncology and dermatology biopharmaceutical company, has retained INC Research, a leading, global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.
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SELLAS selects PPD as strategic CRO partner to advance Zolpidem and WT1 cancer vaccine
SELLAS Life Sciences Group, a Swiss-based development-stage biopharmaceutical company, has signed a definitive master service agreement with Pharmaceutical Product Development (PPD), a leading global contract research organization (CRO), to advance and expand clinical and regulatory development across Sellas' portfolio of drugs and biologics.
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ViiV Healthcare secures Canadian approval for Triumeq to treat HIV-1
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured approval in Canada, for its Triumeq (dolutegravir 50mg, abacavir 600mg, and lamivudine 300mg) to treat patients with Human Immunodeficiency Virus (HIV-1) infection.
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Bristol-Myers, Pharmacyclics and Janssen collaborate for new non-hodgkin lymphoma drug
By PBR Staff Writer
Bristol-Myers Squibb (BMS), Pharmacyclics and Janssen Research & Development have entered into collaboration to conduct a Phase I/II clinical trial to evaluate the safety, tolerability and preliminary efficacy of the combination of Opdivo and Imbruvica in patients with non-Hodgkin lymphoma (NHL).
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