Global News

Catalent Biologics, Zumutor collaborate to enhanced antibodies

Thursday, August 11, 2016

Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Zumutor Biologics, a developer of biosimilars, novel biobetters and New Biological Entities, have announced a successful research study, combining Catalent’s proprietary GPEx technology and Zumutor’s fucose knockout platform, to create new and more efficacious antibodies.

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FDA accepts grants Marathon’s Duchenne drug Deflazacort priority review

Thursday, August 11, 2016

Marathon Pharmaceuticals, a biopharmaceutical company developing treatments for rare diseases, has announced the New Drug Applications (NDA) for the investigational drug deflazacort have been accepted for filing and granted Priority Review by the FDA. The NDAs (one for immediate-release tablet formulations and one for an oral suspension formulation) request approval for deflazacort for the treatment of patients with Duchenne muscular dystrophy (DMD), the most common and most severe form of muscular dystrophy.

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Heron announces FDA approval of Sustol for chemotherapy-induced nausea

Thursday, August 11, 2016

Heron Therapeutics has announced that the FDA has approved SUSTOL (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

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AstraZeneca announces positive phase III SYMBICORT data

Thursday, August 11, 2016

AstraZeneca has announced positive top-line results from two international, multicenter studies in adult and pediatric patients with chronic obstructive pulmonary disease (COPD) and asthma, respectively, that showed SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol was well tolerated and achieved the primary endpoints in both studies.

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Certara updates PK/PD Phoenix Software

Wednesday, August 10, 2016

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced the launch of Phoenix 7.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation.

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