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FeedNavigator (EU) 11/13/2019 15:47
Background Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed. Methods A total of 79 eligible subjects (18–65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin
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In addition, the MAH took the opportunity to update the warning on lactose in accordance with the European Commission (EC) guideline on ‘excipients in the labelling and package leaflet of medicinal products for human use’.
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Seeking Alpha 11/12/2019 21:30
Opiant Pharmaceuticals, Inc. (NASDAQ:OPNT) Q3 2019 Earnings Conference Call November 12, 2019, 04:30 PM ET Company Participants Rahsaan Thompson - General Couns.
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Business Wire 11/12/2019 16:05
Revance’s lead product candidate, DaxibotulinumtoxinA for Injection (DAXI), combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.
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PR Newswire 11/12/2019 16:01
SAN FRANCISCO, Nov. 12, 2019 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the third quarter ended September 30, 2019 and provided updates on...
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Nutritional Outlook 11/12/2019 12:18
Pierce says that Ribus offers a “near complete” line of excipients “that offer clean-label alternatives to the industry standards like magnesium stearate (lubricant), silicon dioxide (flow agent), hydroxypropyl cellulose/HPC (binder), and others.
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Taltz demonstrated sustained effect when compared to Humira through 52 weeks in patients with active psoriatic arthritis. INDIANAPOLIS, Nov. 12, 2019 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE: LLY) announced today the 52-w...
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Updated Date: Tue, 12 Nov 2019 00:00:00 EST.
More from National Library of Medicine - DailyMed Drug Label Updates (NLM): 11/11/2019 16:31
Discussion Genotoxic impurities can occur in drug products based on the manufacturing of the API, degradation of the API, or in some cases, from the excipients (9.
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GlobeNewswire 11/11/2019 07:00
Contraindications to Galafold include hypersensitivity to the active substance or to any of the excipients listed in the PRESCRIBING INFORMATION.
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Task Description Request Please post to the 2019 Pharmacy Inspections and Related Records Web page. Record Date 08/20/2019. Short Title (70 char) Northern Light Pharmacy Amended 483 Issued 08/20/2019. FEI Number 3002159099. Firm Name M Drug, LLC dba Northern Light Pharmacy. Record Type Amended.
More from U.S. Food & Drug Administration (FDA): 11/05/2019 08:03
Conditions : Breast Cancer; HER2 Positive; Combination Chemotherapy Interventions : Drug: Pyrotinib Maleate Tablets; Drug: Albumin Paclitaxel; Drug: Trastuzumab Sponsors : West China Hospital; Jiangsu HengRui Medicine Co., Ltd. Recruiting.
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NutritionInsight 11/04/2019 19:00
Currently, IMCoPharma’s active pharmaceutical ingredients, excipients and final dosage forms are made by various European pharmaceutical manufacturers.
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