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Rani Therapeutics, Novartis partner to test oral biotherapeutics drug delivery platform By PBR Staff Writer
Rani Therapeutics announced that it has entered into a collaboration with Novartis to evaluate Rani's novel oral biotherapeutics drug delivery platform.
Drug Research > Drug Delivery > News
Oramed submits protocol to FDA for Phase IIb Oral Insulin Study By PBR Staff Writer
Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that it has submitted the study protocol for the company’s Phase IIb trial of ORMD-0801, its oral insulin capsule, to the US Food and Drug Administration (FDA).
Drug Research > Drug Delivery > News Boehringer's Stiolto Respimat gets FDA approval for COPD treatment By PBR Staff Writer
Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for once-daily Stiolto Respimat inhalation spray, as a long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Drug Research > Drug Delivery > News
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Omeros' Omidria gets EMA committee positive opinion for cataract and IOL procedures
By PBR Staff Writer
US-based biopharmaceutical firm Omeros has received positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) for Omidria (phenylephrine and ketorolac injection) 1%/0.3%, for use during cataract surgery and other intraocular lens (IOL) replacement procedures.
Drug Research > Drug Delivery > News
Janssen psoriasis drug Stelara gets CHMP positive opinion to treat adolescents
By PBR Staff Writer
Janssen-Cilag International (Janssen) has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of Stelara (ustekinumab) to treat moderate to severe plaque psoriasis in adolescent patients.
Drug Research > Drug Delivery > News
EMA committee issues positive opinion for Merck's Keytruda to treat advanced melanoma
By PBR Staff Writer
Merck has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Keytruda (pembrolizumab), an anti-PD-1 therapy to treat advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients.
Drug Research > Drug Delivery > News
GSK seeks Japanese approval for eosinophilic asthma drug mepolizumab
By PBR Staff Writer
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for mepolizumab, an anti IL-5 monoclonal antibody, as an add-on maintenance treatment for patients with severe eosinophilic asthma who experience exacerbations on standard treatment.
Drug Research > Drug Delivery > News
Vical completes enrollment in Phase II trial of investigational CMV vaccine
Vical Incorporated announced the completion of enrollment in a Phase II trial of its therapeutic cytomegalovirus (CMV) vaccine in solid organ transplant recipients.
Drug Research > Drug Delivery > News
ImmunoClin to offer CRO Services for Part II of Phase I crotoxin trial for Celtic Biotech
By PBR Staff Writer
Spotlight Innovation has selected ImmunoClin to act as its contract research organization (CRO) for its subsidiary Celtic Biotech Iowa's Part II of its Phase I clinical trial, Crotoxin to treat patients with advanced cancer using an intravenous route of administration.
Drug Research > Drug Delivery > News
Discovery Labs begins patient enrollment in Phase IIa dose expansion trial of Aerosurf
By PBR Staff Writer
US-based biotechnology firm Discovery Laboratories has started enrolment in the next phase of its Phase IIa clinical trial of Aerosurf, an investigational drug/device product developed to treat premature infants with respiratory distress syndrome (RDS).
Drug Research > Drug Delivery > News
Alcyone Lifesciences, DNAtrix enter clinical collaboration for brain cancer
Alcyone Lifesciences, a leader in neural intervention systems for neurological conditions and targeted drug delivery, and DNAtrix, a privately held biotechnology company and a leader in oncolytic virus therapy, have entered into an exclusive clinical collaboration.
Drug Research > Drug Delivery > News
Takeda to distribute Kaketsuken's seasonal influenza vaccine in Japan
By PBR Staff Writer
Japan-based Takeda Pharmaceutical has entered into an agreement for the distribution of Chemo-Sero-Therapeutic Research Institute's (Kaketsuken) seasonal influenza vaccine (Influenza HA Vaccine 'Kaketsuken') in Japan.
Drug Research > Drug Delivery > News
Designing Wellness for Fun and Satisfaction: Gummies - Based Nutrition
| By Softigel pbr
The gummy delivery form for vitamins, minerals and supplements is the single-largest source of growth among the supplements category. Vitamin users report preference for gummy/soft chewable products because these offer not only pleasure and a fun experience, but efficacy and convenience. The selection of materials during the design process of the formula is critical for the final product in order to meet the expectations of the consumers, which is to find a healthy product that will give them a delicious reward as well. Based on the design and development process, this paper reviews review in detail the stage of selection of materials and validation as a critical phase to obtain a product that represents quality and stability as well as the specific requirements of the costumers and the consumers.
Drug Research > Drug Delivery > White Papers
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